Tag: digital health

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) has issued a comprehensive report highlighting critical vulnerabilities within the Medicare Advantage (MA) program, specifically regarding the oversight and screening of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) providers. According to the federal watchdog, the Centers for Medicare & Medicaid Services…

Zimmer Biomet Holdings, Inc., a global leader in musculoskeletal healthcare, has announced a proposal to further reduce the headcount at its manufacturing facility in Winterthur, Switzerland. This move marks the latest chapter in a multi-year effort to streamline the company’s global operations and transition production to more cost-effective regions. The proposal is part of a…

Beta Bionics, a medical technology leader in the field of automated insulin delivery (AID) systems, announced on Monday that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its first tubeless insulin delivery device, the Mint patch pump. This regulatory milestone marks a significant shift in the competitive landscape of…

In a definitive move to streamline its sprawling healthcare portfolio, Medtronic PLC has officially launched a share exchange offer that marks the final stage of the separation of its diabetes business, MiniMed. The procedural milestone, detailed in a regulatory filing on Monday, September 14, 2026, sets the stage for Medtronic to transition into a more…

The United States Food and Drug Administration (FDA) has fundamentally altered the landscape of medical device marketing submissions by shifting the focus from isolated validation testing to a comprehensive, process-oriented approach to usability engineering. Central to this transition is the FDA’s 2026 human factors content guidance, which is now formally integrated into the eSTAR v7.0…

Zimmer Biomet Holdings, Inc., a global leader in medical technology and musculoskeletal healthcare, has announced a significant restructuring of its executive leadership team as part of a broader strategy to streamline operations and accelerate its ongoing commercial transformation. Effective October 1, the company will promote three internal veterans to key presidential roles while simultaneously eliminating…

Axogen, a global leader in the development of innovative solutions for peripheral nerve repair and regeneration, has announced its definitive agreement to acquire the assets of BioCircuit Technologies, a medical device company focused on the development of sutureless nerve repair solutions. The centerpiece of the acquisition is NerveTape, a highly specialized, sutureless device designed to…

Boston Scientific has successfully restored its global manufacturing, order fulfillment, and shipping operations following a significant cybersecurity incident that paralyzed the company’s infrastructure for several weeks. In a formal statement released on Wednesday, the Marlborough, Massachusetts-based medical device giant confirmed that its distribution network is currently operating at or above normal capacity as it aggressively…

The Advanced Research Projects Agency for Health (ARPA-H), a federal agency within the U.S. Department of Health and Human Services (HHS), has officially launched a multi-institutional initiative to transform the management of chronic heart failure through the development of "agentic" artificial intelligence. By partnering with a consortium of technology firms and academic medical centers, including…

The Centers for Medicare and Medicaid Services (CMS) has officially finalized a landmark policy update that significantly expands Medicare coverage for Transcatheter Aortic Valve Replacement (TAVR) to include patients with severe aortic stenosis who do not yet exhibit outward symptoms. This regulatory shift, which aligns federal reimbursement policy with the latest clinical evidence and Food…