FreMon Scientific, in preparation for a second European Union CE Mark medical device audit, is in the pre-production assembly line development stage.
FreMon Scientific
FreMon Scientific
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.
UN Ambassador Nikki Haley
Recently at the UN, FreMon Scientific’s co-founder Fred Thacher had a front row seat and introduction to UN Ambassador Nikki Haley. We’re engaging with the UN as we seek global distribution for our next gen blood & tissue thawing device, ZipThaw.
Testing ZipThaw in San Diego
Aran R&D and FMS continue their collaboration with the San Diego Blood Back to perfect the ZipThaw and ZipSleeve prototypes.
Aran R&D visits the San Diego Blood Bank
Aran R&D is a publicly traded engineering firm specializing in the design, engineering and manufacturing of FDA certified and CE Mark approved medical devices and equipment. Aran is under contract with FreMon Scientific to complete manufacturing engineering of the fully tested ZipThaw202 and ZipSleeve prototypes as tested by the New York Blood Center.
Latest ZipThaw Exploratory Design
Enjoy a sneak peek of an advanced design concept of ZipThaw’s patented dry warming and thawing chamber.
FMS Team Design Review
Last week FMS reconvened in Israel to further develop ZipThaw and ZipSleeve ahead of submitting the devices to the FDA.
FMS Leadership back in Israel
The FMS leadership has reconvened in Israel to oversee the evolution of ZipThaw.