Amid continued recall concerns, devices from Medtronic and Baxter were recently assigned the most serious recall type be the FDA.
Medtronic has received U.S. FDA approval for its Harmony Transcatheter Pulmonary Valve, the first minimally invasive therapy created to treat patients with a specific type of congenital heart defect of the right ventricle.Read More
This recall, linked to two patient deaths, is the third in 12 months for Medtronic’s HeartWare HVAD ventricular assist device, reports MedTech Dive.Read More
The Carpediem Cardio-Renal Pediatric Dialysis Emergency Machine is intended to provide continuous renal replacement therapy to patients weighing between 2.5 and 10 kilograms.Read More
The U.S. government has issued an alert about vulnerabilities that could compromise the cybersecurity of a paired cardiac device.Read More
Medtronic plc announces the planned acquisition of Avenu Medical, a privately held medical device company based in San Juan Capistrano, Calif., focused on the minimally invasive creation of arteriovenous fistulae for patients with end-stage renal disease undergoing dialysis.Read More
The Department of Justice is looking into whether Medtronic’s acquisitions led to suppressed ventilator competition in the market.Read More