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Fewer than 30% of FDA-cleared AI devices share key safety, adverse event info prior to approval
Does BMI affect AI's accuracy when assessing CT scans?
New GE HealthCare partnership expands access to prostate cancer imaging agent
Repetitive head impact in soccer players increases risk of brain damage, MRI shows
Expert panel develops new breast biopsy guidelines
artificial intelligence
Factors making healthcare AI devices more likely to face recall

Deviations from a device’s intended use most often trigger FDA recalls, “highlighting unique safety challenges” in AI, experts write June 11 in JAMA. 

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Oprah Winfrey blesses new CT scanner she helped fund in Hawaii

Maui Memorial Medical Center, a 214-bed acute care hospital in Wailuku, celebrated the new computed tomography machine with its imaging team on June 8. 

FDA issues recall of imaging systems
'Risk of electrical shock' prompts recall of imaging systems

A handful of fluoroscopy units manufactured by GE HealthCare are the subject of a new recall by the U.S. Food and Drug Administration. 

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Researchers land $3.2M grant to advance MRI's role in diagnosing glioblastoma

The team’s work will emphasize the role of specialized MRI techniques capable of detecting subtle changes around tumors with the help of pH-based imaging.

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International experts issue new MRI-based prostate cancer screening guidance

The exam should be performed on patients with greater than 10 years of life expectancy and between the ages of 50 and 70, with earlier imaging recommended for black men. 

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House committee votes to halt prior authorization pilot impacting radiology services

Lawmakers have opted against authorizing funding for the Wasteful and Inappropriate Service Reduction Model, citing concerns it will overburden patients and providers. 

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Whole-body MRI may be as effective as PET/CT for cancer staging, even at half the price

Though both modalities offer providers insight into the extent of a patient’s disease, WB-MRI may be more beneficial for patients than the current standard of care. 

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Lower No Surprises Act dispute fees officially go into effect

The NSA independent dispute resolution process was updated by federal agencies on May 28, with the final rule including a slew of changes that affect radiology providers. 

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Radiologists tout support for bipartisan bill to address interventional ‘payment crisis’

The Promoting Fairness for Medicare Providers Act seeks to smooth out reimbursement differences between office- and hospital-based settings. 

Around the web

Radiology Business
Why RadNet is betting heavily on AI to reshape radiology workflows

RadNet Chaiman and CEO Howard Berger, MD, explains why the company has invested tens of millions into DeepHealth to rapidly build up a new business model. 

 

Cardiovascular Business
AI turns mammograms into CVD risk assessments—no outside data required

Thanks to AI, clinicians can use mammograms to do a lot more than identify signs of breast cancer. Researchers explored data from nearly 50,000 patients, presenting their findings in Heart.

Radiology Business
Fewer than 30% of FDA-cleared AI devices share key safety, adverse event info prior to approval

A new analysis is prompting questions regarding how rigorously many of the AI-enabled tools approved by the U.S. Food and Drug Administration are evaluated prior to their clearance.