FreMon Scientific filed a 510(k) application with the FDA for ZipThaw202 and ZipSleeve.
FreMon Scientific
FreMon Scientific
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.
Working with Aran R&D
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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January 2018 ZipThaw and ZipSleeve Status Update
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:
ZipThaw passes FDA-mandated destructive testing
Friends,
Today Hermon Labs, the FDA-sanctioned lab in Israel, completed destructive tests on ZipThaw202 and is finalizing their report for FreMon Scientific’s FDA and CE Mark certifications.
FDA and CE Mark December Update
Dear investors and prospects,
Thank you for your investment and interest to date. We have news Moni and I are excited to share about our progress towards FDA Clearance, CE Mark and financing.
FDA CE November Progress Report
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.