Semler Scientific Plans To Seek New 510(K) Clearance From FDA For Expanded Use Of QuantaFlo Following Correspondence With FDA - Filing
Semler Scientific Plans To Seek New 510(K) Clearance From FDA For Expanded Use Of QuantaFlo Following Correspondence With FDA - Filing
在與美國食品藥品管理局通信後，塞姆勒科學計劃尋求美國食品藥品管理局新的510（K）許可，以擴大QuantaFLO的使用範圍——備案
Semler will continue to market and sell QuantaFlo as an aid in the diagnosis of PAD, which is responsible for over 99% of its historical revenue to date. The roll-out of QuantaFlo as aid in the diagnosis of other cardiovascular diseases is subject to FDA clearance of the new 510(k) clearance. The new 510(k) is intended to enable expanded labeling for QuantaFlo as an aid in the diagnosis of other cardiovascular diseases in addition to peripheral artery disease, or PAD.
塞姆勒將繼續推銷和銷售QuantaFlo作爲診斷PAD的輔助工具，迄今爲止，PAD佔其歷史收入的99％以上。QuantaFlo作爲其他心血管疾病診斷輔助工具的推出有待美國食品藥品管理局對新的510（k）許可的批准。新的510（k）旨在擴大QuantaFLO的標籤範圍，以輔助診斷除外周動脈疾病（PAD）之外的其他心血管疾病。