U.S. FDA Grants De Novo Clearance for First and Only Artificial Intelligence System for Colonoscopy; Medtronic Launches GI Genius Intelligent Endoscopy Module

- The GI Genius Module Assists Physicians in Detecting Pre-Cancerous Growths; Potentially Addressing 19 Million Colonoscopies Annually

- Transformative AI Colorectal Cancer Prevention   Platform Expands Medtronic Capabilities in Medical Technology Data Analytics and Insights

Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the U.S. Food and Drug Administration (FDA) granted de novo clearance for GI Genius™ intelligent endoscopy module in the United States . The GI Genius module is the first and only commercially available computer-aided detection (CADe) system using artificial intelligence (AI) to identify colorectal polyps. The module, compatible with any colonoscope video, provides physicians with a powerful new solution in the fight against colorectal cancer — the third most common form of cancer globally with 1.8 million new cases in 2018. 1

"More than 19 million screening colonoscopies are performed in the United States each year. A key factor in the prevention of colorectal cancer is the integration of leading-edge technologies into gastroenterology practices to increase detection rates," said Dr. James Weber , a gastroenterologist and chief executive officer of the GI Alliance. "Detection of adenomas during colonoscopy is an important quality metric. The addition of AI can increase the quality of colonoscopies, potentially improving diagnosis and outcomes for colon cancer patients."

"Colonoscopies allow highly skilled gastroenterologists to identify polyps and lesions that might develop into cancer. With GI Genius we can tap into the potential of artificial intelligence approaches to increase detection rates. This important new development helps us in our mission to detect colon cancer early and to improve patient outcomes," said Michael Sapienza , chief executive officer of the Colorectal Cancer Alliance.

The GI Genius module uses advanced AI to highlight the presence of precancerous lesions with a visual marker in real-time – serving as an ever vigilant second observer. It processes images using advanced algorithms that can identify and mark abnormalities consistent with polyps, including small flat polyps that might otherwise go undetected by the human eye. Studies have shown that having a second observer can increase polyp detection rates and every 1% increase in adenoma detection rate (ADR) reduces the risk of colorectal cancer by 3%. 2,3 Use of the GI Genius module has demonstrated a 14% absolute increase in ADR compared to colonoscopy alone for both flat (42% increase) and polyploid (36% increase) lesions, thus increasing accuracy and reducing the rise of interval cancers which can occur between colonoscopies. 4

"Medtronic is committed to preventing colorectal cancer and improving patient outcomes with disruptive technologies that aid screening, increase patient compliance, and improve treatment," said Giovanni Di Napoli , president of the Gastrointestinal business, which is part of the Medical Surgical Portfolio at Medtronic. "With FDA de novo clearance for the GI Genius and its AI capabilities, we expect to enhance and improve colonoscopies and polyp detection. By introducing AI technology into the colonoscopy market, we anticipate improving colonoscopy detection rates and reducing variability in patient outcomes."

Medtronic is the exclusive worldwide distributor of the GI Genius module, which was developed and is manufactured by Cosmo Pharmaceuticals. The GI Genius intelligent endoscopy module received de novo clearance from the U.S. FDA on April 9, 2021 . In addition to the United States , the GI Genius module is available in Europe and select markets in Asia , Australia and the Middle East .

About Medtronic
Medtronic plc ( www.medtronic.com ), headquartered in Dublin, Ireland , is among the world's largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

For detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events, please consult the device manual. For further information, contact your local Medtronic representative.

  1. Globocan. Estimated number of deaths in 2018 worldwide, both sexes, all ages. Globocan Cancer Data. Published 2018. Accessed Jan 2021 .
  2. Wang P, Berzin TM, Glissen Brown JR , et al. Gut 2019; 68:1813-1819.
  3. Corley DA, Jenson CD, Marks AR JR, et al. NEJM 2014;370:1298-306.
  4. Repici, A., Badalamenti, M., Maselli, R., et al. Gastroenterology 2020; doi: https://doi.org/10.1053/j.gastro.2020.04.062 .

Contacts:


John Jordan

Ryan Weispfenning

Public Relations

Investor Relations

+1-508-452-4891

+1-763-505-4626

The GI Genius™ intelligent endoscopy module works in real-time, automatically identifying and marking (with a green box) abnormalities consistent with colorectal polyps, including small flat polyps.

Medtronic plc (PRNewsfoto/Medtronic plc)

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/us-fda-grants-de-novo-clearance-for-first-and-only-artificial-intelligence-system-for-colonoscopy-medtronic-launches-gi-genius-intelligent-endoscopy-module-301266276.html

SOURCE Medtronic plc

Cision View original content to download multimedia: https://www.newswire.ca/en/releases/archive/April2021/12/c2450.html

News Provided by Canada Newswire via QuoteMedia

The Conversation (0)

Medtronic announces cash dividend for third quarter of fiscal year 2025

The board of directors of Medtronic plc (NYSE: MDT) on Thursday, December 5, 2024, approved the company's cash dividend for the third quarter of fiscal year 2025 of $0 .70 per ordinary share. This quarterly declaration is consistent with the dividend increase announcement made by the company in May 2024. Medtronic is a constituent of the S&P 500 Dividend Aristocrats index, having increased its annual dividend payment for the past 47 consecutive years. The dividend is payable on January 10, 2025 to shareholders of record at the close of business on December 27, 2024 .

About Medtronic
Bold thinking. Bolder actions. We are Medtronic . Medtronic plc , headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic , visit www.Medtronic.com and follow Medtronic on LinkedIn .

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Cardiex Limited (ASX:CDX)

Cardiex Limited


Keep reading...Show less

Global Medical Service Robotics Market Project to Exceed $20 Billion in 2024 with Additional Growth Expected

FN Media Group News Commentary - Innovations in robotics technology, including artificial intelligence machine learning, and sensor technology, are enhancing the capabilities of medical robots. These advancements enable more precise surgical procedures, improved rehabilitation processes, and efficient hospital logistics, thus attracting more healthcare facilities to adopt robotic solutions. The market is characterized by a moderate level of merger and acquisition (M&A) activity by the leading players. This is due to several factors, including the desire to expand the business to cater to the growing demand for medical service robots. A report from Grand View Research said that the global medical service robots market size was estimated at USD 20.59 billion in 2024 and is projected to grow at a CAGR of 16.5% from 2025 to 2030. It said: "The growth can be attributed to the introduction of technologically advanced robotic equipment in the healthcare sector and the rise in per capita healthcare spending. Continuous advancements in technology, such as robotic catheter control systems (CCS), data recorders, data analytics, remote navigation, motion sensors, 3D-Imaging, and HD surgical microscopic cameras, are projected to drive industry growth. Furthermore, the introduction of swarm robotics is opening new opportunities for industry. It is a new approach to coordinating multi-robotic systems through swarm intelligence." Active Tech Companies in the markets today include Jeffs' Brands Ltd (NASDAQ: JFBR), Serve Robotics Inc. (NASDAQ: SERV), Symbotic Inc. (NASDAQ: SYM), Microbot Medical Inc. (NASDAQ: MBOT), Medtronic plc (NYSE: MDT).

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Healing People and Planet: 3 Things You Need to Know About This Shared Innovation Challenge

By Ken Washington, Chief Technology and Innovation Officer, and Raman Venkatesh, Chief Sustainability Officer, Medtronic

When you think about healthcare technology, you may imagine the pacemaker assisting your dad's ailing heart, the sutures your child received after a bike accident, or the pulse oximeter placed on your finger during your annual physical exam. You probably don't think about the energy or resources required to manufacture those products, nor the resulting emissions and waste.

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Healing People and Planet: New Impact Report Outlines How Medtronic Is Shaping the Future of Health

Medtronic

Medtronic releases 2024 Impact Report highlighting success in healthcare equity with new data from the Healthy Neighbor program, in addition to community engagement and environmental sustainability progress

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×