India’s Central Drugs Standard Control Organization (CDSCO) posted a draft guidance for medical device software, providing some clarity about the agency’s expectations for this class of products even if it seems to break no new ground.

The largest study ever conducted on light therapy for Parkinson’s disease has found that long-term use of Symbyx Biome Pty Ltd.’s non-invasive, at-home photobiomodulation (PBM) devices significantly improved mobility, anxiety, and overall symptom severity.

SK Biopharmaceuticals Co. Ltd. and Eurofarma Laboratórios SA launched a new joint venture (JV) called Mentis Care Inc. Oct. 21, dedicated to developing an AI-powered platform for epilepsy management.

Radiopharm Theranostics Ltd. completed a AU$35 million (US$22.77 million) placement to advance six of its radiopharmaceutical candidates for both diagnostic and therapeutic uses. The funds raised will go toward clinical trials, drug manufacturing and working capital to extend Radiopharm’s funding runway into 2027.

Chugai Pharmaceutical Co. Ltd. and Rani Therapeutics LLC have entered into a collaboration and global license agreement to develop and commercialize an oral product that encompasses Rani’s oral delivery technology, the Ranipill, and Chugai’s rare disease antibody in development.

Total arterial revascularization (TAR) might not be the most popular approach to coronary artery bypass grafting (CABG), but it is gaining in popularity according to a new study appearing in the Journal of the American College of Cardiology. The authors said that TAR provides superior mortality outcomes compared to bypass grafting that relies on both veins and arteries for graft materials, a finding that might suggest lower rates of downstream angioplasty and stenting.

China’s National Medical Products Administration (NMPA) recently met with a delegation from Singapore’s Health Sciences Authority (HSA) to discuss cooperation in the two agencies’ regulation of medical products, part of a series of efforts by NMPA to expand its use of regulatory reliance.

Japan has long been one of the premier markets for medical technology, but this market has suffered from a reputation for slow adoption of technologies outside the cardiovascular device space, a problem the Pharmaceuticals and Medical Devices Agency is keen to address.

Digital mental health tools are popping up with some regularity lately, but both Australia’s Therapeutic Goods Administration and the U.S. FDA have enough concerns about these products that they are taking a closer look at their risks and benefits.

Histosonics Inc. signed an exclusive distribution agreement with Gunze Medical Ltd. to bring its novel histotripsy-based therapeutic model, the Edison System, to Japan. The strategic alliance with Gunze Medical, a wholly owned subsidiary of Osaka, Japan-based Gunze Ltd., paves a figurative runway for Histosonics to introduce its Edison platform in Japan — one of Asia’s largest medical device markets.