FDA Relies On Short-Term Data To Approve Medtronic's Recapturable TAVR System
The approval comes less than a week after FDA approved Edwards' Sapien 3 third-generation transcatheter aortic replacement valve. Both devices were approved based on short-term outcomes data instead of the two-year data FDA has required of TAVR systems in the past.
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OUS Approvals Analysis: Edwards, Medtronic, Ra Medical Headline A Very Slow Month For Non-US Approvals
Medical devices approved outside the US in October include Medtronic's CoreValve Evolut R, Edwards' Acumen Hypotension Probability Indicator, and two approvals – for two completely different indications – for Ra Medical Systems' excimer laser technology.
In other finding at odds with previous court decisions, federal judge says direct seller Neora doesn’t have an “agency relationship” to its independent sales representatives and isn’t responsible for ad claims they post.
Ruling in Texas federal court on FTC complaint against Neora could serve as instructions for agency on how not to prosecute pyramid scheme allegations and for direct sellers about operating businesses so regulators find no hint of sales associates’ compensation plans based more on recruiting additional participants than on selling products.