Regulatory

CMS Decision on TAVR Puts Patients at the End of the Line, says Heart Valve Voice

WASHINGTON, June 24, 2019 /PRNewswire/ — The Centers for Medicaid and Medicare Services last Friday issued their final National Coverage Decision on how hospitals will be approved to do the TAVR (transaortic valve replacement) procedure, a less invasive valve replacement treatment that avoids open heart surgery and allows patients to resume daily life […]

Micro Medical Solutions Receives FDA IDE Approval for Pivotal Clinical Trial of MicroStent

WILMINGTON, Mass., June 24, 2019 /PRNewswire/ — Micro Medical Solutions (MMS), an innovator in the field of microvascular interventions that improve clinical outcomes and quality of life, announced today that it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA). IDE approval allows MMS to initiate […]

Fujifilm to Showcase Array of Robust Technologies for Echocardiography at ASE 2019

LEXINGTON, Mass. and BOTHELL, Wash., June 21, 2019 /PRNewswire/ — (Booth #500) — Fujifilm will present its cardiovascular medical imaging portfolio including Synapse Cardiology PACS with Epsilon Imaging’s EchoInsight, as well as the SonoSite Edge II point-of-care-ultrasound system (POCUS) at the American Society of Echocardiography annual meeting (ASE 2019). The conference takes place June 21-25, 2019 at the Oregon Convention Center in Portland, OR. “At […]

BD Statement on FDA Circulatory System Devices Panel Regarding Paclitaxel-Coated Devices

FRANKLIN LAKES, N.J., June 20, 2019 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today issued the following statement following the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting related to the potential increase in mortality associated with […]

Philips receives FDA premarket approval for its HeartStart OnSite and HeartStart Home defibrillators

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has approved the company’s premarket approval (PMA) application for its HeartStart OnSite defibrillator [1] and HeartStart Home defibrillator [2], […]

Canon Medical Receives FDA Clearance for Deep Convolutional Neural Network Image Reconstruction Technology for CT

TUSTIN, Calif.–(BUSINESS WIRE)–Building on its advanced image reconstruction technologies, Canon Medical Systems USA, Inc. has received 510(k) clearance on its new deep convolutional neural network (DCNN) image reconstruction technology, ushering in a new era for CT. Canon Medical’s Advanced Intelligent Clear-IQ Engine (AiCE) uses a deep learning algorithm to differentiate signal from […]

Materialise Receives FDA Clearance for Cardiovascular Planning Software Suite

CHICAGO–(BUSINESS WIRE)–TVT2019 – Structural Heart Summit — Materialise (NASDAQ:MTLS), a global 3D printing software and solutions company, has received FDA clearance for its Mimics Enlight cardiovascular planning software suite. The first release will support clinicians planning complex transcatheter mitral valve replacement (TMVR) procedures. Mimics Enlight is based on the strengths of […]

Itamar Medical’s WatchPAT™ One, the First and Only Fully Disposable Home Sleep Apnea Test Receives FDA 510(k) Clearance

New system expands WatchPAT access to additional sleep centers by reducing infrastructure needs and eliminating capital requirements; also reduces infection risk for in-patient sleep apnea testing  CAESAREA, Israel, June 06, 2019 (GLOBE NEWSWIRE) — Itamar Medical Ltd. (Nasdaq:ITMR) (TASE:ITMR), a company that develops, manufactures and markets non-invasive diagnostic medical devices […]

GORE® CARDIOFORM ASD Occluder Receives FDA Approval for the Treatment of Atrial Septal Defects

FLAGSTAFF, Ariz., June 4, 2019 /PRNewswire/ — W. L. Gore & Associates (Gore) announced the U.S. Food and Drug Administration’s (FDA’s) premarket approval (PMA) of the GORE® CARDIOFORM ASD Occluder for the percutaneous closure of ostium secundum atrial septal defects (ASDs). The FDA approval was supported by data collected from the pivotal stage of the Gore […]

Medtronic Gains U.S. FDA Clearance for New Catheter System for HIS Bundle Pacing

DUBLIN – May 29, 2019 – Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) clearance and commercial launch for the SelectSite(TM) C304-HIS deflectable catheter system for use in procedures involving His-bundle pacing (HBP). The SelectSite C304-HIS deflectable catheter system features a deflectable, out-of-plane curve to reach the bundle […]