• Health Canada rejected NuGen Medical Devices' application for an InsuJet needle-free insulin injection system license, citing insufficient clinical safety and effectiveness evidence.
• Canadian sales and further supply remain halted following the lapse of the previous license.
• The refusal does not require a recall of devices lawfully sold in Canada, according to advice received by the company.
• Existing Canadian users are not required to discontinue use, according to the company's regulatory advice.
• Regulatory status outside Canada is not changed by the refusal itself.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. NuGen Medical Devices Inc. published the original content used to generate this news brief via Newsfile (Ref. ID: 202611131715NEWSFILECNPR____20261113_323903_1) on November 13, 2026, and is solely responsible for the information contained therein.