The FDA has granted 510(k) clearance to ZEISS Medical Technology for the ZEISS CLINIC 360, a cloud-and-browser-based software solution for ophthalmic workflows.
Big news! First though: tell me about this clearance.
As with all other 510(k) clearances, this is reserved for medical devices that the federal agency deems to be “substantially equivalent" to an existing, legally marketed device.
- See here for its clearance confirmation in the FDA’s database.
And in this case: The device has received a Class II designation, which means it carries a moderate risk profile and requires both general controls and specific special controls to ensure safety.
Noted. Now talk about ZEISS CLINIC 360.
What it is: A clinical analytics dashboard built on the ZEISS Health Data Platform (HDP).
- To refresh: The ZEISS HDP is a cloud-based digital infrastructure within the ZEISS Medical Ecosystem that connects medical devices, electronic medical records (EMR), and clinical software.
Its design: Is as an all-in-one cloud and browser-based software solution combining diagnostic and medical data into a comprehensive view—operating as an alternative to the company’s ZEISS FORUM ophthalmic data management solution.
Exactly how do these two systems differ?
Whereas the ZEISS Forum offers “on-premise” data management for practices, the ZEISS CLINIC 360 provides “cloud-based” management with flexibility and scalability.
Per ZEISS: This new solution is also available in a subscription-based model with “low upfront costs” and monthly or annual payments.
… tell me more about its functionality.
The platform aggregates patient clinical data—obtained via the ZEISS HDP— to create a comprehensive patient record, enabling clinicians to view their DICOM-enabled diagnostic data from both ZEISS (CIRRUS, CLARUS, and Humphrey Field Analyzer [HFA]) and third-party devices.
And the intended result: An integrated data management approach that streamlines the clinical workflow to help clinicians:
- Evaluate disease progression
- Support treatment decisions
- Improve workflow efficiency
Can we get an example of how this works?
Take glaucoma management.
Per ZEISS, clinicians can use the dashboard to “quickly monitor” glaucoma progression via "intuitive color-coded alerts and trend analysis” of data, such as optical coherence tomography (OCT), intraocular pressure (IOP), and visual field.
“When consultation is needed, clinicians can securely share cases and reports and request input from colleagues through integrated access to the ZEISS Collaborative Care feature, helping to facilitate improved patient care and referrals,” the company stated.
- Another refresh: Also built on the ZEISS HDP, the ZEISS Collaborative Care was launched earlier this year as a software application offering ECPs a set of real-time “collaboration” tools sharable via a secure, browser-based collaboration system.
- Notably: This application is also usable as a connected extension of the ZEISS FORUM.
Nice! And how does ZEISS describe the CLINIC 360?
ZEISS Medical Technology’s Anuj Kalra, head of Chronic Disease Management, referred to the solution as representing “a new standard in patient care support, helping clinicians identify meaningful change more quickly and spend less time searching for what they need.”
Finally, when will this be available to U.S. clinicians?
The company plans to make the ZEISS CLINIC 360 available by “early fall 2026.”
Though no specific date was mentioned, it may be worth keeping an eye out for a potential debut at the American Academy of Ophthalmology annual meeting (booth #3719), Oct. 10-12, in New Orleans, Louisiana.
For more information, reach out to the company directly.