SANTA CLARA, Calif., May 12, 2020 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (Nasdaq: SWAV), a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, today reported financial results for the three months ended March 31, 2020. Recent Highlights Recognized revenue of $15.2 million […]
Author: Ken Dropiewski
Cereno Scientific Expands Footprint Into the United States With a Subsidiary in Boston, MA
STOCKHOLM, May 13, 2020 /PRNewswire/ — Cereno Scientific today announced that the company has expanded its global footprint by establishing a subsidiary with new office space located in Kendall Square at the Cambridge Innovation Center (CIC), Cambridge, Boston, Massachusetts. The CIC is one of the industry’s most recognized biotechnology hubs and has supported more than […]
Medicure Reports Financial Results for Quarter Ended March 31, 2020
WINNIPEG, May 12, 2020 /PRNewswire/ – Medicure Inc. (“Medicure” or the “Company“) (TSXV:MPH, OTC:MCUJF), a cardiovascular pharmaceutical company, today reported its results from operations for the quarter ended March 31, 2020. Quarter Ended March 31, 2020 Highlights: Recorded total net revenue from the sale of products of $3.0 million during the quarter ended March 31, 2020 compared to $4.9 million for […]
Philips receives FDA clearance for the use of its ultrasound portfolio to manage COVID-19-related lung and cardiac complications
May 13, 2020 Philips’ ultrasound portfolio, including Lumify with Reacts handheld tele-ultrasound solution, provides valuable diagnostic insight for front-line care providers Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration […]
CARMAT Obtains Approval for the Reimbursement of Its Total Artificial Heart During the US Clinical Feasibility Study
Centers for Medicare & Medicaid Services (CMS) confirms coverage of the device and routine care items and services PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (Paris:ALCAR) (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart […]
PhaseBio Reports First Quarter 2020 Financial Results and Recent Business Highlights
Initiated PB2452 Phase 3 Trial for the Reversal of the Antiplatelet Effects of Ticagrelor MALVERN, Pa & SAN DIEGO–(BUSINESS WIRE)–PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today reported financial results from the first quarter ending March 31, […]
FDA Clears New XO Cross Microcatheter Platform
New non-tapered metal-alloy catheter platform FDA cleared for use in peripheral vasculature PARK CITY, Utah, May 12, 2020 /PRNewswire/ — Transit Scientific announced the FDA cleared the XO Cross® Microcatheter platform for guidewire support, exchange, and contrast media injection in the peripheral vasculature. Microcatheters are small 0.70-1.30mm outer diameter (OD) catheters used to provide guidewire […]
CardioFocus Announces US FDA Approval of HeartLight® X3 System for the Treatment of Atrial Fibrillation
MARLBOROUGH, Mass., May 12, 2020 /PRNewswire/ — CardioFocus, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the next-generation HeartLight® X3 Endoscopic Ablation System for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF). Approval of the HeartLight X3 System came as a result of a comprehensive submission, including outcomes […]
Micro Medical Solutions: First Case Completed in STAND Study, the Pivotal Clinical Trial of MicroStent
Major milestone reached in journey toward FDA approval for potentially limb-saving treatment of peripheral artery disease WILMINGTON, Mass., May 12, 2020 /PRNewswire/ — Micro Medical Solutions (MMS) today announced the first implantation of the MicroStent vascular stent in the FDA randomized, multicenter pivotal clinical study, STAND (A Clinical Evaluation of the MicroSTent PeripherAl Vascular […]
MyoKardia Announces Primary and All Secondary Endpoints Met in Phase 3 EXPLORER Clinical Trial of Mavacamten for the Treatment of Obstructive Hypertrophic Cardiomyopathy
Highly Statistically Significant Improvements in NYHA Classification, Peak VO2, and LVOT Gradient Observed vs. Placebo Mavacamten Well Tolerated; Safety Results Comparable to Placebo U.S. Regulatory Submission Planned for Early 2021 MyoKardia to Host Conference Call at 8:00 a.m. ET BRISBANE, Calif., May 11, 2020 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq: MYOK) […]



