• AI
  • Molecular Imaging
  • CT
  • X-Ray
  • Ultrasound
  • MRI
  • Facility Management
  • Mammography

Sahara nears FDA clearance

Article

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.

Recent Videos
Pertinent Insights into the Imaging of Patients with Marfan Syndrome
What New Brain MRI Research Reveals About Cannabis Use and Working Memory Tasks
Current and Emerging Legislative Priorities for Radiology in 2025
How Will the New FDA Guidance Affect AI Software in Radiology?: An Interview with Nina Kottler, MD, Part 2
A Closer Look at the New Appropriate Use Criteria for Brain PET: An Interview with Phillip Kuo, MD, Part 2
How Will the New FDA Guidance Affect AI Software in Radiology?: An Interview with Nina Kottler, MD, Part 1
A Closer Look at the New Appropriate Use Criteria for Brain PET: An Interview with Phillip Kuo, MD, Part 1
Teleradiology and Breast Imaging: Keys to Facilitating Personalized Service, Efficiency and Equity
Current and Emerging Insights on AI in Breast Imaging: An Interview with Mark Traill, MD, Part 3
Current and Emerging Insights on AI in Breast Imaging: An Interview with Mark Traill, MD, Part 2
Related Content
© 2025 MJH Life Sciences

All rights reserved.