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US FDA's Gottlieb Takes Digital Device Questions From Senators At Cures Hearing

 
• By David Filmore

The commissioner explained to senators he is trying to go beyond the 21st Century Cures Act to further encourage development of innovative digital devices.

US FDA Commissioner Scott Gottlieb emphasized to Senators Dec. 7 the agency's goal to "go beyond" health-software provisions in the 21st Century Cures Act to allow FDA to exclude from regulation most digital devices and clinical decision software. Gottlieb testified before the Senate Health, Education, Labor and Pensions (HELP) Committee on the same day the agency issued three guidance documents that build on its initiative to streamline digital-health oversight.

Portions of the Medical Electronic Data Technology Enhancement for Consumer's Health Act (MEDTECH Act), originally sponsored by Sens. Michael Bennet,...

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‘Eyes – A Window Into The Heart’: Retinal AI Tool Predicts Future Risk Of Heart Attack And Stroke

 
• By Natasha Barrow

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Digital Health Roundup: Autonomous Robots, Medtronic’s Surgeon School, Sleep & FDA Rules

 
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Whoops! FDA Says Company Marketed Unauthorized Device. The Company Says The FDA Is Wrong

 
• By Brian Bossetta

A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.

PFA Market Surges As UK NICE Opens Doors And US FDA Approves Boston, J&J Incremental Innovations

 
• By Natasha Barrow

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More from Medtech Insight

Digital Health Roundup: Autonomous Robots, Medtronic’s Surgeon School, Sleep & FDA Rules

 
• By Marion Webb, Brian Bossetta, Shubham Singh, and Natasha Barrow

In this week's Digital Health Roundup, Medtech Insight's team discusses progress on autonomous surgery, Medtronic's new partnership with IRCAD, FDA cybersecurity news, and C-suite interviews with OpenWater, Flow Neuroscience and EnsoData.

Whoops! FDA Says Company Marketed Unauthorized Device. The Company Says The FDA Is Wrong

 
• By Brian Bossetta

A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.

With CMS Coverage Established, Medtronic Looks To Next Steps For Renal Denervation

 
• By Elizabeth Orr

US Medicare has proposed national coverage of renal denervation for patients with uncontrolled hypertension. The treatment is seeing other advances as well, with Medtronic piloting a longer catheter and a multi-organ approach and a blood test to identify the best candidates fresh on the