An electronic pen that tracks upper limb and hand motions to diagnose Parkinson’s disease is to be repurposed to detect neurotoxic side effects of immunotherapy for cancer, following the award of a grant from Johnson & Johnson Innovation.
Ultromics Ltd. has been granted a U.S. FDA breakthrough device designation for its artificial intelligence (AI)-enhanced platform to aid early diagnosis of cardiac amyloidosis. Echogo Amyloidosis uses AI to analyze echocardiograms and detect the presence of cardiac amyloidosis, using a single commonly acquired ultrasound view of the heart. The platform was developed with the support of Janssen Biotech Inc., part of the Janssen Pharmaceutical Companies, a unit of Johnson & Johnson.
Regulatory harmonization is perhaps highest on the regulatory wish list of medical device manufacturers, but the FDA’s device center has tamped down expectations of a medical device single review program. Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH) said the agency will release a strategic plan later this year for regulatory harmonization, but declined to offer any details other than to state that differences in risk classification schema are not as significant a source of drag on harmonization as may commonly be believed.
Quest Diagnostics Inc. evidently found what it was looking for, as it agreed to acquire Haystack Oncology Inc. in an all-cash deal valued at up to $450 million with $300 million at closing and $150 million contingent on meeting specific milestones. Haystack focuses on minimal residual disease (MRD) testing, which can detect residual or recurring cancer in its early stages and help guide therapy decisions using blood samples rather than biopsied tissue. The companies expect the transaction to close before the end of June.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3M, Innoblative, Ismart Developments.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aster Insights, Body Vision, Chromacode, Curetis, Dante, Dexcom, ITM, Medgenome, Moleculight, Opgen, Probo, Serpex, Twist Bioscience, Ultra Select.
Four U.S. government agencies have issued an advisory regarding bias in the use of artificial intelligence (AI) and other automated systems, the scope of which includes software products that “make decisions.” The four agencies have pledged to use their enforcement powers to “protect individuals’ rights regardless of whether legal violations occur through traditional means or advanced technologies,” all of which sends a signal to developers of medical software that the FDA is not the only federal government agency that will be looking over their shoulder to evaluate the risk of bias in those algorithms.
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