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U.S. FDA Sign

Prior to the new “RAPID” program announced on Thursday, it could take a year or more for Breakthrough-designated medical devices to earn approval for Medicare coverage. Now, regulators say that timeline could be reduced to as little as two months.

Nicklaus Children’s Hospital patent ductus arteriosus (PDA) closure

The 22-week-old patient was successfully treated by a traveling cardiologist—all without being transported to the cath lab.

Harmony Reynolds, MD, FACC, director of the cardiovascular clinical research center at NYU Langone Health, presented a study at the American College of Cardiology (ACC) 2026 meeting using coronary optical coherence tomography (OCT) and cardiac magnetic resonance imaging (MRI) to determine sex differences in underlying causes of myocardial infarction with no obstructive coronary arteries (MINOCA).

The combination of OCT and MRI can help provide an improved sense of clarity when managing MINOCA patients, according to new data presented at ACC.26 in New Orleans.

 The U.S. Food and Drug Administration (FDA) has granted market clearance for Biotronik's Acticor Sky and Rivacor Sky implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems. The new technology will be launches at the Heart Rhythm Society (HRS) annual meeting this week. #HRS2026

These devices were built to provide better patient data and improve clinician workflows. They will be on display at Heart Rhythm 2026 in Chicago. 

approval regulations checkmark doctor

CMS and the FDA say the goal is to improve patient access to medical devices that address an unmet need.

court brain scan legal gavel lawsuit malpractice judge

“Radiologists should exercise caution when implementing...protocoling workflows that bypass independent radiologist review," one expert writes in the American Journal of Roentgenology

business launch

Co-founders Jonathan Steinberger, MD, and Gabriel Lipshutz, MD, are starting Elmnt IR with an initial location in Los Angeles and more to follow.  

healthcare value value-based care money dollar

About 39% of rads polled by the news website said they fall in this income bracket, placing the profession in a tie with orthopedists. 

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Medmo and Covera Health, both based in New York, officially announced their merger on April 21, with the latter’s lead investor, Insight Partners, funding the deal. 

The companies say they’re entering the next phase of collaboration, offering GEHC mammography systems paired with AI offerings from DeepHealth. 

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Speaking at a Politico health care policy forum, CMS Administrator Mehmet Oz, MD, said he supports Medicaid, adding that “when you love something, you protect it.”

The insurance giant has been piloting a program to speed up reimbursement to hospitals in 10 states, reducing delays by roughly 50%. Now, the company said it will work to lift prior authorization barriers on patient care delivery. The intent is to roll out these changes nationwide by the end of 2026, UnitedHealthcare confirmed.

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Prior to the new “RAPID” program announced on Thursday, it could take a year or more for Breakthrough-designated medical devices to earn approval for Medicare coverage. Now, regulators say that timeline could be reduced to as little as two months.