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Home Industry News Hologic receives FDA clearance to use Frax technology

Hologic receives FDA clearance to use Frax technology

11th September 2008

Hologic has received official clearance from the US Food and Drug Administration (FDA) to incorporate a ten-year bone fracture risk calculator developed in the UK into its bone densitometer systems.

The ruling makes it the first company in the United States to be authorised to use the Fracture Risk Assessment (Frax) calculator, which was put together by the World Health Organisation’s Collaborating Centre for Metabolic Bone Diseases at the University of Sheffield Medical School under the leadership of Professor John Kanis.

The tool uses 11 different risk factors – including age, country-specific fracture data and personal and family fracture histories – to assess a patient’s risk of experiencing a bone fracture within a ten-year period.

It will be incorporated into Hologic’s Discovery and Explorer bone densitometer systems to help healthcare providers identify and preventatively treat those with the highest risk factor.

Hologic chairman and chief executive officer Jack Cumming said: "Frax enables healthcare providers to identify patients who otherwise would go untreated until they experienced a bone fracture."

Based in Bedford, Massachusetts, Hologic develops, manufactures and supplies diagnostic and medical imaging equipment specifically designed for women’s health issues.

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