The Latest Cardiac and Vascular News
– 2022 CGuard EPS revenue of $5.1 million increased 18.9% over 2021 – – Resumed shipments of CGuard EPS to CE Mark territories under the pre-existing Medical Device Directive (MDD) regulatory framework; Company anticipates re-certification under new Medical Device Regulation (MRD) framework in coming weeks – – Continued enrollment in the C-Guardian […]
Fiscal Year 2023 Third Quarter Highlights Net sales of $80.7 million increased 9.1% compared to the prior-year quarter Med Tech net sales of $22.9 million increased 16.6% Med Device net sales of $57.8 million increased 6.4% Gross margin of 50.2% decreased 200 basis points year over year GAAP loss per […]
FREMONT, CA / ACCESSWIRE / March 28, 2023 / Q’Apel Medical Inc. was granted the CE Mark under MDR for Walrus, their U.S. market-leading Balloon Guide Catheter (BGC) utilized in treating patients suffering an acute ischemic stroke. The Walrus BGC has been utilized by Neuro Interventional physicians since 2019 and has successfully treated over 20,000 […]
– Year-end cash resources, together with $125 million proceeds from March 2023 strategic financing, expected to fund operations into mid-2025 – NDA submission for etripamil in patients with PSVT expected for 3Q23 MONTREAL and CHARLOTTE, N.C., March 29, 2023 /PRNewswire/ — Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today reported financial results […]
SUNNYVALE, Calif., March 29, 2023 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the year ended December 31, 2022 and filed its annual report on Form 10-K for the year ended December 31, […]
Announces Receipt of Positive Formal FDA Feedback via the Q-Submission Program Substantially reduces the anticipated time and cost needed to receive a PMA EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that it has […]
ECGenius System & CARDIALYTICS Suite Recognized as Critical to the Evolution of Electrophysiology COPENHAGEN, Denmark, March 28, 2023 /PRNewswire/ — CathVision, a medical technology company developing innovative electrophysiology solutions designed to enhance clinical decision-making in the EP lab, is proud to announce the achievement of significant milestones demonstrating both the clinical and commercial […]
SHANGHAI, March 28, 2023 /PRNewswire/ — Pulnovo Medical Limited, a globally recognized OTM platform, announced the results from its PADN series study during the Late-Breaking Clinical Science (LBCS) session of the second Technology and Heart Failure Therapeutics (THT 2023), with the presentation of its follow-up findings from PADN-5 study. As the first […]
CAUTION: Investigational device. Limited by United States law to investigational use. FIRST U.S. PATIENT ENROLLED IN GORE® VIAFORT Vascular Stent pivotal study FLAGSTAFF, Ariz., March 28, 2023 /PRNewswire/ — W. L. Gore & Associates (Gore) has announced that the first U.S. patient has been enrolled in a prospective, non-randomized, multicenter, single-arm study with 5-year […]
BOSTON, March 28, 2023 /PRNewswire/ — CereVasc, Inc., a privately held, clinical-stage, medical device company developing novel, minimally invasive treatments for neurological diseases, names Adel Malek, MD PhD as the company’s Chief Medical Officer. This new appointment will allow CereVasc to further accelerate the development and clinical strategy of the eShunt® System, the first […]
