FDA
Regulatory news, insights - July 2025
MedCAD’s AccuStride receives US FDA 510(k) clearance; FDA Breakthrough Device Designation for the eShunt System
More in FDA
Zimmer Biomet and Pentax Medical recent FDA approvals.
Medtech approvals around the industry.
How new executive orders may affect US FDA medical device operations
These executive orders may, for example, delay pending regulations, create uncertainty for FDA’s prior guidance related to artificial intelligence, and adversely impact FDA staffing and resources.
Truliant porous 3D tibial implant
AMStent Tracheobronchial Covered Stent System; LinkSymphoKnee implants with TMINI miniature robotic system; Truliant porous 3D tibial implant
Best of 2024: #6 Article – Closing the global product information gap
Regulatory affairs can fuel clinical and quality teams with key product information, help speed time to market, and be a catalyst for innovation. But the truth is most medtechs aren’t seeing these benefits, slowed down by inefficient administrative tasks.
Children’s National, FDA collaborate to advance pediatric device regulatory tools
Groundbreaking collaboration aims to advance medical device development for children.
Cadence expands cleanroom at Virginia facility
The company is expanding the size of its current cleanroom operations to 5,000 square feet.
5 essential ERP features for medical device startups
Implementing an ERP (enterprise resource planning) system tailored to their needs is crucial for ensuring compliance, efficiency, and scalability.
Current regulatory news
FDA 510(k) clearance for miniature robotic system; ISO 13485 certification achieved for quality management system
SurGenTec’s FDA clearance for B-MAN Bone Marrow Aspirate Kit
The B-MAN Kit’s cutting-edge approach to bone marrow aspiration uses a centrifuge-free method for the collection of high-quality aspirate with minimal contaminants.
US FDA Clearance of Siemens Healthineers’ Cardiovascular Ultrasound System, 4D ICE Catheter
ACUSON Origin system offers integrated AI for enhanced clinical decision-making; AcuNav Lumos 4D ICE catheter delivers MPR biplane imaging and real-time 4D color Doppler.
