Outset Medical receives FDA warning letter, FTC critiques Medtronic in antitrust case

11/07/2023 10 min
Outset Medical receives FDA warning letter, FTC critiques Medtronic in antitrust case

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Episode Synopsis

The FDA clearance of Getinge's non-invasive mechanical ventilator showcases the ongoing efforts to develop advanced respiratory devices that can provide critical support to patients in need. Fast Five hosts Sean Whooley and Danielle Kirsh detail what the ventilator does and when patients can expect the ventilators to hit the market.

PainTEQ's successful fundraising round will expand the commercialization of its LinQ implantable sacroiliac (SI) joint stabilization system. Whooley explains the technology behind the device and the company's success in previous procedures using the device.

Chief financial officers play a crucial role in driving financial strategies, ensuring regulatory compliance, and supporting business growth and sustainability, and Fresenius Medical Care appointed a new one to its executive team. Hear how the appointee's career history supports their appointment and how optimistic executives are in today's episode. 

The U.S. Federal Trade Commission wants to have a say in Applied Medical Resources’ antitrust lawsuit against Medtronic. Whooley and Kirsh discuss the ongoing lawsuit, why Medtronic wants to dismiss the lawsuit and what the FTC has to say about it.

The decline in Outset Medical's stock following the receipt of an FDA warning letter demonstrates the impact that regulatory compliance and product quality have on investor confidence. The Fast Five hosts discuss the details in the warning letter and if it will affect Outset Medical's production of devices.

Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

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