Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Accuray, Baibys, Paige AI.
2024 saw the completion of several cellular-resolution brain maps, including the entire fly brain and a comprehensive connections map of a cubic centimeter of human brain. 2025 began with the addition of another important map. In the Jan. 1, 2025, issue of Nature, researchers from the Allen Institute presented a map of areas and cell types where aging most affected the mouse brain.
Quanterix Corp. plans to merge with Akoya Biosciences Inc., in an all-stock transaction that both companies hope will bolster their fortunes. The transaction will create an integrated solution for ultra-sensitive detection of blood- and tissue-based protein biomarkers.
The U.S. FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program has its benefits, but industry had some sharp words for the agency in commenting on the 2024 ASCA draft guidance. The Advanced Medical Technology Association stated that FDA reviewers asked for full conformity test results for roughly 5% of premarket applications, a rate seen as excessive given the program’s design.
The U.S. FDA posted a draft guidance that would revisit a 2014 final guidance on sex-specific data drawn from medical device clinical trials, expanding the scope to include considerations of gender.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Becton, Dickinson and Co, Clarity, Clinic Barcelona, Element Biosciences, Helix, Human Longevity, Illumina , Komodo Health, Neurosigma, Nowdiagnostics, Piccolo Medical, R3 Vascular, Reveal Genomics, Revvity, Seastar, Sleepscore, Spectrum Vascular, SS Innovations.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brain.q, Exagen, Imvaria, Medtronic, Q'Apel, Roche, Spear Bio, Werfen, Gore.
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