NeuroLogica Corp. landed 510(k) clearance from the Food & Drug Administration for its inSPira HD portable, high-resolution single photon emission computed tomography system.
The Danvers, Mass.-based imaging equipment maker said the system is a battery-powered, high-resolution, portable SPECT designed primarily for brain imaging.
The company says the device provides better resolution that conventional technologies “because it presents an entirely new method of SPECT detection, acquisition and reconstruction.” That means 3mm spatial resolution, compared with the 5mm to 10mm spatial resolution of conventional machines.
David Webster, vice president of sales and marketing, told MassDevice that NeuroLogica is already marketing its new, $479,000 device and is set for its first installation in November. In the U.S., Canada and China, Webster told us, the company will us its direct sales force; elsewhere it will use distribution channels, he said.
“We’ll be going for the CE Mark [in the European ±Union] in Q4 this year and we expect to roll it out internationally in Q1 next year,” Webster said.