Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aktiia, Axosim, Vyant Bio, Butterfly Network, Forest Neurotech, Inspira Technologies, Xtant Medical, RTI Surgical.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Bifurcation Systmes, Life Molecular Imaging, Sintau Intl., Medinol, MTF Biologics, Think Surgical.
Artificial intelligence (AI) is in full development, and advances are already used in many fields, including medicine. In oncology, these tools can identify a tumor in an image with 99% accuracy. But they can also miss it if the algorithm was not developed with the right data or the correct decisions. The 2023 European Society for Medical Oncology (ESMO) Congress brought together in Madrid doctors and deep learning experts to discuss the challenges and advances of AI in this area. And what’s better than asking an AI what its trainer has told it about AI?
Seastar Medical Holding Corp. was granted a third breakthrough device designation by the U.S. FDA for its Selective Cytopheretic device (SCD), a biomimetic membrane-based device used to treat patients with acute inflammatory conditions, which can cause organ failure and death. The latest designation is for its use in patients with hepatorenal syndrome. It follows other indications including cardiorenal syndrome and in adults with acute kidney injury (AKI).
With an eye on increasing U.S. competitiveness and expanding the opportunities of technology hubs beyond those already established on the country’s two coasts, the Biden administration designated 31 communities, out of more than 370 applicants, as Regional Innovation and Technology Hubs.
The U.S. FDA is once again revising its guidance on how drug and device makers can share scientific reprints and reference texts with health care providers regarding off-label uses of their approved or cleared products.
RSS
