The U.S. FDA draft guidance for enforcement of in vitro diagnostics for emergent threats without a public health emergency has proposed some significant restrictions, which drew several negative responses.

An artificial intelligence algorithm developed at Sheba Medical Center in Israel can identify patients at high risk of pulmonary embolism as soon as they walk through the hospital doors, a study published in the Journal of Medical Internet Research found. Using only information available from the patient’s medical history, the machine learning tool flagged high-risk patients before the initial clinical checkup occurred.

The U.S. FDA’s draft guidance for in vitro diagnostics under a Section 564 public health declaration broke little new conceptual ground, but the Association for Molecular Pathology (AMP) urged the agency to reconsider the COVID-19 experience.

Seoul, South Korea-based Adel Inc. raised ₩17 billion (US$12.39 million) in bridge financing to advance its pipeline of Alzheimer’s disease therapies, including its tau antibody-based ADEL-Y01 candidate, currently in a U.S.-based phase I study.

In what represents just the second PCT filing to have emerged from Valar Labs Inc., the company’s co-founders – Joshi Anirudh, Viswesh Krishna, and Damir Vrabac – describe their development of an AI-derived histologic signature for predicting patient outcomes to treatments for pancreatic cancer.

Immunovia AB significantly increased the accuracy of its test for the early detection of pancreatic cancer, achieving an 85% sensitivity and a specificity of 98%.

In Pumpkinseed Technologies Inc.’s first public patenting, the company’s co-founders describe their development of new proteomics platform that merges nanotechnology, biochemistry, silicon photonics and machine learning for high-resolution phenotyping to deliver new biological insights.

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.

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 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.