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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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US congressman helps secure $750,000 for rural hospital’s radiology expansion

Rep. Mike Simpson, R-Idaho, announced the news on June 10, with the money going toward Madison Memorial Hospital in Rexburg. 

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RadNet secures $250M new loan, gets downgrade from Moody’s

The ratings agency contends RadNet is constrained by its geographic concentration in 11 states and high fixed costs, including sizable interest expenses. 

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Portable PET/CT scanner guides bedside IR procedures

Though these treatments are typically done with assistance from real-time fluoroscopy, there is ample evidence nuclear imaging may offer more benefits.

Cybersecurity lock
Siemens Healthineers receives $7M grant to spearhead cybersecurity research

Funding will back the imaging manufacturer's efforts to boost the cyber resilience of medical devices and equipment. 

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Augmented reality improves novice users' ultrasound skills

Using a virtual reality headset, the system, dubbed AR-VIU (augmented real-time volumetric imaging in ultrasound), creates a 3D rendering of anatomy based on 2D ultrasound images.

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Large language model helps radiology department boost patients’ report comprehension

Emory University has utilized OpenAI’s GPT-5 to create LLM-produced radiology report summaries, clickable terms with embedded educational content, and AI-generated videos. 
 

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.