In this podcast, iRhythm CEO Mike Coyle discusses his decision to join the digital health leader in January. Coyle’s had to hit the ground running as iRhythm manages some challenging decisions from regional Medicare payors, but he also sees great opportunity for the company’s Zio platform across the healthcare spectrum. In this conversation, Coyle discusses […]
Medtronic
FDA approves Medtronic’s next-gen Pipeline Flex device with anti-clotting tech
Medtronic (NYSE:MDT) announced today that it received FDA approval for its Pipeline Flex embolization device with Shield Technology. Fridley, Minn.–based Medtronic’s Shield Technology is a proprietary platform designed to advance flow diversion therapy through a surface-modified implant device that demonstrates a reduction in material thrombogenicity — a reduction in the tendency of the surface treatment material […]
Medtronic touts 2-year study results for In.Pact AV drug-coated balloon
Medtronic (NYSE:MDT) today touted safety and effectiveness results from a 24-month study of its In.Pact AV drug-coated balloon. Fridley, Minn.-based Medtronic said in a news release that the data demonstrated that the In.Pact AV DCB is the first and only DCB to show sustained and superior effectiveness through two years compared to standard percutaneous transluminal angioplasty […]
Medtronic blood pump recall is serious
Medtronic (NYSE: MDT) is recalling a blood pump that can stop during cardiopulmonary bypass surgery due to electrical failure. The Bio-Console 560 extracorporeal blood pumping console is used to pump and return blood to a person during bypass, a procedure that temporarily takes over the function of the heart and lungs. The cardiopulmonary bypass procedure […]
9 medical devices you should keep an eye out for in 2021
The medical device industry weathered the COVID-19 pandemic well — and is now set to roll out a host of innovations in 2021. Economists generally expect the U.S. to see a boom as we emerge from the pandemic and resulting recession. Medtech companies appear set to ride the wave this year, with plans to seek approval or […]
Medtronic has another serious HVAD recall
The FDA is reporting 12 deaths related to a recall of Medtronic (NYSE:MDT) HeartWare Ventricular Assist Device controller ports. The recall — which Medtronic initiated on Feb. 26 and FDA designated as Class I — is related to 855 complaints and eight reports of injuries, according to the FDA. Medtronic said today that the FDA’s […]
Medtronic launches 7-day infusion set for diabetes in Europe
Medtronic (NYSE:MDT) announced today that it launched the Medtronic Extended infusion set for diabetes in select European countries. Fridley, Minn.–based Medtronic touts the Extended infusion set as the first and only infusion set that a diabetes patient can wear for up to seven days, as most typically infusion pumps that deliver insulin to the body require […]
Medtronic has a serious recall of ICDs and CRT-Ds
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 […]
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 […]