China’s National Medical Products Administration is arguably more active than regulatory agencies in many nations in advancing guidance for AI in medical technology, but Chang-Hong Whitney, President/CEO of Whitney Consulting Ltd., told BioWorld that the premarket review process still carries some unpredictability.

Alimetry Ltd. is making waves far beyond its home market with its first-in-class wearable Gastric Alimetry device that measures gut function – an area long considered a black box in gastroenterology.

Japan’s Pharmaceuticals and Medical Devices Agency has traditionally been less than receptive to clinical data from other nations, but that aversion is slowly giving way. Ames Gross of Pacific Bridge Medical told BioWorld that a trial conducted in another nation with significant representation of those of Japanese ancestry can go a long way toward obviating the need for a trial conducted in Japan.

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.

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.

Telix Pharmaceuticals Ltd. received an FDA complete response letter (CRL) a day after the Aug. 27 PDUFA date for its BLA for radiopharmaceutical renal cancer imaging agent, Zircaix (TLX250-CDx, 89Zr-DFO-girentuximab).

The Medical Device Authority of Malaysia reported on Aug. 22 the piloting of a bilateral medical device approval program with Singapore to streamline the review and launch of medical devices in both countries.

After making a significant strategic investment in Oxganox Ltd. earlier this year, Terumo Corp. quickly returned to buy the organ preservation company. On Aug. 25, the companies announced that Terumo would acquire Organox for $1.5 billion, marking Terumo’s entry into the organ transplant sector. The transaction is one of the largest exits ever for the U.K. med-tech sector.

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.