US Approvals Analysis: Cook Churns Out 510(k)s In Q3
The privately held Indiana-based device firm has accelerated its 510(k)-clearance output this year, leading all firms with 19 in the third quarter, and pulling neck-and-neck with perennial leader Medtronic for 2017. Overall, FDA remains relatively steady on 510(k) volumes and is maintaining its accelerated pace of novel-device approvals.
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The likes of Apple, Samsung and FitBit join traditional medtech players Johnson & Johnson and Roche, along with digital-health startups in a new US FDA pilot program intended to define best-practice software design as a means to "pre-certify" companies and reduce pre-market requirements. FDA's Bakul Patel and the CEO of one pilot participant, Pear Therapeutics, weighs in.
Pear Therapeutics' reSET mobile application to treat substance addictions in combination with outpatient therapy programs has been approved by US FDA. The agency approved the software after a multi-site clinical trial showed patients were significantly more successful remaining abstinent after using the app.
Abbott Laboratories accounted for two of five original PMA approvals recorded by US FDA in August. That update and more from Medtech Insight's Approvals Tracker.