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News You Need to Know Today
Indian-made TAVR valve outperforms Sapien, Evolut | Apple Watch Faces import ban over oximetry| Billing codes added for DCB
Tuesday, November 18, 2025
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Today's News and Trends

Myval TAVR valve outperforms Sapien and Evolut in the late-breaking LANDMARK trial

The LANDMARK trial continues to show positive outcomes for the TAVR valve made in India.

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Meril Life Sciences, an India-based medical device company founded in 2006, developed the Myval TAVR valve. The Myval transcatheter heart valve (THV) is non-inferior to the Sapien 3 THV after one year, according to new transcatheter aortic valve replacement (TAVR) data published in The Lancet.
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Myval TAVR valve outperforms Sapien and Evolut in the late-breaking LANDMARK trial

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Meril Life Sciences, an India-based medical device company founded in 2006, developed the Myval TAVR valve. The Myval transcatheter heart valve (THV) is non-inferior to the Sapien 3 THV after one year, according to new transcatheter aortic valve replacement (TAVR) data published in The Lancet.
The LANDMARK trial continues to show positive outcomes for the TAVR valve made in India.
READ MORE >

U.S. International Federal Trade Commission reviews ban on new Apple Watch pulse oximeter

Masimo’s complaint over the new version of the Apple Watch could lead to an import ban if it is found that the technology infringes on its patents.

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Apple has officially introduced the Apple Watch Ultra 3, which will provide notifications when it detects signs of chronic high blood pressure once the technology is cleared by the U.S. Food and Drug Administration (FDA).
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U.S. International Federal Trade Commission reviews ban on new Apple Watch pulse oximeter

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Apple has officially introduced the Apple Watch Ultra 3, which will provide notifications when it detects signs of chronic high blood pressure once the technology is cleared by the U.S. Food and Drug Administration (FDA).
Masimo’s complaint over the new version of the Apple Watch could lead to an import ban if it is found that the technology infringes on its patents.
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New physician Medicare payments for the Agent drug-coated balloon set for 2027

Boston Scientific said two category III CPT codes are set to become permanent category I codes for physician payments starting Jan. 1, 2027. 

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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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New physician Medicare payments for the Agent drug-coated balloon set for 2027

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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.
Boston Scientific said two category III CPT codes are set to become permanent category I codes for physician payments starting Jan. 1, 2027. 
READ MORE >

Featured Articles

SCAI: To improve cardiogenic shock outcomes, reduce lactate levels

SCAI feels this is the best way forward to try lowering mortality rates, but the group is asking cardiologists to help by gathering more data. 

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Society of Cardiovascular Angiography and Interventions (SCAI) President Srihari S. Naidu, MD, professor of medicine at New York Medical College, explains the SCAI initiative to improve outcomes in cardiogenic shock by monitoring and lowering patient lactate levels.
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SCAI: To improve cardiogenic shock outcomes, reduce lactate levels

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Society of Cardiovascular Angiography and Interventions (SCAI) President Srihari S. Naidu, MD, professor of medicine at New York Medical College, explains the SCAI initiative to improve outcomes in cardiogenic shock by monitoring and lowering patient lactate levels.
SCAI feels this is the best way forward to try lowering mortality rates, but the group is asking cardiologists to help by gathering more data. 
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Siemens Healthineers and Boston Scientific partner on next-generation intracardiac echo for LAAO

The agreement also will make Boston Scientific the exclusive distributor for the new ICE catheter optimized for left atrial appendage occlusion workflows.

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Deployed Watchman LAA occluder on Siemens 3D ICE ASE 2023.
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Siemens Healthineers and Boston Scientific partner on next-generation intracardiac echo for LAAO

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Deployed Watchman LAA occluder on Siemens 3D ICE ASE 2023.
The agreement also will make Boston Scientific the exclusive distributor for the new ICE catheter optimized for left atrial appendage occlusion workflows.
READ MORE >

FDA clears new cloud-enabled Philips cardiovascular IT system

The cloud-enabled system provides the foundation for future AI-enabled tools, better workflows and analytics.

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The U.S. Food and Drug Adminstration (FDA) granted 510(k) clearance for the latest release of Philips Healthcare's Cardiovascular Workspace imaging and information management system. It enables cloud-hosted availability and software-as-a-Service (SaaS) deployment.
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FDA clears new cloud-enabled Philips cardiovascular IT system

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The U.S. Food and Drug Adminstration (FDA) granted 510(k) clearance for the latest release of Philips Healthcare's Cardiovascular Workspace imaging and information management system. It enables cloud-hosted availability and software-as-a-Service (SaaS) deployment.
The cloud-enabled system provides the foundation for future AI-enabled tools, better workflows and analytics.
READ MORE >

Drinking coffee may reduce risk of recurrent AFib

Physicians often tell AFib patients they should limit coffee consumption to protect their hearts. This new analysis, however, suggests that may not be necessary.

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Heart in coffee at TCT 2023. Photo by Dave Fornell
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Drinking coffee may reduce risk of recurrent AFib

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Heart in coffee at TCT 2023. Photo by Dave Fornell
Physicians often tell AFib patients they should limit coffee consumption to protect their hearts. This new analysis, however, suggests that may not be necessary.
READ MORE >

AI-enabled coronary plaque quantification outperforms traditional risk scores

Researchers used AI-enabled software developed by Cleerly to evaluate the CCTA results of more than 6,000 patients. The software was consistently effective, identifying patients who may face an increased risk of poor outcomes. 

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Cleerly AI plaque and coronary artery analysis at SCCT 2023. Photo by Dave Fornell
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AI-enabled coronary plaque quantification outperforms traditional risk scores

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Cleerly AI plaque and coronary artery analysis at SCCT 2023. Photo by Dave Fornell
Researchers used AI-enabled software developed by Cleerly to evaluate the CCTA results of more than 6,000 patients. The software was consistently effective, identifying patients who may face an increased risk of poor outcomes. 
READ MORE >

$64M raised for new cardiogenic shock drug—research already underway

Procizumab was developed to change the trajectory of shock by addressing an underlying molecular driver rather than just managing symptoms.

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Illustration showing how procizumab captures circulating dipeptidyl peptidase 3 (cDPP3) to block this key molecular driver of shock. Illustrations courtesy of 4TEEN4
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$64M raised for new cardiogenic shock drug—research already underway

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Illustration showing how procizumab captures circulating dipeptidyl peptidase 3 (cDPP3) to block this key molecular driver of shock. Illustrations courtesy of 4TEEN4
Procizumab was developed to change the trajectory of shock by addressing an underlying molecular driver rather than just managing symptoms.
READ MORE >

FDA clears AI-powered ‘thermometer of the future’ with ECG sensors

BeamO combines electrocardiogram sensors, a stethoscope and a thermometer into a single device that patients can use at home to learn more about their health. Findings can then be submitted for a cardiologist to review.

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Withings BeamO
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FDA clears AI-powered ‘thermometer of the future’ with ECG sensors

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Withings BeamO
BeamO combines electrocardiogram sensors, a stethoscope and a thermometer into a single device that patients can use at home to learn more about their health. Findings can then be submitted for a cardiologist to review.
READ MORE >

In Other News

Nebraska’s lawsuit against Optum and Change Healthcare can move forward, judge rules

The UnitedHealth Group subsidiaries had attempted to have the case dismissed. However, a court rejected the motion. Nearly half of Nebraskans were impacted by the infamous February 2024 data breach on Change Healthcare.

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Optum UnitedHealthcare UnitedHealth Group HQ
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Nebraska’s lawsuit against Optum and Change Healthcare can move forward, judge rules

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Optum UnitedHealthcare UnitedHealth Group HQ
The UnitedHealth Group subsidiaries had attempted to have the case dismissed. However, a court rejected the motion. Nearly half of Nebraskans were impacted by the infamous February 2024 data breach on Change Healthcare.
READ MORE >

Minnesota hospital still pushing noncompetes, despite AG investigation

Such contract clauses are illegal in the state. However, physicians at St. Luke's Hospital in Duluth said they’re being pressured to sign them or face dismissal. 

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noncompete contract clause employment pen sign
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Minnesota hospital still pushing noncompetes, despite AG investigation

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noncompete contract clause employment pen sign
Such contract clauses are illegal in the state. However, physicians at St. Luke's Hospital in Duluth said they’re being pressured to sign them or face dismissal. 
READ MORE >

Teleradiology firm must pay $715K judgment to overseas outsourced imaging group

Univabs took The Radiology Group to court in May after an independent arbitrator ruled TRG owed the India-based imaging firm the six-figure sum, which it refused to pay. 

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court judge gavel business man bankruptcy lawsuit
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Teleradiology firm must pay $715K judgment to overseas outsourced imaging group

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court judge gavel business man bankruptcy lawsuit
Univabs took The Radiology Group to court in May after an independent arbitrator ruled TRG owed the India-based imaging firm the six-figure sum, which it refused to pay. 
READ MORE >

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