The French national authority for health (HAS) has provisionally set up CEDiag, a committee for assessing diagnostic, prognostic or predictive health technologies. This new national committee will cover the field of clinical procedures, including radiology, clinical biology and anatomo-cytopathology examinations, diagnostic drugs such as contrast agents used in medical imaging and radiopharmaceutical drugs, as well as medical devices such as self-testing kits.

The U.S. FDA has given the greenlight to Sparrow Acoustics Inc. (dba Sparrow Bioacoustics) for its Stethophone, a software-based technology that allows doctors and nurses to check a patient’s heart and lung sounds using a smartphone. Providers simply hold the smartphone against the patient’s chest to listen for possible abnormalities.

The question wasn’t if, but when and how, someone would challenge the Medicare negotiation provision laid out in the Inflation Reduction Act (IRA) that was signed into U.S. law last year.

Having already notched approvals in the EU and U.K., Astrazeneca plc hopes to prime the pump for a U.S. approval of nirsevimab as a respiratory syncytial virus (RSV) prophylactic for infants when it makes its case June 8 before the FDA’s Antimicrobial Drugs Advisory Committee.

As Monica Bertagnolli, U.S. President Joe Biden’s choice to be the next NIH director, meets with senators to gather support for her confirmation, she’s sure to be grilled by some of them about her stance on whether the agency can march in on drug patents based on a drug’s list price. Up until now, NIH directors have said no. A change in that policy, along with nearly flatline NIH spending and other new government initiatives, could impact private investment in drug R&D by increasing the cost of research and lowering the return on investment.