The U.S. FDA issued general correspondence letters to two device testing labs located in China. This is the latest in a series of moves by the agency to crack down on falsified or otherwise invalid device testing data.
The controversy over budget scoring by the Congressional Budget Office (CBO) once again prompted legislation that would overhaul the membership of a health advisory panel that may affect legislation dealing with the Medicare program. The Health Panel Act of 2025 requires the panel be composed of six members each appointed by Republicans and Democrats. The bill's sponsor said this is crucial to ensure diversity of political views, which is said to be lacking as the panel is currently constituted.
The U.S. Department of Justice arrested two men in connection with fraudulently billing the Medicare program for COVID-19 tests, some of which were billed for deceased beneficiaries. The case is notable for its use of foreign nationals recruited to set up non-existent labs to file the claims, seeming to signal a new front in efforts to corral Medicare fraud in the U.S.
The U.S. FDA approved Phraxis Inc.’s Endoforce Connector for endovascular venous anastomosis, which eliminates the need for surgical dissection for individuals undergoing hemodialysis for kidney failure. The device is designed to reduce tissue trauma and improve long-term graft performance.
Edwards Lifesciences Corp. released new economic and clinical data on severe aortic stenosis (AS) demonstrating intervening in a patient with the disease before symptoms develop can reduce costs to the health care system by $36,000. Data also shows earlier intervention can also lead to fewer follow-ups and hospitalizations for heart failure, after treatment.
The Trump administration nominated John Squires of the firm of Dilworth Paxson to take the post of director of the Patent and Trademark Office, but the appointment faces a few hurdles.
In what represents their first patenting, researchers from New York’s Stony Brook University filed for protection for development of a system and method that uses computer vision to analyze microscale facial movements in order to objectively help diagnose, monitor, and treat disorders of consciousness.
Hinge Health Inc.’s flexibility produced big rewards as the digital therapy company for physical rehabilitation finally began trading on the NYSE under the symbol HNGE on May 22 after delaying its IPO twice. Hinge co-founders Daniel Perez and Gabriel Mecklenburg rang the opening bell for the stock exchange to celebrate the offering’s $437 million haul.
U.S. FDA commissioner Marty Makary appeared at the May 22 Senate Appropriations Committee with the news the White House proposed an FDA budget for fiscal 2026 of $6.8 billion including user fees. This is a cut of 11.5% that will not likely go over well on Capitol Hill as the FY 2026 budget process unwinds.
Medtronic plc revealed plans to spin off its underperforming diabetes unit as a separate public company during its fourth quarter 2025 earnings call May 21. The company expects to complete the separation within 18 months.