News & Press Releases

This New York Law Journal special section column discusses some of the lurking pitfalls when the relationship between the government and the private law firms on which the government relies becomes a little too close. The column is authored by Mintz Members David Siegal and Jason P.W. Halperin, both of whom are former federal prosecutors from the U.S. Attorney’s Office for the Southern District of New York. Associate Peter Mulcahy assisted in the preparation of the column.

This in-depth Washington Post piece looks at Apple’s latest venture into health care - a new Apple Watch technology to detect atrial fibrillation. The piece notes, however, that the technology is not intended for people who have atrial fibrillation. The Post delves into questions raised by the introduction of a mass-market monitoring tool for the heart. Bethany Hills, Member and Chair of Mintz's FDA practice, is among the industry sources quoted providing commentary in the piece.

Aaron Josephson, ML Strategies Senior Director who previously worked for the Food & Drug Administration (FDA), discusses the FDA's proposed rule on the de novo pathway. Aaron notes that this could provide necessary clarity for device manufacturers, modernize the 510(k) premarket notification process and help the FDA achieve the performance goals laid out by Congress.

ML Strategies Senior Director Aaron Josephson, a former FDA senior policy advisor, is quoted in this feature story that looks at claims made that the FDA's Medical Device Enforcement and Quality Report was released in an effort to silence criticism that the FDA does not take sufficient enforcement action when appropriate.

This article notes the pushback the Food & Drug Administration (FDA) and Commissioner Gottlieb are facing after introducing a new plan to overhaul FDA’s clearance process for certain low­ and moderate ­risk medical devices. Mintz Member and Chair of the FDA practice Bethany Hills is among the industry sources quoted providing commentary in the piece.

In an effort to modernize and tighten its medical device clearance process, the Food & Drug Administration (FDA) announced plans to publish the names of devices cleared using predicate devices that are 10 years and older. ML Strategies Senior Director Aaron Josephson, a former FDA Senior Policy Advisor, is among the industry sources quoted in the article providing commentary.