FreMon Scientific is pleased to announce the FDA has now cleared ZipThaw™ for frozen plasma thawing as a Class II medical device. ZipThaw, used with the ZipSleeve™ anti-contaminant disposable barrier, is the world’s first dry and portable precision plasma thawing system. Clinicians can now deliver vital plasma to patients at the right time and temperature.
ZipThaw and ZipSleeve have earned CE Mark, ISO certification, UL Listing and now FDA clearance for thawing fresh frozen plasma (FFP) and plasma frozen within 24 hours after phlebotomy (FP24).
We are delighted with the FDA’s clearance of ZipThaw as an effective and safe plasma thawing device for clinical use,” said FreMon Scientific CEO Dr. Farideh Bischoff.
“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.”
In most of the world, blood banks thaw plasma using hot water baths. The water baths are heavy, they require significant bench space, they are difficult to keep clean and often lead to waste since clinicians have to pre-order thawed plasma from a central location. They also only measure ambient water temperature, not the specimen’s actual temperature.
FreMon Scientific has designed the next generation thawing device that is safe, dry, easy to use, light enough to carry, and that uses a disposable, medical-grade sleeve to reduce contamination and increase accuracy. ZipThaw is proven to preserve coagulation factors needed in life saving transfusion procedures.
ZipThaw requires nearly no maintenance, thawing is precisely measured and the end-to-end thawing process is easier to manage with fewer technical staff.
“We are excited to start the new year with the opportunity to provide clinicians with an effective device that can improve their patients’ lives,” says CEO Dr. Bischoff.