Several American states are forging into a legislative vacuum where regulation of AI is concerned as Congress continues to delay action. Adoption of AI regulations on a state level increases the risk of a fragmented regulatory landscape, as already exists in U.S. privacy law, further complicating the path forward for med-tech companies deploying AI algorithms.

Vicentra BV aims to make its Kaleido 2 insulin patch pump and automated insulin delivery system even smaller than its current device, already amongst the smallest, lightest and most precise insulin device on the market, new CEO Tom Arnold told BioWorld. As the company works to meet growing demand for its product, Kaleido has the potential to transform diabetes care, he said.

The U.S. FDA’s approval of Telix Pharmaceuticals Ltd.’s kit for preparing prostate-specific membrane antigen-PET imaging for prostate cancer widens the opportunities for patients who live far away from large hospitals. The FDA’s nod for the imaging agent, TLX007-CDx, now branded as Gozellix, has a long shelf life and needs less equipment and preparation compared to some other agents.

Researchers from The Ohio State University have filed for protection of Neurothread, a wire-type neurotransmitter-sensing platform that utilizes the cross-section of commercially available ultrathin microwires as microelectrodes.

The final U.S. Medicare national coverage determination for transcatheter tricuspid valve replacement (TTVR) devices comes with an expected coverage with evidence development mandate, but some analysts expect that TTVR devices will face competition from tricuspid transcatheter edge-to-edge repair (T-TEER) devices, the subject of an impending national coverage analysis.