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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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MRI2CT clears NextMR to build 3D lumbar bone views from a standard MRI

MedDevice Startups Staff · Oct 7 · 1 min read · Via AuntMinnie

MRI2CT said on October 7 that FDA cleared NextMR, software that generates 3D bone visualization of the lumbar spine and sacrum from a standard diagnostic MRI. The company says output arrives in under 60 seconds from conventional sequences on 1.5T and 3T scanners.

Clinicians reach it through a cloud web interface or their DICOM environment, with nothing installed locally. MRI2CT is based in Claymont, Delaware, and run by chief executive Shmulik Shpiro. The clearance covers visualization, so anyone planning to size hardware off these images should read the indication wording before it reaches a case.

Questions & Answers

What did FDA clear for MRI2CT?

FDA cleared MRI2CT's NextMR, announced October 7, 2026. The software generates 3D bone visualization of the lumbar spine and sacrum from a standard diagnostic MRI, without a CT scan or added radiation.

How fast is MRI2CT's NextMR?

MRI2CT says NextMR produces output in under 60 seconds from conventional MRI sequences on 1.5T and 3T scanners. Clinicians access it through a cloud web interface or their DICOM environment, with no local software installation.

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