Profile: Neomatrix is a developer of innovative devices that allow women and doctors to promote optimal breast health. Our product, the HALO breast pap test, is the only fully automated, non-invasive breast cancer risk assessment test designed for use in the primary care setting. The HALO breast pap test is a safe and effective method to collect nipple aspirate fluid for cytological evaluation. The collected fluid can be used in the determination, and/or differentiation of normal versus pre-malignant versus malignant cells. The test provides important benefits to clinicians such as routine NAF risk assessment and objective assessment for documentation. It is a consistent & reproducible, fully automated, user friendly test that requires no specialized training or certification. It can be performed by office staff & easily transported from room to room. It is a simple, 5 minutes procedure, and can be performed during annual check up.
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• Biopsy Instruments (FDA Code: KNW / 876.1075) A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. |
• Biopsy Instruments (FDA Code: KNW / 876.1075) |
• Breast Cancer Detection Kit Test |
• Breast Cancer Test |
• Diagnostic Test Kits |