orthobiologics
Miracell’s FDA Clearance Is a Big Deal for Regenerative Medicine. Here’s Why.
The FDA just cleared a Korean stem cell extraction system that outperforms the Harvard standard it was benchmarked against The benchmark matters. When the FDA clears a medical device under the 510(k) pathway, it grants clearance based on demonstrated substantial equivalence to a predicate device already on the market. Miracell chose SmartPReP as its predicate.…
