MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Home » HeartFlow wins UnitedHealthcare coverage for FFRct analysis

HeartFlow wins UnitedHealthcare coverage for FFRct analysis

By

HeartFlow

HeartFlow said today that it won reimbursement coverage from insurer UnitedHealthcare, which will now cover its HeartFlow FFRct fractional flow reserve analysis for its 45 million members.

HeartFlow’s FFRct technology works by taking the data from a standard CT scan and applying algorithms that result in a color-coded 3D “map” detailing the changes in flow across coronary lesions.

The Redwood City, Calif.-based company touted that with the new coverage, its HeartFlow FFRct is available to 235 million individuals in the US.

“This decision by UnitedHealthcare underscores the significant value that the HeartFlow Analysis brings to payers, physicians and patients, from both a clinical and economic standpoint. Not only is the HeartFlow Analysis now accessible to tens of millions of additional people, but this advancement also positions HeartFlow as an integral part of the standard approach to heart disease diagnosis and treatment,” prez & CEO Dr. John Stevens said in a press release.

The company said that UnitedHealthcare also adopted a policy which allows for the use of coronary CTA as a first-line test for symptomatic individuals, and that its FFRct analysis is approved to further assess coronary disease seen on a coronary CTA.

In March, HeartFlow said it inked a collaborative research agreement deal with the Imperial College London for research in the areas of medical imaging and deep learning using the company’s FFRct technology.

In case you missed it

RSS From Medical Design & Outsourcing

  • Reflow Medical launches low-profile reinforced support catheters
    Reflow Medical today announced it has launched its Reflow Spex Low Profile reinforced support catheters. The Spex LP catheters are designed to provide the lowest profile tip to access and cross the tightest and most complex lesions with a supportive system. It comes in 0.014 in. and 0.018 in. sizes and can be combined with… […]
  • CDER head Woodcock to lead FDA for now
    FDA veteran Dr. Janet Woodcock has been tapped as interim FDA commissioner by the Biden administration, according to published reports. An article by BioCentury also said that former FDA commissioner David Kessler, who had been mentioned as a possible replacement for current commissioner Stephen Hahn, will be a consultant to the agency but will not… […]
  • What’s next for the FDA and for Stephen Hahn?
    Outgoing FDA commissioner Stephen Hahn says he needs some time to reflect on his future after leading the FDA for a little over a year. It’s hard to blame him. Hahn’s brief tenure at FDA has been rocky, to say the least. (News of his temporary replacement broke on Thursday, when the incoming Biden administration… […]
  • Medicare to cover breakthrough devices
    FDA-designated breakthrough devices will have Medicare coverage the same day they are approved, under a final rule issued this week by the Centers for Medicare and Medicaid Services (CMS). The Medicare Coverage of Innovative Technology (MCIT) rule will provide national Medicare coverage as early as the same day as FDA market authorization for breakthrough devices… […]
  • FDA debuts plan for AI-based Software as a Medical Device
    The FDA today released its first plan to regulate artificial intelligence/machine learning (AI/ML)-based Software as a Medical Device (SaMD). The plan is a response to feedback received from the agency’s April 2019 discussion paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device.” It outlines five actions that the FDA… […]
  • EU allows remote audits for medical devices during pandemic
    The European Union has announced that it will temporarily allow remote audits of medical devices and in vitro diagnostics under the new regulations (MDR IVDR), set to go into effect on May 2021 and 2022 respectively. In a document published Monday, the European Commission agreed with industry and notified bodies that the ongoing COVID-19 pandemic… […]
  • Apple magnetic charger, smartwatch may deactivate Medtronic ICD
    A new study in the Heart Rhythm Journal showed a magnetic charger for the iPhone 12 was able to deactivate a Medtronic implantable cardioverter defibrillator (ICD). The iPhone 12 has a circular array of magnets deployed around a central charging coil, making it compatible with the company’s wireless “MagSafe” accessories, according to the study published… […]
  • BREAKING: Steris to acquire Cantel Medical in $4.6B deal
    Steris (NYSE:STE) announced today that it will acquire Cantel Medical (NYSE:CMD) for $4.6 billion — a major merger in the infection prevention space. The deal is expected to close by June 30, pending customary closing conditions, regulatory approvals and an OK by Cantel shareholders. News of the merger comes a month and a half after Steris closed… […]
  • How Abbott stayed two steps ahead of COVID-19
    Developing a fast COVID-19 that resembled a pregnancy test and building two factories to boost productions — those were but two of the quick-thinking actions that Abbott (NYSE:ABT) officials took in the early months of a deadly coronavirus pandemic. Abbott began tracking the virus in China at the end of 2019 and into early 2020. By February,… […]
  • BREAKING: Big medtech suspends political contributions in wake of Electoral College vote
    Just as they lined up to condemn last week’s attack on the U.S. Capitol, major medtech companies are suspending political contributions because of 147 federal lawmakers’ refusal to acknowledge the Electoral College win by President-elect Joe Biden and Vice President-elect Kamala Harris. Boston Scientific announced on Sunday that it has chosen to temporarily suspend its… […]
  • Neurofeedback could help prostheses feel lighter: Here’s how
    Researchers at ETH Zurich have developed a prosthesis system that connects to the body’s nervous system to help amputees perceive a prosthetic weight as lower. The prosthesis system provides feedback to the wearer using electrodes implanted in the thigh that are connected to the leg nerves. Information from the tactile sensors under the sole of… […]