Other News

EchoNous Receives FDA Clearance for Lexsa Linear Probe, Designed for Kosmos Ultraportable Ultrasound Platform

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 […]

Helius Medical Technologies, Inc. Announces FDA Breakthrough Device Designation for the Treatment of Dynamic Gait and Balance Deficits Following a Stroke

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 […]

Orchestra BioMed™ Announces Peer-Reviewed Publication of MODERATO II Study Results Showing a Statistically Significant Reduction in Blood Pressure in Pacemaker-Indicated Patients Treated with BackBeat Cardiac Neuromodulation Therapy™

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 […]

SINOMED announces the first commercial implantation and European launch of the HT Supreme Drug Eluting Stent

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 […]

Vivalink Announces Real-World Evidence Data Platform to Power Virtual Patient Care and Decentralized Clinical Trials

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 […]

Qardio announces QardioDirect; the end-to-end Remote Patient Monitoring and telehealth service to manage chronic care patients.

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 […]

Neovasc Announces Submission of COSIRA-II Protocol Supplement to FDA

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 […]

Merit Medical Launches One-Vac™ Evacuated Drainage Bottle for Percutaneous Fluid Collection and Discard

Advanced design makes sample collection simple, efficient, and safe SOUTH JORDAN, Utah, Aug. 16, 2021 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy, […]

Humacyte Announces Addition of Chief Commercial Officer and Integration of Commercial-Scale Manufacturing into Clinical Trial Programs

Appoints proven commercial leader B.J. Scheessele as Chief Commercial Officer In-house Durham, N.C. facility is operational and supplying clinical trial material produced in commercial-scale manufacturing system Company’s proprietary modular manufacturing systems can produce an estimated 40,000+ vessels annually in current facility when scaled up DURHAM, N.C., Aug. 17, 2021 (GLOBE […]