A beyond-the-skin imaging device moves toward the bedside — and the market

By John Battiston

Most of us have had our blood oxygen levels measured with a pulse oximeter at the doctor's office. Clip the device to a fingertip and read the number: If oxygen saturation is too low, we know that something is wrong.

Anuradha Godavarty, Ph.D., has spent more than a decade asking a bigger question: What if you could see that same oxygen information not at a single fingertip, but across an entire appendage, without ever touching the patient at all? That is the promise of NIROS, the near-infrared optical scanner developed in Godavarty's Optical Imaging Laboratory.

A professor in the Department of Biomedical Engineering at Virginia Commonwealth University's College of Engineering, Godavarty is now advancing the device from a validated laboratory prototype toward a commercial-ready product. Funding comes, in part, through a Commercialization Fund award from VCU TechTransfer and Ventures, part of the Office of the Vice President for Research and Innovation.

Seeing what the naked eye can't

NIROS uses near-infrared light, the same portion of the spectrum a pulse oximeter relies on, to measure how much oxygen-rich blood is reaching tissue just beneath the skin. Unlike a pulse oximeter, it captures that information across a whole region rather than a single point, and it does so with a camera-based system that never makes contact with the patient.

Godavarty compares NIROS to a platform technology like ultrasound, with one core system that adapts to many uses. Wherever blood flow beneath the skin is compromised, NIROS can offer a picture: Diabetic foot ulcers, pressure ulcers in immobilized patients, burns and their associated vascular problems. In each case, clinicians currently lack a simple way to confirm whether enough oxygenated blood is reaching the tissue that needs it.

That gap matters most in high-stakes scenarios. For instance, Godavarty notes, in reconstructive "free flap" surgeries - in which healthy tissue is separated from one part of the body and transplanted to an injured or unhealthy area - the first 72 hours determine whether transplanted tissue survives. Until now, surgeons have only been able to watch oxygen reaching the flap at discrete points, not across the entire flap area.

Output from the NIROS scanner maps blood flow across the hand, with color showing where oxygen-rich blood is and isn't reaching the tissue. (John Battiston)

Two design choices set NIROS apart from established methods: The device requires no injected contrast agents, and it never touches the patient. Both features have direct commercial implications, moving tissue imaging out of specialized facilities and toward the bedside and the outpatient clinic.

Injected dyes immediately narrow where and how a technology can be used. "The moment I have to inject a contrast agent to see, it can only be administered at a certain facility, and I cannot make this a bedside or outpatient procedure," Godavarty said.

Contact-based imaging carries its own limits. Many of the wounds NIROS is designed to assess are infected, painful or bleeding, situations where touching the equipment against a patient is suboptimal. The non-contact approach, Godavarty found, changes the experience for patients as much as for clinicians.

"When we were showing it to patients and telling them we won't even touch you, they were more appreciative," she said.

To date, Godavarty's team has imaged hundreds of patients across sites in the United States and in India. There are no safety concerns with the device, as it uses only near-infrared LEDs, with no radiation or ionizing energy involved.

Tapping into a bigger market

Godavarty's team initially only tested the technology on patients with diabetic foot ulcers, until a telltale pattern emerged: Almost every patient was compromised in their peripheral vasculature.

"Whenever clinicians intervene surgically to open up closed peripheral arteries and vessels, they have no way to visually tell if they have good perfusion to the surface of the foot," Godavarty said. "So we said, 'Why don't we position this as a technology that looks at peripheral vascular compromises on a larger picture?'"

That repositioning points NIROS at a far larger opportunity. The global peripheral artery disease market is already valued at an estimated $7-10 billion, and is projected to keep climbing as populations age and diabetes rates rise. Within that market, tissue-perfusion imaging has become a high-value asset in vascular labs, wound care centers and limb-salvage programs, the settings where oxygenation determines whether a wound heals or a limb is lost.

Godavarty sees vascular surgeons, interventional cardiologists, interventional radiologists and wound care specialists as the earliest customers. At VCU Health, she plans to collaborate with plastic surgeon and burn specialist Prabhu Snethil-Kumar, M.D., and vascular surgeon Daniel Newton, M.D., as NIROS moves toward clinical evaluation.

"What stands out about Dr. Godavarty's approach is that she's engaging industry and clinicians throughout the development process, not just at the end," said Thomasine Isler, innovation and industry engagement manager at TechTransfer and Ventures. "By incorporating real-world feedback early, she's building a technology that solves clinical problems and has a stronger path to commercialization."

The Optical Imaging Laboratory team, from left: Ph.D. student Aasma Dahal; postdoc Shivan Shukla, Ph.D.; Godavarty; and Ph.D. student Himaadri Shakhar Roy. Many of the lab's students and postdocs are listed as co-inventors on the patents underlying NIROS. (John Battiston)

From lab prototype to FDA-ready device

After four or five iterations, Godavarty's team has a prototype that clinicians already like. But the leap to a product means conforming to regulators' requirements and focusing on user-friendly design.

"It's very different when you're doing research. We don't care if the prototype's outer wiring is yellow or blue," Godavarty said. "But imagine something you're buying off the shelf. You want that device to look compact and clean. It's a whole different mindset. That's what we are learning in these last few months."

The Commercialization Fund award will support that transition through prototype refinement, regulatory consultation and software development. Godavarty frames the work as a shared effort built over years and many hands.

"It could be one person's dream, but it just became everybody's effort towards it," she said, crediting the students and postdocs of her Optical Imaging Laboratory. Many of them are listed as co-inventors on the underlying patents.

For Godavarty, who joined VCU in January after 21 years building her lab in Florida, the motivation is the same one that drew her to biomedical engineering in the first place: Watching something leave the lab and reach the people it was built for.

"If you can make something that you can take to the next level of being able to see it in the clinic - that's the biggest excitement that keeps driving me," she said.