The force is with Field Medical Inc. as it celebrates the U.S. FDA’s decisions to grant breakthrough device designation (BDD) to its Fieldforce ablation system and to accept it into the agency’s Total Product Life Cycle Advisory Program pilot. Field Medical designed the Fieldforce pulsed field ablation catheter specifically to treat ventricular tachycardia. The BDD applies to its use in monomorphic scar-related VT.
The recent $73 million raised by Cradle NV in a series B financing round will allow the company to build out its operations and improve its artificial intelligence-powered protein engineering platform.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: EDAP, Icecure, Novocure, Oncocyte, Spotitearly, Heartvista.
New hires and promotions in the med-tech industry, including: Acuamark Diagnostics, Atomvie Global Radiopharma, Avania, Exai Bio, Firefly Neuroscience.
A federal jury awarded Insulet Corp. $452 million against Eoflow Co. Ltd., concluding that Eoflow and other defendants stole trade secrets to create the Eopatch, a device with striking similarities to Omnipod, Insulet’s market-dominating tubeless insulin pump.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Centerline Biomedical, Lifesignals, Lungpacer Medical, Magstim, Nano-X Imaging.
After raising AU$7 million (US$4.5 million) in is initial public offering on the Australian Securities Exchange last week, Renerve Ltd. is already exploring mainland China for its portfolio of nerve repair and regeneration products.
Beacon Biosignals Inc. can rest easy now that it has received U.S. FDA authorization of its predetermined change control plan for the Dreem 3s, a wearable sleep monitor that conducts electroencephalograms as users sleep. The authorization allows Beacon to incorporate updates to the Dreem 3S sleep-staging algorithm acquired through machine learning without submitting a new 510(k) application.
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