Medtronic announces 510 clearance for PillCam Small Bowel 3 @HOME endoscopy procedure

Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its PillCam™ Small Bowel 3 system for remote endoscopy procedures. The PillCam™ SB3 @HOME program combines Medtronic's PillCam technology with Amazon logistics, a combination intended to ensure both timely and accurate results for patients from the comfort of their homes.

PillCam SB3 @HOME provides a telehealth option for direct visualization and monitoring of the small bowel, to help better detect lesions not detected by upper and lower endoscopy that may: 1) indicate Crohn's disease, 2) locate obscure bleeding, or 3) identify sources of iron deficiency anemia (IDA).

"As the future of medicine continues to move toward remote settings, we have great opportunity to deliver diagnostic testing and other minimally invasive procedures from patients' homes," said Giovanni Di Napoli , president of the Gastrointestinal business, which is part of the Medical Surgical Portfolio at Medtronic. "The pandemic necessitated more remote innovation, and our capabilities have exceeded expectations to provide better quality care to patients without the risk of COVID infection and without adding to the burden on the medical staff. PillCam SB3 @HOME offers a convenient option for a contactless procedure and helps ensure that patients can access care in a timely manner."

The system is designed to deliver images of the mucosa and offers innovative features, such as adaptive frame rate technology, to support image acquisition that is uniquely suited to each patient's motility, as well as the tools needed to record those images and allow the clinician to interpret study results. The software's advanced technology helps providers read and interpret study results, efficiently.

"Early diagnosis and treatment are key to achieving the best outcome for GI patients, and fortunately with telehealth options, patients can receive their GI diagnosis conveniently from home," said Dr. Michael Bass of GI Specialist of Delaware . "The COVID-19 pandemic has underscored the importance of early detection and not delaying care following the onset of symptoms. This system allows for patients to remain in the comfort and safety of their own home while giving providers access to the high-quality images needed to make a diagnosis."

PillCam Small Bowel 3 is only cleared for remote use in the U.S. It is not approved for this use in other geographies.

About PillCam™ SB3 @Home
Once a GI physician identifies a patient and places an order for a PillCam SB3 @HOME procedure kit, the procedure date is confirmed and the PillCam SB3 @HOME kit is delivered directly to the patient. Through a telehealth appointment, a healthcare provider guides the patient through the remote procedure, and the patient returns the data recorder and sensor belt to Medtronic once the procedure is complete. Over the course of the eight-hour procedure, the PillCam SB3 capsule transmits approximately 50,000 images. These images are securely transferred to the cloud where there are accessed by a GI physician who reviews the images to make a diagnosis.

Prior to the 510(k) clearance, PillCam SB3 @HOME was given temporary FDA-approval during the National Public Health Emergency. Medtronic's PillCam™ capsule endoscopy has been used for more than 20 years as a minimally invasive, patient-friendly option for the detection of gastrointestinal diseases. PillCam SB is now in its 3rd generation and has impacted more than 4 million patients worldwide.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, 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 90,000+ passionate people across 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 (NYSE:MDT), visit www.Medtronic.com and follow @Medtronic on Twitter and LinkedIn .

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.

Contacts:


Sabrina Zimring

Ryan Weispfenning

Public Relations

Investor Relations

+1-720-774-3454

+1-763-505-4626

(PRNewsfoto/Medtronic plc)

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-announces-510k-clearance-for-pillcam-small-bowel-3-home-endoscopy-procedure-301423726.html

SOURCE Medtronic plc

News Provided by PR 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

×