“In an impressive eight-month timeline,” South Korea’s Lunit Inc. completed the $193 million (AU$292 million) acquisition of Volpara Health Technologies Ltd. to globally advance artificial intelligence (AI)-based cancer care.

The U.S. FDA’s May 23 advisory hearing for the Shield test for colorectal cancer by Guardant Health Inc., included the expected debate over whether patients would abandon colonoscopy thanks to the advent of a new blood-based test. While much of that debate was fed by what some saw as the test’s poor performance regarding adenoma, the advisory committee voted 6-3 that the benefits outweigh the risks in a decision the FDA is likely to affirm.

The U.S. FDA’s May 23 advisory hearing for the Shield test for colorectal cancer by Guardant Health Inc., included the expected debate over whether patients would abandon colonoscopy thanks to the advent of a new blood-based test. While much of that debate was fed by what some saw as the test’s poor performance with regard to adenoma, the advisory committee voted 7-2 that the benefits outweigh the risks in a decision the FDA is likely to affirm.

Once-daily insulin treatment is getting a challenge from Novo Nordisk A/S’s once-weekly option. The U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee meets Friday, May 23, to review the BLA for once-weekly Awiqli (insulin icodec), a human insulin analogue from Novo for adults with type 1 diabetes mellitus.

At its investor presentation on May 22, Roche Diagnostics, a unit of Basel Switzerland-based Roche Holding AG reported on the company's pipeline plans, which include a slew of new tests, instrument upgrades, and the forthcoming launch of its fully automated mass spectrometry instrument.

Milleporesigma, Merck KGaA’s North American life sciences business, agreed to acquire Mirus Bio LLC from Gamma Biosciences LP for $600 million. Mirus develops tailored transfection solutions that deliver nucleic acid into cells used in production of viral vector-based gene therapies. It also provides contract development and manufacturing services. The transaction is expected to close in the third quarter of 2024, subject to U.S. regulatory approvals and customary closing conditions.

Abbott Laboratories announced a class I recall of the Heartmate 3 left ventricular assist system (LVAS) that affects nearly 890 units distributed over the past three years, a move triggered by reports of blood leakage or air entry into the device during implant procedures.

Nuvo Group Ltd. recently completed a business combination with Los Angeles Media Fund (LAMF) Global Ventures Corp, a special purpose acquisition company, and became a listed company in a bid to bring its Invu pregnancy monitoring and management platform to as many women as possible. “We are totally focused on women's health and trying to drive better outcomes through pregnancy care,” Rice Powell, CEO of Nuvo, told BioWorld.

News out of the Heart Rhythm Society 2024 meeting May 16-19 highlighted the rapid disruption pulsed field ablation (PFA) devices have wrought in cardiac arrhythmia treatment, so it is little surprise to see that PFAs are among the top five technologies with transformative potential identified by Clarivate plc in its Medical Technologies to Watch in 2024 report. The impact of the other four – continuous glucose monitors (CGM) for diabetes, neurostimulation devices, surgical robotics and renal denervation – has been just as revolutionary, if longer in being realized.

The U.S. Trade Representative (USTR) once again called out the usual cast of characters in this year’s Special 301 Report for not playing by the rules when it comes to protecting intellectual property. And once again, industry asked the USTR to go further by placing new players on the list.