Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Orthonovis, Sebela, Tandem.
Citing recent executive orders that suggest additional cuts to the federal workforce may be in the offing, U.S. Sens. Patty Murray, D-Wash., and Jeanne Shaheen, D-N.H., wrote to Health and Human Services Secretary Robert Kennedy urging him to end “indiscriminate cuts that will cause lasting harm to FDA’s public health mission” and to protect the agency’s statutory obligations.
The U.S. FDA hasn’t taken up criminal justice as a sideline, but it did just clear Sonio Suspect. Far from a social miscreant, Suspect improves detection of fetal anomalies by 22 points by automatically detecting multiple types of abnormal findings and allows for detection as early as 11 weeks of gestation.
Berlin Heals Holding AG recently raised over CHF7 million (US$7.8 million) in a financing round for C-MIC, a small implantable device it believes can reverse heart failure.
Med-tech firms raising money in public or private financings, including: Boston Scientific, Firefly Neuroscience Inc., Organox, Pavmed, Sonar, Veris Health.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Co-Diagnostics, Eyenovia, Fresenius, Philips, Quest, Sectra, Siemens Healthineers, Spectra Laboratories.
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