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. Read More
“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. Read More
Volta Medical SAS reported positive results from the Tailored-AF study which compared its artificial intelligence software-guided ablation procedure in combination with pulmonary vein isolation to a conventional anatomical ablation targeting PVI alone, to treat persistent atrial fibrillation. Read More
Weighing in on the side of 21 drug and device companies accused of knowingly aiding and abetting terrorist attacks against U.S. troops and civilians in Iraq from 2005 to 2011, the U.S. solicitor general is asking the Supreme Court to grant the companies’ petition for cert and then vacate a 2022 appellate court decision in Joshua Atchley v. Astrazeneca plc, remanding it for reconsideration in light of a related opinion the justices handed down a year ago. Read More
Despite the ongoing war, speakers at Biomed Israel this week reported that business and investment in Israel’s med-tech industry continues largely unchanged. Read More
Novo Nordisk A/S’s once-weekly human insulin analogue for adults with type 1 diabetes mellitus could be a useful tool for patients and physicians, the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee said May 24, but it also agreed that the risks outweighed the benefits for improving glycemic control. Read More
The med-tech sector experienced some relief in the first quarter of 2024 (1Q24) as total financings climbed to $6.38 billion, eclipsing the value of any quarter in 2023. For perspective, the final quarter of 2023 recorded $3.32 billion, and 1Q23 raised $4.69 billion, with an average of $4.42 billion in financings per quarter in 2023. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alma, Autonomix, Exicure Heartbeat Health, Karoo Health, Stereotaxis. Read More
