News

startup business healthcare medtech heart
Medtech startup co-founded by cardiologist seeks FDA clearance for new-look perfusion device

Tulyp Medical, a French medtech startup, has emerged from stealth focused on securing FDA clearance for a patented perfusion device.

Dexcom is recalling a specific version of the Android smartphone app associated with its G6 Continuous Glucose Monitoring (CGM) System.
FDA highlights new Class I recall for Dexcom CGM app

Dexcom recalled its G6 smartphone app after a software error was causing it to stop working with no warning. This is a Class I recall, which means failing to follow the company's instructions could result in a serious adverse event.

Medicare physician fee schedule final rule 2026.
Medicare Physician Fee Schedule cuts cardiologist pay because CMS says doctors should be more efficient

The new, negative 2.5% efficiency adjustment will be applied to the vast majority of Medicare payments for physician services. It was opposed by cardiology and most other medical societies. 

The Penumbra thrombectomy pulmonary embolism clots extraction catheter displayed at TCT 2025. Photo by Dave Fornell
Pulmonary embolism thrombectomy use increases by more than 700%

Medicare claims submitted between 2017 and 2022 showed a 712% increase in thrombectomy for pulmonary embolism (PE) and a 137% increase in thrombectomy for deep vein thrombosis (DVT).

Well-known cardiologist Peter A. Soukas, MD, FACC, FSCAI, FSVM, FACP, has become chief medical officer of carotid stent maker InspireMD Inc.
Cardiologist Peter Soukas becomes chief medical officer of carotid stent company

The company said the move will help it prepare for what is expected to be a rapid expansion of carotid stenting.

At the recent American College of Cardiology (ACC) Legislative Committee meeting, leaders warned that ongoing federal policy uncertainty threatens patient access and the stability of cardiovascular care. Cathie Biga, MSM, immediate past president of the ACC, outlined growing concerns over telehealth, shrinking Medicare reimbursement, and mounting physician workforce shortages driven by visa restrictions.
ACC raises red flags over telehealth, payment reform and the cardiologist shortage

"We need telehealth the way we had it for COVID," Cathie Biga told Cardiovascular Business at TCT 2025. "We don't want to go back to having it so restricted."

phenylephrine FDA
COVID-19, other infections linked to major cardiovascular risks—researchers push for vaccination

Adults are three times as likely to have a heart attack or stroke after a COVID-19 infection than when they are healthy. The risks are even greater for the flu.

A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]
How to minimize bleeding risks after TAVR

Bleeding events remain a serious complication after TAVR. By identifying high-risk patients early and planning ahead, however, care teams can keep them to a minimum.

Biolimus-coated balloons can effectively treat small-vessel coronary artery disease, new first-in-human study confirms

Researchers compared the new-look drug coated balloon with an uncoated balloon, publishing their findings in JACC: Cardiovascular Interventions.

The most successful case to date of a pig organ being transplanted into a human occurred back in January, when specialists at the University of Maryland Medical Center (UMMC) in Baltimore transplanted a modified pig heart into 57-year-old David Bennett. The FDA approved the heart transplant transplant through an emergency authorization typically reserved for experimental procedures seen as a patient’s last chance at survival. Bennett did die of heart failure two months later, but UMMC specialists had been “
Find more heart failure news

Links to more heart failure content

The most successful case to date of a pig organ being transplanted into a human occurred back in January, when specialists at the University of Maryland Medical Center (UMMC) in Baltimore transplanted a modified pig heart into 57-year-old David Bennett. The FDA approved the heart transplant transplant through an emergency authorization typically reserved for experimental procedures seen as a patient’s last chance at survival. Bennett did die of heart failure two months later, but UMMC specialists had been “
FDA may allow clinical trials of pig organ transplants into human patients

The FDA would approve trials on a case-by-case basis, according to an anonymous source close to the situation. 

AFib ablation makes financial sense, especially among heart failure patients

The additional costs associated with AFib ablation appear to be justified, researchers wrote.

Around the web

Radiology Business
4D MRI techniques could help advance the development of artificial hearts

Researchers recently used advanced 4D flow MRI to track blood in a pulsating artificial heart, revealing dynamics that closely mirror those of a healthy human organ.

Health Exec
MGMA: Congress needs to act soon to preserve access to telemedicine programs

Congress needs to act soon to extend telemedicine services that were greatly expanded under COVID provisions, or they will expire by October. Anders Gilberg, senior vice president of government affairs at the Medical Group Management Association, explains concerns raised by doctors and lawmakers.

 

Health Exec
MGMA: Ending ACA subsidies could strain health system, leave millions uninsured

Anders Gilberg, senior vice president of government affairs at the Medical Group Management Association, explains the political and patient care issues involved with ending Affordable Care Act subsidies.