In what represents its first patenting, San Diego-based Intrigue Health Inc. seeks protection for a diagnostic kit that its inventors say will bring clinical laboratory quality testing directly into the home and to non-health care facilities. They say their invention will enable consumers to move from symptom to treatment in hours from the convenience of where they are, which will lead to better health outcomes and much happier consumers.
The U.S. Department of Justice (DOJ) has released the metrics for prosecutions under the False Claims Act (FCA) for fiscal year 2023, ringing up recoveries of nearly $2.7 billion, the 15th consecutive year in which recoveries exceeded $2 billion.
The U.S. FDA’s approach to predetermined change control plans (PCCP) for medical devices has been widely viewed through the lens of artificial intelligence software, but the potential scope of PCCP is much broader than merely evolutionary software and iterative device designs.
Woven Orthopedic Technologies LLC secured a second U.S. FDA 510(k) clearance for the use of its Ogmend implant enhancement system in spine surgery. The approval is for the large size Ogmend sleeve which is compatible with pedicle screws up to 10.5 mm and will give surgeons a tool to be able to easily secure stable fixation between the screw and bone during orthopedic surgery.
Alamar Biosciences Inc.’s substantially oversubscribed series C pushed the company’s total funds raised to $250 million. The company closed the first $100 million on Feb. 26 and expects to close an additional $28 million within 30 days. The target for the series C was $100 million. The funds will be used to drive market adoption of its Argo HT system and nucleic acid linked immune-sandwich assay sequencing (NULISAseq) inflammation panel 250 for deep profiling of immune response.
With the number of people with dementia in Australia expected to nearly double by 2054, the federal government is funding a new AU$50 million (US$32.76 million) biomedical and med-tech incubator program to develop new therapies, medical devices and digital health technologies to address dementia and cognitive decline.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ensodata, Virtual Incision.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agiliti, Diacarta, Natera, Oncoassure, Pulmonx, Quanterix, Retrieve.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Castle Biosciences, Icecure, Laplace Interventional, Orchestra Biomed.
RSS
