Device makers are often cited in U.S. FDA warning letters for making claims not seen in the approved labeling, but the authors of a recent review of artificial intelligence (AI) products cleared by the FDA suggest that FDA documents and marketing materials should disclose the presence of AI in these products. The authors of an article in the Journal of the American Medical Association said that only about 80.6% of the products were represented with accurate statements about the presence of AI, although FDA regulation does not require that marketing materials make such disclosures.

280Bio Inc. has received FDA approval of its IND application for the KRAS inhibitor YL-17231. 280Bio will start phase I enrollment in the U.S. in the fourth quarter of this year for the treatment of advanced cancer patients with RAS mutations in their tumors.

The U.S. FDA’s draft guidance for predetermined change control plans (PCCP) is a groundbreaking document for med-tech regulation, but stakeholders see a few holes in the draft version. One of the issues for device manufacturers is that the guidance seems to exclude any possibility of inclusion of a new intended use or indication for use in a PCCP, while others seek more detail on how this policy can be applied to the device component of a combination product, two elements that may prove complicated to address in the final guidance.

The U.S. FDA’s draft guidance for predetermined change control plans (PCCP) is a groundbreaking document for med-tech regulation, but stakeholders see a few holes in the draft version. One of the issues for device manufacturers is that the guidance seems to exclude any possibility of inclusion of a new intended use or indication for use in a PCCP, while others seek more detail on how this policy can be applied to the device component of a combination product, two elements that may prove complicated to address in the final guidance.

Poseida Therapeutics Inc. has received FDA clearance of its IND application for P-CD19CD20-ALLO1, an allogeneic dual chimeric antigen receptor (CAR) T-cell product candidate being developed for relapsed or refractory B-cell malignancies in partnership with F. Hoffmann-La Roche Ltd. The company is actively focused on opening clinical sites for a phase I study in adults with relapsed or refractory B-cell malignancies.

The FDA has cleared C4 Therapeutics Inc.’s IND application for CFT-8919, an orally bioavailable Bidac (bifunctional degradation activating compound) degrader designed to be potent and selective against EGFR L858R for non-small-cell lung cancer (NSCLC).

Rapid point-of-care diagnostics company Lumos Diagnostics Inc. saw its stock shoot up 327% on the news that it finally gained U.S. FDA 510(k) clearance for its Febridx rapid, point-of-care test for bacterial infections. Febridx is a finger prick blood test that can indicate if a person has a bacterial or viral acute respiratory infection within 10 minutes.

Leadless cardiac electrophysiology devices have been around for a while now, but Abbott Laboratories of Abbott Park, Ill., has managed to beat the competition in the market for dual chamber pacing via two leadless devices. The company reported July 5 that the U.S. FDA has approved the Aveir DR, a two-unit device configuration that provides pacing for both the right ventricle and the right atrium and which some analysts believe helps to make Abbott shares an underappreciated asset for investors.