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Blood flow, perfusion imaging device receives FDA clearance
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RFPi announced that a blood flow and perfusion imaging medical device for use during open surgery has received 510(k) clearance from the FDA.
The device (iCertainty) shows real-time perfusion and blood flow in critical tissues and vascular structures during surgeries without the use of dyes, injections, direct patient contact, radiation or procedure interruption, according to a press release from the company. It has been cleared for imaging in tissues up to 4 mm to 5 mm.
“Repeat surgery rates in iCertainty’s target indications run as high as 20% — a figure that masks a tremendous amount of patient discomfort, uncertainty and inconvenience, as well as financial loss for hospitals and insurers,” Jeffrey Basham, CEO of RFPi, said in the press release. “iCertainty offers an entirely new and advanced standard of imaging detail, speed, ease and flexibility that should benefit surgeons, hospitals and third-party payers — and most importantly, the patients they all care for.”
The device uses multispectral physiologic visualization technology, which utilizes high-speed imaging cameras, low-energy lasers, algorithms and proprietary analysis techniques for real-time quantification and visualization of blood flow and perfusion, according to the press release.
The company closed on its series A round of financing in 2017 and is currently securing series B financing for commercialization and marketing, according to the press release.
“iCertainty has the potential to permanently change noninvasive medical imaging,” Basham said in the press release.
Disclosure: Basham is an employee of RFPi.