Shots:
The US FDA has granted 510(k) clearance to Miracell’s SMART M-CELL PRP Concentration System and Bone Marrow Concentration System, including associated blood and bone marrow kits
Clearance was based on substantial equivalence to SmartPReP, with the system demonstrating high cell viability, efficient growth factor extraction, and integrated performance across centrifuge and kit components
SMART…
Shots:
The company has submitted a 510(k) application to the US FDA for its proprietary AI-assisted module designed for use with CapsoCam Plus
The CapsoCam Plus capsule endoscopy system is designed to visualize small bowel mucosa and detect abnormalities in adults and children (age ≥ 2 yrs)
The reading tool is expected to improve the…

