The Latest Cardiac and Vascular News
BOULDER, Colo., Aug. 18, 2021 /PRNewswire/ — CardioNXT announced today that it received marketing clearance from the U.S. Food and Drug Administration (FDA) for the platform technology comprised of the iMap 3D Navigation & Mapping System™, Activate Software™, Sensor Enabled Axis Patient Patches™, and MultiLink Sensor Enabled Catheter™. The CardioNXT technology platform enables […]
DANVERS, Mass.–(BUSINESS WIRE)–The United States Food and Drug Administration (FDA) has granted breakthrough device designation to Abiomed’s (NASDAQ: ABMD) Impella ECP expandable percutaneous heart pump. The designation means the FDA will prioritize Impella ECP’s regulatory review processes including design iterations, clinical study protocols and pre-market approval (PMA) application. Impella ECP is the smallest […]
SELENE HF adds to existing evidence that HF decompensation starts several weeks before hospitalization BERLIN, Aug. 18, 2021 /PRNewswire/ — BIOTRONIK today announced the results from a new study published in EUROPACE this week confirming that heart failure (HF) decompensation can be predicted early when monitored using an algorithm that combines existing remote monitoring trends and baseline […]
Latest Addition to the Kosmos Platform Now Enables Full-Body Imaging at Point-of-Care in a Hand-Carried Device REDMOND, Wash.–(BUSINESS WIRE)–EchoNous, the leader in portable AI-guided ultrasound tools and software, announced today that the U. S. Food and Drug Administration (FDA) has cleared Lexsa, the company’s new 128-channel linear probe, for use […]
NEWTOWN, Pa., Aug. 17, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that it has received Breakthrough Designation from the U.S. Food and Drug Administration (“FDA”) for its PoNS™ device with the proposed indication for […]
Double-blind, randomized trial data show a clinically meaningful and statistically significant net reduction of 8.1 mmHg in 24-hour ambulatory systolic blood pressure at 6 months in treated vs. control patients Very high (85%) response rate to therapy despite 81% of treated patients having isolated systolic hypertension (ISH), a more dangerous […]
TIANJIN, China, Aug. 17, 2021 /PRNewswire/ — SINOMED, a leading international medical device company, announced the first commercial implantation of the HT Supreme® Drug-Eluting Stent (DES) at University Hospital Galway in partnership with the National University of Ireland Galway (NUI Galway), marking the start of the European launch. The procedure was successfully performed by […]
End-to-end Biometrics Data Platform accelerates virtual healthcare application development CAMPBELL, Calif., Aug. 17, 2021 /PRNewswire/ — Vivalink, a leading provider of digital healthcare solutions for real-world evidence data, announces today the launch of its enhanced Biometrics Data Platform to accelerate the development and deployment of patient monitoring and data analysis applications for ambulatory and remote […]
SAN FRANCISCO, Aug. 17, 2021 /PRNewswire/ — Qardio, Inc. announced today the launch of QardioDirect; a premier end-to-end Remote Patient Monitoring (RPM) and telehealth service. QardioDirect is an all-inclusive service for RPM that works seamlessly with both patient and doctor. Qardio delivers device kits directly to the patient after prescription, and our team […]
VANCOUVER and MINNEAPOLIS, Aug. 17, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc Inc. (“Neovasc” or the “Company”) (Nasdaq, TSX: NVCN) announced today that it has filed a supplement to the COSIRA-II Investigational Device Exemption (IDE) Study with the U.S. Food and Drug Administration (FDA). Following multiple productive discussions with FDA over the […]
