Heidelberg Engineering GmbH has received FDA clearance for the SPECTRALIS Flex Module, a multimodal diagnostic imaging platform.
Hold up … didn’t the FDA already clear a SPECTRALIS platform?
You’re thinking of Heidelberg’s SPECTRALIS Optical Coherence Tomography-Angiography (OCTA) Module with SHIFT technology.
To note: That product—and respective 510(k) clearance granted in July 2024—is separate from this latest clearance.
Ah, gotcha. Well, tell me more about SPECTRALIS.
The non-contact ophthalmic diagnostic imaging platform includes a modular design that enables clinicians to “configure each SPECTRALIS to the specific diagnostic workflow of a practice or clinic” by combining scanning laser fundus imaging with high-resolution OCT.
To note: Each design is upgradable, allowing for new modules to be developed.
A total of 10 SPECTRALIS modules are currently available—including glaucoma, multicolor, anterior segment, and widefield imaging—with multimodal imaging options extending to:
- OCT
- Multiple scanning laser fundus imaging modalities
- Widefield and ultra-widefield
- Scanning laser angiography
- OCTA
Now to this Flex Module.
The multimodal, diagnostic imaging-only platform is designed to provide imaging for the posterior segment in pediatric and adult patients in a supine position, according to Heidelberg.
More about its design: The platform features a movable stand with an adjustable arm that enables flexibility for imaging capabilities in multiple positions and acquisition environments.
- Beneficiaries of this: Patients unable to be imaged with standard tabletop OCT devices as well as pediatric patients and systemically unwell patients.
Let’s talk imaging modalities.
The Flex Module’s imaging-only multimodalities extend to:
- High-resolution OCT
- OCTA
- Fluorescein angiography (FA)
- Indocyanine green angiography (ICG)
- Blue laser autofluorescence
- Multicolor widefield and ultra-widefield imaging
What else to know?
The Flex Module has an optional backup battery that provides an additional 20 minutes of autonomy—enabling clinicians to avoid interruptions when moving the device between power outlets.
Very cool! So where can I see this for myself?
In fact, if you’re attending the American Academy of Ophthalmology (AAO) annual meeting, check out the Beyeonics booth (#4444) to see the SPECTRALIS Flex Module.
Academy 2024 kicks off Oct. 18-21 in Chicago, Illinois.
If not, click here to request more information on the product.
And when can we expect this to launch?
No word as yet, so stay tuned!