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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.

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. 

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

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

Medicare Advantage Part C clipboard payment

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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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. 

Lantheus

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

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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 RSNA

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

Dynamic chest radiography could be an alternative to pulmonary function tests for diagnosing COPD

The X-ray technique uses continuous radiographic acquisition during respiration to assess lung function.

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A new analysis published in Emergency Radiology examines how likely it is for these discrepancies to lead to changes in diagnosis and patient care. 

cancer chemotherapy survivor

The new guidance, published in JACC, focuses on three classes of commonly used anticancer therapies.

cardiologists going through the certification process

After an official request from Edwards Lifesciences, CMS is rethinking its coverage policy for the use of TAVR to treat asymptomatic severe aortic stenosis. The agency is accepting public comments on this topic until Jan. 14. 

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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. 

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

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