Australia’s Therapeutic Goods Administration (TGA) made significant changes to some of its regulations, including those for software-based medical devices. The TGA said that entities that are switching their products to a higher risk classification can continue to offer them for six months after Nov. 1, 2024, if they have an application on file with the TGA, but only if the sponsor notified the agency of such intent prior to May 25, 2022.

Researchers from the Wellcome Sanger Institute, and their collaborators at The Institute of Cancer Research, London and the University of Cambridge assessed the health impact of all possible genetic changes in the tumor protection gene, BRCA1-associated protein 1 gene.

The pilot version of the U.S. FDA’s advisory program for breakthrough medical device life cycle management was initially limited to cardiovascular devices, but the agency has announced an expansion into other product areas. Going forward, orthopedic, radiological and ophthalmic devices will be eligible for the FDA’s Total Life Cycle Advisory Program, which will aid applicants in obtaining both faster and more trouble-free market access.

Serac Imaging Systems Ltd. is seeing encouraging results from ongoing trials at three sites, which are comparing its Seracam portable hybrid gamma-optical camera for medical imaging to standard of care nuclear medicine imaging, Mark Rosser, CEO of the company, told BioWorld.

Nearly 80% of people in Australia and the U.S. that used Genetic Technologies Ltd.’s Genetype multi-risk assessment test showed an elevated risk for at least one disease covered by the test.

The years’ long effort by activist investor Politan Capital Management LP to take control of the Masimo Corp. board of directors and oust Masimo CEO and founder Joe Kiani took a turn for the weird this week as news emerged that Masimo Chief Operating Officer Bilal Muhsin notified the board that he would step down if Kiani were pushed out.