The U.S. FDA’s discussion paper for health equity for medical devices reiterates standing policy on clinical trial enrollment, such as that the device’s pivotal study should be reflective of the intended use population.
Ondine Biomedical Inc.’s Steriwave light-activated antimicrobial technology will be used in a pilot program at Leeds Teaching Hospitals NHS Trust in the U.K. to help fight infections in patients undergoing skull base sinus surgery. The Steriwave technology offers a quick nasal decolonization treatment that reduces the need for antibiotics and the risk of postoperative infections.
The U.S. FDA’s program to foster at-home health care is in its early stages and seeks to promote the development of technologies that will enable home health care services.
Medtronic plc looks to establish a moat around its diabetes pump position with an exclusive global partnership with Abbott Laboratories to develop a Freestyle Libre-based CGM that works with Medtronic’s smart dosing devices and insulin pump.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diality, Thermo Fisher Scientific.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Daxor, Infusystem, Luminopia, Medaxiom, Smith & Nephew, Vascular Therapies, Zywie.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Tuesday Health, Lunit, Molculight, SPR Therapeutics.
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