Good job ! real-time breast tumor detection as surgery

Breast Cancer Detection Device Gets Nod from FDA July 5, 2012 By Dale McGeehonAn advisory panel from the U.S. Food and Drug Administration has favorably recommended the U.S. use of a real-time breast cancer detection device that is used in the operating room. The medical device, manufactured by Dune Medical Devices Ltd. in Framingham, Mass., tests whether all tumor tissue has been removed in surgery, reports Gali Weinreb in Globes online. Called the MarginProbe system, the device should reduce the number of repetitive surgeries among breast cancer patients, the company reports in a press release. "We are very pleased with the panel's positive decision on the MarginProbe System for use in the U.S.," says Dune's Chief Executive Officer Dan Levangie. "We believe that the MarginProbe System will give surgeons a powerful tool in their fight against breast cancer and provide women a substantially better chance of avoiding additional surgeries. We will work closely with the FDA to complete the approval process and intend to launch the MarginProbe System in the U.S. immediately thereafter." The device uses electromagnetic waves to identify possibly cancerous tissue on the edges of a breast tumor, reports Mass Device. The areas where cancer is detected in areas just outside tumors are called positive margins. The company cites studies showing that the device's detection of positive margins helps cut in half the number of additional procedures to remove residual cancer. If, when using the device in surgery, it detects no remaining cancerous tissue, doctors may determine that the surgical procedure is completed. If the device finds cancerous tissue after the tumor has been excised, the procedure can continue. Currently, excised tumors are sent for a biopsy, the results of which often are available a day after the surgery is over. If the biopsy determines that margins of the excised tissue is cancerous, the patient has to have another operation. Dune Medical reports that between 30% and 60% of current breast cancer surgical procedures require additional operations. The medical device has won approval in the European Union. The company submitted a pre-market approval in the United States based on a 600-patient pivotal study. 

FDA顧問小組發行沙丘的 MarginProbe 系統的正面意見

Published on June 23, 2012 沙丘醫療設備今天宣佈了美國食品藥品監督管理局 (FDA)顧問小組投票了 (10 到 1) 傾向於沙丘的 MarginProbe 系統用於乳腺癌手術，作為對外科手術進行時的外科毛利鑒定當前標準方法的附屬。沙丘在數據基礎上 2011 提交了一種 Premarket 應用 (PMA) 的 4月從主要在美國進行的 600 名患者舉足輕重的研究。「我們對關於 MarginProbe 系統的面板的正決策非常滿意用於美國」，總執行官丹 Levangie 說沙丘的。 「我們相信 MarginProbe 系統將產生外科醫生在他們的戰鬥的一個強大的工具與乳腺癌并且提供婦女避免另外的手術的一個充分地更好的機會。  我們嚴密地與糧食與藥物管理局一起使用完成審批流程和打算緊接後發行 MarginProbe 系統在美國」。歷史上，在作乳房守恆手術的 30%-60% 婦女之間必須作另外的手術在第一次手術期間，因為醫生不能達到負毛利。 這個舉足輕重的試用數據顯示那通過使用 MarginProbe 系統在第一運算時，與標準方法一道，外科醫生將有這個能力極大減少按照最初的手術的正毛利的費率。來源沙丘醫療設備