After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for its kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granting it a priority review with a PDUFA date of Aug. 27, 2025.

The world of machine learning-enabled medical technology is advancing rapidly, and regulators are struggling to keep up, and Health Canada has joined the ranks of regulators who are tackling these technologies.

Royal Phillips NV opted to withdraw the Tack endovascular repair device only six years after the U.S. FDA’s approved it. Tack is designed to repair vascular dissection caused by angioplasty. The associated recall lists 20 injuries and no fatalities, but the device design might be a culprit in forcing the withdrawal of the Tack.

Guangdong Fapon Biopharma Inc. has obtained IND clearance from the FDA for FP-008, its first-in-class immunocytokine for patients with solid tumors refractory to anti-PD-1 therapy.

On March 1, 2025, former NIH director Francis Collins’ announced that he had fully resigned from the NIH, where he continued to lead a laboratory after his resignation as director. Collins gave no reason for his resignation, but it comes just before this week’s confirmation hearings for Jay Bhattacharya, who is U.S. President Donald Trump’s nominee to lead the NIH and who Collins called a “fringe epidemiologist” during the COVID pandemic. It is a bitter irony that when Collins resigned as NIH director in 2021, then-President Joe Biden said that “countless researchers will aspire to follow in his footsteps.”

The U.S. Patent and Trademark Office has reversed a 2022 agency memorandum on discretionary denials of patent procedures, such as inter partes reviews.

The Apple Watch may be able to alert wearers to heart palpitations, but Google LLC’s Pixel Watch 3 can now detect when a user’s heart stops – and call emergency services. The pulse detection featured received clearance from the U.S. FDA on Feb. 26 and Google plans to make it available on its Pixel Watch 3 starting in March. Pulse detection is already available for watches sold in the U.K. and EU.

Royal Philips NV recently secured EU MDR certification for the remote scanning capabilities on its Radiology Operations Command Center Console. The solution allows radiologists to remotely assist technologists in real-time by controlling scans to acquire images needed for improved diagnostic confidence and patient outcomes.

Nick Decker, directory of global regulatory policy for Roch Holding AG’s Roche Diagnostics division, said the FDA is moving carefully into the PCCP space, and industry, too, is taking a measured approach in adopting the PCCP concept.