2024 Biological Device Application Approval #1: Aeon ACKit Platelet and Plasma Separator

SciFocus/May 2024 -- The FDA has granted approval to Aeon ACKit, a device designed for safe and rapid preparation of autologous platelet-rich plasma (PRP) at the patient's point of care. This approval marks a significant advancement in bone graft handling for bony defects.

Key Highlights:

- Device Purpose: Aeon ACKit is used for PRP preparation from peripheral blood, mixed with autograft or allograft bone to enhance handling in bony defects.

- Non-Clinical Testing: Rigorous studies included sterilization verification, shelf life, biocompatibility, and various performance tests.

- Clinical Testing: While no clinical data was used for approval, safety and effectiveness were established through robust non-clinical performance testing.

- Substantial Equivalence: Aeon ACKit is deemed substantially equivalent to the cleared device Aeon CPKit, demonstrating similar indications, technology, safety, and performance.

This approval underscores Aeon ACKit's readiness for enhancing bone graft procedures, offering clinicians a reliable tool for improved patient care.

If you're enjoying this content, sign up to SciFocus daily newsletter by Biopatrika for all the biggest stories in Science, healthcare, STEM, startups, and how we're advocating to "Bring Science to Society."

For partnership or advertisement opportunities, feel free to contact us here or visit www.biopatrika.com.

Career Opportunities: Biopatrika Career Hub https://www.dhirubhai.net/groups/13946324/

Follow Virender Singh and Biopatrika on LinkedIn.