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News You Need to Know Today
FDA OKs blood clot tech for PE | Pushing for better healthcare policies | Do physicians need business training? | New TAVR data
Tuesday, June 17, 2025
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Today's News and Trends

FDA clears blood clot removal system for treating pulmonary embolism

The Aventus Thrombectomy System was already cleared to treat blood clots in the peripheral arteries. This latest approval comes after positive results from an IDE study were published in JSCAI.

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Inquis Medical Aventus Thrombectomy System
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FDA clears blood clot removal system for treating pulmonary embolism

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Inquis Medical Aventus Thrombectomy System
The Aventus Thrombectomy System was already cleared to treat blood clots in the peripheral arteries. This latest approval comes after positive results from an IDE study were published in JSCAI.
READ MORE >

AMA House of Delegates helps cardiology groups influence healthcare policies

American College of Cardiology Board of Governors Chair David E. Winchester, MD, MS, examines the many benefits of working with the American Medical Association House of Delegates to bring about significant change.

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healthcare policy reform government
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AMA House of Delegates helps cardiology groups influence healthcare policies

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healthcare policy reform government
American College of Cardiology Board of Governors Chair David E. Winchester, MD, MS, examines the many benefits of working with the American Medical Association House of Delegates to bring about significant change.
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Why more doctors should pursue business and leadership training

“Just as medicine has its own language, so does business," two surgeons explained in a new editorial. 

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money maze payment reimbursement
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Why more doctors should pursue business and leadership training

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money maze payment reimbursement
“Just as medicine has its own language, so does business," two surgeons explained in a new editorial. 
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Next-day discharge after TAVR is still safe when alternative access is required

Even TAVR patients not treated using transfemoral access can typically go home the very next day. 

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Doctor patient
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Next-day discharge after TAVR is still safe when alternative access is required

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Doctor patient
Even TAVR patients not treated using transfemoral access can typically go home the very next day. 
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Featured Articles

Q&A: Cardiologist and EARLY TAVR co-author questions study’s execution

The EARLY TAVR clinical trial made a significant impact, paving the way for the FDA to approve multiple transcatheter heart valves for the treatment of asymptomatic patients. However, one cardiologist who participated in the trial has some serious concerns with how its findings were presented to the public. 

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Hemal Gada, MD, cardiologist
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Q&A: Cardiologist and EARLY TAVR co-author questions study’s execution

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Hemal Gada, MD, cardiologist
The EARLY TAVR clinical trial made a significant impact, paving the way for the FDA to approve multiple transcatheter heart valves for the treatment of asymptomatic patients. However, one cardiologist who participated in the trial has some serious concerns with how its findings were presented to the public. 
READ MORE >

‘Unqualified and fraudulent’ cardiologist linked to three patient deaths

The doctor is accused of using fake credentials for several months and performing approximately 50 procedures. This is the second time in recent months someone has been accused of impersonating a heart specialist and treating patients.

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doctor_patients.jpg
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‘Unqualified and fraudulent’ cardiologist linked to three patient deaths

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doctor_patients.jpg
The doctor is accused of using fake credentials for several months and performing approximately 50 procedures. This is the second time in recent months someone has been accused of impersonating a heart specialist and treating patients.
READ MORE >

FDA-cleared software increases throughput for flurpiridaz back-to-back rest-stress imaging

The new F-18 flurpiridaz radiotracer is expected to help drive cardiac PET growth, but it requires waiting between rest and stress scans. Software from MultiFunctional Imaging can help care teams combat that problem.

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Imagers reviewing flurpiridaz F-18 (Flyrcado) myocardial perfusion PET images. Image from GE Healthcare
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FDA-cleared software increases throughput for flurpiridaz back-to-back rest-stress imaging

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Imagers reviewing flurpiridaz F-18 (Flyrcado) myocardial perfusion PET images. Image from GE Healthcare
The new F-18 flurpiridaz radiotracer is expected to help drive cardiac PET growth, but it requires waiting between rest and stress scans. Software from MultiFunctional Imaging can help care teams combat that problem.
READ MORE >

Medtronic’s diabetes spin-off gets a name, kicking off ‘new and exciting chapter’

The new name will be familiar to anyone who knows the history of Medtronic's diabetes business.

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business launch
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Medtronic’s diabetes spin-off gets a name, kicking off ‘new and exciting chapter’

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business launch
The new name will be familiar to anyone who knows the history of Medtronic's diabetes business.
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In Case You Missed It

Death from heart disease more common in rural areas—what can cardiologists do?

Rishi Wadhera, MD, detailed new data that show how socioeconomic factors are driving cardiovascular death rates, especially in younger adults.

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Rishi Wadhera, MD, MPP, MPhil, associate director of the Richard A. and Susan F. Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center, and associate professor of medicine at Harvard Medical School, Explains a report showing socioeconomic factors are driving increased cardiovascular death rates, especially in younger adults, and urges action to address these health disparities.
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Death from heart disease more common in rural areas—what can cardiologists do?

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Rishi Wadhera, MD, MPP, MPhil, associate director of the Richard A. and Susan F. Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center, and associate professor of medicine at Harvard Medical School, Explains a report showing socioeconomic factors are driving increased cardiovascular death rates, especially in younger adults, and urges action to address these health disparities.
Rishi Wadhera, MD, detailed new data that show how socioeconomic factors are driving cardiovascular death rates, especially in younger adults.
READ MORE >

FDA sees promise in new total artificial heart technology, granting it ‘breakthrough’ status

The device was built as a bridge to transplant for patients with end-stage heart failure. It is made of titanium and approximately the size of an adult’s fist.

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Surgeons in Houston have performed the world’s first successful human implant of BiVacor’s Total Artificial Heart (TAH) technology. The procedure was completed July 9, 2024, at The Texas Heart Institute at Baylor St. Luke’s Medical Center. It was part of an early feasibility study (EFS) first approved by the U.S. Food and Drug Administration (FDA) back in December 2023. BiVacor has received the FDA’s breakthrough device designation for its titanium Total Artificial Heart (TAH).
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FDA sees promise in new total artificial heart technology, granting it ‘breakthrough’ status

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Surgeons in Houston have performed the world’s first successful human implant of BiVacor’s Total Artificial Heart (TAH) technology. The procedure was completed July 9, 2024, at The Texas Heart Institute at Baylor St. Luke’s Medical Center. It was part of an early feasibility study (EFS) first approved by the U.S. Food and Drug Administration (FDA) back in December 2023. BiVacor has received the FDA’s breakthrough device designation for its titanium Total Artificial Heart (TAH).
The device was built as a bridge to transplant for patients with end-stage heart failure. It is made of titanium and approximately the size of an adult’s fist.
READ MORE >

New-look peripheral stent with expandable spikes receives FDA’s de novo classification

California-based Reflow Medical gained the approval after submitting data from the DEEPER REVEAL clinical trial. The device was associated with a high success rate and improved outcomes in CLTI patients.

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Reflow Medical Spur Peripheral Retrievable Stent System. Reflow Medical, a California-based medtech company focused on cardiovascular disease treatments, has received the FDA’s de novo classification for its Spur Peripheral Retrievable Stent System. De novo classification represents an alternative pathway to gaining FDA approval when no comparable devices are currently available.
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New-look peripheral stent with expandable spikes receives FDA’s de novo classification

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Reflow Medical Spur Peripheral Retrievable Stent System. Reflow Medical, a California-based medtech company focused on cardiovascular disease treatments, has received the FDA’s de novo classification for its Spur Peripheral Retrievable Stent System. De novo classification represents an alternative pathway to gaining FDA approval when no comparable devices are currently available.
California-based Reflow Medical gained the approval after submitting data from the DEEPER REVEAL clinical trial. The device was associated with a high success rate and improved outcomes in CLTI patients.
READ MORE >

In Other News

Signs of Alzheimer's evident on imaging up to 15 years prior to symptom onset in Down syndrome population

By identifying these structural changes prior to the onset of symptomatic neurodegeneration, providers may be able to initiate preventive therapies sooner.

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Signs of Alzheimer's evident on imaging up to 15 years prior to symptom onset in Down syndrome population

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By identifying these structural changes prior to the onset of symptomatic neurodegeneration, providers may be able to initiate preventive therapies sooner.
READ MORE >

Fraud prevention expert charged with over 167 suspected incidents of healthcare fraud

Faranak Firozan, 47, is a cybersecurity expert at Nvidia who regularly spoke on the topic of “cyber laundering.” Prosecutors in California allege she submitted fraudulent medical claims to an employer-sponsored insurance plan, bilking Cigna out of $100,000.

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healthcare insurance fraud scam scheme legal lawsuit
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Fraud prevention expert charged with over 167 suspected incidents of healthcare fraud

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healthcare insurance fraud scam scheme legal lawsuit
Faranak Firozan, 47, is a cybersecurity expert at Nvidia who regularly spoke on the topic of “cyber laundering.” Prosecutors in California allege she submitted fraudulent medical claims to an employer-sponsored insurance plan, bilking Cigna out of $100,000.
READ MORE >

Industry News

 

Biome Analytics appoints Dr. Javier Valle as chief medical officer

Biome Analytics is proud to welcome Javier Valle, MD—renowned interventional cardiologist and national quality leader—as our new chief medical officer. His deep clinical expertise and commitment to high-value care will help shape the future of cardiovascular performance improvement.  
READ MORE >
 

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