BETA
Dutch ophthalmic device company connecting corneal measurements, cataract surgery planning and intraoperative IOL alignment.
Cassini Technologies develops ophthalmic diagnostics and surgical guidance tools from The Hague, Netherlands, with U.S. commercial activity and support. Its current portfolio centers on Cassini Ambient, an LED-based corneal topographer, and the Cassini Guidance System for intraoperative visualization during cataract surgery.
Cassini Connect OR links Ambient measurements with surgical planning, guidance and optional femtosecond laser connectivity. These tools support assessment of corneal astigmatism and positioning of toric intraocular lenses. The FDA device records describe the Guidance System as surgeon-confirmed visualization software that neither interprets information nor recommends treatment.
Published research evaluates Cassini measurement repeatability and agreement with other instruments; a 32-eye study found repeatable measurements but discouraged interchangeable use across devices. Company-hosted workflow summaries and surgeon testimonials provide additional context, with less evidence than full comparative clinical publications. Innovation Industries lists Cassini as an active investment; audited revenue, installed-base and customer totals were not established.
The reviewed FDA device categories are exempt from 510(k) premarket notification, subject to applicable exemption limitations. Other FDA requirements still apply unless separately exempted. Device listing and exemption do not constitute FDA approval. The topographer UDI names CASSINI 2.0/3.0 rather than Ambient; exact current Ambient/module labeling remains unconfirmed. [2][3][4][5][20][21][26]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [28][29]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Reflection-based LED corneal diagnostics for cataract assessment and planning; current company materials describe anterior and posterior analysis with model-dependent capabilities. [21][2][4]
Exemption documentedMarketed; exact configuration and regional labeling should be confirmed
Real-time non-diagnostic surgical video with surgeon-driven graphical guidance based on preoperative data; neither interprets information nor recommends treatment. [25][3][5][11]
Exemption documentedMarketed; exact configuration and regional labeling should be confirmed
The reviewed company materials emphasize upgrades and integration of the marketed Connect OR platform. No separately named investigational U.S. device program was established. Surgical Planner and FLACS connectivity are platform modules, not additional FDA-authorized devices. [22][21][25]
Cassini identifies an ongoing Leica Microsystems collaboration; its technical support specifies supported Proveo 8x monitor configurations and excludes unsupported 3D displays and MyVeo headsets. [6]
Company history dates the connected diagnostic-to-OR platform introduction to 2023. [23]
Company history identifies Ambient as the third-generation topographer launched in 2019. [23]
Innovation Industries announced a Series A investment on February 26, 2018; the announcement did not disclose an amount. [8]
Company timeline dates the first generation to 2013; this is a product milestone, not a confirmed company founding date. [23]
Accessed 10/20/2026