The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.

This week, the US and UK announced a partnership to promote AI safety. Boston Scientific recalls embolic agent. LumiCell received FDA approval for its imaging agent to detect residual cancer. Scout receives an award to develop an STI test; and Osso VR leverages the Apple Vision Pro for VR medical training.

The company announced a series B-2 financing of $158m that it plans to use for pivotal Phase II development of TORL-1-23, which it called a first-in-class agent.

Most advisory committee members supported approval of the breast cancer imaging product, but indicated labeling and advertising should be carefully crafted to avoid overhyping the likelihood patients experience a clinical benefit.