The FDA extended Medicrea's 510(k) clearance for its UNiD ASI software.
What you should know:
1. The FDA extended the clearance to include a database of the company's implant portfolio to assist with device planning and selection.
2. Surgeons can now use the UNiD ASI platform preoperatively to build their surgical planfor every implant in Medicrea's portfolio.
3. Medicrea's President and CEO Denys Sournac said the clearance will allow Medicrea to "reform this antiquated delivery model by optimizing the implants provided for each surgery."
4. Mr. Sournac said Medicrea is the only manufacturer that can streamline inventory required to operate and provide patient-specific devices in preoperative surgical planning.