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December 18, 2024
BlinkLab Achieves Pivotal Step Towards FDA Approval for Autism Diagnostic App
BlinkLab Limited (ASX:BB1) (“BlinkLab”, or the “Company”), an innovative digital healthcare company is pleased to announce a positive outcome from its Pre-Submission meeting with the FDA yesterday. The FDA has confirmed the study design and data requirements in order to achieve 510(k) clearance and subsequently launch the diagnostic app in the U.S. The Company plans to complete both programs within 12-16 months after the necessary approvals and site engagements have been secured.
Highlights
- Positive outcome received from a Pre-Submission meeting with the U.S. Food and Drug Administration (“FDA”) regarding the regulatory pathway for BlinkLab Dx 1 diagnostic app.
- The FDA has confirmed the design for the BlinkLab Dx 1 registrational program, which will consist of an Initial Study Phase that then transitions into the Main Study. The Initial Phase will recruit up to 100 children with the main registrational study up to 1,000 subjects recruited from up to ten clinical sites.
- Several leading clinical sites across the U.S. have already been selected with ethics submission and site activation in process.
- The initial phase (of 100 children) will be used to:
- Familiarise the investigators and personnel at clinical sites.
- Train in-person and virtual recruitment strategies.
- Test the procedures of subjects screening and data collection.
- These steps are part of the Company’s strategy to de-risk the main FDA registrational study and to ensure the highest quality of the data collected and diagnostic accuracy of the BlinkLab App.
- FDA has confirmed the study protocol, statistical analysis plan, clinical endpoints and final data requirements to achieve 510(k) clearance for “BlinkLab Dx 1” as an aid in the diagnosis of autism.
U.S. FDA registrational study in Autism Underway
To support its FDA registration in the US, BlinkLab has initiated a large clinical study in children with autism. The goal of the study is to obtain FDA 510(k) clearance for BlinkLab Dx 1 to serve as a digital diagnostic aid for autism. BlinkLab has received positive feedback from the FDA on final clinical study design and data requirements in order to achieve FDA 510(k) clearance. Clinical site selection is in progress with ethics approvals and onboarding about to be complete for several sites.
The upcoming clinical program will consist of an Initial Study Phase that will precede the main registrational study. The Initial Study Phase will enrol 100 subjects with the main study continuing recruitment of up to 1,000 children with autism aged 2-11 years old. The FDA trial will involve leading clinical and research sites across the US, ensuring a diverse population of children in terms of race, ethnicity and gender. BlinkLab plans to complete both programs within 12-16 months after the necessary approvals and site engagements have been secured. This dual study approach ensures that clinical experts on sites as well as families participating in the study are fully trained and familiar with the BlinkLab Dx 1 diagnostic application and its functionalities.
Both phases of the study will incorporate a prospective, double-blinded, within-subject comparison design in order to establish BlinkLab’s diagnostic accuracy. This will involve comparing BlinkLab Dx 1 output to the DSM-5 based diagnostic standards. Following completion of the study, should data meet the accuracy outputs, BlinkLab will submit the study report and supporting documentation for FDA 510(k) clearance in order to gain access to the U.S. autism diagnostic market.
Brian Leedman, Chairman of BlinkLab commented on the milestone: “This pivotal outcome in our FDA regulatory study process marks a significant milestone in our achievements as a listed Company. With this guidance from the Pre-Submission Meeting, we are confident in our study design and ability to bring BlinkLab Dx1 to market. We look forward to updating the market in early 2025 as to our progress in site selection, recruitment and results of the initial study”.
Henk-Jan Boele, CEO BlinkLab, commented: "I am pleased that we had such a productive discussion with the FDA regarding our regulatory trial. Truly appreciate their support and alignment on addressing the unmet medical need. We look forward to collaborating closely with the FDA on advancing BlinkLab Dx 1."
Click here for the full ASX Release
This article includes content from Blinklab Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
BB1:AU
25 September 2024
BlinkLab Limited
Investor Insight
BlinkLab’s transformative AI-based healthcare technology is at the forefront of innovations in the global medical field that are quickly gaining traction among keen investors.
Overview
BlinkLab (ASX:BB1) offers a smartphone-based diagnostic platform that leverages computer vision, artificial intelligence (AI) and machine learning (ML). A company started by neuroscientists at Princeton University, Blinklab has developed its novel technology over several years, providing an app-enabled, smartphone-based diagnostic tool for evaluating children with neurodevelopmental conditions such as autism and ADHD.
The app turns a smartphone into a diagnostic tool that helps to conduct remote and rapid tests that can assist in diagnosing neurodevelopmental conditions. BlinkLab’s smartphone app provides a screening tool that can help with diagnoses much earlier than the age that children are typically assessed at present (approximately 5-6 years old). It is also a remote (i.e., accessible) and inexpensive means of beginning the assessment process, which can typically be very costly and take up to multiple years currently.
BlinkLab’s smartphone app facilitates early diagnosis, reduces costs, and improves accuracy.
BlinkLab’s smartphone-based technology, which uses AI and machine learning (ML), makes it attractive to investors. Like other industries, AI is becoming very popular in the healthcare sector. According to Statista, the AI healthcare market is expected to proliferate from $11 billion in 2021 to $187 billion in 2030. The increasing use of AI is driven by advanced ML algorithms, access to data, and use of 5G technology. AI and ML technologies can evaluate and analyze enormous volumes of data faster than humans.
Artificial intelligence, and particularly machine learning, has the potential to serve as the great equaliser for many behavioural healthcare concerns like autism. According to recent data, 97 percent of adults in the United States own a cellular device, and nine in ten own a smartphone. A 2022 Global State of Digital report by We Are Social shows 66.9 percent, or about 5.34 billion, of the world’s population are mobile users. As these percentages continue to rise and internet-powered devices become ubiquitous, access to digital health services can become democratised on a global scale. While autism spectrum disorder (ASD) services are currently restricted to relatively privileged populations, digital solutions powered by emerging data, science, and methodologies can make access to autism therapy more accessible.
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09 September
Nebius Shares Soar on US$17.4 Billion Microsoft AI Deal
Nebius Group (NASDAQ:NBIS) surged on Tuesday (September 9) after announcing a multibillion-dollar deal with Microsoft (NASDAQ:MSFT) to provide dedicated artificial intelligence (AI) infrastructure.
Valued at US$17.4 billion over five years and expandable to US$19.4 billion if demand increases, the arrangement will see Nebius supply Microsoft with computing capacity from a new data center under construction in Vineland, New Jersey.
The news sent Nebius shares up 43.3 percent to US$91.75, their highest level on record.
For Nebius, a spinout from Russian tech giant Yandex that has grown into a full-stack AI infrastructure provider, the agreement represents a milestone in its long-term expansion strategy.
“Nebius’s core AI cloud business, serving customers from AI startups to enterprises, is performing exceptionally well,” said Arkady Volozh, the company's founder and CEO, in a statement. “We have also said that, in addition to our core business, we expect to secure significant long-term committed contracts with leading AI labs and big tech companies. I’m happy to announce the first of these contracts, and I believe there are more to come."
Microsoft’s mounting need for external infrastructure comes as it outpaces its in-house capacity amid a broader surge in demand for generative AI services. The company, already a key backer of OpenAI, has struck similar agreements with CoreWeave (NASDAQ:CRWV) to secure high-performance computing resources.
By turning to firms like Nebius, Microsoft is looking to bridge shortages of the advanced graphics processing units (GPUs) needed to run large AI models. The company's Vineland facility, part of a wave of new greenfield projects, will provide the dedicated GPU clusters that Microsoft requires to scale its AI services. The arrangement will allow Microsoft to lock in additional computing power, while providing Nebius with long-term revenue visibility.
Beyond its cloud business, Nebius also operates or invests in related ventures, including autonomous driving technology developer Avride, edtech platform TripleTen and database company ClickHouse.
As mentioned, the scale of Nebius' Microsoft contract has immediately reshaped investor sentiment. Nebius shares, which have already more than doubled this year, gained nearly half their value in a single session.
The rally spilled over to CoreWeave, which has its own multibillion-dollar contract with Microsoft and OpenAI.
Analysts suggest that the Microsoft deal positions Nebius to attract additional marquee customers, including other hyperscalers and frontier AI labs, as the company ramps up its global footprint.
Currently, there are expectations that the company, once considered a niche spinoff, could become one of the central players in supplying infrastructure for the AI boom.
Deliveries to Microsoft are expected to begin later this year.
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Securities Disclosure: I, Giann Liguid, hold no direct investment interest in any company mentioned in this article.
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08 September
OpenAI Taps Broadcom to Build Custom AI Chips in Face of GPU Supply Concerns
OpenAI, the company behind ChatGPT, is reportedly set to begin large-scale production of its own artificial intelligence (AI) chips through a partnership with Broadcom (NASDAQ:AVGO).
Experts in the space see the move as a bid to cut reliance on chip giant NVIDIA (NASDAQ:NVDA) and ease the global shortage of processors driving platforms like ChatGPT.
The news came after Broadcom CEO Hock Tan told analysts in a September 4 call that the company had secured a fourth major customer that has committed to a US$10 billion order.
Tan said the deal would bring “immediate and fairly substantial demand” beginning next year. Although he did not name the customer, sources have since identified it as OpenAI. Both companies have declined to comment publicly.
OpenAI has long relied on NVIDIA's graphics processing units (GPUs) for its AI needs, but securing enough GPUs has become increasingly difficult as demand for large-scale computing surges.
OpenAI CEO Sam Altman has been blunt about the challenge. In February, he wrote on X: “It is a giant, expensive model. We really wanted to launch it to plus and pro at the same time, but we’ve been growing a lot and are out of GPUs.”
Altman added at the time that OpenAI was preparing to add “tens of thousands of GPUs next week … (hundreds of thousands coming soon, and I’m pretty sure y’all will use every one we can rack up).”
However, shortfalls have slowed the rollout of new models, including GPT-4.5 earlier this year, and have pushed OpenAI to explore alternatives. The Broadcom deal marks its clearest step yet in building in-house hardware.
Broadcom has been developing custom processors it calls XPUs, or accelerated processing units, which are designed for specific high-intensity applications such as AI training. A person close to the project told the Financial Times that the new chips are intended to serve OpenAI internally rather than be sold to outside customers.
The prospect of custom silicon entering the AI infrastructure market has lifted Broadcom, which has climbed more than 30 percent this year. After Tan’s announcement, shares rose nearly 11 percent in New York trading.
For OpenAI, the investment is both a hedge and a necessity. The company has been racing to scale up computing capacity as businesses and consumers adopt ChatGPT in greater numbers. Last month, Altman said OpenAI planned to double its compute fleet “over the next 5 months” to meet demand from its newest model, GPT-5.
Alongside the Broadcom chips, OpenAI has made other major moves as well: it has signed a multibillion-dollar data center contract with Oracle (NYSE:ORCL) in July, struck a smaller cloud deal with Alphabet's (NASDAQ:GOOGL) Google in June and announced its own data center initiative called Stargate at the beginning of the year.
The deal with Broadcom also comes as Altman has been working to frame OpenAI not only as a leader in cutting-edge research, but also as a driver of economic opportunity. In a message earlier this month, he said that while AI will be disruptive, it also has the potential to “unlock more opportunities for more people than any technology in history.”
He pointed to initiatives such as the OpenAI Academy and a new jobs platform designed to help workers and companies connect over AI skills, with the goal of certifying 10 million Americans in AI fluency by 2030.
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Securities Disclosure: I, Giann Liguid, hold no direct investment interest in any company mentioned in this article.
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04 September
10 Generative AI Stocks to Watch as ChatGPT Soars
The launch of OpenAI’s ChatGPT created a major buzz around artificial intelligence (AI) stocks.
ChatGPT is an AI chatbot software application that uses machine-learning techniques to emulate human-written conversations. This technology is called generative AI, and it's been making an impact on myriad industries, including marketing, security, healthcare, gaming, communication, customer service and software development.
The potential behind generative AI has been the primary driver behind a major stock rally that has helped the S&P 500 (INDEXSP:.INX) and Nasdaq Composite (INDEXNASDAQ:.IXIC) reach multiple new highs since 2023.
According to Fortune Business Insights, the generative AI market is expected to grow at a compound annual growth rate of 39.6 percent between 2024 and 2032 to reach an impressive US$967.65 billion.
Although investors can’t directly take a position in privately owned OpenAI, several technology stocks offer exposure to the expected growth in generative AI technology.
Below, the Investing News Network showcases 10 generative AI stocks that stand to benefit the most from the rise in advancements and adoption of AI chatbot technologies, plus seven smaller generative AI companies that may be perfectly positioned to profit from their advancements.
Data was gathered using TradingView’s stock screener. All market cap and share price data was current as of September 2, 2025.
Biggest generative AI stocks to watch
These 10 tech giants offer investors exposure to generative AI by offering their own chatbots and generative AI products, developing the hardware and software necessary for AI and integrating AI into their product.
1. NVIDIA (NASDAQ:NVDA)
Market cap: US$4.15 trillion
Current share price: US$170.74
NVIDIA is a pioneer and global leader in graphics processing unit (GPU) technology. The company designs the specialized chips used to train AI and machine-learning models.
While it has been well known in computer and gaming spaces for decades, NVIDIA's progress in the AI sector has been the biggest growth driver in recent years. The company currently holds the title of the world’s most valuable company, coming in ahead of rivals Microsoft, Apple and Alphabet.
NVIDIA's new Blackwell GPU architecture, now in full production, delivers a significant performance leap for AI workloads compared to its predecessor. A new Blackwell Ultra system is set to be released later in 2025.
Generative AI's explosive growth is driving the market for chips designed by companies like NVIDIA and Marvell Technology (NASDAQ:MRVL), as well as for memory chips from companies like Micron Technology (NASDAQ:MU), which are another important component to training generative AI systems.
2. Microsoft (NASDAQ:MSFT)
Market cap: US$3.75 trillion
Current share price: US$505.12
The technology behemoth Microsoft has invested US$13 billion in OpenAI throughout the years, and the company's current AI solutions, Bing AI and Copilot, are based on OpenAI's technology. Microsoft has also partnered with Palantir Technologies (NASDAQ:PLTR) to provide AI tools to US defense and intelligence agencies.
More recently, Microsoft's AI branch, dubbed MAI, has branched out. In August 2025, Microsoft officially launched its first proprietary foundation model, MAI-1-preview, for its Copilot assistance, as well as a new speech model, MAI-Voice-1, designed for efficient, real-time audio processing.
3. Apple (NASDAQ:AAPL)
Market cap: US$3.41 trillion
Current share price: US$220.72
Apple has been incorporating its version of AI, Apple Intelligence, into its iPhones, MacBooks and Apple Watches. Its next major product reveal is scheduled for September 9, 2025.
The company's main goal is to deliver AI capabilities while maintaining user privacy by prioritizing on-device processing. For more complex tasks, it uses Private Cloud Compute, a secure system that runs on Apple's custom silicon chips and is designed to ensure data is not stored or made accessible to Apple.
Apple has partnered with OpenAI to integrate ChatGPT into its ecosystem. The upcoming iPhone 17 series is rumored to feature new AI-driven capabilities and enhanced integration of Apple Intelligence.
4. Alphabet (NASDAQ:GOOGL)
Market cap: US$2.56 trillion
Current share price: US$211.35
Alphabet, Google’s parent company, has played a key role in advancing generative AI. Its flagship AI model, Gemini, powers a wide range of services, with new versions continuously being rolled out. The company designs its own custom AI accelerator chips, like the TPU v5p, which are used to train large-scale language models and power its AI services.
Alphabet's subsidiary, DeepMind, focuses on AI research and development. Its AI system AlphaFold won the Nobel Prize in Chemistry in 2024 for its ability to predict the structure of proteins based on a protein's unique amino acid sequence.
AI continues to be embedded across Google's services as well. For example, AI Overviews displayed in Google Search results reach over two billion users per month as of mid-2025.
5. Amazon (NASDAQ:AMZN)
Market cap: US$2.40 trillion
Current share price: US$225.34
Amazon subsidiary and cloud-computing platform Amazon Web Services (AWS) evolved out of Amazon’s transition from an online retailer to one of the world’s largest technology companies. AWS’s wide range of services includes computing, storage, databases, networking, analytics, machine learning and AI.
AWS has many AI business tools on offer across four verticals: AI services, AI platforms, AI frameworks and AI infrastructure. Generative AI is nothing new to Amazon, as the technology forms the basis of conversational experiences with Amazon’s all-too-familiar Alexa.
Since its launch in 2023, Bedrock, a service that enhances software with generative AI capabilities, has expanded its catalog of foundation models to include OpenAI's open-weight models and Anthropic's Claude 4. At its AWS Summit in New York, the company announced Amazon Bedrock AgentCore, an innovation to help businesses rapidly deploy and scale AI agents with enterprise-grade security and tool integration.
6. Meta Platforms (NASDAQ:META)
Market cap: US$1.85 trillion
Current share price: US$735.11
Meta Platforms has expressed its commitment to continued research within the generative AI sphere with an open-source approach to its software developments. The giant behind Facebook, Instagram and WhatsApp is one of the most influential companies in tech, sharing ranks with the likes of Microsoft and Alphabet.
Meta AI, which is built with Meta Llama 3, is integrated into Meta's apps and also exists as a standalone website. The company's products use machine learning to streamline Facebook ad campaign generation and help businesses reach the right consumers. This strategy has led to Meta's ad business being a primary driver of revenue.
Meta CEO Mark Zuckerberg has maintained that increased spending on AI infrastructure is necessary to maintain its competitive position. The company has made massive infrastructure investments over the last year and has been aggressively hiring top-tier AI talent.
7. Oracle (NYSE:ORCL)
Market cap: US$632.83 billion
Current share price: US$225.30
Oracle is a tech company that's been around since the 1970s. In the early 2000s, it began buying up other software companies, and today it is one of the leading providers of cloud-based database management software. Its primary AI service, Oracle Cloud Infrastructure Generative AI, was released on January 23, 2024.
Oracle has positioned itself as a neutral platform, offering its customers a choice of top-tier models from various providers. It has recently expanded its offerings to include Google's Gemini models and has also deployed OpenAI's GPT-5 across its cloud applications and database portfolio.
Oracle maintains a longstanding partnership with NVIDIA, leveraging its hardware for large-scale AI workloads. This collaboration has culminated in the company building a zettascale supercomputer using as many as 131,072 NVIDIA Blackwell GPUs to tackle complex generative AI challenges.
8. Palantir Technologies (NASDAQ:PLTR)
Market cap: US$372.67 billion
Current share price: US$157.29
Palantir Technologies' generative AI strategy is centered on its AI Platform, a product designed to help governments and commercial enterprises integrate AI into their operations with a focus on security and human-in-the-loop control.
Rather than building models for general use, Palantir provides a platform that enables customers to leverage large language models from various providers, like OpenAI and Google, within their own private, secure networks.
9. Salesforce (NYSE:CRM)
Market cap: US$252.86 billion
Current share price: US$241.73
Salesforce is a global leader in cloud-based customer relationship management software.
In 2023, the company announced a strategy to embed generative AI across its entire product portfolio to transform how businesses interact with their customers.
In early 2025, Salesforce announced the retirement of its Einstein Copilot brand in favor of a new name, Agentforce, a fully autonomous AI agent that can handle complex, multi-step tasks across a company's sales, service and marketing operations. The company has reported that AI agents are handling up to 50 percent of customer support conversations, which has led to a significant workforce restructuring.
10. Cisco Systems (NASDAQ:CSCO)
Market cap: US$268.49 billion
Current share price: US$67.80
Multinational digital communications firm Cisco Systems is a leader in IT and communications networks.
Its strategy focuses on providing the hardware, software and security solutions enterprises need to build and deploy their own AI applications. The company has a large portfolio of multi-cloud products and applications, alongside strong relationships with Azure, AWS, NVIDIA and Google Cloud. Cisco’s AI and machine-learning offerings encompass a wide range of computing solutions for enterprises, including a focus on cybersecurity. Cisco has also brought to market new generative AI tools for IT professionals, including its own AI Assistant.
In January, the company introduced Cisco AI Defense, an end-to-end solution that protects against the misuse of AI tools, data leakage and sophisticated threats beyond the capabilities of older security systems.
Generative AI stocks to watch
The following companies have not yet reached the market capitalization of our top 10, but are each worth billions of dollars and have made some amazing achievements in generative AI technology in their own right, making them interesting prospects for investors.
In alphabetical order, they are:
- C3.ai, a company providing software as a service products to the financial and oil and gas industries. Its partnership with Alphabet allows C3.ai generative AI applications to be available on Google Cloud.
- CrowdStrike (NASDAQ:CRWD), a cybersecurity provider that monitors and analyzes Internet activity, detecting threats and blocking attacks with its generative AI-powered security analysis software, Charlotte AI. This service is available to every Falcon user and provides real-time feedback on a company’s risk landscape.
- Dell Technologies (NYSE:DELL), a supplier of crucial high-performance computing hardware required to train and run generative AI models.
- DynaTrace, a data-analysis company that provides real-time feedback on IT infrastructure for various companies using its generative AI assistant, Davis.
- IBM (NYSE:IBM), a foundational US company that develops and trains its own proprietary generative AI models, such as the Granite family of large language models. Its strategy is built on the IBM watsonx platform, which is a comprehensive suite of AI tools and services.
- Juniper Networks (NYSE:JNPR), a company that develops and markets routers, switches, network management software, network security products and software-defined networking technology. In 2021, the company introduced AI services to its networking technology and in early 2024 the company unveiled the industry's first AI-Native Networking Platform.
- SAP (NYSE:SAP), a software company out of Germany with a line of generative AI products, including its Joule AI agent, that aid companies in resource planning. The company has been collaborating with UC Berkley's Sky Computing Lab to further research how cloud technology can support AI applications.
- UiPath (NYSE:PATH), a software company with roots in Romania and headquarters in New York. UiPath designs robotic process automation software to reduce or eliminate boring or repetitive tasks like data extraction and file management, saving companies in a wide range of industries hundreds of hours thanks to its AI and generative AI software.
FAQs for generative AI
What is generative AI?
Generative AI is an emerging AI technology based on deep learning models and algorithms that can generate text, images or sounds in response to prompts given by users.
What are generative AI examples?
Some of the most notable examples of generative AI are ChatGPT, DALL-E 2, Midjourney, Stable Diffusion, Gemini, Copilot and DeepSeek.
OpenAI's DALL-E 2 is an AI system that can create realistic images and art from a description in natural language. Similar to DALL-E 2, Midjourney generates images from prompts. Stable Diffusion is a latent text-to-image diffusion model capable of generating photo-realistic images given any text input. Microsoft's Copilot is a feature of the Bing search engine that leverages the same technology as ChatGPT.
What are the hottest generative AI startups?
According to technology and business magazine e-Week, in addition to ChatGPT creator OpenAI, some of the other leading generative AI startups include Hugging Face, Synthesis AI, Jasper and Cohere.
This is an updated version of an article first published by the Investing News Network in 2023.
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Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.
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04 September
RemSense Eyes More Strategic Partnerships for Global Growth
RemSense (ASX:REM) is looking to secure more strategic partnerships as the company eyes global expansion, according to CEO and Managing Director Warren Cook.
“We have a strong pipeline of services to deliver to our existing clients that's going to take us right up through to the end of the year and into the early new year. For our global growth, we see partnerships as a critical part of our strategy to give us scale and capacity to grow throughout other parts of the region,” Cook said in an interview with the Investing News Network.
RemSense’s 3D visualisation technology — called virtualplant — is used by some major companies, including Woodside Energy Group (ASX:WDS,NYSE:WDS) and Chevron (NYSE:CVX).
“(We’re) just growing globally, with projects in the US, Bangladesh and now our more recent one in Norway, and Newmont (TSX:NGT,NYSE:NEM,ASX:NEM), one of the largest gold companies in the world,” Cook said.
“Those are just the three tier ones, and then we've got other tier two, tier three customers who are very loyal to us, like Triangle Energy (ASX:TEG). We delivered services to the likes of BHP (ASX:BHP,NYSE:BHP,LSE:BHP), Rio Tinto (ASX:RIO,NYSE:RIO,LSE:RIO). So we're really putting a lot of effort into broadening our customer base, both in in tiers and globally.”
Watch the full interview with Warren Cook, CEO and managing director of RemSense, above.
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03 September
Canada's Stealthy AI Strategy: Why the Future is B2B, Not Just Chatbots
As global giants chase consumer-facing artificial intelligence (AI), Canada has adopted a different approach.
The northern nation has excelled in developing B2B AI solutions for enterprises, governments and research institutions. This discreet strategy aims to cultivate a trusted AI environment, fostering innovation and economic growth within Canada, while building a resilient ecosystem safeguarded from external influences.
While the spotlight often falls elsewhere, Canada’s AI strategy could present a unique opportunity for investors seeking long-term growth in the evolving AI landscape.
Understanding the two faces of AI
While public attention often gravitates toward chatbots and image generators, many of the most impactful AI innovations are systems that optimize supply chains, detect fraud in financial transactions or accelerate drug discovery.
Enterprise AI, as these systems are often referred to, offers solutions to complex challenges that are unique to large corporations, financial institutions and government entities.
A significant portion of Canada’s AI buildout has been focused on institutional or B2B use cases, even if business adoption has been slower compared to the US. The country’s AI approach involves an organized strategy largely guided by the government, conducive to creating AI products and services designed specifically for large organizations.
Canada's blueprint for AI adoption within federal departments is laid out in a report released earlier this year, which lists building a central AI capacity as the first of four key priority areas.
A related initiative, the Canadian Sovereign AI Compute Strategy, outlines how Canada will ensure it has the physical computing capacity to compete globally and maintain data sovereignty.
It includes a C$2 billion investment to build and provide access to domestic AI computing power and infrastructure. This initiative is a key focus for Evan Solomon, Canada's minister of AI and digital innovation.
Cohere, a privately owned leading Canadian AI company that specializes in enterprise-focused large language models, exemplifies the country’s strength in this space.
Cohere's B2B AI strategy takes off
Founded in 2019, Cohere has become a prime example of a successful B2B strategy. The company develops highly specialized, institutional AI solutions for industries like finance, healthcare and logistics.
Its focus on privacy and security enables it to serve large markets needing specialized and secure solutions, providing enterprise-grade large language models and tools for custom AI applications.
Underscoring its growing success, Cohere secured US$500 million in an August funding round led by Canadian funds Radical Ventures and Inovia Capital, bringing its valuation to US$6.8 billion. The company has formed working relationships with several tech industry giants, including Oracle (NYSE:ORCL) and SAP (NYSE:SAP), and has onboarded former executives from Uber Technologies (NYSE:UBER) and Meta Platforms (NASDAQ:META). Global consulting firm McKinsey also works with Cohere to help its clients integrate generative AI into their operations.
A key part of Cohere's work is Cohere North, an enterprise-ready AI platform that Dell Technologies (NYSE:DELL) began offering to its enterprise customers this past May as part of a complete AI package.
In the financial sector, Cohere and the Royal Bank of Canada (TSX:RY,NYSE:RY) have partnered to introduce North for Banking, a secure generative AI platform designed to enhance productivity and data security specifically within the financial services sector. A January press release emphasizes the goal of speeding generative AI solutions.
This summer, Cohere teamed up with Bell Canada (TSX:BCE,NYSE:BCE) to supply specialized AI models to government and enterprise customers, with Bell providing the infrastructure layer with its AI Fabric network of data centers.
BUZZ High Performance Computing, a subsidiary of Canadian digital infrastructure company Hive Digital Technologies (TSXV:HIVE,NASDAQ:HIVE), contributes to the Cohere-Bell endeavor by providing NVIDIA (NASDAQ:NVDA) GPU clusters as the foundational hardware layer for large-scale AI workloads.
Cohere has also received backing from the Canadian government, with Ottawa signing a memorandum of understanding (MOU) with the company to integrate AI into public services on August 19.
The non-binding agreement acknowledges the company’s public sector ambitions and the government's interest in leveraging AI for productivity and domestic sourcing.
According to Cohere co-founder and CEO Aidan Gomez, this MOU represents “the beginning, hopefully, of our technology being rolled out quite broadly within the Canadian government.”
Cohere struck a similar agreement with the UK government in June.
Government support for Canadian AI ventures
Canada's approach to AI is built on stable, institutional-grade solutions and is championed by the administration of Prime Minister Mark Carney, offering a nuanced and attractive proposition for discerning investors.
Focusing on the B2B market provides a foundation of stability, as it offers stable, predictable revenue through multimillion-dollar, long-term contracts and full-stack solutions that ensure customer loyalty and economic resilience.
Many investments also have government support, providing a somewhat “de-risked” play for investors.
The Carney administration has made public commitments to incorporate AI into the public sector, promised to provide tax incentives for companies and said it will slash regulatory red tape on AI infrastructure projects like data centers.
The Department of Finance has already introduced draft reforms to the Scientific Research and Experimental Development program that would extend refundable tax credits to Canadian public companies.
Finally, the strategy is buoyed by a robust domestic investment landscape.
Canadian investors have historically provided strong financial backing for homegrown AI startups. Firms like BDC Capital, Real Ventures and MaRS Investment Accelerator Fund have taken the lead in terms of deal count, demonstrating a strong, homegrown commitment to fostering the Canadian AI ecosystem from its earliest stages.
Canada's quiet AI leadership
Canada's stealthy AI strategy is cementing its role as a quiet yet formidable force in the global AI landscape.
Companies like Cohere, bolstered by initiatives such as AXL's initiative to launch 50 Canadian AI companies in the next five years, underscore a commitment to developing and retaining Canadian AI talent and intellectual property.
For discerning investors, this focus on stable, institutional solutions offers a significant and differentiated long-term growth story beyond the consumer AI buzz.
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Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.
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02 September
Syntheia Announces Closing of Private Placement
Syntheia Corp. (CSE: SYAI)(CSE: SYAI) (syntheia.ai) (the "Company"), is pleased to announce that further to its press release dated July 23, 2025, it has closed the first tranche of its non-brokered private placement financing for gross proceeds of $1,464,599.88 through the issuance of 12,204,999 units (each, a "Unit") at a price of $0.12 per Unit (the "Offering").
Each Unit is comprised of one common share in the capital of the Company (each, a "Common Share") and one Common Share purchase warrant (each, a "Warrant"). Each Warrant is exercisable to acquire one Common Share at a price of $0.16 until September 2, 2030 (the "Expiry Date"), subject to an accelerated expiry in the event the volume weighted average trading price of the Common Shares exceeds $0.20 for 20 consecutive trading days, the Company may, within 10 business days of the occurrence of such event, deliver a notice to the holders of the Warrants accelerating their Expiry Date to a date that is not less than 30 days following the date of such notice and the issuance of a press release by the Company announcing the acceleration notice (the "Accelerated Exercise Period"). Any unexercised Warrants shall automatically expire at the end of the Accelerated Exercise Period.
In connection with the Offering, the Company paid: (i) a cash commission of $37,488.00; and (ii) 312,400 finder's warrants (each, a "Finder's Warrant") to certain finders (the "Finders"). Each Finder's Warrant is exercisable to purchase one additional common share (each, a "Finder's Share") at a price of $0.16 per Finder's Share. The Finder's Warrants have the same terms as the Warrants issued under the Offering.
Gross proceeds raised from the Offering will be used for working capital, general corporate purposes, and to satisfy part of the purchase price for the asset acquisition as previously announced on July 4, 2025. All securities issued in connection with the Offering will be subject to a hold period of four months plus a day from the date of issuance and the resale rules of applicable securities legislation.
This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in the United States. The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act") or any state securities laws and may not be offered or sold within the United States or to U.S. Persons as defined under applicable United States securities laws unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.
About Syntheia
Syntheia Corp. is an early-stage artificial intelligence technology company, channeling its efforts into refining and expanding its proprietary, conversational AI-based platform (the "Syntheia AI Platform"). The Syntheia AI Platform represents the integration of natural language processing ("NLP") technology, enabling it to not only understand but also respond to human language with accuracy. The Syntheia AI Platform, a generative, AI-powered algorithm equipped with a human-like voice, boasts self-learning capabilities derived from NLP methodologies.
Currently in beta testing, the Syntheia AI Platform is crafted to offer a suite of automated solutions, particularly for retail-focused businesses where customer interaction and service are key to operations. At the heart of the Syntheia AI Platform is its use of AI to emulate human cognitive processes, combined with a sophisticated large language model, which is integral for interpreting and generating human-like language responses.
For further information, please contact:
Tony Di Benedetto
Chief Executive Officer
Tel: (416) 791-9399
Cautionary Statement
Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this news release.
This news release contains certain "forward-looking information" within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as "plan", "expect", "project", "intend", "believe", "anticipate", "estimate", "may", "will", "would", "potential", "proposed" and other similar words, or statements that certain events or conditions "may" or "will" occur. These statements are only predictions. Forward-looking information is based on the opinions and estimates of management at the date the information is provided, and is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking information. The Company undertakes no obligation to update forward-looking information if circumstances or management's estimates or opinions should change, unless required by law. The reader is cautioned not to place undue reliance on forward-looking information.
The securities of the Company have not been and will not be registered under the United States Securities Act of 1933, as amended and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirement. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.
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