Stryker Corp. continued its recent buying spree with the purchase of Molli Surgical Inc., a company that develops wire-free soft tissue localization technology for breast-conserving surgery. Styker said Molli’s offerings strengthen its advancing surgical solutions in breast cancer care.

U.S. federal preemption of state law for devices approved by the FDA is a matter of record, but a recent case affirms the staying power of Supreme Court jurisprudence on that point.

Radiopharmaceutical company Telix Pharmaceuticals Ltd. received a U.S. FDA refusal to file letter for its BLA seeking approval of renal cancer imaging agent TLX250-CDx (89Zr-DFO-girentuximab) for clear cell renal cell carcinoma (ccRCC).

Noze Inc. breathes a little easier with a new $5 million equity investment from the Bill & Melinda Gates Foundation to support the development of Diagnoze, a breath-based, hand-held diagnostic device. The foundation provided two earlier grants focused on diagnosing tuberculosis in low- and middle-income countries. “We're thrilled to see our partnership with the Bill & Melinda Gates Foundation continue to grow,” Noze CEO Karim Aly told BioWorld.

The proposal to overhaul the use of terminal disclaimers in U.S. patent filings won over no fans among former directors of the U.S. Patent and Trademark Office, but device and drug makers, too, are concerned about the proposal.

The U.S. Agency for Healthcare Research and Quality posted a request for information on the current state of multi-cancer screening tests for a review that poses several questions.

Sunbird Bio Inc.’s Neural EV-tau aggregate assay demonstrated 92% correlation with PET scans in identifying individuals with Alzheimer’s disease, a study presented at the Alzheimer’s Association International Conference in Philadelphia, on July 30 found.

The U.S. FDA proposed to overhaul guidances for maxillofacial systems that accumulated at least 18 years' of dust, in an effort to keep up to date with modern medical technology.

C2N Diagnostics LLC’s two-factor blood test, Precivity AD2, showed 90% accuracy in diagnosing Alzheimer’s disease in a study presented at the Alzheimer’s Association International Conference in Philadelphia on July 28 and simultaneously published in the Journal of the American Medical Association. The following day, Quanterix Corp. presented results from its study that showed a multi-marker approach could maintain the 90% accuracy of its Lucentad test, while reducing the percentage of uncertain results from more than 30% to 10%, in line with the intermediate results demonstrated by Precivity.