FDA: Approval for Novel Medical Devices Remains a High Priority, Despite COVID-19
According to the FDA’s Center for Devices and Radiological Health (CDRH) Annual Report, in addition to its significant efforts to fast track the approval of COVID-19 related devices, the CDRH...
Medtronic’s Intellis and Vanta Neurostimulators Receive FDA Approval for DPN
Medtronic announced that its Intellis™ neurostimulator and the Vanta™ neurostimulator have both received approval from the U.S. Food and Drug Administration (FDA) for the treatment of chronic pain associated with diabetic...
First-in-Human Porcine Heart Transplant Performed
Surgeons at the University of Maryland School of Medicine performed the first successful porcine (pig) to human heart transplant, a procedure referred to as “xenotransplantation.” The patient, 57 year old...
Acquisition of BK Medical Expands GE Healthcare’s Precision Health Presence
GE Healthcare announced on December 21, 2021, that it has completed the $1.45 billion acquisition of BK Medical from Altaris Capital Partners. According to the press release, the acquisition expands...
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FDA Issues Draft Guidance for Software Contained in Medical Devices
On November 3, 2021 the FDA issued draft guidance titled “Content of Premarket Submissions for Device Software Functions.”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...
