FreMon Scientific based in San Diego, CA is pleased to announce the FDA has cleared ZipThaw™ as a plasma thawing Class II medical device.
Over the past year ZipThaw, along with the anti-contaminant disposable ZipSleeve™, have earned CE Mark, ISO certification and UL Listing. As of today, ZipThaw and ZipSleeve are also FDA cleared for clinical use in the USA. This means that clinicians and researchers in all territories recognized by both the FDA and CE Mark can thaw fresh frozen plasma with ZipThaw and ZipSleeve.
“We’re delighted with the FDA’s recognition that ZipThaw is an effective, accurate and safe plasma thawing device,” said CEO Dr. Farideh Bischoff. “ZipThaw speeds vital specimens to patients in need, and it gives clinicians and researchers confidence with accurate, degree-by-degree measurement of the specimen’s temperature. Today is a big win for patients, clinicians, medical researchers, and for the entire FreMon Scientific team.”
The FreMon Scientific team has developed a better way to thaw plasma. In most of the world, blood plasma is thawed by hot water baths. The baths are heavy, hard to clean and often lead to waste. FreMon Scientific started with designs for a next generation thawing device that is safe, dry, portable — and that uses a disposable, medical-grade anti-contamination sleeve with patented sensors.
Today, FreMon Scientific is now cleared to sell ZipThaw and ZipSleeves to a global clinical and research audience. All ZipThaw and ZipSleeve manufacturing and production is based in the USA with top-tier medical device partners in Minnesota and Massachusetts, respectively. ZipThaw now has distributors in the western USA, the UK & Ireland, Germany, and across the Middle East.
“We are thankful on this holiday season for the opportunity to improve patients’ lives,” says CEO Dr. Bischoff. Learn more about ZipThaw and ZipSleeve: fremonscientific.
