The FDA’s Sept. 5, 2024, draft guidance for the use of patient preference information (PPI) over the total product life cycle represents a new set of requirements for device makers when obtaining such information. Going forward, device makers may be required to provide more detail about patient heterogeneity, including when the benefit-risk calculation varies by subpopulation.

With an eye on shutting down national security threats and securing American innovation, the U.S. House overwhelmingly passed the Biosecure Act Sept. 9 with a vote of 306-81. The next stop on the bill’s path to enactment is a Senate vote and, if it gets that, then on to the president’s desk.

Johnson & Johnson subsumed five of its medical technology business under the Johnson & Johnson Medtech name. Ethicon, Depuy Synthes, Biosense Webster, Abiomed and Cerenovus no longer exist as independent entities, but J&J announced no changes in the product lineup.

The U.S. FDA’s final guidance for device remanufacturing was the result of a nearly decade-long policy examination, and the agency’s Sept. 10 webinar highlighted a few key questions. The FDA’s Angela Krueger said the agency “always encourages transparency” on the part of manufacturers to ensure device safety and performance but said the FDA does not endorse disclosure of trade secrets in providing information on device servicing.

Femasys Inc. checked off a box on the way to launch of its Fembloc non-surgical birth control method with U.S. FDA clearance of Femchec. An enhanced version of the Femvue product used to diagnose fallopian tube abnormalities, Femchec enables confirmation of successful blockage of the fallopian tubes to prevent pregnancy without use of radiation.

Germitec SA received U.S. FDA de novo clearance for Chronos, its chemical-free, ultraviolet-C-based disinfection device for endocavitary and external ultrasound probes. The technology will help to protect patients and aid health care professionals in tackling cross-contaminations in U.S. hospitals, Vincent Gardès, CEO of Germitec, told BioWorld.

A Delaware chancery court decreed that Johnson & Johnson Inc. owes investors in Auris Health Inc. more than $1 billion over allegations that J&J had undercut Auris products after the 2019 acquisition of Auris. The outcome highlights the hazards of acquisitions of companies that are competitive in a particular product space, but a shift in FDA policy regarding robotic surgical systems may have also played a role in this outcome.

The U.S. Centers for Medicare & Medicaid Services posted a Sept. 6 statement regarding a cyber incident involving nearly 950,000 patient records held by a Medicare administrative contractor.

The FDA reported several class I recalls in the first week of September 2024, a list that includes products such as Medtronic plc’s McGrath line of laryngoscopes, some of which should be jettisoned.

Abbott Laboratories’ diabetes unit opened the month with a two-cannon salvo – a partnership with Beta Bionics Inc. that will integrate Abbott’s Freestyle Libre 3 Plus continuous glucose monitor with the Ilet Bionic Pancreas system and the roll out of its over-the-counter Lingo CGM in the U.S.