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FDA defines 'transparency' for AI medical devices

AuntMinnie

“Transparency is the degree to which appropriate information about a device – including its intended use, development, performance, and, when available, logic – is clearly communicated to stakeholders,” the group wrote. The full article is available here.

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Growth Areas in Medical Devices and Hiring For Those Roles

MRI Network

The need for more remotely accessible services like telemedicine and a range of advanced medical devices is accelerating growth across the industry. Recent reports highlight that the MedTech (medical technology) industry is set to grow to a value of $595 billion in 2024.

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FDA issues guidance on scanning interference with implanted medical devices

AuntMinnie

Despite reported issues with CT scanning interfering with certain medical devices, the U.S. Food and Drug Administration (FDA) has said CT is still the preferred imaging modality for patients with medical devices. CT is safer than magnetic resonance imaging (MRI) for people with devices of unknown MRI safety status."

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Hyperfine, Inc. Launches AI-powered Brain Imaging Software for Enhanced Image Quality and Ease of Use

Imaging Technology

a 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 launch of the AI-powered eighth generation of Swoop system software. milla1cf Tue, 01/09/2024 - 11:12 January 9, 2024 — Hyperfine, Inc. ,

Imaging 104
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Positron Corporation Enters New Manufacturing & Components Supplier Cooperative with Neusoft Medical Systems Subsidiary for New PET-CT Device

Imaging Technology

Through its role as manufacturer, Positron will be able to observe and comply with FDA requirements and perform future device and procedural reviews more efficiently. Going forward Positron will adhere to all FDA requirements, quality systems regulations, and import regulations.

Medical 98
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Siemens Healthineers Announces FDA Clearance of syngo Virtual Cockpit Remote Scanning Technology

Imaging Technology

milla1cf Tue, 01/23/2024 - 13:53 January 23, 2024 — Siemens Healthineers announces the Food and Drug Administration (FDA) clearance of syngo Virtual Cockpit, a private, secure communication platform for real-time image visualization, acquisition, and collaboration between healthcare professionals across multiple sites.

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How imaging AI developers can avoid pitfalls when testing algorithms

AuntMinnie

Postoperative changes and medical devices – Previous reports suggest that AI algorithms “are not properly trained” to recognize postoperative changes and how they impact image interpretation, the authors noted. Also, medical devices such as catheters, implants, prosthetics, or pacemakers can impact AI’s performance.

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