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. Read More
Investors ate up the opportunity to be part of Gemelli Biotech Corp.’s series A funding round, which raised $19 million to support the company’s growth and expand access to its diagnostic tests for gastrointestinal (GI) diseases. Blue Ox Healthcare Partners led the round with founding investor Cedars-Sinai and support from Carolina Angel Network, Cerracap Ventures and several family offices. Read More
Regulatory harmonization of artificial intelligence (AI) and machine learning (ML) is high on the checklist for companies that want to develop these products, but legislatures and regulatory agencies across the globe seem less interested. Koen Cobbaert, senior manager for quality standards and regulation with Royal Philips NV, told BioWorld that there is a race on to be the first market with a full-fledged set of regulations, a fact of life that does little to advance the cause of harmonization. Read More
Investors are backing imaging diagnostics company Magnetic Insight Inc. with $17 million to develop its magnetic particle imaging (MPI) technology. The clinical imaging application consists of two core technologies: hardware and a tracer that, together, produce 3D images of how a patient’s body works. Venture firm Celesta Capital led the series B round with Alumni Ventures Group, Gaingels and existing investors 5AM Ventures and Sand Hill Angels participating. Read More
Becton, Dickinson & Co. (BD) recalled intraosseous needle set kits and power drivers. The action was triggered by difficulties in separating the stylet from the needle. The FDA also announced a class I recall of the Volara respiratory clearance system by Baxter Healthcare Corp., of Deerfield, Ill., because of issues with an in-line ventilator adapter. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Epic, Ginkgo Bioworks, Haemonetics, Hygieia, Movement Group, Murato Vios, Myriad Genetics, Pointclickcare. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Paige. Read More
