USA – Wearable dialysis system gains breakthrough designation from FDA

AWAK Technologies recently announced the FDA has granted breakthrough device designation to its wearable PD system that incorporates AWAK’s sorbent technology.

According to a company press release, the FDA’s breakthrough designation is granted to expedite the development and review of certain devices that demonstrate potential to provide a more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases.

“To qualify as a breakthrough device, there must either be no FDA-approved alternative treatments available or the technology must offer significant advantages over the existing approved alternatives,” according to the press release…