Shanghai Heartcare Medical Technology Corp. Ltd. received marketing approvals for three medical devices designed for stroke, namely its left atrial appendage (LAA) occluder, the aspiration catheter, and the support catheter.
The Embold fibered detachable coil developed by Boston Scientific Corp. to obstruct or reduce the rate of blood flow during therapeutic treatment in the peripheral vasculature, has won U.S. FDA 510(k) clearance.
Cvrx Inc. secured U.S. FDA approval for magnetic resonance-conditional labeling for its Barostim system, a neuromodulator that improves symptoms of patients with heart failure. With the latest approval, patients with the implanted system can have magnetic resonance imaging (MRI) at 1.5T under the specified conditions.
Abbott Laboratories reported results from its PERSIST-END study demonstrating that close to nine in 10 patients treated for persistent atrial fibrillation (AF) with its Tacticath contact force ablation, sensor-enabled (Tacticath SE) were free of symptoms of their arrhythmia over 15 months of follow-up. The study’s findings, which supported a November 2021 FDA approval for persistent AF, also showed significant improvement in patients’ quality of life and a more than 50% cut in the use of health care resources, the company said.
Acutus Medical Inc. is selling its left-heart access portfolio to Medtronic plc in a deal worth upwards of $50 million. The portfolio of devices includes a line of sheath-compatible septal crossing devices and steerable sheaths. Under the terms of the agreement, Medtronic will make an upfront cash payment to Acutus of $50 million and additional undisclosed payments based on milestones and future sales.
Be’er Sheva, Israel-based Dia Imaging Analysis Ltd. has partnered with technology conglomerate Intel Corp. to accelerate the analyzing time of its artificial intelligence (AI)-based cardiac ultrasound software. Dia said Intel’s Open Vino toolkit will optimize the processing time of its Lvivo Seamless solution by over 40%.
Investors showed some love to French remote patient monitoring and cardiac data startup Implicity SAS, contributing $23 million to the company’s series A financing round. New investors Crédit Mutuel Innovation and Bpifrance led the round with support from BNP Paribas Development and returning seed investors Serena, Xange and Karista.
Carmat SA just completed a funding exercise, raising nearly $44 million to resume production and implantation of its Aeson total artificial heart, designed for patients suffering from end-stage bi-ventricular heart failure. The capital raise was achieved by issuing 4.05 million new shares on the Paris Euronext exchange, at a fixed price of $10.81 a share.
Royal Philips NV has signed an agreement to acquire Vesper Medical Inc., a U.S.-based developer of minimally invasive peripheral vascular devices. The deal expands Philips’s portfolio of technologies for the treatment of deep venous disease. The transaction is expected to be completed in the first quarter of 2022. Financial details were not disclosed.
PARIS – Royal Philips NV has signed a deal to acquire Cardiologs Technologies SAS and its artificial intelligence technology. The financial terms surrounding the transaction have not been disclosed. The two companies expect to close the deal in the coming months.