Sahara nears FDA clearance
Hologic's Sahara ultrasound-based bone densitometer has moved one step closer to clearance. The Food and Drug Administration's Radiology Advisory Panel has unanimously recommended approval of the company's premarket approval (PMA) application with
Hologic's Sahara ultrasound-based bone densitometer has moved one step closer to clearance. The Food and Drug Administration's Radiology Advisory Panel has unanimously recommended approval of the company's premarket approval (PMA) application with conditions for Sahara, which assesses a patient's skeletal status by measuring bone mineral density at the heel with an ultrasound exam.
Designed for office-based use, Sahara results are available in about a minute via a self-contained printer, according to Waltham, MA-based Hologic. Physicians can then review the results to determine whether the patient should begin pharmacotherapy to prevent or treat osteoporosis, according to the company.
To assure the sensitivity of Sahara results to risk of fracture, the FDA panel has requested additional analysis of existing data to demonstrate a correlation between Sahara and the company's WalkerSonix ultrasound device. When cleared, Sahara will provide an entree for Hologic into the lucrative primary-care market. Sahara will be sold into that market by medical product distributor Physician Sales & Service, which already sells other Hologic products. Sahara is available in Europe, Asia, and Latin America.