HeartFlow Expects FDA Go-Ahead For Imaging-Based FFR Software Any Day Now
This article was originally published in The Gray Sheet
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.
You may also be interested in...
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.
Most current cardiac diagnostic imaging tests are highly inexact, relying heavily on clinicians' observations. HeartFlow is adapting advanced computer modeling to cardiology to produce a precise, predictive, noninvasive diagnostic that doubles as a treatment planning tool. The test could eliminate unnecessary procedures for patients and save the system money, but is that what interventionalists want?
Pink Sheet Podcast: Adcomm Rejects NurOwn For ALS, FDA In Shutdown Mode, Limited Price Negotiation Savings
Pink Sheet reporters and editors consider the fallout from Brainstorm Cell Therapeutics Inc.’s negative US FDA advisory committee decision on its ALS drug, the impact of a government shutdown on the agency, and a study showing only a limited possibility for significant savings in the first round of Medicare price negotiations.