Overture Life, the first company to achieve live births from both robotic fertilization and robotic egg freezing, today announced the U.S. commercial introduction of ICSI.A, its robotic intracytoplasmic sperm injection (ICSI) workstation, following completion of FDA establishment registration and device listing. ICSI.A is a Class II medical device in a category exempt from FDA premarket notification; with registration and listing complete, Overture has satisfied the premarket requirements that apply to the device in the United States. The introduction gives American fertility laboratories access, for the first time, to robotic precision for ICSI, the fertilization procedure performed by hand since its invention more than three decades ago and used in the majority of U.S. IVF cycles.
In ICSI, an embryologist orients an egg roughly 100 microns across, immobilizes a single sperm and injects it, repeating the procedure 100 to 200 times on a heavy retrieval day. Fertilization and blastocyst rates are documented to vary between embryologists working in the same laboratory under the same protocols (Reproductive BioMedicine Online, 2025). ICSI.A’s motorized micromanipulation system controls the positioning and navigation of the injection needle and holding pipette, while the embryologist performs the steps of penetration and injection and commands every decision. The system logs each procedure, giving laboratories an objective record of every injection for quality assurance, review and training.
“ICSI is one of the most technically demanding procedures in an IVF laboratory, where even small movements require tremendous precision,” said Luis Guzmán, PhD, Lab Director at CERAS. “Robot-assisted micromanipulation represents an important step forward because it gives embryologists greater control over how instruments are positioned and guided while keeping the critical decisions and injection procedure in their hands. It’s about combining the expertise of the embryologist with the precision of robotics to advance how fertility care is delivered.”
“We were the first to demonstrate that robotic fertilization could produce healthy children. We published the evidence, then built the technology and clinical partnerships to bring robotics into fertility laboratories around the world,” said Hans Gangeskar, co-founder and CEO of Overture Life. “With ICSI.A entering the U.S. market, clinics can adopt that work without replacing the laboratories they’ve already built. We think the next generation of embryologists will consider robotic precision at the microscope as fundamental as the microscope itself.”
Overture’s clinical research produced the world’s first babies born following automated sperm injection, documented in a 2023 study published in Reproductive BioMedicine Online and conceived at New Hope Fertility Center in New York. In that study, 13 of 14 robotically injected eggs fertilized successfully, compared with 16 of 18 injected manually. The company’s fertilization program has since developed an AI vision system, piezo-assisted injection and closed-loop fluidics. The vision system tracks eggs, needles and pipettes 20 times per second, runs entirely on the device with no external computing or connection required, and was trained on some 3,000 images from Overture’s own instruments in clinical use. Piezo-assisted injection penetrates the egg’s protective layers with controlled microscopic pulses, while closed-loop fluidics position and orient eggs in response to visual feedback. A fully automated sequence of egg pickup, injection and deposition is currently in beta. Overture’s Center of Excellence network has grown to nine partner sites on four continents, including Pinnacle in the United States, CERAS in Peru, Memorial Hospital in Turkey, Bloom IVF in India and Seoul IVF in South Korea.
“Our Center of Excellence network spans nine sites on four continents: high-volume and low-volume laboratories, public and private, with different media, labware and protocols,” said Matt Combs, Chief Commercial Officer of Overture Life. “A clinic shouldn’t have to replace its entire laboratory to introduce robotics. Overture builds systems for individual IVF procedures that work within the infrastructure and teams clinics already have. Starting at ASRM, American fertility centers can adopt the first of them.”
ICSI.A joins Overture’s modular portfolio alongside DaVitri for automated egg and embryo freezing and m|z for non-invasive embryo assessment, with additional laboratory automation in development. ICSI.A is designed for the roughly 450 IVF laboratories operating in the United States, installing into existing lab workflows rather than requiring clinics to rebuild around it.
Overture will exhibit ICSI.A at the ASRM 2026 Scientific Congress & Expo, October 24 to 28 in Baltimore. Fertility clinics can contact info@overture.life or visit overture.life.
About Overture Life
Overture Life is pioneering automation in assisted reproductive technology and is the first company to achieve live births from both robotic fertilization and robotic egg freezing. Its modular platform includes DaVitri for automated egg and embryo vitrification, ICSI.A for robotic sperm injection and m|z for non-invasive embryo assessment, with additional laboratory automation technologies in development. The company operates in the United States and Spain, works with fertility centers and commercial partners worldwide, and is backed by investors including GV, Khosla Ventures and Overwater Ventures. For more information, visit www.overture.life.
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