PRNewswire01.06.20
The FDA has cleared FreMon Scientific’s ZipThaw for frozen plasma thawing as a Class II medical device. ZipThaw, used with the ZipSleeve anti-contaminant disposable barrier, is a 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.
"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, which are heavy, require significant bench space, 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.
ZipThaw requires nearly no maintenance, thawing is precisely measured, and the end-to-end thawing process is easier to manage with fewer technical staff. Also, ZipThaw is proven to preserve coagulation factors needed in life saving transfusion procedures.
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.
"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, which are heavy, require significant bench space, 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.
ZipThaw requires nearly no maintenance, thawing is precisely measured, and the end-to-end thawing process is easier to manage with fewer technical staff. Also, ZipThaw is proven to preserve coagulation factors needed in life saving transfusion procedures.
