Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Nano-x, Tyber.
In breast cancer, neoadjuvant chemotherapy reduces the tumor before surgery. However, the response to this treatment does not depend solely on the subtype of malignancies. Other factors could play a key role in its effectiveness, as shown in a study that described how the estrous cycle phases contribute to this variation.
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.