Baxter Completes $10B+ Acquisition of Hillrom
On December 13, Baxter International Inc. (“Baxter”) announced the completion of one of the biggest medtech acquisitions of 2021, acquiring Hillrom (a global medical equipment maker headquartered in Chicago) for...
Two Drugs Recalled Due to Manufacturing Issues
By Mark Rubinshtein (December 13, 2021) Two pharmaceutical companies have issued recalls in December due to manufacturing issues that may impact the safety and quality of their drug products. Edge...
FDA Breakthrough Device Designation for Biology-Guided Radiotherapy (“BgRT”) Device
On December 1, 2021, RefleXion Medical, Inc. (“RefleXion”), announced that the U.S. Food and Drug Administration (“FDA”) has granted the company breakthrough device designation for its biology-guided radiotherapy (“BgRT”) for...
Johnson & Johnson to Separate its Consumer Health Business
Johnson & Johnson announced on November 12, 2021, that it is planning to separate its Consumer Health Business and create a new publicly traded Consumer Health Company. The press release...
FDA Issues Draft Guidance for Software Contained in Medical Devices
On November 3, 2021 the FDA issued draft guidance titled “Content of Premarket Submissions for Device Software Functions.” The final version will eventually replace the FDA’s “Guidance for the Content...
Federal Circuit Reverses PTAB’s Invalidation of Patent Claims for an Artificial Heart Valve (Snyders vs St. Jude)
On October 5, 2021, the U.S. Federal Circuit reversed a finding of invalidity by the Patent Trial and Appeal Board (PTAB) for patent claims related to an “artificial valve for...
Bioventus’ Shareholders Approve Acquisition of Misonix
Bioventus recently announced that its shareholders approved its agreement to acquire Misonix. Bioventus agrees to pay Misonix shareholders either 1.6839 shares of Bioventus class A common stock or $28.00 for...
Best Buy to Acquire Remote Patient Monitoring Company Current Health
Best Buy Co., Inc. announced that it has agreed to acquire Current Health. The deal between the companies is expected to close by the end of Best Buy’s fiscal...
Alpha Tau Receives FDA Breakthrough Device Designation for Alpha DaRT Treatment of GBM
Alpha Tau Medical Ltd. (“Alpha Tau”) is a medical technology start-up focused on the research, development, and commercialization of its Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) treatment for solid cancerous...
NeoChord Announces Successful Completion of First-in-Human Procedure with its Mitral Chordal Repair Technology
NeoChord, Inc. (“NeoChord”) announced on October 4, 2021 that it successfully completed a first-in-human procedure with the NeXuS Transcatheter Mitral Chordal Repair (TMVr) device NeoChord is developing. NeoChord also reported...
Medical Device Company Pleads Guilty to Dealing in Non-FDA Approved Devices
The United States Department of Justice announced that medical device company Affordable Healthcare Solutions, LLC has pleaded guilty to charges related to unapproved prescription hyaluronic acid medical devices, as reported...
Boston Scientific To Acquire Blood Clot Removal Tech Company Devoro Medical
Boston Scientific Corp. has agreed to acquire Devoro Medical Inc. in a deal expected to close this year. Boston Scientific previously held a 16% equity stake in Devoro Medical and...
