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US Senators Press CMS To Expand Coverage Of Dementia Diagnostic Scan

 
• By Hannah Daniel

US Senators sent a letter to CMS and HHS urging the expansion of amyloid PET scan coverage. 

• Source: Shutterstock

It’s time for the Center for Medicare and Medicaid Services to re-evaluate its coverage of beta amyloid positron emission tomography (PET) scans, US Senators say.

Amyloid PET scans are minimally invasive procedures that can tell normal tissue from amyloid beta tissue, which is a type...

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Warning Letters – June 2025

The US FDA posted eight device-related warning letters in June, touching on industry sectors from urinalysis test strips to ophthalmic devices.

Study: FDA’s Breakthrough Path Speeds Access, But Raises Safety Questions

 
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Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.

Burden Is Too Heavy For Medtechs To Go It Alone On Complex Medtech AI Projects

 
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FDA Commissioner’s Voucher Program Should Include Devices, Transplant Technology Firm Says

 
• By Elizabeth Orr

The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.

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Medtronic, Philips Cement New Pact To Embed Next-Gen Tech In Monitoring Platforms

 
• By Shubham Singh

Under the terms of the new agreement, Philips will also begin bundling essential supplies – including ECG, noninvasive blood pressure (NIBP) components, and batteries – with its Medtronic-enabled monitors.

Bivacor Rotary Heart Could Upend The Artificial Heart Market, If It Reaches Its Destination

 
• By Marion Webb

Bivacor aims to be first to the US market with a permanent total artificial heart, starting with use as a bridge to transplant. CMO William Cohn says data from countries with low transplant rates could support pivotal trials and long-term use.

Study: FDA’s Breakthrough Path Speeds Access, But Raises Safety Questions

 
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