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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. 

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

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“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.  

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

lawyers attorneys

Of all lawsuits filed against patients in 2024 in one U.S. state, physician practices and other non-hospital healthcare entities accounted for 80% of cases. That’s a complete inversion from just six years prior.  

AI in healthcare

In the three or so years since it burst into healthcare, ambient AI scribe technology has run away with the win in the market-uptake race. What has been the return on investment in all those software packages? 

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The U.S. Department of Justice said it worries its lawsuit could ultimately bankrupt the telehealth group, leaving little money for alleged victims. The company is said to have refused to cancel member accounts, forcing patients to file credit card disputes to get refunds. This is in addition to other arguably more serious accusations levied by the DOJ.

california usa

The idea was floated as part of a proposed budget for the state released by Democrats in the Senate. If passed, only the top 2% of corporations in California would be impacted. The levy would generate $5 billion to $8 billion annually for Medicaid. 

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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.