FDA has issued a Class I designation of a Medtronic (NYSE: MDT) recall involving 239,171 ICDs and CRT-Ds with potential battery life problems. The agency reported 444 complaints regarding the devices: Evera, Viva, Brava, Claria, Amplia, Compia, and Visia implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-Ds) distributed from Aug. 31, 2012, to May […]
Medtronic
AI-aided colon cancer tech gets FDA nod
Cosmo Pharmaceuticals announced today that it received marketing authorization for its GI Genius AI-based lesion detecting system. GI Genius is an intelligent endoscopy system that uses AI/machine learning to detect lesions in the colon such as polyps or suspected tumors in real-time during a colonoscopy, according to a news release. The device, which received FDA […]
MedTech 100 roundup: Industry roars back
In the blink of an eye, the medtech industry exited its spring slump and neared its all-time best performance levels. MassDevice‘s MedTech 100 Index offered signs of a rebound last week and has built on that momentum, registering a final tally of 109.39 points on April 9. That represents a 2.9% increase from the 106.26-point mark […]
Medtronic stent graft recall is serious
The FDA has deemed the recall of the Medtronic (NYSE:MDT) Valiant Navion thoracic stent graft system as Class I, the most serious kind. Medtronic’s Valiant Navion is designed to repair lesions of the descending thoracic aorta, using a long catheter to place the stent graft inside the aorta before it expands to fit within the aorta to […]
Medtronic commits to helping people of color with diabetes
Medtronic (NYSE:MDT) announced today that it entered multiple partnerships to improve health equity for people of color living with diabetes. Fridley, Minn.-based Medtronic committed investments in partnerships with the American Diabetes Association (ADA) and the T1D Exchange, along with additional research efforts, to better understand and address such disparities, according to a news release. The […]
Medtronic kicks off newly expanded R&D center in India
Medtronic (NYSE:MDT) today announced the inauguration of its newly expanded 150,000 ft2 Medtronic Engineering and Innovation Center (MEIC) in Hyderabad, India. The Fridley, Minn.–based medical device giant is spending $160 million over five years to turn Hyderabad into its largest R&D center outside the U.S. Medtronic expects the number of employees at the facility to […]
Medtronic can’t shake suit over FDA clearance of spinal devices
A federal appeals court has ruled that Medtronic must face a whistleblower lawsuit over FDA clearance of certain spinal fusion devices. The Dan Abrams Company sued Medtronic in 2015 claiming that Medtronic defrauded the FDA into granting 510(k) clearance to certain Verte-Stack cervical vertebral body replacement (VBR) devices used in spinal fusion surgeries. The lawsuit […]
MedTech 100 roundup: Heading back to previous heights?
Although March brought on tough times for top stocks in the medtech industry, April is already showing signs of a rebound. The year’s strong start, during which MassDevice‘s MedTech 100 index notched an all-time best of 110.96 points (Feb. 15) came to an end later that month and carried over into March, with the index hitting its lowest […]
DTW Podcast: Earnhardt shares how Abbott shifted gears to counter pandemic; Grail still looks to upend oncology
This week, we’ll talk with Abbott’s medical devices EVP Lisa Earnhardt about how the life sciences giant pivoted during the pandemic. Earnhardt shares what programs were given greater priority when the lockdown’s impact became clear and why the company performed so well in one of its key businesses. We also explore this week’s news that […]
4 innovative devices delivered through catheters
Physicians use catheters to deploy numerous life-saving devices across the healthcare realm, from cardiovascular to neurovascular. They typically insert the thin, flexible tubes in a process called catheterization to deploy devices such as left ventricular assist devices (LVADs), transcatheter aortic valve replacements (TAVRs) and occluders to stop bleeding. The catheter industry is regularly innovating to […]
Medtronic veteran Brooke Story to lead BD’s Integrated Diagnostic Solutions
Another Medtronic veteran is leaving the company to take on new challenges elsewhere, and this time it involves BD. Brooke Story will become worldwide president of BD Integrated Diagnostic Solutions, effective April 5. Story has been at Medtronic for 15 years, most recently serving as president of Pelvic Health and Gastric Therapies at the medtech […]
