iRhythm FDA warning letter alleges violations & deaths, Shacey Petrovic joins Imperative Care board

08/06/2023 10 min
iRhythm FDA warning letter alleges violations & deaths, Shacey Petrovic joins Imperative Care board

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Episode Synopsis

The FDA clearance of Teleflex's Wattson temporary pacing guidewire represents an important milestone in cardiac care for the company. Fast Five hosts Danielle Kirsh and Sean Whooley explain how the technology works and what executives hope to achieve with the device. 

Inari Medical's launch of its RevCore and Triever16 Curve catheters marks a significant development in the field of endovascular care. These catheters offer advanced capabilities for the treatment of venous and arterial diseases, providing physicians with enhanced tools for precise and minimally invasive interventions. Whooley details what the catheters do and the reception the devices have had from doctors. 

Know Labs' non-invasive glucose monitoring prototype showcases the company's dedication to developing advanced technologies that improve the lives of individuals with diabetes. By offering a non-invasive glucose monitoring option, this device has the potential to enhance patient compliance, simplify self-care routines, and empower individuals with real-time glucose data. The Fast Five hosts discuss how the technology could be incorporated into everyday wearables. 

The appointment of former Insulet CEO Shacey Petrovic to the board of directors at Imperative Care highlights the valuable expertise and leadership she brings to the medical device industry. Hear more about the vast experience she brings to the company and how optimistic executives are.

The FDA warning letter addressed to iRhythm, outlining alleged violations and patient deaths, sheds light on the critical importance of adherence to regulatory standards and patient safety in the medical device industry. Whooley details all of the violations in the letter and iRhythm's response to the allegations.

Check out the show notes at MassDevice.com/podcast for insights into today's episode.

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