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US Approvals Analysis: 2016 Another Record Year For FDA Novel Device Approvals

Executive Summary

The agency approved a total of 91 original PMAs, panel-track PMA supplements and de novo classifications in 2016, outpacing last year's record for approvals of novel devices or indications, according to Medtech Insight's Approvals Tracker. Medtronic topped both the novel device approvals and 510(k) clearance lists for the year. Roche, Abbott, Siemens and GE also showed strong approval and clearance counts.

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US Approvals Analysis: Original PMA Slowdown, De Novo Upswing Among Recent Trends

The volume of original PMAs coming to US FDA for review is down recently, while panel-track supplement, de novo and 510(k) volumes are up. October, meanwhile, was a relatively light month for novel device approvals, but better-than-average for 510(k) clearances.

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.

US Approvals Analysis: Abbott Leads Another Strong Month For Novel Approvals

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.

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