LAGUNA HILLS, Calif., July 31, 2019 /PRNewswire/ — Adagio Medical, Inc., the developer of iCLAS™, the company’s ultra-low temperature intelligent continuous lesion ablation system for the treatment of cardiac arrhythmias, announces that the first PsAF patient was successfully treated with its new One Shot+™ cryoablation catheter in a procedure that utilizes only anatomical markers with limited usage […]
Rhythm
PhysIQ Inc. Receives FDA Clearance of Continuous Ambulatory Respiration Rate Algorithm Enabling Artificial Intelligence-based Analytics for Biopharma Companies and Payers
FDA 510(k) cleared Respiration Rate analytic adds to physIQ’s growing portfolio of FDA 510(k) algorithms Clearance allows physIQ to power its higher-level AI analytics with validated vital sign inputs PhysIQ’s cloud-based analytics provide flexibility to biopharma companies and payers looking for consistent output while deploying a variety of devices across […]
SentreHEART Announces Initial Clinical Use of the LARIAT® with EpiRAIL™ Procedure for Left Atrial Appendage Exclusion
REDWOOD CITY, Calif.–(BUSINESS WIRE)–SentreHEART, Inc., announced it has successfully completed nine First-In-Human procedures utilizing the LARIAT® with EpiRAIL™ at John Paul II hospital in Krakow, Poland. The LARIAT with EpiRAIL is an epicardial-only, percutaneous approach to complete and permanent closure of the left atrial appendage (LAA) in patients with atrial fibrillation […]
Magenta Medical Closes Funding Round Led by NEA in Its First-Ever Life Sciences Investment in Israel
KADIMA, Israel, July 29, 2019 /PRNewswire/ — Magenta Medical, the developer of heart failure solutions based on proprietary miniaturized blood pump technology, today announced a financing round led by global venture capital firm New Enterprise Associates (NEA), with participation from existing investors, including Pitango Venture Capital, JVC Investment Partners and a group of private […]
Eko Launches ‘Eko Home,’ a Cardiac Remote Monitoring Application Enabling Powerful Drug-Data Combinations to Enhance Clinical Studies and Pharmaceutical Trials
San Francisco, July 25, 2019 (GLOBE NEWSWIRE) — Eko, a Silicon Valley-based digital health company applying machine learning in the fight against heart disease, today announced Eko Home, a first-of-its-kind service that enables precise remote monitoring of cardiac function using ECG and heart sounds. Eko Home can be used to create […]
U.S. FDA Accepts Correvio’s Resubmitted New Drug Application For Brinavess (vernakalant)
VANCOUVER, July 25, 2019 /PRNewswire/ – Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for Brinavess™ (vernakalant hydrochloride, IV), an antiarrhythmic drug for the rapid conversion […]
HeartHero Closes Series A Round, Secures Funding for FDA Submission
DENVER–(BUSINESS WIRE)–HeartHero announces the closing of its oversubscribed Series A funding round. This funding secures a pathway for Elliot, an industry disruptive Automated External Defibrillator (AED), to be submitted for FDA Class III approval and CE mark. This round provides resources for high-volume manufacturing and launches HeartHero’s unique go-to-market strategy for […]
Ablative Solutions Announces Enrollment and Randomization of First Patient in Global Clinical Trial Evaluating Company’s Novel Therapy for Uncontrolled Hypertension
SAN JOSE, Calif., July 23, 2019 /PRNewswire/ — Ablative Solutions, Inc., a company pioneering new approaches to the treatment of hypertension, today announced the enrollment and randomization of the first patient in the TARGET BP I global clinical trial. Piedmont Heart Institute in Atlanta is the first hospital center worldwide to enroll and randomize […]
ZOLL Acquires Mobilize RRS LLC.
CHELMSFORD, Mass.–(BUSINESS WIRE)–ZOLL® Medical Corporation, an Asahi Kasei Group Company that manufactures medical devices and related software solutions, today announced it has acquired substantially all of the assets of Mobilize RRS LLC., of Pittsford, N.Y., a privately held company that markets the Mobilize Rescue Systems app and associated rescue kits, which are designed […]
EBR Systems Awarded Prestigious Forfait Innovation Package for WiSE CRT System by French Ministry of Social Affairs and Health
SUNNYVALE, Calif., July 22, 2019 /PRNewswire/ — EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced that the College of the French National Authority for Health (Haute Autorite de Sante, HAS) awarded a Forfait Innovation Package for the company’s WiSE™ Cardiac Resynchronization Therapy (CRT) System. […]
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