Pixyl Received the US FDA's 510(k) Approval for the Pixyl.Neuro

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Pixyl Received the US FDA's 510(k) Approval for the Pixyl.Neuro


  • The US FDA cleared Pixyl.Neuro, AI software for brain MRI analysis that increased detection rates by 28%, accelerated MRI reading time & 83% of stable MS MRI tests to improve patient care
  • Pixyl.Neuro utilizes generative AI technology to provide reliable performance in real-world applications by automatically analyzing brain MRI images to facilitate the quick detection, early diagnosis, and objective monitoring of neurological conditions
  • Pixyl complied with the latest FDA AI guidelines in obtaining approval, furthermore, Pixyl.Neuro has been certified as a CE-mark class IIa under the new Medical Device Regulations in the EU

Ref: PR Newswire  Image: Pixyl

Related News:- Masimo Received the US FDA's 510(k) Approval for the Masimo W1 Medical Watch

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Kritika Jha

Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.

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