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CMS Pushes Back Cardio, Ortho Bundled-Pay Models

 
• By Sue Darcey

Trump's new CMS Chief Seema Verma has only been in place for a week, but an agency decision to delay implementation of two bundled-payment initiatives – one on cardiac care and one on joint replacements – underscores the administration's wariness of mandatory value-based payment models.

A CMS delay of two Affordable Care Act-inspired alternative bundled-payment plans for cardiac care and joint replacement underscores the new administration's unfavorable position on mandatory alternative episode-of-care payment plans designed to replace Medicare fee-for-service.

In a March 21 notice, CMS says the start date for new bundled-payment models for orthopedic and cardiac...

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Fallouh Healthcare Receives Grant Funding From Innovate UK

 
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Fallouh Healthcare has received £305,050 in grant funding from Innovate UK as part of the European Union’s Eureka Eurostars program. The company aims to detect cardiac tamponade, a condition that affects patients after heart surgery. Currently, there is no way to accurately diagnose the condition.

Volta Files For US FDA Approval Of Next-Gen Cardio Mapping Software After Winning Labeling Expansion

 
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Ceryx Medical Amasses £11M To Develop Adaptive Cardiac Pacing Technology

 
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More from Device Area

Fallouh Healthcare Receives Grant Funding From Innovate UK

 
• By Natasha Barrow

Fallouh Healthcare has received £305,050 in grant funding from Innovate UK as part of the European Union’s Eureka Eurostars program. The company aims to detect cardiac tamponade, a condition that affects patients after heart surgery. Currently, there is no way to accurately diagnose the condition.

Newborn Screening Tests Among FDA Classifications

 
• By Elizabeth Orr

The US FDA has announced classifications for five device types, including four diagnostics as well as a hand cream to protect healthcare workers exposed to radiation. Two of the products are newborn screening tests.

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 
• By Natasha Barrow

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.