In place Medical Corporation won FDA 510(k) leeway for its Intact extraction framework to be utilized to safeguard evacuated breast tissue of up to 30mm in breadth. Once the territory is arranged, the wand is embedded through a 6mm-8mm cut and the tip grows to encompass the tissue. A 10 second blast of radiofrequency vitality is conveyed through the tip removing the tissue around the example and liberating it for simple evacuation. The specimen keeps up its building design and is prepared for standard histologic assessment. The gadget accompanies four distinctive bushel sizes that wrap around the example, while the same wand is utilized with every one of the four. Dr. Pat Whitworth, Director, Nashville Breast Center, noted, “This new FDA clearance is highly significant, not just for Intact Medical, but more importantly, for women’s health professionals and patients, globally. The expanded clearance recognizes the unique features and significant advantages of the Intact technology compared to core needle biopsy and open surgical excision procedures in certain situations. Specifically, for small breast lesions up to 30mm in diameter, the ability of the Intact system to remove and preserve the entire lesion architecture for assessment by the pathologist combines the minimally-invasive benefits of core biopsy with the diagnostic assurances of traditional surgical excisional biopsy. As someone who has performed more than 1,000 procedures with the Intact, I can attest to the advantages of this option for my patients.” John Vacha, President and Chief Executive Officer of Intact Medical, noted, “This FDA clearance represents an important milestone for the company and is an acknowledgement of the unique capabilities of the Intact technology.
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