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FDA clears CCTA AI plaque assessment | Former surgeon general joins Eko | Boston Scientific launches stents vs. DCB trial

News You Need to Know Today
FDA clears CCTA AI plaque assessment | Former surgeon general joins Eko | Boston Scientific launches stents vs. DCB trial
Friday, August 22, 2025
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Today's News and Trends

FDA clears CCTA AI coronary plaque assessment from Artrya

Australia-based Artrya Limited says its AI-enabled Salix Coronary Plaque module offers near real-time, point-of-care CCTA assessment and management of coronary artery disease. 

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Australia-based Artrya Limited said its Salix Coronary Plaque module AI-powered cloud platform offers near-real time, point-of-care CCTA assessment and management of coronary artery disease.
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FDA clears CCTA AI coronary plaque assessment from Artrya

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Australia-based Artrya Limited said its Salix Coronary Plaque module AI-powered cloud platform offers near-real time, point-of-care CCTA assessment and management of coronary artery disease.
Australia-based Artrya Limited says its AI-enabled Salix Coronary Plaque module offers near real-time, point-of-care CCTA assessment and management of coronary artery disease. 
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Boston Scientific launches study comparing drug-coated balloons to standard care

"This important study will evaluate the potential benefits of the AGENT DCB for patients with certain anatomical features in de novo coronary lesions, where the avoidance of stents is preferable to help circumvent potential complications,” said Janar Sathananthan, MD, chief medical officer, interventional cardiology therapies, Boston Scientific. 

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Boston Scientific said it initiated the AGENT DCB STANCE trial to assess the safety and effectiveness of the Agent Drug-Coated Balloon (DCB) compared to the standard of care using either percutaneous coronary intervention (PCI) with drug-eluting stents (DES) and/or balloon angioplasty. The trial will enroll more than 1,600 patients and is expected to a primary completion date in 2028.
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Boston Scientific launches study comparing drug-coated balloons to standard care

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Boston Scientific said it initiated the AGENT DCB STANCE trial to assess the safety and effectiveness of the Agent Drug-Coated Balloon (DCB) compared to the standard of care using either percutaneous coronary intervention (PCI) with drug-eluting stents (DES) and/or balloon angioplasty. The trial will enroll more than 1,600 patients and is expected to a primary completion date in 2028.
"This important study will evaluate the potential benefits of the AGENT DCB for patients with certain anatomical features in de novo coronary lesions, where the avoidance of stents is preferable to help circumvent potential complications,” said Janar Sathananthan, MD, chief medical officer, interventional cardiology therapies, Boston Scientific. 
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Former US surgeon general joins Eko as medical advisor

"Eko is transforming how we detect cardiovascular disease—making cutting-edge, AI-powered tools accessible to frontline providers," said former U.S. Surgeon General Jerome Adams, MD.

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Eko Health announced former U.S. Surgeon General Jerome Adams, MD, MPH, FASA, a board-certified anesthesiologist and executive director of the Center for Community Health Enhancement and Learning at Purdue University, joined the company as a distinguished medical advisor.
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Former US surgeon general joins Eko as medical advisor

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Eko Health announced former U.S. Surgeon General Jerome Adams, MD, MPH, FASA, a board-certified anesthesiologist and executive director of the Center for Community Health Enhancement and Learning at Purdue University, joined the company as a distinguished medical advisor.
"Eko is transforming how we detect cardiovascular disease—making cutting-edge, AI-powered tools accessible to frontline providers," said former U.S. Surgeon General Jerome Adams, MD.
READ MORE >

Featured Articles

Shine working toward U.S. production of Mo-99 for SPECT nuclear imaging

Greg Piefer, PhD, chief executive and founder of Shine, a Wisconsin-based radiopharmaceutical company that is building the world’s largest medical isotope production facility in Janesville, Wisconsin, explains progress on the company's fusion reactor that will become the first sustained U.S. commercial supplier of molybdenum-99 in decades.

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 Greg Piefer, PhD, CEO and founder of Shine, explains the timeline to restart U.S. production of molybdenum-99 (Mo-99) for nuclear imaging.
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Shine working toward U.S. production of Mo-99 for SPECT nuclear imaging

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 Greg Piefer, PhD, CEO and founder of Shine, explains the timeline to restart U.S. production of molybdenum-99 (Mo-99) for nuclear imaging.
Greg Piefer, PhD, chief executive and founder of Shine, a Wisconsin-based radiopharmaceutical company that is building the world’s largest medical isotope production facility in Janesville, Wisconsin, explains progress on the company's fusion reactor that will become the first sustained U.S. commercial supplier of molybdenum-99 in decades.
READ MORE >

Cardiovascular device approvals continue to lead the FDA's Breakthrough Device Program

Cardiology is number one in FDA Breakthrough Device designations at 218, the highest number out of all other clinical categories. This includes 16 new devices cleared in the past year.

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The U.S. Food and Drug Administration (FDA) updated the Breakthrough Device Program designations data this week, which now includes 1,176 Breakthrough Device designations, of which 160 have gained market clearance. Cardiovascular devices lead these with 243 devices, the highest number out of all other clinical categories. This includes 16 new cardiovascular devices cleared in the past year.
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Cardiovascular device approvals continue to lead the FDA's Breakthrough Device Program

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The U.S. Food and Drug Administration (FDA) updated the Breakthrough Device Program designations data this week, which now includes 1,176 Breakthrough Device designations, of which 160 have gained market clearance. Cardiovascular devices lead these with 243 devices, the highest number out of all other clinical categories. This includes 16 new cardiovascular devices cleared in the past year.
Cardiology is number one in FDA Breakthrough Device designations at 218, the highest number out of all other clinical categories. This includes 16 new devices cleared in the past year.
READ MORE >

FTC challenge to Edwards JenaValve acquisition could delay FDA approval

Edwards Lifesciences asked the U.S. Federal Trade Commission (FTC) this week to dismiss the complaint against the company's acquisition of JenaValve this week. A healthcare market analysis firm also said the FTC actions will likely impact the timing of an FDA clearance of the Trilogy heart valve.

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jenavalve TAVR valve for aortic regurgitation acquired by Edwards
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FTC challenge to Edwards JenaValve acquisition could delay FDA approval

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jenavalve TAVR valve for aortic regurgitation acquired by Edwards
Edwards Lifesciences asked the U.S. Federal Trade Commission (FTC) this week to dismiss the complaint against the company's acquisition of JenaValve this week. A healthcare market analysis firm also said the FTC actions will likely impact the timing of an FDA clearance of the Trilogy heart valve.
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Hemodynamic deterioration 1 year after TAVR found in 6% of patients

Hemodynamic valve deterioration after one year was more common in patients with a small aortic annulus. In fact, receiving a larger valve was linked to a “protective” quality that appeared to help keep the risk of such complications to a minimum.

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Illustration of cardiologists going through the certification process. American College of Cardiology President B. Hadley Wilson, MD, discussed why the ACC and other leading cardiology groups are so eager to create a new, independent medical board. This has been a long-term goal for many years, he said, and now it may become a reality. 
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Hemodynamic deterioration 1 year after TAVR found in 6% of patients

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Illustration of cardiologists going through the certification process. American College of Cardiology President B. Hadley Wilson, MD, discussed why the ACC and other leading cardiology groups are so eager to create a new, independent medical board. This has been a long-term goal for many years, he said, and now it may become a reality. 
Hemodynamic valve deterioration after one year was more common in patients with a small aortic annulus. In fact, receiving a larger valve was linked to a “protective” quality that appeared to help keep the risk of such complications to a minimum.
READ MORE >

Gene discovery highlights connection between the kidneys and cardiovascular disease

“Our findings reveal how changes in cell metabolism and increased oxidative stress can activate damaging pathways in blood vessels," explained Xiaofeng Yang, MD, a researcher at Temple University.

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Kidney image. About 80% of chronic kidney disease patients actually die from cardiovascular complications. Although the link between these diseases is well established, the actual biological mechanism involved has not been fully understood. But researchers at Temple University recently uncovered a key piece to this connection, where chronic kidney disease and high-fat diets combine to trigger blood vessel inflammation. Their findings are published online in Redox Biology.[1]
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Gene discovery highlights connection between the kidneys and cardiovascular disease

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Kidney image. About 80% of chronic kidney disease patients actually die from cardiovascular complications. Although the link between these diseases is well established, the actual biological mechanism involved has not been fully understood. But researchers at Temple University recently uncovered a key piece to this connection, where chronic kidney disease and high-fat diets combine to trigger blood vessel inflammation. Their findings are published online in Redox Biology.[1]
“Our findings reveal how changes in cell metabolism and increased oxidative stress can activate damaging pathways in blood vessels," explained Xiaofeng Yang, MD, a researcher at Temple University.
READ MORE >

FDA announces Class I recalls for heart pump accessories due to safety risk

Abbott has warned healthcare providers about a new issue with the mobile power units of certain HeartMate 3 LVADs. 

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Recall | Product recall
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FDA announces Class I recalls for heart pump accessories due to safety risk

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Recall | Product recall
Abbott has warned healthcare providers about a new issue with the mobile power units of certain HeartMate 3 LVADs. 
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Lipoprotein(a) tests could transform patient care—is it time for universal screening?

"Lp(a) represents the most important potential potential paradigm shift in cardiovascular disease prevention that we'll experience over the next five to 10 years," Seth Baum, MD, explained in a new interview.

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Seth Baum, MD, FACC, FACPM, FAHA, FNLA, FASPC, Chairman of the Board for the Family Heart Foundation, past president of the American Society for Preventive Cardiology, clinical affiliate professor of biomedical science at Florida Atlantic University, and chief medical officer of Flourish Research, explains why testing for familial hypercholesterolemia (FH) and elevated Lipoprotein(a) could be critical to identify more patients with elevated risk of cardiac events, but have their LDL well controlled.
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Lipoprotein(a) tests could transform patient care—is it time for universal screening?

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Seth Baum, MD, FACC, FACPM, FAHA, FNLA, FASPC, Chairman of the Board for the Family Heart Foundation, past president of the American Society for Preventive Cardiology, clinical affiliate professor of biomedical science at Florida Atlantic University, and chief medical officer of Flourish Research, explains why testing for familial hypercholesterolemia (FH) and elevated Lipoprotein(a) could be critical to identify more patients with elevated risk of cardiac events, but have their LDL well controlled.
"Lp(a) represents the most important potential potential paradigm shift in cardiovascular disease prevention that we'll experience over the next five to 10 years," Seth Baum, MD, explained in a new interview.
READ MORE >

In Other News

Patients file $5M class-action lawsuit against 1 of America’s oldest radiology practices

"Jane Doe,” who is under 18, and legal representatives claim Radiology Associates of Richmond failed to safeguard private health information. 

READ MORE >
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Patients file $5M class-action lawsuit against 1 of America’s oldest radiology practices

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"Jane Doe,” who is under 18, and legal representatives claim Radiology Associates of Richmond failed to safeguard private health information. 
READ MORE >

CVS Caremark hit with $289M judgment following whistleblower claim

That number includes $285 million in damages. CVS Health’s PBM was found to have committed fraud when it pressured insurers to overbill Medicare Advantage plans for patient care services.

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healthcare insurance fraud scam scheme legal lawsuit
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CVS Caremark hit with $289M judgment following whistleblower claim

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healthcare insurance fraud scam scheme legal lawsuit
That number includes $285 million in damages. CVS Health’s PBM was found to have committed fraud when it pressured insurers to overbill Medicare Advantage plans for patient care services.
READ MORE >

Medical researchers: ‘Doctors must be the leaders in the digital evolution of medicine.’

The roots of medicine are in the promotion of human welfare, aka humanitarianism. Healthcare AI can either degrade or reinforce this heritage. Who picks the path? 

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physician with patient
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Medical researchers: ‘Doctors must be the leaders in the digital evolution of medicine.’

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physician with patient
The roots of medicine are in the promotion of human welfare, aka humanitarianism. Healthcare AI can either degrade or reinforce this heritage. Who picks the path? 
READ MORE >

Epic partners with Microsoft to roll out AI-powered clinical scribe

Epic confirmed on Tuesday that its long-rumored AI scribe feature is a reality. The company said it’s working with Microsoft-owned Nuance—and with clinical documentation standout Abridge—to add the feature to its platform.

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Epic sign at HQ campus DF
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Epic partners with Microsoft to roll out AI-powered clinical scribe

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Epic sign at HQ campus DF
Epic confirmed on Tuesday that its long-rumored AI scribe feature is a reality. The company said it’s working with Microsoft-owned Nuance—and with clinical documentation standout Abridge—to add the feature to its platform.
READ MORE >

MGMA warns of government overreach in the proposed 2026 Medicare Physician Fee Schedule

The Medical Group Management Association shares concerns about the draft fee schedule published in July. A major concern is the government possibly changing how RVUs are set, rather than allowing the medical specialty representatives to have a say.

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Anders Gilberg, MGA, senior vice president, government affairs at Medical Group Management Association (MGMA), shares concerns about the draft fee schedule published in July. A major concern is the government possibly changing how relative value units (RVUs) are set, rather than allowing the American Medical Association and medical speciality representatives having a say. #MGMA
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MGMA warns of government overreach in the proposed 2026 Medicare Physician Fee Schedule

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Anders Gilberg, MGA, senior vice president, government affairs at Medical Group Management Association (MGMA), shares concerns about the draft fee schedule published in July. A major concern is the government possibly changing how relative value units (RVUs) are set, rather than allowing the American Medical Association and medical speciality representatives having a say. #MGMA
The Medical Group Management Association shares concerns about the draft fee schedule published in July. A major concern is the government possibly changing how RVUs are set, rather than allowing the medical specialty representatives to have a say.
READ MORE >

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