Fractyl Health Inc. closed $100 million in new financing Wednesday to expand and accelerate clinical development efforts to reduce dependence on insulin among type 2 diabetes patients. The startup, which changed its name from Fractyl Laboratories Inc., will use the financing to support additional late-stage clinical studies for determining the potential of its Revita DMR. Read More
Mindup, an Israeli digital health incubator, added Phenofast Ltd. to its portfolio this week, banking on the startup’s ability to resolve a critical, ongoing problem for hospitals and community physicians treating patients with urinary tract infections (UTIs). Phenofast hopes to bring clarity to antimicrobial susceptibility testing (AST) and relief to patients in record time. Read More
Livanova plc has launched an IDE trial of its Aura6000 sleep apnea device, following approval by the FDA to proceed with the study. The implantable pulse generator (IPG) is designed to treat patients with moderate to severe obstructive sleep apnea (OSA) who do not get relief from a traditional continuous positive airway pressure (CPAP) machine or refuse to use one. Read More
With paralysis affecting more than 5 million Americans, devices that serve as brain-computer interfaces (BCIs) are increasingly important, even if few are commercially available. The FDA has responded to the predicament with a leapfrog guidance, a preliminary form of guidance designed to foster more interaction with industry and encourage developers to move along on development programs for devices that will aid patients in restoring lost motor and/or sensory capabilities. Read More
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has been stepping up efforts to bring innovative medical devices to market faster and make the regulatory approval process more predictable and further speed up approval processes that have been known for long delays. Read More
More than four months after its original PDUFA date of Feb. 2, 2021, Mallinckrodt plc’s Stratagraft gained FDA approval for use in deep partial-thickness thermal burns. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Natera, Novocure, Motus GI, Relievant Medsystems. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alydia Health, Behold.ai, Electrocore, Intermountain Healthcare, Medx Health, Myriad Genetics, Organon & Co., Pieriandx, Si-Bone, Vidaceuticals Health Products. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ormo, Stratatech. Read More
