Med-tech firms raising money in public or private financings, including: Adient Medical, Brain Scientific, Forza, , Pulse Biosciences, Third Rock Ventures.
U.S. FDA Commissioner Robert Califf offered the keynote address at this year’s annual meeting of the Food and Drug Law Institute (FDLI), revisiting recent events that have roiled the agency’s staff and reputation. Califf made a point of emphasizing the need for new statutory authorities in connection with the supply chains for FDA-regulated products, and remarked that his return to the agency will not be a reversion to the norm in this context.
Ekso Bionics Holdings Inc. added a new indication for its robotic Eksonr exoskeleton with a U.S. FDA 510(k) clearance for use of the mobility device in patients with multiple sclerosis (MS). The green light for MS follows clearances for stroke and spinal cord rehabilitation in 2016 and acquired brain injury (ABI) in 2020.
The U.S. FDA has granted clearance for Earlitec Diagnostics Inc.’s Earlipoint evaluation tool for the diagnosis and assessment of autism spectrum disorder (ASD) in children aged 16-30 months. The eye-tracking technology utilizes Dynamic Quantification of Social-Visual Engagement (DQSVE), which captures a child’s moment-by-moment looking behavior. The clearance was based on positive results from two studies in which more than 500 children were enrolled.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Beckley Psytech, Conmed, Digital Therapeutics Alliance, Endo Tools, Healthware Group, Hyperfine, In2bones, Ksana Health, Moleculight, Orthopediatrics, Outset, Pega Medical.
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