A dynamic chart of the latest executive orders (EOs) from the Trump administration that have been published in the Federal Register and that directly impact the biopharmaceutical and medical technology sectors.
The U.S. FDA granted 510(k) clearance to Distalmotion SA's Dexter, its surgical robotic system, for use in cholecystectomy in adults. The greenlight from the regulatory body is the second nod Dexter has received following de novo clearance granted in 2024 for use in inguinal hernia repair.
The U.S. FDA’s device guidance drought ended with the issuance of one draft and one final guidance, the latter of which deals with the Q-sub program for early interaction with sponsors of device applications. Per a request by industry, the agency indicated it is amenable to including FDA policy staff during these meetings, which may help to avoid surprises in premarket applications.
A court decision blocking President Donald Trump’s reciprocal and trafficking tariffs was hardly a day old before the U.S. Court of Appeals for the Federal Circuit stepped in late May 29 to grant a temporary stay while it considers the administration’s appeal. The stay adds further uncertainty to the path ahead for drug and device companies.
The doctrine of inherent disclosure is not one of the more common methods for invalidating patent claims, but this doctrine led the U.S. Court of Appeals for the Federal Circuit to declare that several claims found in a patent held by Carl Zeiss X-Ray Microscopy Inc. are invalid.
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 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.
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.
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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