FreMon Scientific filed a 510(k) application with the FDA for ZipThaw202 and ZipSleeve.
FreMon Scientific filed a 510(k) application with the FDA for ZipThaw202 and ZipSleeve.
ZipThaw and ZipSleeve technology is now protected with a total of 6 patents having been filed.
We’re deep into the FDA and CE Mark approval process for ZipThaw.
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.
We have big news to share. Yesterday FreMon Scientific passed a key CE Mark milestone with ZipThaw and ZipSleeve.
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 and ZIpSleeve have advanced from prototype to nearly production ready.
ZipThaw202 will be the first to market next generation technology blood and tissue products warming device and disposable.
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.
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.
Aran R&D and FMS continue their collaboration with the San Diego Blood Back to perfect the ZipThaw and ZipSleeve prototypes.
Enjoy a sneak peek of an advanced design concept of ZipThaw’s patented dry warming and thawing chamber.
Last week FMS reconvened in Israel to further develop ZipThaw and ZipSleeve ahead of submitting the devices to the FDA.
The FMS leadership has reconvened in Israel to oversee the evolution of ZipThaw.
Greetings from Israel. Moni and Fred are at a working lunch with the ZipThaw and ZipSleeve production engineering team atf Aran R&D.
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Dr. Viscomi, Moni and I thank you for your confidence and investment in FreMon Scientific. 2018 portends manufacturing and sales. Your 2017 investment resulted in the following achievements:
From: FreMon Scientific, Inc (FMS) – Fred Thacher, CEO
Subject: Recent FDA, CE Mark, Production Engineering and Finance Activities
Date: November 15, 2017, by Fred Thacher FMS CEO and Co-Founder
Last week: Moni and I met in Israel with the FDA/CE Mark agent Qsite and with Mintz Levin FDA attorney to review production engineering requirements for compliance.