Review Paradigm For Fractionated Lasers Earns FDAer An Award
This article was originally published in The Gray Sheet
Executive Summary
In 2004, Richard Felten, a senior device reviewer at FDA, encountered a device he had not seen before
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Cook Medical's Formula
Firm files a PMA application for its Formula balloon expandable stent for renal artery disease and expects approval next year. Announced Sept. 24, the submission includes data from the 100-patient REFORM clinical trial, which completed enrollment in June 2009 (1"The Gray Sheet" June 18, 2009). The device features a low-profile design and does not shorten upon expansion, the company claims
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.