PET niche developer Naviscan arrived at the RSNA meeting with permission from the FDA to launch its Stereo Navigator, a biopsy guidance feature for its breast-specific PET scanner. Stereo Navigator can localize lesions as small as 2 mm. It uses a stereotactic frame fixed between the scanner’s paddles to guide a biopsy needle into the breast. Localization is verified using a PET-visible line source inserted into the needle track. This allows the user to confirm trajectory and position. The PET-guidance accessory is compatible with biopsy devices from Ethicon Endo-Surgery, Hologic, and SenoRx.
PET niche developer Naviscan arrived at the RSNA meeting with permission from the FDA to launch its Stereo Navigator, a biopsy guidance feature for its breast-specific PET scanner. Stereo Navigator can localize lesions as small as 2 mm. It uses a stereotactic frame fixed between the scanner's paddles to guide a biopsy needle into the breast. Localization is verified using a PET-visible line source inserted into the needle track. This allows the user to confirm trajectory and position. The PET-guidance accessory is compatible with biopsy devices from Ethicon Endo-Surgery, Hologic, and SenoRx.
Mammography AI Platform for Five-Year Breast Cancer Risk Prediction Gets FDA De Novo Authorization
June 2nd 2025Through AI recognition of subtle patterns in breast tissue on screening mammograms, the Clairity Breast software reportedly provides validated risk scoring for predicting one’s five-year risk of breast cancer.
Mammography AI Platform for Five-Year Breast Cancer Risk Prediction Gets FDA De Novo Authorization
June 2nd 2025Through AI recognition of subtle patterns in breast tissue on screening mammograms, the Clairity Breast software reportedly provides validated risk scoring for predicting one’s five-year risk of breast cancer.
2 Commerce Drive
Cranbury, NJ 08512