DOJ indicts former Stimwave CEO over alleged non-functioning neuromod implant

The U.S. Justice Dept. (DOJ) announced today that it filed a two-count indictment charging former Stimwave CEO in connection with a scheme around the company’s neuromodulation technology.

Damian Williams, the United States Attorney for the Southern District of New York, Michael J. Driscoll, the Assistant Director in Charge of the New York Field Office of the FBI, and Fernando P. McMillan, the Special Agent in Charge of the New York Field Office of the FDA – Office of Criminal Investigations — announced the charges filed against Laura Perryman.

The charges allege connection with a scheme to create and sell a non-functioning, dummy medical device. DOJ said Stimwave designed the implant for patients suffering from chronic pain. It alleges that the scheme resulted in “millions of dollars in losses to federal healthcare programs.”

Perryman founded and served as CEO of Florida-based Stimwave until her termination in 2019. She was arrested thi…

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Chinese company faces federal charges in ‘fake’ N95 respirator case

N95 respirator [Image from the FDA]

A Chinese manufacturer has been charged with producing and exporting to the United States nearly half a million misbranded and defective masks that falsely purported to be N95 respirators, the federal government reported.

King Year Packaging and Printing Co. Ltd. (King Year) faces three counts of violating the Federal Food, Drug and Cosmetic Act (FDCA) and one felony count of making a false statement by filing misleading registration documents with the FDA. The criminal complaint was filed in Brooklyn (N.Y.) federal court.

N95 respirators are designed to filter out 95% of airborne particles and have been in high demand as personal protective equipment for healthcare providers caring for COVID-19 patients.

According to the complaint, from April 6, 2020, to April 21, 2020, King Year manufactured 495,200 defective and misbranded masks that it claimed to be N95 respi…

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