FDA clears Lunar vertebral morphometry

The Food and Drug Administration has given Lunar 510(k) clearancefor the final pieces of its automated vertebral morphometry techniquefor its Expert-XL bone densitometer. Vertebral morphometry addsinformation about bone size and shape to the bone density dataacquired by densitometers.

Lunar's vertebral morphometry application allows clinicians tomake computerized measurements of vertebral dimensions and howthese dimensions change over time, then compare them to a referencebase of a normal population to determine whether the measurementsare abnormal. Lunar's 510(k) clearance was for use of the referencebase and adds to clearances received last year for other partsof the technology.

Automated vertebral morphometry is a major selling point of Expert-XL,according to David Weissburg, marketing manager for the Madison,WI, company. Although the technique is not in widespread clinicaluse, it has promising clinical potential and is commonly usedby pharmaceutical companies developing drugs for the treatmentof osteoporosis.

"It provides a new level of information about bone status,"Weissburg said.

Lunar is offering vertebral morphometry as an option on Expert-XLsystems, and most ship with the option. The company has been shippingthe application to overseas customers since the Expert line waslaunched in 1994, according to Weissburg.

Vertebral morphometry was an issue in a patent dispute last yearbetween Lunar and archrival Hologic of Waltham, MA. The disputewas settled with a patent cross-licensing deal between the companies(SCAN 10/11/95).