US-based medical imaging solutions provider Subtle Medical has received CE Mark certification for its AI-powered imaging software SubtleHD, enabling its launch in Europe.
The software is designed to enhance MRI image quality, reduce scan times by up to 80%, and optimise radiology workflows.
Also, it addresses the long MRI wait times, a prevalent issue in many European countries.
SubtleHD is valid in the European Union (EU) and other CE Mark-recognised regions.
It offers a vendor-neutral AI solution for radiologists, imaging centres, and hospitals.
The software easily integrates with existing MRI scanners, allowing faster scans and accommodating more patients without necessitating expensive hardware upgrades.
Subtle Medical chief commercial officer Josh Gurewitz said: “Receiving CE Mark for SubtleHD marks a major step in expanding access to higher quality MRI imaging across Europe.
“With SubtleHD, hospitals and imaging centres now have the newest and by far the best image enhancement solution for MRI to hit the market.
“It unlocks unparalleled efficiency and image quality-helping radiologists read faster, reduce burnout, and improve patient care with existing resources.”
SubtleHD employs advanced denoising and sharpening techniques to produce ultra-clear images that frequently surpass standard-of-care quality.
It supports all body parts and contrasts, including both 2D and 3D imaging, and provides a turnkey solution for image quality and speed.
The software benefits imaging institutions by improving image quality, enhancing diagnostic confidence and expediting reads, particularly on older magnets with image quality issues.
Shorter scan times help maintain schedules, reduce patient wait times, and increase daily scan slots, enhancing revenue without additional equipment investments.
SubtleHD improves scanner sustainability by enhancing the performance of existing MRI scanners, extending their lifespan and enabling centres to maximise current resources.
In addition, shorter scan times enhance patient comfort and reduce motion-related artefacts and rescans, contributing to a better overall patient experience.
Last month, Subtle Medical received the US Food and Drug Administration (FDA) approval for SubtleHD software and launched its Subtle-ELITE suite of AI-powered software tools.
The Subtle-ELITE suite comprises SubtleHD, SubtleSYNTH, and SubtleALIGN solutions.
