The U.S. FDA cleared Respiree Pte. Ltd.’s 510(k) for its RS-001 cardio-respiratory wearable that measures respiration and offers passive cardio-respiratory monitoring.

The Sept. 3 congressional hearing on AI in health care raised questions about whether the U.S. FDA enjoys the statutory authorities it needs to properly regulate this class of products, but witnesses at the hearing said a lack of trust in AI is a substantial roadblock to adoption.

Patients often wait for a long time to see a mental health specialist to get the help they need, and Greymind AI’s mental health platform, Reboot AI, offers a stop-gap measure to provide structured early intervention with built-in escalation to human clinicians.

Lee Dae-hong founded Aivis Inc. in January 2021 as an AI-powered pathology software company, having led the development of the world’s first commercial under-display fingerprint recognition algorithm that was later incorporated into the Galaxy S10 and Galaxy A series of smartphones of Samsung Electronics Co. Ltd.

The U.S. FDA has cleared Artrya Ltd.’s 510(k) for its Salix coronary plaque (SCP) module that is a bolt-on module to the company’s Salix coronary anatomy platform.

Researchers at the Massachusetts Institute of Technology have developed a generative AI model that was able to generate novel antibiotic structures from either chemical fragments or de novo, starting from ammonia, methane, water or no starting point at all. In a study that was published online in Cell, the team tested two dozen of more than 10 million structures that were proposed as potential antibiotics by the model.

Researchers at the Massachusetts Institute of Technology have developed a generative AI model that was able to generate novel antibiotic structures from either chemical fragments or de novo, starting from ammonia, methane, water or no starting point at all. In a study that was published online in Cell, the team tested two dozen of more than 10 million structures that were proposed as potential antibiotics by the model.

Researchers at the Massachusetts Institute of Technology have developed a generative AI model that was able to generate novel antibiotic structures from either chemical fragments or de novo, starting from ammonia, methane, water or no starting point at all. In a study that was published online in Cell, the team tested two dozen of more than 10 million structures that were proposed as potential antibiotics by the model.

Australia’s Therapeutic Goods Administration recently reported that it has concerns about the use of digital scribes, stating that any such software that analyzes or interprets clinical conversations may qualify as a regulated medical product.

AI and machine learning products have proven complicated for regulatory authorities across the globe, but entities in the business of conducting health technology assessments also have their hands full according to several sources.