The U.S. FDA cleared Artrya Ltd.’s Salix Coronary Anatomy software that analyzes coronary computed tomography angiogram scans via AI to better diagnose coronary artery disease.

A new guidance by the International Medical Device Regulators Forum for good machine learning practices draws heavily on a 2021 playbook provided by Canada, the U.K. and the U.S., an outcome that also supports the notion that there is no point in reinventing a highly functional regulatory wheel.

In what represents the first PCT filing emerging in the name of Ayble Health Inc., protection is sought for a system for adaptive, multi-level processing of health data to be used in the individualized management of immune-mediated inflammatory diseases such as inflammatory bowel disease and irritable bowel syndrome.

Children with autism spectrum disorder (ASD) often must wait years before they get a diagnosis, and that wait time can result in missed opportunities for changing behaviors associated with autism.

Australia is the skin cancer capital of the world, but with a shortage of dermatologists, patients often wait too long to get skin checks that could end up costing them their lives.

Australia is the skin cancer capital of the world, but with a shortage of dermatologists, patients often wait too long to get skin checks that could end up costing them their lives.

Seoul, South Korea-based Neudive Inc. is advancing a game-like digital therapeutic called Buddy-in as a software solution for children and adolescents with autism spectrum disorder to practice and improve social skills.

A decade ago, when Asia Pacific Medical Technology Chairman (APACMed) John Collings was running a medtech business in China, he was flying high with multiple rounds of investment under his belt and preparing to launch two new technologies, but the company hit a regulatory hurdle that delayed the launch and he found himself grappling for answers, he told the APACMed Forum held Sept. 5 in Singapore.

South Korean med-tech companies Nunaps Co. Ltd. and Share & Service are the latest to clear domestic approvals for digital therapeutics as the government ramps up R&D funding for artificial intelligence-based medical technologies.

The U.S. FDA’s September 2022 guidance for clinical decision support (CDS) software was controversial the moment the agency posted the document, prompting the filing of a citizen’s petition five months later. The CDS Coalition has penned a June 8 letter to FDA commissioner Robert Califf in an effort to draw a reaction from the agency, but the letter was accompanied by a summary of an analysis of CDS software with a machine learning (ML) component that suggests that such products that are in development may have to be reconsidered.