Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

HeartFlow Cleared To Launch Non-Invasive FFR Software In U.S.

This article was originally published in The Gray Sheet

Executive Summary

FDA granted market access to HeartFlow's fractional flow reserve-computed tomography software, the first non-invasive fractional flow reserve technology for assessing coronary artery blockages.

You may also be interested in...



HeartFlow Receives Clearance For Noninvasive Testing Of Coronary Artery Disease

HeartFlow recently gained FDA go-ahead for its FFR-CT technology, a first-of-its-kind, noninvasive diagnostic test that allows physicians to assess blood flow in patients with coronary artery disease. With more than 25 million patients who could potentially benefit from this test in the US, EU, and Japan alone, the market potential for this technology is enormous.

People Briefs: Edwards Lifesciences, Cyberonics, Heartflow and Direct Flow

Edwards Lifesciences gains corporate VP from Medtronic. Cyberonics exec resigns. More people briefs.

HeartFlow Expects FDA Go-Ahead For Imaging-Based FFR Software Any Day Now

HeartFlow anticipates rolling out its computed tomography-based coronary fractional flow reserve software (FFRCT) in the U.S. very soon, following an imminent FDA decision on the system. The firm hopes its cloud-based software system, which relies on advanced computational fluid dynamics algorithms and CT imaging, will offer an enhancement on catheter-based FFR to interventional cardiologists.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

MT033527

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel