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BioWorld - Thursday, June 19, 2025
Home » Topics » U.S., BioWorld MedTech

U.S., BioWorld MedTech
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Toy bulldozer moving FDA letter blocks

FDA continues offensive against bogus device test results

May 28, 2025
By Mark McCarty
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.
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U.S. Capitol building, Washington D.C.

US House takes on CBO health panel controversy

May 27, 2025
By Mark McCarty
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.
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Gavel with whistle

DOJ makes arrests for COVID fraud in excess of $227M

May 27, 2025
By Mark McCarty
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.
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Phraxis Endoforce

Phraxis Endoforce receives FDA approval for anastomosis

May 23, 2025
By Annette Boyle
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.
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Device in heart
EuroPCR 2025

Edwards' data shows benefits of early intervention in aortic stenosis

May 23, 2025
By Shani Alexander
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.
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U.S. Capitol building

PTO director candidate Squires appears at Senate Judiciary

May 23, 2025
By Mark McCarty
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.
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SeeMe
Patents

Seeme helps measure, detect consciousness after TBI

May 23, 2025
By Simon Kerton
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.
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Businessman and IPO virtual screen

Hinge Health rings NYSE bell as IPO raises $437M

May 22, 2025
By Annette Boyle
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.
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U.S. White House

White House eyes 11% cut in FDA budget authority for 2026

May 22, 2025
By Mark McCarty
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.
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Hands holding torn contract

Medtronic aims to sweeten appeal by unloading diabetes unit

May 21, 2025
By Annette Boyle
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.
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