The U.S. FDA recently convened an advisory hearing to discuss whether three in vitro diagnostics should be reclassified from class III to class II, including tests for the pathogens responsible for Hepatitis B and tuberculosis. The panel agreed that all three of the test types should be reshuffled to the lower-risk class II category, suggesting that test developers now have an opportunity to jump into a market with lower-cost tests that won’t need expensive and drawn-out clinical studies to obtain the FDA’s seal of approval.

Artificial intelligence (AI) is an increasingly common matter of medical practice and thus not just another buzzword, and the U.K. National Institute for Health and Care Excellence (NICE) has opened a program for evidence generation for the use of AI to contour external beam radiotherapy to the tumor of treatment.

New hires and promotions in the med-tech industry, including: Cerus, Implicity, Intervenn, Veracyte.

Med-tech firms raising money in public or private financings, including: Bioprotect, Evvy, Know Labs, Sharps Technology.

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aspekt Solutions, Everads Therapy, Femasys, Kriya Therapeutics, Nanovibronix, Onward Medical, Siemens Healthineers, Signati, Varian.

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Laminate Medical Tecnologies.