Other News

CORRECTING and REPLACING Surmodics Reports Second Quarter Fiscal 2018 Results, Increases Fiscal 2018 Guidance

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–The fifth bullet in the Recent Highlights section should read: EPS of $0.11, Non-GAAP EPS of $0.07 (instead of EPS of $0.11, Non-GAAP EPS of $0.15). The correct figure of $0.07 is represented in the Second Quarter Fiscal 2018 Financial Results section and throughout the financial tables. […]

Nobles Medical Launches Sales of its NobleStitch™ EL for PFO Closure in Spain

BARCELONA, Spain, May 2, 2018 /PRNewswire/ — NMT2 announces the further expansion of the NobleStitch™ EL with the addition of Hospitals in Barcelona, the first to perform PFO closure cases in Spain has been Vall Hebron Hospital.   Dr. Gerard Marti, Consultant in Interventional Cardiology and Structural Heart disease at the Hospital Vall Hebron was the first […]

New Study Examines Online Vs Offline ECG Monitoring to Detect Difficult-to-Diagnose Arrhythmia

BOSTON, May 2, 2018 /PRNewswire/ — Medicalgorithmics, S.A. (WSE: MDG) today announced the presentation of a large study evaluating online vs offline ECG monitoring methods to diagnose paroxysmal atrial fibrillation (AF), often difficult to detect because of its episodic nature. Research will be presented at the Heart Rhythm Society Annual Scientific Sessions, May 9-12 at […]

Abbott’s XIENCE Sierra™ Heart Stent Receives National Reimbursement in Japan to Treat People with Coronary Artery Disease

ABBOTT PARK, Ill., May 2, 2018 /PRNewswire/ — Abbott (NYSE: ABT) today announced that Japan’s Ministry of Health Labour and Welfare (MHLW) granted national reimbursement for XIENCE Sierra™, the newest generation of the company’s gold-standard XIENCE everolimus-eluting coronary stent. XIENCE Sierra improves upon previous versions of XIENCE with an enhanced stent design, a new delivery […]

iSchemaView Receives FDA Clearance for RAPID CTA Leader in Advanced Cerebrovascular Imaging First to Meet the Needs of Large and Small Centers and Hospitals with New CTA Support and 3D Imaging Added to Complete Suite of RAPID Offerings

Menlo Park, Calif. – May 1, 2018 – iSchemaView, the leader in cerebrovascular imaging analysis, today announced it has received final clearance from the U.S. Food and Drug Administration (FDA) for RAPID CTA, the company’s 3D imaging solution for Computed Tomography Angiography. RAPID CTA is the newest addition to iSchemaView’s industry […]

Vascugen Licenses Stem Cell Technology for Blood Vessel Regeneration Developed at IU School of Medicine

INDIANAPOLIS, May 1, 2018 /PRNewswire/ — Vascugen Inc. today announced that it has licensed a suite of intellectual property developed at the Indiana University (IU) School of Medicine related to blood vessel formation from adult stem cells. The regenerative medicine company is focused on finding therapies to repair tissues damaged by reduced blood flow due to disease […]

CryoLife to Present at Deutsche Bank 43rd Annual Health Care Conference

ATLANTA, May 1, 2018 /PRNewswire/ — CryoLife, Inc. (NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease, announced today that it will participate in a fireside chat presentation at the upcoming Deutsche Bank 43rd Annual Health Care Conference on Tuesday, May 8, 2018, at the Intercontinental Hotel in Boston. A live webcast of […]

Ortho Clinical Diagnostics Supports ERAS® Cardiac Surgery Consensus Statement of Best Practices to Enhance Recovery After Heart Surgery

RARITAN, N.J., May 1, 2018 /PRNewswire/ — Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, welcomes and supports today’s inclusion of the biomarkers in the NephroCheck® Test, an FDA-cleared and CE-marked urine test that indicates kidney stress in advance of acute kidney injury (AKI), in consensus guidelines released by ERAS® Cardiac Surgery. The new […]

Actelion Submits Supplemental New Drug Application to US FDA Seeking Approval of OPSUMIT® (macitentan) for the Treatment of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

CHERRY HILL, N.J. and ALLSCHWIL, Switzerland, April 30, 2018 /PRNewswire/ — Actelion Pharmaceuticals Ltd, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking to expand the indication of OPSUMIT (macitentan) to include the treatment […]

Edwards Lifesciences Enters Into Accelerated Share Repurchase Agreement

IRVINE, Calif., May 1, 2018 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, announced today that it entered into an accelerated share repurchase (ASR) agreement to repurchase an aggregate of $400 million of Edwards’ common stock.  Under the terms of this ASR agreement, […]