The U.K. National Institute for Health and Care Excellence reported it will streamline its health technology assessment, but the bigger news might be that the agency will no longer require new technologies prove to be cost saving to win an endorsement from the agency.

The U.S. FDA reported the launch of its in-house generative AI (GenAI) tool, dubbed Elsa, for a variety of purposes. FDA commissioner Marty Makary assuaged industry’s privacy concerns by promising that the algorithm does not train on data submitted by makers of devices and pharmaceuticals.

Erasca Inc. has obtained IND clearance by the FDA for ERAS-4001, an oral selective pan-KRAS inhibitor, for the treatment of patients with KRAS-mutant solid tumors.

The U.S. FDA’s decision to grant breakthrough device designation for Bivacor Inc.’s titanium total artificial heart (TAH) sent real hearts aflutter at the Huntington, Calif.-based company’s headquarters. While the designation supports use of the TAH as a bridge to transplant for adults with biventricular or univentricular heart failure for whom current options are insufficient or unsuitable, Bivacor hopes its device will eventually serve as a long-term heart replacement.

The U.S. FDA declined to appeal the outcome of a lawsuit eviscerating the agency’s final rule for regulation of lab-developed tests despite a 60-day window to do so.

Shanghai Circode Biomed Co. Ltd. has obtained IND clearance from the FDA for HM-2002 for ischemic heart disease. It previously received IND clearance in China in January this year.

Abbott Laboratories recently received FDA clearance for Tendyne, its transcatheter mitral valve replacement system. The news comes on the heels of Edwards Lifesciences Corp. securing a CE mark for its Sapien M3 system and is a boon for mitral valve therapies amid ongoing frustrations about the slow adoption of TMVR technologies.