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CMS Proposes New TCET Pathway, But How Much Difference Will It Make?

 
• By Hannah Daniel

While many industry groups have praised the introduction of TCET, a replacement for the repealed MCIT rule, a Washington Analysis expert has his doubts.

Hearing aids on Medicare Healthcare card.
• Source: Shutterstock

The Center for Medicare and Medicaid Services has released a plan to cover breakthrough devices during a transition period while they await full coverage. Senior Healthcare analyst and vice president of Washington Analysis John Leppard is “skeptical” that this proposal will have a remarkable impact on device coverage.

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Makary Proposes Combined Adverse Event Reporting Systems In Megyn Kelly Interview

 
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In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.

FDA Issues A Pair Of Early Alerts For Intravascular Catheters

 
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Upcoming CMS Meetings Address Tremor-Control Devices, Lab Test Reimbursement

 
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The US Medicare agency will hold three public meetings in June and July addressing tremor treatment devices and clinical diagnostic lab tests. The first meeting on June 25 will focus on endpoints for Parkinson’s device trials, while subsequent meetings will address payment rates and codes for laboratory tests.

Precision Neuroscience’s FDA Clearance For Core Component Of Brain Implant Expected to Accelerate R&D

 
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Precision Neuroscience’s FDA Clearance For Core Component Of Brain Implant Expected to Accelerate R&D

 
• By Marion Webb

Precision’s recent FDA clearance for a core part of its next-generation wireless brain-computer interface system opens the pathway to a safer, more humane BCI for researchers to use compared to higher-risk intracortical arrays, according to BCI expert Naveen Rao.

Trump’s Preliminary 2026 HHS Budget Plan Protects US FDA User Fee Collection

 
• By Cathy Kelly

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

J&J Survey: Clinician Burnout And Aging Populations Drive Demand For AI And Robotics In Future Health Care

 
• By Shubham Singh

According to a survey of health care professionals by J&J, over 45% of surveyed respondents reported experiencing symptoms of burnout, including emotional exhaustion and reduced sense of personal accomplishment. This affects not just clinicians, but also the quality and safety of care they deliver. Most clinicians (72%) say that data and technology could significantly help alleviate this burden.