Press Releases

DUBLIN — September 18, 2018 — Medtronic plc (NYSE:MDT) today announced that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) to initiate a single-arm study to evaluate the CoreValve Evolut(TM)TAVR system in patients with bicuspid aortic valves…
FLAGSTAFF, Ariz. (SEPTEMBER 17, 2018) — W. L. Gore & Associates, Inc. (Gore) today announced the first European patient implant of the GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System. This next-generation endovascular aneurysm repair (EVAR) device is indicated to…
Minneapolis, MN—September 13, 2018—Researchers at the Minneapolis Heart Institute Foundation®(MHIF) enrolled their first patient in the TVINCITIES study (aorTic Valve dIsease aNd raCIal dispariTIES). This study is an example of physician-initiated research conducted at MHIF and is inspired and…
DUBLIN – September 10, 2018 – Medtronic plc (NYSE:MDT) today announced the start of the Onyx ONE Clear Study in the U.S. and Japan that will evaluate one-month dual antiplatelet therapy (DAPT) in high bleeding risk patients implanted with the Resolute Onyx™ Drug-Eluting Stent (DES) during…
London—September 7, 2018—BTG plc (LSE: BTG), the global specialist healthcare company, today announces it has acquired Novate Medical Ltd. (“Novate”), a medical device company focused on the prevention of pulmonary embolism (PE) in patients at high risk of venous thromboembolic events. Novate…
Frauenfeld, September 05, 2018 — SIS Medical, a Swiss manufacturer of innovative cardiology products, is launching three new models of its balloon catheters. EasyT, NIC 1.1 hydro and NIC Nano hydro have characteristics that define new standards for this type of catheters. They also recently…
DUBLIN and MUNICH — August 28, 2018 — Medtronic plc (NYSE:MDT) today announced new findings from the CRYO4PERSISTENT AF clinical trial demonstrating improved quality of life, reduced symptoms from abnormal heart rhythms, and low incidence of reinterventions and repeat ablation procedures. The…
PHILADELPHIA, Aug. 27, 2018 — Jonathan Chen, MD, will join Children's Hospital of Philadelphia (CHOP) as Chief of the Division of Cardiothoracic Surgery on September 1, 2018. Dr. Chen joins a world-renowned surgical team who are pioneers in developing innovative surgical techniques, including…
KIRKLAND, Wash., Aug. 27, 2018 — Prevencio, Inc. today announces data demonstrating its HART PAD™ test accurately diagnoses peripheral artery disease (PAD) in diabetes mellitus (DM) patients, a patient population in which PAD prevalence has traditionally been difficult to assess. Researchers…
Santa Monica, CA, Aug. 14, 2018 — BioSig Technologies, Inc. (OTCQB: BSGM), announced that the Company has received 510(k) clearance for its first product, PURE EP System, from the U.S. Food and Drug Administration (FDA).   The non-invasive PURE EP System is a computerized system intended for…
Redwood City, Calif. — August 14, 2018 — iSchemaView, the leader in cerebrovascular imaging analysis, today announced accelerated adoption of the RAPID advanced imaging platform. Over 575 stroke centers in 22 countries around the world have now committed to using the RAPID platform, with 520…
Vienna, VA (August 13, 2018) — B. Kelly Han, MD, FSCCT, is the recipient of the inaugural 2018 DeHaan Award for Innovation in Cardiology, and presented the first Dehaan Award Lecture at the Society of Cardiovascular Computed Tomography (SCCT) 13th Annual Scientific Meeting in Dallas, Texas on…
MARLBOROUGH, Mass., Aug. 8, 2018 — Boston Scientific Corporation (NYSE: BSX) today announced it has signed an agreement to acquire VENITI, Inc., a privately-held company in Fremont, California which has developed and commercialized the VICI VENOUS STENT® System for treating venous obstructive…
LONDON—Aug. 6, 2018—LivaNova PLC (NASDAQ: LIVN), a market-leading medical technology company, today announced the conclusion of the PRELUDE feasibility study for its Caisson Transcatheter Mitral Valve Replacement (TMVR) system. The PRELUDE first-in-human study evaluated the Company’s TMVR system…
DUBLIN — July 31, 2018 — Medtronic plc (NYSE:MDT) has received U.S. Food and Drug Administration (FDA) approval for the Implantable System for Remodulin® (ISR) to treat patients with pulmonary arterial hypertension (PAH). Through a first-of-its-kind collaboration, the Medtronic SynchroMed(TM) II…
BREA, California, July 25, 2018 — A recent article in the Annals of Emergency Medicine reported on the diagnostic accuracy of the newly released Beckman Coulter Access hsTnI assay in expediting the emergency department (ED) disposition for patients evaluated for suspected acute coronary syndrome…
DALLAS, July 19, 2018 — Ensuring patients with heart failure have access to the latest evidence-based care, and improved outcomes and quality of life, is at the core of a hospital certification program offered by the American Heart Association, the world’s leading voluntary organization…
SAN CARLOS, Calif., July 17, 2018 — BAROnova, Inc., announced today that it has submitted a Pre-Market Approval (PMA) application for the TransPyloric Shuttle device intended for the treatment of obesity to the Food and Drug Administration (FDA). Obesity is a worldwide epidemic with over 40% of…
KALAMAZOO, Michigan, USA, July 16, 2018 — Stryker Corporation announced today that the U.S. Food and Drug Administration has granted pre-market approval (PMA) for the Surpass Streamline Flow Diverter to treat unruptured large and giant wide neck intracranial aneurysms.  The device is the second…
DUBLIN — July 12, 2018 — Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) labeling expansion for the Medtronic SelectSecure(TM) MRI SureScan(TM) Model 3830 cardiac pacing lead to include stimulation of the bundle of His. It is the only pacing lead on the market…
MIAMI, July 11, 2018 — Scientists from the Diabetes Research Institute (DRI) at the University of Miami Miller School of Medicine today announced the launch of a new clinical trial that will assess the impact of high-dose omega-3 fatty acids and vitamin D supplementation on halting the…