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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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Qure.ai joins forces with Nuance

AuntMinnie

has joined Nuance Communication'. secures EU medical device regulation certification Qure.ai Artificial intelligence (AI) software developer Qure.ai Read more on AuntMinnie.com Related Reading: Nuance releases new AI healthcare documentation app Qure.ai secures FDA clearance for qER-Quant

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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. ,

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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.

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FDA Cautions Consumers Against Use of RoyalVibe Ultrasound Devices

Vesta Teleradiology

However, the FDA has not reviewed these devices, and they lack the necessary 510(k) clearance or premarket approval. FDA to evaluate and approve medical devices. The FDA reviews the submission to ensure the new device shares the same intended use and technology as the predicate device. What is 510(k) Clearance?

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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.