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Artivion, an Atlanta-based medical device company, has received a Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration (FDA) for its AMDS Hybrid Prosthesis designed to treat DeBakey Type 1 dissections when malperfusion occurs. This HDE ensures select patients can be treated with the device before the FDA makes its final approval decision.

FDA approves surgical device for high-risk aortic procedures

The AMDS Hybrid Prosthesis was designed to help clinicians treat DeBakey Type 1 dissections complicated by malperfusion. It works as a complement to hemiarch replacement, preserving the native arch and making reinterventions possible if needed.

Neurovascular device recalled due to safety concerns

The recall includes a total of nearly 45,000 devices that should be returned to the manufacturer.

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Uneven access to radiology AI could deepen healthcare disparities

New Neiman research explores how Medicare's New Technology Add-On Payment has impacted use of an AI triage tool for pinpointing severe strokes.

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House committee advances radiology-backed legislation to curb prior authorization

The Improving Seniors’ Timely Access to Care Act seeks to streamline the “often cumbersome and time-consuming” task of approving requests for medical imaging in Medicare Advantage.

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Radiology vendor Nanox Imaging warns of ‘going concern’ risk as losses deepen

The publicly traded, Israel-based company reported its quarterly earnings result on June 25, including a net loss of $14.3 million, up 8% from the previous year.

FDA denies Lantheus’ application for new PET imaging agent

The Bedford, Massachusetts-based manufacturer has for months sought to roll out LNTH-2501—a radioactive diagnostic kit for localizing neuroendocrine tumors.

Is the No Surprises Act working? Government watchdog is uncertain

The nonpartisan Congressional Budget Office said it needs more data to determine what savings the 2020 law is bringing to the U.S. healthcare system—but early data indicate it falls short of expectations.

Aidoc's chest X-ray reporting tool earns FDA Breakthrough Device designation

The product analyzes chest radiographs and creates high quality draft report text to help radiologists complete interpretations more efficiently while direct oversight.

Radiology gets 68 new FDA-cleared algorithms

Radiology makes up more than 76% of all of the FDA-cleared clinical AI algorithms.

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Thousands of heart surgery kits recalled due to FDA quality concerns

Specific lots of several procedure kits have been recalled after the FDA identified quality issues during a recent inspection.

Shockwave Medical announces new studies evaluating carotid IVL platform

Carotid artery disease causes up to 30% of all strokes, but severely calcified lesions can make treatment quite complex. The hope is that IVL can be as successful in this area as it has been in the treatment of coronary and peripheral artery disease.

Performing transcatheter aortic valve replacement (TAVR) with the J-Valve transcatheter heart valve (THV) may help limit the risk of coronary artery obstruction (CAO) in high-risk patients, according to a new study published in Clinical Interventions in Aging.[1]

TAVR with Edwards Lifesciences valve for severe AR linked to ‘encouraging’ data

All patients presented with severe aortic regurgitation. The study's findings were presented at New York Valves 2026 and published in JSCAI.

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