HeartFlow Archives - Medical Design Sourcing

HeartFlow earns reimbursement win for AI-based coronary solutions

HeartFlow announced today that the American Medical Association (AMA) transitioned reimbursement codes for its coronary artery disease assessment.

The AMA changed the non-invasive, AI-based FFRCT treatment to a Category I Current Procedural Terminology (CPT) code. It went into effect on Jan. 1, 2024. Mountain View, California-based HeartFlow says the new code supports FFRCT as the standard of care in assessing patients with suspected CAD.

FFRCT Analysis and coronary computed tomography angiography (CCTA), provide an alternative to traditional ischemia testing methods. These methods include stress EKG, stress ECG, SPECT, PET and more. According to HeartFlow, these methods can result in false negatives 20%-30% of the time.

HeartFlow’s method non-invasively diagnoses CAD and offers guidance on subsequent treatment decisions. The AI-powered technology provides insights into each patient’s condition with a patient-specific model of the heart’s blood flow. It …

HeartFlow hits 250,000-patient mark

HeartFlow announced today that it surpassed 250,000 patients receiving its FFRCT Analysis for non-invasively diagnosing coronary artery disease.

FFRCT Analysis and coronary computed tomography angiography (CCTA), provide an alternative to traditional ischemia testing methods. These methods include stress EKG, stress ECG, SPECT, PET and more. According to HeartFlow, these methods can result in false negatives 20%-30% of the time.

HeartFlow’s method non-invasively diagnoses CAD and offers guidance on subsequent treatment decisions. The AI-powered technology provides insights into each patient’s condition with a patient-specific model of the heart’s blood flow. It serves customers reliably with a median turnaround time registering less than 1.5 hours.

With its 250,000 patient cases, HeartFlow has partnerships with 1,000 global hospitals. That includes 80% of the top-50 heart hospitals in the U.S., according to a news release. The company a…

Data supports portfolio of HeartFlow precision coronary care solutions

HeartFlow today announced positive results from clinical studies evaluating its portfolio of coronary care technologies.

Mountain View, California-based HeartFlow said the studies demonstrate the accuracy, utility and efficiency of its portfolio. The RevealPlaque, Decode and Smart-CT studies looked at the company’s coronary computed tomography angiography (CCTA)-based systems.

HeartFlow presented results at the Society of Cardiovascular Computed Tomography (SCCT) Conference in Boston.

The company’s RoadMap Analysis non-invasively helps to identify stenoses in the coronary arteries. Its FFRCT Analysis assesses coronary blood flow and the Plaque Analysis characterizes and quantifies coronary atherosclerosis. Together, the comprehensive solution offers data not currently available with traditional non-invasive diagnostic tools. HeartFlow says this allows clinicians to see the full picture of the patients’ coronary artery disea…

FDA clears HeartFlow’s AI-powered analysis tech

HeartFlow announced that the FDA granted 510(k) clearance to its AI-powered Plaque analysis and Roadmap Analysis products.

Mountain View, California-based HeartFlow designed its technology around coronary computed tomography angiography (CCTA). It now offers non-invasive coronary artery anatomy, physiology and plaque information based on CCTA.

The company said in a news release that it is the first to offer all three based on CCTA. RoadMap provides coronary artery anatomy. HeartFlow’s FFRCT offers physiology and Plaque analysis delivers plaque information. Altogether, these products enable physicians to gain a more comprehensive understanding of coronary artery disease (CAD). The company said they provide a way to accurately predict the risk of heart attack.

“The 510(k) clearance of our Plaque and RoadMap analyses represents a major milestone in the company’s commitment to provide physicians with richer clinical insights to help diagnose and treat …

The biggest medtech personnel moves so far in 2022

In the ever-changing world of medtech, those who are leading the companies are bound to move around a bit.

At the end of last year, we compiled a list of medtech’s biggest personnel changes in 2021. Throughout just over half of 2022, we’ve already seen a slew of major moves around some of the space’s most powerful players.

Here is a list of some of the biggest personnel changes in medtech so far in 2022:

3M’s healthcare president retires 3M Health Care Business Group President Mojdeh Poul [Image courtesy of 3M]Mojdeh Poul, the president of 3M’s healthcare business, announced in May that she would retire from the position and her retirement was made effective on July 1.

Poul joined 3M in 2011 as the global business VP of critical and chronic care solutions. She later became VP and general manager of the company’s food safety business and president of numerous 3M divisions, including infection prevention, 3M Canada, and sa…

HeartFlow announces new CEO

HeartFlow announced today that John Farquhar has been appointed as the company’s president and CEO, effective today.

Farquhar, a former Medtronic executive, was appointed as COO of HeartFlow in August 2021 and has served as the company’s president and a member of the board since Jan. 1, 2022.

According to a news release, co-founder and CEO Dr. John H. Stevens will continue to serve on HeartFlow’s board of directors as vice chair after transitioning out of the CEO position.

“On behalf of the entire HeartFlow team, I want to thank John Stevens for his substantial contributions during his tenure as the company’s CEO,” HeartFlow Chairman William C. Weldon said in the release. “As a continuing board member, we will benefit from his drive towards maximizing value for all our stakeholders as we continue to transform the landscape of precision heart care.”

Before joining Mountain View, California-based Hear…

HeartFlow SPAC deal is called off

HeartFlow and a special purpose acquisition company called Longview Acquisition Corp. have called off merger plans that would have taken the cardiac test company public.

HeartFlow, in a news release out this evening, described the move as a mutual decision — a “result of current unfavorable market conditions.”

Stock markets in the U.S. have been on a rollercoaster in recent weeks amid inflation worries, expectations of a resulting Fed rate hike, tough earnings reports for social media companies such as Meta (formerly Facebook), ongoing COVID-19 and supply chain woes, and more. (There’s also good news: U.S. jobs and wages are rising rapidly.)

When HeartFlow and Longview announced the SPAC deal plans in July 2021, the merger was valued at $2.4 billion, plus an estimated $400 million in cash after closing.

HeartFlow officials said at the time that the $599 million of gross proceeds from the deal would enable it to accelerate the gr…

HeartFlow appoints former Medtronic executive as chief operating officer

HeartFlow today announced that it has appointed John Farquhar as chief operating officer, effective immediately.

Farquhar will be responsible for executing the Redwood City, Calif.-based company’s strategic vision.

“We are thrilled to add an executive of John’s caliber and accomplishments to the HeartFlow leadership team,” CEO and president John Stevens said in a news release. “In his new role, he will lead and provide strategic oversight of our key operational areas to ensure excellence and disciplined growth as HeartFlow continues to transform the diagnosis and management of coronary artery disease.”

Farquhar has more than 20 years of experience providing strategic oversight. He most recently served as VP and GM of Medtronic’s aortic business. He has also held numerous leadership roles for Medtronic’s cardiovascular and diabetes groups.

“I am excited to join an innovative, high-growth company with a compelling vision to change …

MedTech 100 roundup: Industry shatters all-time best with remarkable rise

The medtech industry’s steady growth provided optimism in recent weeks, but an unforeseen leap sees it hitting new heights now.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (July 16) at 145.88 points, a remarkable 27.1% rise week-over-week, registering by far the greatest increase the index has seen since its inception.

Remarkably, the industry’s July 9 tally of 114.79 points a week prior had, at that point, been known to be the index’s all-time best to date. The new high set on Friday of last week totals an increase of 31.09 points.

Medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too, especially after this latest unpredictable rise. The industry has registered a 58% increase from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus it has fully eclipsed 100% growth from the mid-pand…

HeartFlow to go public in $2.8B SPAC merger

HeartFlow today said that it will go public by merging with a SPAC called Longview Acquisition Corp.

The merger is valued at $2.4 billion with an estimated $400 million in cash after closing. The transaction is expected to deliver up to $599 million of gross proceeds to HeartFlow to accelerate the growth of its noninvasive, personalized cardiac tests.

“We believe that our non-invasive, artificial intelligence-enabled, cloud-based enterprise software solution can transform cardiovascular care with risk assessment, diagnosis planning and treatment management,” HeartFlow president, CEO and cofounder John Stevens said in a news release. “Importantly, we have brought together a talented group of individuals with deep expertise in technology, cardiovascular medicine, and the business of healthcare and a deep commitment to patients to deliver on this vision. I’m incredibly proud of the HeartFlow team in reaching this important milestone.”

Through the deal, the …