Medical Alley’s Medtronic, Boston Scientific and St. Jude Medical Secure Key US PMA Approvals
Medical Alley companies are innovation leaders, while OUS companies continue to gain ground in the US market; FDA approval times getting longer again.
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 2 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...
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