ZipThaw is claimed to be the world's first dry and portable precision plasma thawing system
ZipThaw portable precision plasma thawing system (Credit: PRNewswire / FreMon Scientific, Inc.)
FreMon Scientific has secured clearance from the US Food and Drug Administration (FDA) for its ZipThaw as a Class II medical device for frozen plasma thawing.
ZipThaw, which is designed to be used with the ZipSleeve anti-contaminant disposable barrier, is claimed to be the world’s first dry and portable precision plasma thawing system.
The new system enables clinicians to deliver vital plasma to patients at the right temperature.
FreMon already secured CE mark approval for its ZipThaw and ZipSleeve product. The FDA approval allows the system to be used for thawing fresh frozen plasma (FFP) and plasma frozen within 24 hours after phlebotomy (FP24).
ZipThaw uses a disposable and medical-grade sleeve to reduce contamination and increase accuracy
The next generation thawing device uses a disposable and medical-grade sleeve for the reduction of contamination and improves accuracy.
According to the company, ZipThaw is proven to preserve the coagulation factors required in life-saving transfusion procedures.
ZipThaw needs almost no maintenance, as well as helps in precise measuring of thawing. It also facilitates the management of the end-to-end thawing process with fewer technical staff.
FreMon Scientific CEO Dr Farideh Bischoff said: “ZipThaw delivers plasma to patients requiring transfusions, and with ZipSleeve’s patented sensors, the system gives accurate, degree-by-degree measurement of the specimen’s actual temperature during the thawing process, not its surroundings.
“Today marks a new era in plasma thawing for patients, clinicians, and researchers seeking a more effective approach that is efficient, reproducible and safe.”
Based in San Diego of California, FreMon Scientific is engaged in the development of platforms and devices for efficient processing and use of blood, plasma and tissue products.
In July 2019, Baxter International secured 510(k) clearance from the FDA or PrisMax system and integrated TherMax blood warmer, the next-generation platform for continuous renal replacement therapy (CRRT) and therapeutic plasma exchange (TPE).
Developed using suggestions from more than 650 healthcare providers across the world, the PrisMax system enables to simplify therapy delivery and provides flexibility to the hospitals to meet the unique demands of the ICU.