CurveBeam AI receives FDA breakthrough device designation for bone fragility software

Fact checked byGina Brockenbrough, MA

CurveBeam AI Ltd. has announced FDA breakthrough device designation of OssView, an investigational bone fragility software to be used for women older than 70 years of age, according to company press release.

OssView computes a structural fragility score (SFS) to detect microstructural deterioration in patients with osteopenia, according to the release.

FDA HQ in Washington — Source: Adobe Stock

“We are extremely pleased to be moving forward with the SFS diagnostic through the FDA breakthrough device program,” Greg Brown, CEO of CurveBeam AI, said in the release. “There is a clear need for an improved clinical aid like SFS to help clinicians more effectively assess bone health and prevent fractures. We are looking forward to progressing its clearance with the FDA,” Brown added.

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CurveBeam AI receives FDA breakthrough device designation for bone fragility software

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