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 has also maintained its high priority focus on supporting innovation of new medical devices in the United States. As provided in the Report, according to CDRH...

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 peripheral neuropathy (DPN), in a January 24, 2022 press release. The approval grants patients suffering from DPN access to both...

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 David Bennett, was recovering and doing well three days after the procedure.  The surgical team continues to monitor Mr. Bennett’s condition. According...

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 GE Healthcare’s $3 billion ultrasound business from diagnostics into surgical and therapeutic interventions and adds to GE Healthcare’s capability in the...

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 a purchase price of ~$10.5 billion.  The deal had originally been announced by Baxter in September 2021. According to a statement on Baxter’s...

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 Pharma issued a voluntary recall for all drug products produced in its FDA-registered 503B outsourcing facility in Colchester, VT.  Edge stated that products...