Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bosotn Scientific, Neurent, Viz.ai.
Fineheart SA will soon begin a first-in-human study of Flowmaker, its fully implantable left ventricular assist device, in France, after receiving authorization from the French National Agency for the Safety of Medicines and Health Products to initiate the trial.
The bankruptcy of genetic testing service 23andme Holding Corp. prompted a reaction from many quarters, but a June 11 Senate hearing highlighted an interest in federal privacy legislation that would be directed toward genetic privacy as well as comprehensive and preemptive federal privacy legislation.
The U.K.’s National Health Service reported June 10 that patients in the U.K. will be the first in Europe to enjoy the benefits of the Edison ultrasound histotripsy for ablation of liver cancer tumors as part of an effort to bring products to market more quickly to deal with unmet needs.
South Korea’s Ministry of Food and Drug Safety on June 9 approved Vuno Inc’s AI-based Med-DeepECG Kidney software as a non-invasive method to screen for kidney dysfunction.
What does it take to create space in a market dominated by a single player? Three challengers to Johnson & Johnson's Shockwave shared their strategies for gaining traction in intravascular lithotripsy (IVL) at the Device Talks meeting June 11 in Minneapolis.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Demant, Femasys, Kind Group GmbH, Onconetix, Nvidia Corp, Quantum-Si, Seastar Medical, Spiderwort Biotechnologies.
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