Company
A controlled approach to cryoablation.
Focused Cryo, Inc. is a medical device company in Sandy Springs, Georgia, building cryoablation technology that gives physicians control over where the freeze is delivered.
What we do
Direction as a design variable.
Cryoablation has long been delivered as a freeze that forms all the way around the probe. We designed the Focused Cryotherapy System so the physician can also choose to deliver it on one side.
The result is an FDA 510(k) cleared platform: an argon-powered console, temperature-guided software, and a disposable dual-mode probe that delivers either a 360° circumferential or a ~180° directional freeze.
FDA 510(k) clearance
The Focused Cryotherapy System was cleared by the US Food and Drug Administration in December 2025.
Headquarters
Design, development, and customer support are based in metro Atlanta.
How we build
Designed, built, and tested in Georgia.
Every console is built and released by our own team in Sandy Springs, under a quality system built to FDA and international standards.
Built in-house
Console electronics and circuit boards, firmware, wiring, gas subsystem, assembly, and packaging, each under its own controlled work instruction.
Tested before release
Every console passes a multi-step release test covering pressure regulation and leak hold on every channel, all temperature channels, CT import, interlocks, and emergency stop, with a device history record for each unit.
Designed with users
The system was evaluated in a simulated-use human factors study with 15 interventional radiologists and 15 CT technologists.
Quality system built to FDA QMSR (21 CFR 820), ISO 13485:2016 and ISO 14971:2019, with design and testing to IEC 60601-1, -1-2 and -1-6, IEC 62366, IEC 62304, ISO 10993, and ISO 11135. Product cybersecurity includes a threat model, penetration testing, and a Software Bill of Materials.
Working with us
Partners and clinicians.
We work with physicians, hospitals, and industry partners interested in directional cryoablation. Tell us what you are working on.
See the system in person.
Request a demonstration, labeling, or a conversation with our team.