“The company has submitted a 510(k) premarket notification application to the U.S. Food and Drug Administration for the first version of its multisource Nanox.Arc 3-D digital tomosynthesis system,” Nanox said.
“A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device,” the FDA says on its website.
“Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims.”
Shares of Nanox, Neve Ilan, Israel, recently traded at $32.55, up 16%. The stock had slumped 48% in the six months through the close of Wednesday trading.
The company sees "a significant unmet medical need globally for a more accessible and cost-effective medical imaging solution,” Chief Executive Ran Poliakine said in a statement.
“If cleared by the FDA, we believe our Nanox.Arc 3-D digital tomosynthesis can address this need.”
The system is designed for operation with multiple alternately switched X-ray tubes arranged around the patient.
In other health-care news, Altimmune (ALT) - Get Report on Wednesday reported progress from its Phase 1 trial of ALT-801, a drug for obesity and liver disease. The study was conducted with healthy overweight and obese subjects in Australia.
Also Wednesday, MannKind (MNKD) - Get Report received priority review status from the FDA for a lung-disease medicine being developed by its partner, United Therapeutics (UTHR) - Get Report.
The FDA "accepted for priority review the new drug application for Tyvaso DPI (inhaled treprostinil)," which treats pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease, United said.
Meanwhile, Kindred Biosciences (KIN) - Get Report said Wednesday that it’s being acquired by Elanco Animal Health (ELAN) - Get Report for about $440 million. Elanco will buy Kindred for $9.25 a share.