Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic, Route 92 Medical, Yourbio Health.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Axonics, Curative, Devyser Diagnostics, Fractyl Health, Intermed Labs, Thermo Fisher, Radian.
The amount of money raised by med-tech companies in the first quarter (Q1) of 2023 is the lowest amount raised for the industry during any quarter going back to 2018.
Reach Neuro Inc. has been granted FDA breakthrough device designation for a rehab platform that delivers small electrical impulses to the spinal cord to help restore shoulder, arm and hand movement to individuals suffering from chronic stroke. The company said Avantis restores a patient's ability to control movement, not only giving the patient immediate relief, but making it possible to return to therapy and continue making even further improvements.
The U.S. Supreme Court has handed down a broadly unanimous decision that allows the targets of Federal Trade Commission (FTC) enforcement action to appeal that action to federal district court prior to the conclusion of the agency’s review or enforcement process. The outcome could prove a boon to life science companies that may now challenge FTC actions against mergers and acquisitions prior to the conclusion of that action, a point at which the company’s options have narrowed drastically.
Biocartis Group NV recent entered an agreement with Apis Assay Technologies Ltd. to develop Apis’ breast cancer subtyping assay on its Idylla platform, is part of the Belgium company’s mission to bring complex molecular testing to as many patients as possible, outgoing Biocartis CEO Herman Verrelst, told BioWorld. The Idylla platform is a fully automated, real-time PCR based molecular testing system. With the technology failing to penetrate the U.S. market, and the share price tanking in recent years, the Belgium-based company recently appointed Roger Moody to the top job, effective Apr. 24, 2023.
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