Hardware Podcasts

Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape

Global Medical Device Podcast · 7 Jan 2021 · 44m · Episode 174

What this episode covers

Mike Drues, president of Vascular Sciences, argues that the FDA's current focus on 'locked algorithms' stifles true AI in medical devices, citing only 29 cleared products as evidence of regulatory hesitation. He proposes three pragmatic solutions to enable adaptive AI: pre-validating a range of dynamic changes, allowing software to recommend changes for manufacturer approval, and enabling devices to learn collectively from a 'herd' of similar units. Drues contends that these engineering challenges have significant precedent in traditional device development, such as catheter sizing, and urges the industry to lead the conversation on good machine learning practices rather than waiting for FDA guidance.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Vascular Sciences, Green Light Guru
Also
FDA, SAM D, 510 K, PMA

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