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.

Cognetivity Neurosciences Ltd. is making progress in promoting its cognitive assessment tool as the brain health equivalent of a blood pressure check, following feedback from clinicians indicating the test could have broad applicability.

The FDA has rejected Artrya Ltd.’s 510(k) application for its Salix coronary anatomy (SCA) software that analyzes heart computed tomography scans via artificial intelligence (AI) to better diagnose coronary artery disease. “The FDA has advised that the Artrya Salix product is not equivalent to the predicate device,” Artrya CEO John Barrington told BioWorld.

Brazil’s health care regulator plans to start enforcing in July new regulations for software as a medical device (SaMD), clearing up doubts about its oversight over intangible health care assets such as software.

Singapore’s Health Sciences Authority (HSA) recently updated its guidelines for software as medical devices (SaMDs) to broaden its scope on a number of related matters. The new guidelines were finalized after an industry input period when the HSA collected feedback until the middle of August 2021. It marks the second revision of HSA guidelines on SaMDs, the first revision was meted out in April 2020. 

Pfizer Australia Holdings Pty Ltd. has made an offer to acquire digital health company Resapp Health Ltd. in all cash offer worth AU$100 million (US$74.25 million). The two companies have entered into a binding scheme that is contingent upon shareholder agreement and regulatory clearances in Australia. Shareholders will vote on the proposed acquisition in June, and directors have unanimously recommended that shareholders vote in favor of the acquisition.

PERTH, Australia – Australian digital health company Resapp Health Ltd. received clearance from Australia’s Therapeutics Good Administration and CE mark certification in the EU for its stand-alone cough counter application that tracks cough frequency using a smartphone. The class I software as a medical device is the first regulatory approval for such an application, which uses Resapp’s machine learning algorithms to identify cough events from audio recorded using the smartphone’s in-built microphone.

The FDA’s device center has revisited the 2005 guidance for the content of premarket submissions for device software functions, a document that puts much more emphasis on risk compared to the legacy 2005 guidance.