DANVERS, Mass.–(BUSINESS WIRE)–Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart recovery and support technologies, today reported fourth quarter fiscal 2019 revenue of $207.1 million, an increase of 19% compared to revenue of $174.4 million for the same period of fiscal 2018. For fiscal year 2019, total revenue was $769.4 […]
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Cardiovascular Systems, Inc. Reports Fiscal 2019 Third-Quarter Financial Results
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, today reported financial results for its fiscal third quarter, ended March 31, 2019. CSI’s third-quarter revenues were $63.3 million, an increase of […]
Surmodics Reports Second Quarter Fiscal 2019 Results
EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, today announced results for its fiscal 2019 second quarter ended March 31, 2019, and updated its financial outlook for fiscal 2019. Summary of Second Quarter and Recent Highlights […]
First-of-its-Kind Large Access Dilator Launches in U.S., Following Cleveland Clinic Case
TORONTO, May 2, 2019 /PRNewswire/ – Baylis Medical announced today the U.S. launch and first clinical use of its ExpanSure™ Transseptal Dilation System, used in a left-atrial appendage (LAA) closure case performed at the Cleveland Clinic, in Cleveland, Ohio. The ExpanSure dilator combines a sheath and dilator into a single tool, and facilitates larger […]
Concept Medical Inc. Granted ‘Breakthrough Device Designation’ From FDA for Its MagicTouch Sirolimus Coated Balloon
TAMPA, Florida, May 2, 2019 /PRNewswire/ — Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA) for MagicTouch, its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of coronary in-stent restenosis (ISR). In-stent restenosis (ISR) is the gradual re-narrowing of a stented coronary artery lesion, due to […]
FDA Approves Initiation of STEMI DTU Pivotal Randomized Controlled Trial
DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ: ABMD) announces that, on April 26, the FDA approved initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial. The prospective, multi-center, two-arm trial plans to enroll 668 patients undergoing treatment for a STEMI heart attack. Half the patients will be randomized to receive […]
Medtronic Receives FDA Approval for CareLink SmartSync Device Manager
DUBLIN – May 2, 2019 – Medtronic plc (NYSE:MDT) today announced that the company has received U.S. Food and Drug Administration (FDA) approval for the CareLink SmartSync(TM) Device Manager. With the introduction of SmartSync, physicians will now be able to use an Apple® iPad® to program and manage data from Medtronic’s BlueSync-enabled […]
Sotera Wireless to Showcase Its Life-Saving ViSi Mobile 1.5G at the 2019 IHI Patient Safety Congress
SAN DIEGO–(BUSINESS WIRE)–Sotera Wireless, maker of the ViSi Mobile® Surveillance Monitoring System will be exhibiting at the Institute for Healthcare Improvement Patient Safety Congress (IHI) on May 15-17 in Houston, TX. The IHI Patient Safety Congress brings together people who are passionate about providing the highest quality care and patient […]
GENETIC-AF Phase 2B Trial Results Published in the Journal of American College of Cardiology: Heart Failure
WESTMINSTER, Colo., May 01, 2019 (GLOBE NEWSWIRE) — ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today announced that the paper “GENETIC-AF: Bucindolol for the Maintenance of Sinus Rhythm in a Genotype-Defined Heart Failure Population” was published in JACC: Heart Failure, a journal […]
Biofourmis’ RhythmAnalytics™ Platform Receives FDA Clearance for AI-Based Automated Interpretation of Cardiac Arrhythmias
BOSTON, April 30, 2019 /PRNewswire/ — Biofourmis announced today that the U.S. Food and Drug Administration (FDA) has granted the company clearance for its RhythmAnalyticsTM platform, a cloud-based software for automated interpretation of cardiac arrhythmias. It uses an enhanced deep-learning technique to detect over 15 types of cardiac arrhythmias along with beat-by-beat morphology computation which […]



