Prospective Study to Evaluate Safety and Performance of Indigo® System and CAT RX Aspiration Catheter ALAMEDA, Calif. – October 10, 2019 – Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced enrollment of the first patient into the CHEETAH study, a prospective, multi-center U.S. study to […]
Other News
FDA Classifies Medtronic Sherpa Delivery Catheter Field Action Initiated in March 2019 as Class I Recall
DUBLIN, Oct. 09, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced the U.S. Food and Drug Administration (FDA) has classified the company’s voluntary field action initiated in March 2019 related to the 6F Sherpa™ NX Active Coronary Guide Catheter as a Class I recall. The catheter is used during coronary […]
Corvia Medical’s Interatrial Shunt Device (IASD®) Receives Breakthrough Device Designation For Heart Failure
TEWKSBURY, Mass., Oct. 9, 2019 /PRNewswire/ — Corvia Medical, Inc., a privately-held company with a first-in-class structural heart device to treat heart failure, today announced the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its InterAtrial Shunt Device (IASD) for heart failure. The IASD is […]
Novoheart Grants Stock Options
VANCOUVER, British Columbia, Oct. 08, 2019 (GLOBE NEWSWIRE) — Novoheart Holdings Inc. (“Novoheart” or the “Company”) (TSXV: NVH; FWB: 3NH) announces that it has granted incentive stock options to purchase an aggregate of 1,150,000 common shares of the Company (the “Options”) to non-executive directors of the Company. Option Grants The Options have […]
The subscription period in Acarix’ rights issue commence today
Malmö, 9 October 2019 The subscription period in Acarix’ rights issue commence today The board of directors of Acarix AB (“Acarix” or the “Company”) resolved on 25 September 2019, pursuant to the authorization granted by the extra general meeting on 16 August 2019, to carry out a new share issue […]
First Patient in Middle East Treated With Cardiovascular Systems, Inc. Peripheral Orbital Atherectomy System
Introduction of Orbital Atherectomy Expands Treatment Options for Patients with Peripheral Artery Disease ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today that the first patient in the United […]
Medtronic Receives FDA Breakthrough Device Designation for Developing Stent Graft System to Treat Thoracoabdominal Aortic Aneurysm
News Follows Medtronic Receiving FDA Breakthrough Device Designation for its Valiant Navion™ LSA Branch Thoracic Stent Graft System DUBLIN, Oct. 08, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its Valiant® TAAA Stent Graft System […]
PQ Bypass Announces Unconditional IDE Approval From U.S. FDA to Start TORUS SFA Stent Graft Pivotal Study (TORUS-2)
TORUS-2 marks second Investigational Device Exemption approved for company in less than two years. MILPITAS, Calif.–(BUSINESS WIRE)–PQ Bypass, Inc., a clinical-stage medical device company, today announced it has received full approval of its investigational device exemption (IDE) trial of the company’s TORUS stent graft, a novel stent graft platform designed […]
BioVentrix Enrolls and Treats First Patient in REVIVE-HF European RCT for Ischemic Heart Failure Patients
SAN RAMON, Calif., Oct. 8, 2019 /PRNewswire/ — BioVentrix, Inc. announced the first patient was enrolled and treated in the REVIVE-HF European study, a prospective multi-center, dual-arm randomized controlled study evaluating the treatment of ischemic cardiomyopathy induced heart failure with the Revivent TCTM System compared to Guideline-Directed Medical Therapy (GDMT) or drug treatment. The patient […]
BioCardia Receives CE Mark Renewal For Helix Biotherapeutic Delivery Catheter And Morph Guide Catheter Through May 2024
SAN CARLOS, Calif., Oct. 08, 2019 (GLOBE NEWSWIRE) — BioCardia (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced renewal of the CE Mark for the Helix™ Biotherapeutic Delivery Catheter and Morph® Universal Deflectable Guide Catheter, both used in the delivery of biotherapeutics to the heart. CE Mark renewal enables […]
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