Promisemed VeriEcto Automatic Biopsy Needles

FDA-Cleared Indications

• The needle is intended to obtain core tissue specimens for diagnostic examination.
• It is intended for use by qualified physicians in clinical procedures where tissue biopsy is indicated.
• The device is intended for single-use percutaneous biopsy procedures.

Clinical Applications

• Percutaneous image-guided core biopsy of a mass or lesion
• Sampling tissue to evaluate a suspected tumor or other abnormality
• Biopsy of accessible soft-tissue lesions when a core specimen is needed
• Obtaining tissue for histopathologic examination

Reported off-label uses

• Sampling selected organs or lesions outside the labeled indications when a clinician determines that the device is appropriate

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The specific needle sizes, lengths, and tissue-sampling configurations should be confirmed in the product labeling and available catalog for the selected model.
• The needle is intended for single use and should not be resterilized or reused.
• Ultrasound, CT, fluoroscopy, or another appropriate imaging method may be used to guide placement, depending on the biopsy site.
• MRI compatibility should not be assumed unless the specific device labeling identifies it as MR Safe or MR Conditional; the needle should generally be kept out of the MRI environment unless its labeling permits use.
• Contraindications and precautions include inability to safely access the target, uncorrected bleeding risk, suspected infection along the access path, and patient factors that make biopsy or required positioning unsafe.