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

HumaScan receives warning letter

Article

HumaScan's marketing efforts for its BreastAlert Differential Temperature Sensor (DTS) system have drawn the attention of the Food and Drug Administration. In an April 24 warning letter to the Cranford, NJ-based company, the agency's Center for Devices

HumaScan's marketing efforts for its BreastAlert Differential Temperature Sensor (DTS) system have drawn the attention of the Food and Drug Administration. In an April 24 warning letter to the Cranford, NJ-based company, the agency's Center for Devices and Radiological Health took issue with advertisements, physician labeling, comments by celebrity spokespersons, and press releases associated with BreastAlert, a noninvasive adjunctive screening device for breast cancer (SCAN 7/9/97). HumaScan holds U.S. and Canadian marketing rights from Scantek Medical, which developed the product.

In particular, the CDRH's warning letter stated that the company has misrepresented the intended use of the device, making both implicit and explicit claims that the device can detect breast disease, including breast cancer. The device was cleared as an adjunct to routine physical examination, including palpation, mammography, and other established procedures for the detection of breast disease. HumaScan officials were not immediately available for comment.

In other company news, HumaScan and BreastAlert's developer, Scantek Medical of Denville, NJ, have restructured their licensing agreement. The move, which was made to provide HumaScan with additional time and financing to pursue its marketing and distribution plans, waives certain HumaScan royalty payments in exchange for HumaScan stock warrants.

HumaScan has also restructured its contract with Zigmed, which provides production equipment for BreastAlert. The purchase price for the equipment has been reduced by approximately $200,000 in exchange for the issuance of warrants to purchase 30,000 shares of HumaScan's common stock at $4.725 per share.

Recent Videos
Emerging Research at SNMMI Examines 18F-flotufolastat in Managing Primary and Recurrent Prostate Cancer
Could Pluvicto Have a Role in Taxane-Naïve mCRPC?: An Interview with Oliver Sartor, MD
New SNMMI President Cathy Cutler, PhD, Discusses Current Challenges and Goals for Nuclear Medicine
Where the USPSTF Breast Cancer Screening Recommendations Fall Short: An Interview with Stacy Smith-Foley, MD
A Closer Look at MRI-Guided Transurethral Ultrasound Ablation for Intermediate Risk Prostate Cancer
Improving the Quality of Breast MRI Acquisition and Processing
Can Fiber Optic RealShape (FORS) Technology Provide a Viable Alternative to X-Rays for Aortic Procedures?
Does Initial CCTA Provide the Best Assessment of Stable Chest Pain?
Making the Case for Intravascular Ultrasound Use in Peripheral Vascular Interventions
Can Diffusion Microstructural Imaging Provide Insights into Long Covid Beyond Conventional MRI?
Related Content
© 2024 MJH Life Sciences

All rights reserved.