最近FDA對海福超音波刀的安全及有效性進行評估及表決，詳見以下全文:

治療攝護腺癌有較少勃起功能障礙副作用的超聲波設備，未能獲得美國FDA顧問的推薦，該設備的製造商市值也因此慘遭腰斬。該超聲波設備稱為Ablatherm，是傳統手術以及放射線治療的替代療法：以機械手臂射入高能量且集中的超聲波，藉以造成癌細胞死亡。雖然製造商聲稱該產品有較低的副作用發生率，但是FDA顧問表示該公司未能提供足夠的證據證明該設備是有效且安全的。

(本文由台大醫學院陳同學翻譯，感謝簡華銓同學幫忙聯繫。)

July.31.2014

Ultrasound Device Used To Treat Prostate Cancer Fails To Win Recommendation Of FDA Advisers.

Bloomberg News (7/31, Edney) reports that “an ultrasound device used in Europe to treat prostate cancer with lower rates of erectile dysfunction failed to win the recommendation of advisers to US regulators who will decide whether the product becomes available” in the US. The product, known as “Ablatherm, is an alternative to traditional surgical and radiation treatments, and uses a robotic arm to insert a high-intensity, focused ultrasound device that kills cancer cells.” The product’s “manufacturer EDAP TMS SA (EDAP) didn’t provide evidence the product is safe and effective, advisers to the Food and Drug Administration voted.”