Brain MRIs can reveal a great deal about brain tumors, but tracking response to treatment, clearly delineating edges and identifying other critical information remain problematic. Neosoma Inc.’s recently granted FDA 510(k) clearance may simplify treatment of the most challenging of these tumors, high-grade gliomas. The Neosoma High-Grade Glioma (HGG) neuro-oncology software device uses artificial intelligence to provide detailed measurements and 3D analysis that enable greater precision in procedures and better monitoring. Read More
Atmo Biosciences Ltd. is gearing up for pivotal trials of its ingestible gas-sensing capsule after a clinical study supported the gas capsule’s ability to determine its location in the gastrointestinal tract. Read More
The U.S. FDA’s device center recently advised companies that make tests for the COVID-19 pandemic that the emergency use authorization program for tests is winding down, albeit with a few exceptions. Read More
The U.S. Congress has reauthorized several user fee programs at the FDA, and the agency has published the user fee levels for several product types, with most of those fees increasing significantly, an example of which is the increase for new drug applications (NDAs) requiring clinical data from $3.12 million to $3.24 million. Fees for medical device premarket approval (PMA) filings will jump from $375,000 to $442,000, including some hefty adjustments for persistent inflation, a problem that may plague the user fee schedules for fiscal 2024 as well. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: CHS, Canadian Hospital Specialties, Cytosorbents, Femasys, Livac, LRE, Owlet. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Cell Standards, Crown Aesthetics, Life Spine. Read More
