US Approvals Analysis: Strong Q3 For Metabolic-Disease Devices

Of the five original PMAs approved last month by US FDA, two target diabetes and one targets obesity. In addition, the agency granted a de novo classification to another obesity device. Overall, FDA had a productive third-quarter for approvals and clearances.

FDA approved background, 3D rendering, blue street sign

[Editors' noteFor sortable and searchable tables of all 2016 US and non-US approvals and clearances, check out our Approvals Tracker.]

Products addressing metabolic conditions attracted the most attention from US FDA's novel device approval pathways in September.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from R&D

More from Business

J&J Bets On Robotics, Cardiovascular To Grow Medtech As Tariff Hit Eases, US Manufacturing Grows

 
• By 

Worldwide medtech sales totaled $8.5bn in Q2, up 6.1%. Sales grew 8% in the US and 4.1% outside the US. Cardiovascular, surgery and vision were the primary growth drivers. Acquisitions and divestitures had net positive impact of 200 basis points, largely due to the acquisition of Shockwave Medical.

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

 

A deep-learning AI-based retinal image scanning tool can predict the risk of cardiovascular events over a 10-year period with 70% accuracy. The test is comparable to routine GP health checks, researchers from the University of Dundee have shown.

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

 
• By 

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