Today we’re constructing ZipThaws on the assembly line as we prepare for distribution.
FreMon Scientific
FreMon Scientific
EU review of ZipThaw in Israel
We’re having a busy week in Israel.
UCSD testing ZipThaw for FDA
We’re thrilled to partner with the University of California, San Diego for FDA testing of ZipThaw.
SDBB Predicate Tests Advancing
Today Fred Thacher, CEO and co-founder of FreMon Scientific, oversaw continued predicate testing of fresh frozen plasma devices at the San Diego Blood Bank.
FMS at AABB 2018 Boston
FMS, led by co-founder Fred Thacher, attends the 2018 AABB in Boston this week. (more…)
Predicate device setup at the SDBB
FDA testing of ZipThaw requires us to set up a predicate plasma thawing device. We’re thrilled to be partnering with the San Diego Blood Bank on this critical data gathering and benchmarking phase.
Production preparation
FreMon Scientific, in preparation for a second European Union CE Mark medical device audit, is in the pre-production assembly line development stage.
ZipThaw Production-Ready Chassis
We’re entering a bold new phase.
San Diego Blood Bank to test ZipThaw
San Diego Blood Bank has agreed to test ZipThaw and ZipSleeve devices.
CE Mark as a Medical Device
FreMon Scientific made CE Mark filings earlier this year with the European Union.
San Diego Blood Bank
We’re grateful for the San Diego Blood Bank’s guidance with ZipThaw.
FDA approval in process
FreMon Scientific filed a 510(k) application with the FDA for ZipThaw202 and ZipSleeve.
Patents are pending
ZipThaw and ZipSleeve technology is now protected with a total of 6 patents having been filed.
ZipThaw in FDA and CE Mark approval process
We’re deep into the FDA and CE Mark approval process for ZipThaw.
FreMon Scientific updates ZipThaw design
After many months of development, Moni Shavit and Fred Thacher of FreMon Scientific announce an updated ZipThaw blood and tissue thawing and warming medical device, designed in partnership with Aran R&D in Caesarea, Israel.
ZipThaw passes a key CE Mark milestone
We have big news to share. Yesterday FreMon Scientific passed a key CE Mark milestone with ZipThaw and ZipSleeve.
San Diego Blood Bank Partnership
FMS is honored to welcome the San Diego Blood Bank to the FreMon Scientific family of companies and academic centers assisting with and guiding the development of this new generation technology for warming and thawing blood and tissue products.
ZipThaw major product updates
ZipThaw and ZIpSleeve have advanced from prototype to nearly production ready.
ZipThaw submitted to FDA
ZipThaw202 will be the first to market next generation technology blood and tissue products warming device and disposable.
ZipThaw & ZipSleeve submitted to FDA and EU
FreMon Scientific, developer of ZipThaw and ZipSleeve next gen blood & tissue products warming and thawing technology, has submitted the Form 510(K) to the FDA and will have the initial CE Mark audit performed by the European Union on June 3.