Orchestra BioMed’s hypertension treatment is the latest medical device to earn the FDA’s breakthrough designation. Medtronic has a commercialization deal with the company for the device, which uses a pacing algorithm to actively lower blood pressure in people with pacemakers.
The agency decided to rescind a rule by the previous administration where Medicare would be required to cover breakthrough devices for up to four years after they receive FDA approval or clearance. CMS said it made the change to address safety concerns with the policy.
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The larger regulatory modernization efforts, which include updates to the 510(k) regulatory approval pathway and the DeNovo Clearance review process are part of the FDA's Medical Device Safety Action Plan.
Your browser does not support iframes. The Brookings Institution is holding a day-long series of broadcasted panel discussions on Breakthrough Designation with the FDA. It’s running from 9:15 a.m. to 4:30 p.m. EDT. It’ll talk about the criteria that qualifies companies in the biopharma industry for breakthrough therapy designation – a status launched in 2012 by […]