Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adifem, Aditxt, Angle, Axena, Evofem, Multiply Labs, Legend Biotech, Mölnlycke, Neurosense, Nuprobe, Ondine, Parmed, Schivo, Spineology.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: B. Braun, Epineuron, Linear Health Sciences, Rhythm AI.
Route 92 Medical Inc. sped past its series F goal, raising an additional $50 million in an extension to the oversubscribed round. The extension brings the total for the series F to $82 million, which the company plans to use to accelerate commercialization of its neurovascular reperfusion and access systems.
Onward Medical NV successfully implanted its Arc-BCI system, which restores direct communication from the brain to the spinal cord enabling lower limb mobility, into a third patient.
The U.S. FDA wrapped up the pilot version of the Accreditation Scheme for Conformity Assessment (ASCA) and reported the formation of a permanent ASCA program, which has been seven years in the making.
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