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Cleerly's founder shares his story | Questioning FDA device approvals | FDA OKs new insulin biosimilar | Getinge makes a shift

News You Need to Know Today
Cleerly's founder shares his story | Questioning FDA device approvals | FDA OKs new insulin biosimilar | Getinge makes a shift
Friday, February 21, 2025
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Today's News and Trends

Embracing the future: James Min left academia to push for a paradigm shift in preventive cardiology

James Min, MD, Cleerly's founder and CEO, changed careers to address what he saw as a major unmet need in cardiology.

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Video of James Min, MD, explaining the future of cardiac care using CT and AI plaque analysis to create a personalized and more accurate cardiac risk assessment, similar to a mammogram for the heart.
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Embracing the future: James Min left academia to push for a paradigm shift in preventive cardiology

Share on Twitter Share on Facebook Share on Linkedin
Video of James Min, MD, explaining the future of cardiac care using CT and AI plaque analysis to create a personalized and more accurate cardiac risk assessment, similar to a mammogram for the heart.
James Min, MD, Cleerly's founder and CEO, changed careers to address what he saw as a major unmet need in cardiology.
READ MORE >

Cardiologist questions FDA’s approval process for high-risk medical devices

The technology used to diagnose, treat and manage cardiovascular disease is always evolving, keeping FDA officials quite busy. But have the agency's standards been slipping in recent years? A cardiologist with Cedars-Sinai Medical Center explored that very question.

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approval regulations checkmark doctor
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Cardiologist questions FDA’s approval process for high-risk medical devices

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approval regulations checkmark doctor
The technology used to diagnose, treat and manage cardiovascular disease is always evolving, keeping FDA officials quite busy. But have the agency's standards been slipping in recent years? A cardiologist with Cedars-Sinai Medical Center explored that very question.
READ MORE >

FDA approves first rapid-acting insulin biosimilar for diabetes

Sanofi's Merilog is a new biosimilar substitute for Novo Nordisk’s NovoLog. It can be used to treat adult and pediatric patients with type 1 and type 2 diabetes.

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Sugar Insulin
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FDA approves first rapid-acting insulin biosimilar for diabetes

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Sugar Insulin
Sanofi's Merilog is a new biosimilar substitute for Novo Nordisk’s NovoLog. It can be used to treat adult and pediatric patients with type 1 and type 2 diabetes.
READ MORE >

Getinge ending production of cardiopulmonary surgical perfusion systems

The global medtech company is also looking to expand its organ transplant and ECMO portfolios.

READ MORE >
Getinge says it is ending production of its cardio-pulmonary surgical perfusion product in 2025, but plans to invest more in its Maquet Cardiosave ECMO system, which has continued market growth. Photo by Dave Fornell
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Getinge ending production of cardiopulmonary surgical perfusion systems

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Getinge says it is ending production of its cardio-pulmonary surgical perfusion product in 2025, but plans to invest more in its Maquet Cardiosave ECMO system, which has continued market growth. Photo by Dave Fornell
The global medtech company is also looking to expand its organ transplant and ECMO portfolios.
READ MORE >

Featured Articles

Sotagliflozin the first drug of its kind to limit heart attacks, strokes in high-risk patients

Sotagliflozin, a dual SGLTI and SGLT2 inhibitor, can significantly reduce the risk of adverse cardiovascular events in patients with type 2 diabetes, CKD and additional cardiovascular risk factors, according to a new study of more than 10,000 patients. 

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heart drugs with stethoscope
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Sotagliflozin the first drug of its kind to limit heart attacks, strokes in high-risk patients

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heart drugs with stethoscope
Sotagliflozin, a dual SGLTI and SGLT2 inhibitor, can significantly reduce the risk of adverse cardiovascular events in patients with type 2 diabetes, CKD and additional cardiovascular risk factors, according to a new study of more than 10,000 patients. 
READ MORE >

CABG still the ‘gold standard’ for revascularization in patients with 3-vessel CAD and CKD

The median follow-up period was more than nine years, allowing researchers to compare long-term outcomes after both CABG and PCI. 

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CABG coronary artery bypass grafting heart surgery
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CABG still the ‘gold standard’ for revascularization in patients with 3-vessel CAD and CKD

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CABG coronary artery bypass grafting heart surgery
The median follow-up period was more than nine years, allowing researchers to compare long-term outcomes after both CABG and PCI. 
READ MORE >

Aspartame linked to surging insulin levels, fatty plaques and inflammation

Aspartame, the artificial sweetener commonly found in diet sodas and sugar-free snacks, may do significant harm to a person’s cardiovascular system.

READ MORE >
Adults who regularly drink sweetened beverages face a heightened risk of atrial fibrillation (AFib), according to new data published in Circulation: Arrhythmia and Electrophysiology.
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Aspartame linked to surging insulin levels, fatty plaques and inflammation

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Adults who regularly drink sweetened beverages face a heightened risk of atrial fibrillation (AFib), according to new data published in Circulation: Arrhythmia and Electrophysiology.
Aspartame, the artificial sweetener commonly found in diet sodas and sugar-free snacks, may do significant harm to a person’s cardiovascular system.
READ MORE >

In Case You Missed It

FDA warns that smartphone-compatible diabetes devices may not work properly

Smartphones have made it easier than ever for patients to monitor their own health, but the technology is far from infallible. 

READ MORE >
smartphone_elderly.jpg
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FDA warns that smartphone-compatible diabetes devices may not work properly

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smartphone_elderly.jpg
Smartphones have made it easier than ever for patients to monitor their own health, but the technology is far from infallible. 
READ MORE >

Heart failure patients see benefits from home-based rehab

Many heart failure patients still skip cardiac rehab altogether. Offering a home-based option could potentially help reverse that trend. 

READ MORE >
heart patient stretching at home
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Heart failure patients see benefits from home-based rehab

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heart patient stretching at home
Many heart failure patients still skip cardiac rehab altogether. Offering a home-based option could potentially help reverse that trend. 
READ MORE >

Oklahoma cardiologist and his clinic pay $270K to settle whistleblower lawsuit

A Tulsa-based cardiology clinic was accused of submitting false claims for E&M services over a period of several years.

READ MORE >
money court scale of justice ruling legal settlement
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Oklahoma cardiologist and his clinic pay $270K to settle whistleblower lawsuit

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money court scale of justice ruling legal settlement
A Tulsa-based cardiology clinic was accused of submitting false claims for E&M services over a period of several years.
READ MORE >

In Other News

Healthcare AI newswatch: Consumer mistrust, humanoid robots, vendor wars, more

Healthcare consumers are wary of healthcare systems packing AI. 

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shocked surprised social media post defamation
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Healthcare AI newswatch: Consumer mistrust, humanoid robots, vendor wars, more

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shocked surprised social media post defamation
Healthcare consumers are wary of healthcare systems packing AI. 
READ MORE >

Center for Devices and Radiological Health hit with federal job cuts

Following the mass layoffs, labeled “the Valentine’s Day Massacre” by some, many have expressed concern with how the move could impact patient care, AI research and more.

READ MORE >
Jobs hiring talent people human resources
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Center for Devices and Radiological Health hit with federal job cuts

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Jobs hiring talent people human resources
Following the mass layoffs, labeled “the Valentine’s Day Massacre” by some, many have expressed concern with how the move could impact patient care, AI research and more.
READ MORE >

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