Other News

Orchestra BioMed™ Enhances Management Team with Appointment of Regulatory Affairs and Combination Product Expert Bob Laughner as Vice President, Regulatory Affairs

NEW HOPE, Pa., April 28, 2020 (GLOBE NEWSWIRE) — Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company developing transformative therapeutic products for large unmet needs in procedure-based medicine, today announced the appointment of Bob Laughner, an expert in global regulatory affairs for combination products, as Vice […]

Coala first smartphone ECG to detect 9 different arrhythmias during COVID-19

Clinical indications expanded by FDA’s Emergency Guidance to enable more concise home-based ECG monitoring IRVINE, Calif., April 28, 2020 /PRNewswire/ — Coala Life, a world leading pioneer in remote and real-time cardiac monitoring solutions, today announces additional expansion of capabilities to help monitor patients from home. The expansion makes the Coala Heart Monitor […]

AtaCor Medical Secures $25M Financing to Continue Extracardiac Pacing Development

SAN CLEMENTE, Calif.–(BUSINESS WIRE)–AtaCor Medical, Inc. announced today that is has completed a $25M Series B financing. The financing syndicate, led by a corporate partner, includes existing investors Broadview Ventures and aMoon Fund as well as new investors Hatteras Venture Partners, Catalyst Health Ventures (CHV) and Longview Ventures, a Broadview affiliate. […]

LivaNova Bi-Flow Cannula Receives CE Mark for ECMO Applications

Bi-Flow is first bidirectional femoral arterial cannula validated for 29 days’ use LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology and innovation company, today announced its Bi-Flow Extracorporeal Membrane Oxygenation (ECMO) cannula earned CE Mark approval for ECMO procedures where femoral artery cannulation can be applied. Bi-Flow previously received CE […]

Merit Medical Reports Earnings for Quarter Ended March 31, 2020, Withdraws FY 2020 Guidance

*  Core revenue on a constant currency basis, non-GAAP EPS, non-GAAP net income, non-GAAP operating margin, non-GAAP gross margin and free cash flow are non-GAAP financial measures. A reconciliation of these and other non-GAAP financial measures used in this release to their most directly comparable GAAP financial measures is included under […]

Edwards Lifesciences Reports First Quarter Results

IRVINE, Calif., April 23, 2020 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today reported financial results for the quarter ended March 31, 2020. First Quarter Results and Outlook Sales grew nearly 14% to $1.1 billion TAVR sales grew 24%; underlying1 sales grew 25% […]

Cagent Vascular Announces FDA 510(k) Clearance for its Serranator Device for the Infrapopliteal Indication and Completion of its PRELUDE-BTK Clinical Trial Enrollment

WAYNE, Pa.–(BUSINESS WIRE)–Cagent Vascular, a developer of serration technology for vessel dilatation in cardiovascular disease interventions, announces FDA 510(k) Clearance of its Serranator® PTA Serration Balloon Catheter for treating below-the-knee (BTK) lesions. The Serranator device is the first and only angioplasty balloon FDA Cleared and CE Marked that embeds serration technology into a […]

CHF Solutions Ships First Commercial Orders of Aquadex SmartFlow™ system to Austria

EDEN PRAIRIE, Minn., April 23, 2020 (GLOBE NEWSWIRE) — CHF Solutions (Nasdaq: CHFS), a medical device company dedicated to changing the lives of patients suffering from fluid overload, today announced that it has shipped the first commercial orders of its next generation Aquadex SmartFlow™ system to Austria, following shipments to […]