Gilde Healthcare Partners BV finally closed its Venture & Growth VI fund after raising €740 million (US$803 million) in commitments. The venture capital firm added €140 million to the €600 million unveiled earlier in the year due to strong interest from institutional investors. Read More
After Cormedix Inc. navigated manufacturing issues that slowed the process, the U.S. FDA approved the antibacterial and antifungal solution Defencath to reduce catheter-related bloodstream infections adults with kidney failure. Read More
The U.S. FDA’s approach to bias covers a large swath of territory, including the potential for bias to creep invisibly into artificial intelligence (AI) products. Yarmela Pavlovic, vice president for global regulatory affairs at Medtronic plc, said at this year’s Artificial Intelligence Summit that regulators may be more wary of the potential hazards of bias in AI compared to non-AI software simply because of the difficulty in anticipating how bias might affect the function of these advanced algorithms. Read More
Ophthalmology company Polyactiva Pty Ltd.’s biodegradable ocular implant provides six months of sustained drug delivery for patients with glaucoma and is the first biodegradable ocular implant that has the potential to be used safely for repeat dosing, Polyactiva CEO Vanessa Waddell told BioWorld. Read More
Medical device companies and trade associations alike have been clamoring for some time for a leaner path to Medicare coverage for their more novel product offerings, a message that may be gaining traction. Read More
Itzhak Zachi Attia, an assistant professor of medicine and co-director of artificial intelligence (AI) in cardiology at Mayo Clinic, has filed for protection of an Al-based tool to detect cardiac amyloidosis (CA) from the analysis of voltage-time data captured from electrocardiograms (ECGs) acquired from a plurality of leads. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Avation Medical, Filterlex Medical, Surmodics. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Inari Medical, Limflow, Inflammatix, Kdx Diagnostics, Nucleus Radiopharma, Relievant, Shine Medical, Tempus Labs. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Cormedix. Read More
