医械业震惊！FDA又封杀国内两家实验室数据！510 (k)、PMA、De Novo都要 ...
近日，医疗器械行业掀起了一场轩然大波！美国食品药品监督管理局（FDA）做出一项震撼性的决定，拒绝接受所有由 Mid-Link（天津海河生物医药科技集团旗下的海河标测公司 ）和苏州大学环境与卫生技术研究所有限公司提供的检测数据 。这一举措犹如一颗重磅炸弹，在行业内激起千层浪，引发了广泛关注和热议。
FDA Issues Nyxoah an Approvable Letter for its Genio® System
INSIDE INFORMATIONREGULATED INFORMATIONFDA Issues Nyxoah an Approvable Letter for its Genio® SystemMont-Saint-Guibert, Belgium – March 26, 2025, ...
Perimeter Files FDA PMA Application for its Next-Generation B-Series OCT with ImgAssist AI 2.0
Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTCQX: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, today announced the submission of a Premarket Approval ...
Ophthalmology Times11 天
Perimeter submits Premarket Approval application with FDA for Perimeter B-Series OCT system
The Perimeter B-Series OCT system combines proprietary AI technology with optical coherence tomography, for use during breast ...
来自MSN3 个月
NVNO Completes Application for VenoValve's PMA, Shares Likely to Gain
NVNO boasts a market capitalization of 59.8 million. The company is estimated to report 31.9% earnings growth in 2024. Positioning enVVeno for Growth in the Bioprosthetic Market VenoValve’s PMA ...