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Commercial AI devices lack clinical validation, study finds

AuntMinnie

Commercial AI devices that lack adequate clinical validation may pose risks for patient care – and unfortunately, that’s true for almost half of the tools cleared so far by the U.S. Most notably, 226 of 521 (43%) lacked published clinical validation data.

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Hyperfine Announces FDA Clearance of Software Update That Enables Faster Acquisition of Best-in-Class Ultra-Low-Field Brain Images

Imaging Technology

mtaschetta-millane Wed, 07/17/2024 - 10:52 July 17, 2024 — Hyperfine , a groundbreaking medical device company that has redefined brain imaging with the world’s first FDA-cleared portable magnetic resonance brain imaging system—the Swoop system—announced the clearance of the ninth generation of AI-powered Swoop system software.

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ACR responds to Congressional query on AI reimbursement

AuntMinnie

MD, issued a nine-page letter to Congress recommending how to solve the reimbursement problem for AI in healthcare and ensure clinical AI is of value to patients and health systems. Proactive facility cybersecurity for protecting sensitive patient data that serves as the input or output of the AI.

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InkSpace Imaging receives FDA Clearance for a 24-channel Small Body Array Compatible with Siemens Healthineers 3T Systems

Imaging Technology

milla1cf Fri, 01/26/2024 - 21:11 January 26, 2024 — InkSpace Imaging , a leader in innovative diagnostic medical device technology, is proud to announce it received FDA clearance for its next-generation Small Body Array for the Siemens Healthineers Magnetom Skyra and Vida series 3T MRI scanners. Friday, January 26, 2024 - 21:11

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Positron Corporation Joins Cardiac PET Industry Coalition (CPIC)

Imaging Technology

CPIC has begun its work by weighing in on 2024 final payment rules, engaging with stakeholders in the cardiac community, and developing a 2024 policy agenda.

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Pixyl receives FDA clearance for AI-powered brain MRI software Pixyl.Neuro

Imaging Technology

Pixyl is an award-winning French medtech specializing in AI-powered MRI solutions to improve patient care. AI-driven MRI analysis opens the possibility of accessing previously unavailable clinically-relevant information to reinforce radiology workflows, especially in the context of neurological disorders.” explains Pr.

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Philips Announces New Interoperability Capabilities That Offer a Comprehensive View of Patient Health for Improved Monitoring and Care Coordination

Imaging Technology

As a world leader monitoring more than 600 million patients each year worldwide, Philips is creating an open patient monitoring ecosystem to bring together disparate medical devices and systems on a single interface. Harmonized data is available to caregivers across the hospital.