Heidelberg Engineering is showcasing several new—and investigational—ophthalmic technologies during this week’s Association for Research in Vision and Ophthalmology (ARVO) meeting in Denver, Colorado.
Take note: Investigational indicates these products have not yet received clearance from the FDA for commercial use and availability.
Duly noted. So where shall we start?
With the company's two still-investigational (yet-to-be-FDA-cleared) ophthalmic technologies.
First up: The global premier of the company's multimodal imaging patform with ultra-high resolution optical coherence tomography (OCT).
Its purpose: To deliver advanced imaging quality via an integration with high-fidelity artificial intelligence (AI) from RetinaAI, an AI and eyecare data management technology utilizing advanced tools to collect, process, and grade large-scale retinal images and biomarker datasets.
- Learn about its FDA 510(k)-cleared RetinaAI Discovery platform, a medical and imaging data management system that applies AI models to support the diagnosis and monitoring of ophthalmic disease progression.
And the significance of of this AI inclusion?
Thanks to RetinaAI’s technology, the platform is reportedly the first “truly automated DICOM workflow,” according to Heidelberg.
Specifically, this workflow encompasses the following in a standardized, fully secured, and "native DICOM format:”
- Image acquisition
- Automated upload to the cloud
- AI-based analysis
Nice! And what was that second ophthalmic tech?
Next up is the Heidelberg OPERA, a fully digital surgical microscope featuring intraoperative OCT, an ergonomic C-shaped arm, and digital binoculars for a more comfortable, heads-up position.
- Keep in mind: This is also still an investigational device under development.
What it does: Delivers a fully integrated, next-generation imaging technology with 5K ultra high-definition (UHD) resolution for real-time, detailed visualization during surgery.
- Display options include digital binoculars, a 55-inch 3D 4K monitor, and/or additional monitors connected via a wireless transmitter or HDMI and HD-SDI connections
So both products will be at the Heidelberg booth?
Indeed! While they aren’t yet available for commercial use, ophthalmic surgeons can get a preview of the company’s potential (future) addition to its ophthalmic tech portfolio.
Gotcha. Now let’s talk product advancements.
Among those also in development:*
- For the SPECTRALIS platform
- Green autofluorescence (AF)
- 250 kHz scan speed with enhanced TruTrak for OCT-angiography (OCTA)
- Dense ART scans
- For the ANTERION platform
- Key measurements exports to enable other DICOM-supported application integrations
*These features are currently pending 510(k) clearance, though the platforms themselves are already FDA-cleared and commercially available across the United States.
Any others we missed?
Yes! Regarding the Heidelberg Eye Explorer (HEYEX) 2.
To refresh: The HEYEX is a comprehensive platform for ophthalmic image management, device integration, and workflow optimization.
- As for HEYEX 2: This next-gen platform offers the same core functionality as the HEYEX but is built for larger networks and growth (more scalable, networked, secure, and workflow-integrated).
And keep in mind: The HEYEX and HEYEX 2 have received FDA 510(k) clearance for clinical use in image / data management as a software (picture archiving and communication systems [PACS]).
So what’s the update for this?
Heidelberg noted new developments to enable “secure, flexible, remote access to imaging data.”
Also included:
- A web browser-based HEYEX 2 solution
- Updates to the Heidelberg AppWay (a cloud-based marketplace and workflow solution within HEYEX 2 that gives surgeons access to third-party AI analytics)
Are these new features already commercially available in the U.S.?
Not quite … the company emphasized that “not all features are commercially available in all markets.”
That being said, we’d recommend reaching out to Heidelberg directly to confirm the status of these new features.
Better yet: If you’re on-site at ARVO this week, stop by booths #9001 & #9009 to speak with a representative.
- Notably: Heidelberg is—for the very first time—sharing an exhibition booth with EssilorLuxottica, its parent company.