Medical Alley companies are innovation leaders, while OUS companies continue to gain ground in the US market; FDA approval times getting longer again.
Figure 1: Micra™
Transcatheter Pacing System
Cardiology dominated original PMAs in the first half of 2016, claiming 32% of approvals (6/19). Miniaturization, compatibility and reduced patient invasiveness were key drivers of the new devices. Medical Alley’s Medtronic and St. Jude Medical both had miniaturized leadless pacing systems under review at the FDA, with Medtronic gaining approval for the Micra™ Transcatheter Pacing System in Q2.
Boston Scientific scored two original PMA approvals in Q2 (MR compatible pacing system and the Blazer™ ablation catheter) while Sorin, CardioFocus and Rex Medical received approval for cardiac devices. St. Jude Medical added to its growing neuromodulation portfolio with the PMA approval of the Axium Neurostimulator System for chronic intractable pain.
510k clearances to US companies continued the steady and long term decline, down 4% from a year ago. Over the past 20 years, US company clearances are down 44%, from 2231 in the first half of 1996 to 1468 through the first half of 2016. Despite the continued drop in volume, the average time to achieve clearance is now the second longest on record (156 days), a 73% increase in time from the 20-year low achieved in 2005 (90 days).
PMA supplement approvals are up 13% from 2015 and 375% over the past 10 years, driven by dramatic increases in 30-day notifications (up 640% over same time period).
As the Medical Alley Association has reported, the US market is a key target of OUS companies and the competitive landscape continues to shift; OUS companies have now gained a record share of the 510k clearances.
With six consecutive quarters of declining US and increasing OUS clearances, OUS entities now claim 37% of all 510k clearances (up from the <20% consistent from 1996 – 2014). OUS success is driven by patient monitoring (67%), diagnostic imaging (58%) and Ob/Gyn (58%) technologies. US companies retained a leadership position in orthopedics (75%) and cardiology (75%), the top two clearance categories.
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See the Q2 2016 FDA Approvals Report