Regulatory

XableCath Receives Second FDA Clearance for Its Peripheral Arterial Catheters

SALT LAKE CITY–(BUSINESS WIRE)–XableCath, Inc., innovators of products designed to aid in the treatment of peripheral artery disease (PAD), announced that its second catheter, XableCath™ abrasion tip support catheter, was cleared by the FDA. The XableCath blunt tip catheter received FDA clearance at the end of 2017. This clearance gives […]

Avinger Receives FDA Clearance of Next Generation Pantheris Device

REDWOOD CITY, Calif., May 23, 2018 (GLOBE NEWSWIRE) — Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), announced today that the Company received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its next generation Pantheris® Lumivascular atherectomy system, the first-ever image-guided […]

CERENOVUS Receives FDA Clearance For Next Generation Stent Retriever Device Used To Treat Ischemic Stroke

IRVINE, Calif., May 21, 2018 /PRNewswire/ — CERENOVUS, part of the Johnson & Johnson Medical Devices Companies, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for EMBOTRAP II Revascularization Device, a next generation stent retriever used to capture and remove life-threatening blood clots from […]

CardioFocus® Announces FDA Approval Of The Next-Generation HeartLight® Excalibur Balloon™ Designed For The Treatment Of Paroxysmal Atrial Fibrillation*

MARLBOROUGH, Mass., May 7, 2018 /PRNewswire/ — CardioFocus, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted approval for the HeartLight Excalibur Balloon, a next-generation technology designed for the treatment of paroxysmal atrial fibrillation (PAF)*. The Excalibur Balloon leverages the proven universal balloon design of the company’s FDA-approved HeartLight® Endoscopic Ablation System and introduces an […]

Abbott Expands Cardiac Arrhythmias Portfolio with FDA Clearance of Advanced Mapping Catheter

ABBOTT PARK, Ill., May 3, 2018 /PRNewswire/ — Abbott  (NYSE: ABT) today announced U.S. Food and Drug Administration (FDA) clearance of the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™. Advisor HD Grid employs a new design that allows physicians to see things differently, capturing and analyzing data in a novel manner to create […]

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 […]

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 […]

Conavi Medical Announces FDA 510(k) Clearance of the Novasight Hybrid System with Simultaneous Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) Capabilities

TORONTO–(BUSINESS WIRE)– Conavi TM Medical Inc. (www.conavi.com) is pleased to announce that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its NovasightTM Hybrid System. The system enables simultaneous imaging of coronary arteries with both intravascular ultrasound (IVUS) and Optical Coherence Tomography (OCT). IVUS or OCT are typically […]

Surmodics Announces FDA Clearance of a New .018” Low-Profile PTA Balloon Dilation Catheter

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its .018” Low-Profile percutaneous transluminal angioplasty (PTA) balloon dilation catheter, designed and indicated for a broad […]

Medtronic IN.PACT(TM) Admiral(TM) Drug Coated Balloon Receives FDA Approval to Treat Long SFA Lesions

DUBLIN – April 23, 2018 – Medtronic plc (NYSE: MDT) today announced that it has received U.S. Food and Drug Administration (FDA) approval for the IN.PACT(TM) Admiral(TM) Drug-Coated Balloon (DCB) to treat long superficial femoral artery (SFA) lesions up to 360mm in patients with peripheral artery disease (PAD). Approval was based […]