Dublin-based Medtronic plc. has issued an urgent device correction letter to customers using the company’s Stealthstation robotic surgical system due to a software error that may provide inaccurate information about the location of the system’s surgical tip in the cranial anatomy.

The U.S. appeals court for the District of Columbia has reversed a lower court’s ruling that the device industry cannot appeal a Library of Congress rule that allows third-party access to the software used to govern the operations of medical devices. While the latest outcome in this controversy is a win for device makers, the trajectory of this case is anything but certain as the next step may be an en banc hearing at the circuit court or an appeal to the U.S. Supreme Court.

Medical device manufacturers based in China may feel the FDA has a bullseye on their backs, but two firms located in Canada were the subjects of recently posted FDA warning letters.

The saga of Illumina Inc.’s attempt to reacquire Grail Inc., seems to have come to an end with a capitulation to market regulatory authorities, but Illumina has chosen to spin off Menlo Park, Calif,-based Grail rather than sell the company outright.

The U.S. FDA’s draft guidance for control of thermal effects of medical devices may not have broken new conceptual ground, but two trade associations are of the view that the draft is nonetheless expansive in a manner that raises serious questions.

The U.S. FDA has received a citizen petition to grant over-the-counter status to continuous positive airway pressure (CPAP) machines, an oddly timed petition given a recent enforcement action against one of the prime movers in the CPAP space.

New York-based Cleerly Labs Inc., petitioned several U.S. Medicare administrative contractors for coverage of the use of the company’s artificial intelligence product for analysis of CT coronary arteries to evaluate the disease burden of plaque.

The Parliament of the U.K. has dissolved right on schedule, leaving the members of the House of Commons with a raft of policy issues to deal with in the next assembly. One of these issues is a bill originating in the House of Lords, the Artificial Intelligence Bill, which seems technologically agnostic and thus may represent a risk of duplicative oversight of AI for health care purposes.

The U.S. Department of Justice announced May 29 that Innovasis Inc., of Salt Lake City and two of the company’s executives have agreed to pay $12 million over allegations of payment of kickbacks to surgeons.

The European Council formally approved another delay for the In Vitro Diagnostic Regulation implementation, which now gives developers of existing high-risk in vitro diagnostics until December 2027 to obtain a renewed CE mark.