Optomed USA, Inc. is introducing a next-generation, handheld fundus camera to its inventory: the Optomed Lumo.
Let’s start with this company.
Headquartered in Alpharetta, Georgia, Optomed USA is a wholly owned subsidiary of the Finland-based medical technology (MedTech) company Optomod Plc.
Its specialty: Developing a product inventory of fundus cameras and desktop cameras for eye screenings in 60+ countries across the globe.
- Most notably:
- In 2013, Optomed launched Smartscope PRO—the world’s first handheld fundus camera meeting the fundus camera standard ISO 10940 resolution requirements
- In May 2025, the FDA granted clearance to the first handheld artificial intelligence (AI) fundus camera: Aurora AEYE, marketed by AEYE Health
Talk more about those fundus cameras.
Optomed’s handheld fundus cameras combine with software and an optional AI integration to enable diabetic retinopathy (DR) and edema detection.
Excluding this new addition, the company offers three handheld devices:
- Smartscope PRO
- Non-mydriatic camera for capturing images of the posterior and anterior segment; ideal for veterinarians
- Aurora AEYE
- Enables detection of more than mild DR with +90% accuracy in sensitivity and specificity
- Aurora IQ
- Versatile non-mydriatic camera for capturing full color and fluorescein images of the retina and anterior of the eye
Now to this latest addition.
The Optomed Lumo is a portable, non-mydriatic fundus camera designed for “flexibility and ease of use” in capturing and storing high-quality images of the eye in a variety of healthcare settings—enabling service to patients in regions where access may be traditionally limited.
Included in its capabilities:
- Intuitive user guidance via a large 5-inch touch screen, automatic imaging functions, and programmable (not to mention customizable) workflows
- Advanced optics via a patented optical concept (dubbed High-Contrast Optical Design) for capturing high-resolution retinal images
- Features a 12 MP high-sensitivity (and low-noise) CMOS sensor that delivers a wide (50°) field of view
And as a bonus: The Lumo functions both as a handheld and a stationary device.
How does it integrate with healthcare systems?
The device integrates with hospital picture archiving and communication systems (PACS) through a wireless DICOM.
A note from the company: “USB and WLAN connections enable fast data transfer to medical records,” as well as to the Optomed mobile application (for mobile devices).
- An optional cloud connectivity also supports image review and compatibility with a select number of third-party tools, according to Optomed.
Does data security come with it?
Indeed it does, including:
- AES-256 data encryption
- User authentication
- PIN code protection
- Remote software updates
Now to its regulatory status: What FDA clearance does it have?
The device is cleared by the FDA under the PJZ product code for ophthalmic medical devices.
- Quick PJZ refresh: This classification is reserved for prescription devices—cameras and ophthalmic / general-use ophthalmic cameras—indicated only for the camera and storage of images of the eye and surrounding area in the general population.
- Notably, PJZ cameras cannot:
- Be indicated for a specific patient population
- Include any type of “diagnostic” or “aid in the diagnosis” claims in their indications for use
- Reference any specific disease in their indications for use
- Notably, PJZ cameras cannot:
Plus: PJZ cameras are required to meet optical performance characteristics aligned with the ISO 10940-2009 standard.
Duly noted. Last question: How can I add this to my practice?
Reach out to the company for pricing and availability.