Abk Biomedical Inc. has completed an oversubscribed $30 million series C funding round to support IDE approval for Eye90 microspheres designed to improve outcomes for patients with liver cancer. The departure point for the technology’s development is U.S. FDA-cleared Y90 technology such as Boston Scientific’s Therasphere and Sir-Spheres developed by Sydney, Australia-based Sirtex Medical Ltd. “They are the only radioembolization microspheres on the market and that is the clinical space in which we will be submitting our IDE application,” Abk chief business officer Gary Donofrio told BioWorld. “Hopefully we’ll get approvals for the pivotal study and eventually to market in that space. It’s going to be great to be able to innovate and improve on what’s already been done there.” Read More
The U.S. FDA managed to wrap up a guidance for clinical decision support (CDS) products after several years, one of several projects the agency was liable for in the area of digital health. While a much-needed draft guidance for change control for artificial intelligence algorithms made the guidance agenda for the FDA’s new fiscal year, that draft is only a B draft guidance priority, suggesting that a final guidance might not emerge until calendar year 2024, possibly later. Read More
Perception Vision Medical Technologies Co. Ltd. (Pvmed) raised around $14 million in a series A financing round, to further develop artificial intelligence (AI) cancer treatment solutions for the two major tumor treatment methods, radiotherapy, and surgery. Read More
Numares Health AG received $21.2 million from the European Investment Bank (EIB) in support to its automated and software based IVD platform for obtaining high-quality nuclear magnetic resonance metabolomics data from blood or urine biopsy samples. Read More
Metabolic health is at an odd juncture. With the advent of glucagon-like peptide (GLP-1) agonists, pharmacologically induced weight loss has matured into a viable therapeutic option at long last. And research into the drug class is continuing apace. Read More
In 2022, neuroscience research made significant advances by understanding the role of large-scale neuronal connections in disorders. So did cancer research. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Nuwellis, Seastar Medical, T2 Biosystems, Vizient. Read More
