The granting of emergency use authorization by the U.S. FDA to Roche AG for its four-in-one molecular test for SARS-CoV-2, Influenza A/B viruses and respiratory syncytial virus will allow the company to quickly bring the test to near-patient care environments ahead of the flu season, to address a real need in the marketplace, Ian Parfrement, head of the point of care customer area, at Roche Diagnostics, told BioWorld. Read More
Sherlock Biosciences Inc. is on the case of the missing tests – the lack of diagnostic testing for sexually transmitted infections, that is. Sherlock’s over-the-counter molecular, disposable tests combine CRISPR and synthetic biology chemistries to provide results in 30 minutes in the privacy of the user’s home. Read More
The U.S. FDA is keen to develop tools for oversight of artificial intelligence (AI) as demonstrated by a batch of research projects designed to inform the review of medical applications of AI. The agency’s concern is that there is a dearth of “robust evaluation methods” for evaluating AI products, thus the need for tools that will allow the agency to clear or approve such products with an assurance that these algorithms are safe and effective for their intended use. Read More
Incheon, South Korea-based Next Biomedical plans to offer one million shares on the Korea Exchange at a price band of ₩24,000 (US$17.42) to ₩29,000 per share. The IPO is scheduled for August 2024 and expected to raise ₩24 billion to ₩29 billion. Read More
The U.S. National Institutes of Health has jumped into the artificial intelligence pool with a prognostic that predicts a patient’s response to immune checkpoint inhibitors as cancer therapies. Read More
The U.S. FTC’s campaign against the Orange Book listing of patents claiming device components gained momentum when a federal judge in New Jersey ordered Teva Pharmaceuticals USA Inc. to delist five device patents pertaining to its Proair HFA (albuterol sulfate) inhaler. Read More
Focused on oral therapies for obesity, diabetes and rare diseases, Boston-based Syntis Bio Inc., which raised $15.5 million through seed funding last year, emerged from stealth to advance its synthetic tissue-lining technology and a pipeline of candidates. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Neusoft, Osteotec, Positron, Revelai, Trimmed, Zimmer Biomet. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accuray, Avicenna.ai, Getinge. Read More
