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.
The rash of firings at agencies of the Department of Health and Human Services has provoked a Feb. 28 letter from Reps. Dianna DeGette (D-Colo.) and Frank Pallone (D-N.J.), blasting the dismissals and insinuating that the dismissals were politically motivated.
The U.S. Patent and Trademark Office has reversed a 2022 agency memorandum on discretionary denials of patent procedures, such as inter partes reviews.
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.
A number of regulatory agencies have signed on to the Medical Device Single Audit Program (MDSAP) for postmarket uses, but the U.S, FDA cannot use these audits for premarket purposes.
The routine use of software to interpret the results of lab-developed tests (LDTs) leaves clinical labs in a complicated spot in 2025 thanks in no small part to an ongoing lawsuit over the U.S. FDA’s final rule for LDTs.
The U.S. Court of Appeals for the Federal Circuit occasionally remands a patent litigation case to district court for a variety of reasons, as seen in a decision involving Trudell Medical and D R Burton.
The U.K. Medicines and Health Care Products Regulatory Agency reported a pilot program for the use of RWE in regulatory decision making, which is largely directed toward drug products.
