Dr. Jeff Shuren, FDA CDRH Director, to Retire
On July 23, 2024, Dr. Jeff Shuren, the director for the Center for Devices and Radiological Health (CDRH), announced that he will retire. Dr. Shuren became director of the CDRH...
Edwards Lifesciences to Acquire Innovalve
Edwards Lifesciences recently announced that it would acquire Innovalve Bio Medical, an early-stage transcatheter mitral valve replacement (“TMVR”) company. Edwards had the option to acquire Innovalve following an initial investment...
FTC’s Proposed Noncompete Ban in Doubt
On April 23, 2024, the United States Federal Trade Commission (“FTC”), via a 3-2 vote, issued a final rule, which, according to the FTC’s rule summary, provides a comprehensive ban...
Boston Scientific Agrees to Acquire Silk Road Medical in $1.16B Deal
Press releases report that Boston Scientific (BSX) has entered an agreement to acquire medical device developer Silk Road Medical in a deal totaling $1.16 billion. Silk Road Medical has reportedly...
Delaware Court Denies Preliminary Injunction Seeking To Block Liquidia’s YUTREPIA Launch
The United States District Court for the District of Delaware recently denied United Therapeutics Corporation‘s motion for a preliminary injunction. The motion sought to prevent Liquidia Technologies, Inc. from launching...
Becton, Dickinson and Company (BD) Announces Acquisition of Edwards Lifesciences’ Critical Care
BD (Becton, Dickinson and Company) has announced the acquisition of Edwards Lifesciences’ Critical Care product group for $4.2 billion. The acquisition follows Edwards’ previously announced plans to spin off Critical...
UK Proposes Approving Medical Devices Based on Approval in Other Countries
Device manufacturers may soon have access to a new framework for marketing and selling medical devices in the United Kingdom. On May 21, 2024, the UK Medicines and Healthcare products Regulatory...
Florida Man Makes Medical Device – A Survey of MedTech in the Sunshine State
Florida is more than just the home of alligators and presidential candidates. The state was recently ranked as the fourth largest “medical device state” in the U.S., after California, Minnesota,...
Quest to Collaborate with PathAI To increase Its AI Capabilities
Quest Diagnostics recently announced a multi-faceted collaboration with PathAI to improve diagnoses in cancer and other diseases using AI pathology innovations. Under a first agreement, Quest will acquire some of the...
FDA Clears Profound Medical’s AI Model for Treating Prostate Cancer
Profound Medical (Nasdaq: PROF) has received FDA 510(k) clearance for its second AI model aimed at treating prostate cancer. Profound Medical is a Toronto-based company, which specializes in developing and...
FDA Dataset Helps Firms Scrutinize Third-Party Chemistry Labs
Medical devices that contact the human body undergo biocompatibility safety assessments prior to market release, including tests for physiochemical properties. The Food and Drug Administration’s (FDA) Center for Devices and...
Johnson & Johnson to Acquire Shockwave Medical in $13.1B Deal
Johnson & Johnson (J&J) reported on April 5, 2024, that it has entered an agreement to acquire Shockwave Medical, a company in the cardiovascular medical device sector, in a deal...
