Pomerantz Appointed Lead Counsel in Nano-X Imaging Securities Litigation

On January 25, 2022, U.S. Magistrate Judge Peggy Kuo of the Eastern District of New York appointed Pomerantz LLP as Lead Counsel on behalf of Davian Holdings Limited, the Lead Plaintiff in McLaughlin v. Nano-X Imaging Ltd., 21-cv-5517 (E.D.N.Y.), a securities action brought on behalf of a class of defrauded investors concerning allegations that Nano-X Imaging Ltd. (“Nano-X” or the “Company”) misrepresented the regulatory and commercial prospects of its Nanox.ARC digital x-ray medical imaging system.

Nano-X develops medical imaging technology, including digital x-ray systems, cloud-based image analysis and online diagnosis solutions, and billing services systems.

Allegations against Nano-X include that: (i) the Company’s application to the U.S. Food and Drug Administration (“FDA”) for 510(k) clearance of the Nanox.ARC – establishing it as a safe and effective device – was deficient; (ii) as a result, it was unlikely that the FDA would approve the application in its current form; and (iii) as a result, Nano-X had overstated the Nanox.ARC’s regulatory and commercial prospects.

On June 17, 2021, Nano-X submitted a 510(k) application to the FDA for the Nanox.ARC. Following this submission, the Company touted the Nanox.ARC’s regulatory and commercial prospects in various public statements and SEC filings.

Then, on August 19, 2021, Nano-X reported that it had “received a request for additional information from the [FDA] concerning the Company’s last 510(k) submission of its multi-source device, Nanox.ARC[,]” and that ”[t]he submission file is placed on hold pending a complete response to the FDA’s list of deficiencies[,]” with ”[t]he Company’s response . . . due within 180 days from the date of the request for additional information.”

On this news, Nano-X’s share price fell $2.25 per share, or 9.5%, to close at $21.43 per share on August 19, 2021.