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FDA panel votes not to endorse Medtronic renal denervation system

The Medtronic Symplicity Spyral Renal Denervation system uses a catheter that curls in the renal artery to place radiofrequency electrodes against the vessel wall to ablate the nerves that control vasodilation, so the artery can be propped in the fully open position.

The Symplicity Spyral RDN system. Graphic courtesy of Medtronic.

The vote was close, initially ending with a tie, but the panel ultimately decided there were too many questions related to the device's long-term benefits for patients with uncontrolled hypertension.

  • Read more about FDA panel votes not to endorse Medtronic renal denervation system

FDA temporarily halts mammography services at critical access hospital, claiming they posed ‘serious risk to human health’

mammogram mammography breast cancer

Phelps Memorial Health Center has completed the necessary remedies, including notifying any women who underwent breast imaging the last two years.

  • Read more about FDA temporarily halts mammography services at critical access hospital, claiming they posed ‘serious risk to human health’

Radiologist appointed CEO of ‘healthcare AI company creation platform’ Ascertain

Mark Michalski Ascertain

Mark Michalski, MD

Source

Ascertain

The company has raised $100 million in seed funding and earlier this year started Optain, which aims to identify diseases via retinal imaging. 

  • Read more about Radiologist appointed CEO of ‘healthcare AI company creation platform’ Ascertain

FDA clears new AI-powered MRI system from Fujifilm

Fujifilm Echelon Synergy MRI

Source

Fujifilm

The Echelon Synergy MRI machine utilizes proprietary deep learning reconstruction technology to enhance sharpness and acquire images faster. 

  • Read more about FDA clears new AI-powered MRI system from Fujifilm

Same hospital, same insurer, but imaging prices twice as high for commercial vs. Medicare Advantage plans

scale money prices shopping transparency reimbursement dollar coins

When stated in dollar terms, the median price for imaging services was $490 across commercial plans compared to $191 in MA, experts wrote in Health Affairs. 

  • Read more about Same hospital, same insurer, but imaging prices twice as high for commercial vs. Medicare Advantage plans

Beloved cardiologist Albert Waldo remembered for his lasting impact on electrophysiology

candles funeral dead respect

Waldo was a founding member of the North American Society of Pacing and Electrophysiology, which is now known as the Heart Rhythm Society, and was revered for his helpfulness and kindness.

  • Read more about Beloved cardiologist Albert Waldo remembered for his lasting impact on electrophysiology

FDA panel votes in favor of Recor Medical renal denervation system

The U.S. Food and Drug Administration (FDA) has approved Recor Medical’s Paradise Ultrasound Renal Denervation (RDN) system for uncontrolled hypertension. The Recor system gained FDA clearance in November 2023.

Paradise Ultrasound image courtesy of Recor Medical. 

A few members of the panel did question the device's efficacy and long-term durability. The FDA will now use these findings to make its final decision related to the system's approval. 

  • Read more about FDA panel votes in favor of Recor Medical renal denervation system

Rad AI announces new artificial intelligence-powered software for radiology reports

artificial intelligence robot evaluates healthcare data. Novo Nordisk announced a new collaboration with Valo Health, a healthcare technology company focused on using artificial intelligence (AI) technology to identify new drug treatments for cardiovascular disease (CVD).

After previewing the new software in September, Rad AI will make it commercially available throughout the United States at RSNA 2023 in Chicago.

  • Read more about Rad AI announces new artificial intelligence-powered software for radiology reports

Radiologist dies from fall while hiking at Wisconsin state park

Devil’s Lake State Park bluff

Devil’s Lake State Park

Source

Travel Wisconsin

Jason Gillum, MD, of Fort Wayne, Ind., was hiking with another individual at Devil’s Lake State Park when the two became separated. 

  • Read more about Radiologist dies from fall while hiking at Wisconsin state park

Appeals court revives whistleblower suits alleging unqualified broker made radiology referral decisions

Allstate Insurance Co. first filed the complaints in 2020 against Discovery Radiology Physicians, OneSource Medical Diagnostics and four physicians, alleging insurance fraud. 

  • Read more about Appeals court revives whistleblower suits alleging unqualified broker made radiology referral decisions

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