Ispire Technology Inc. announced that its joint venture, IKE Tech LLC, has received an Acceptance Review letter from the U.S. Food and Drug Administration (FDA) for its component Pre-Market Tobacco Product Application (PMTA). This letter confirms that the PMTA for IKE Tech's Bluetooth Low Energy (BLE) System-on-a-Chip meets regulatory requirements.
The acceptance moves the application into the FDA's filing review phase, marking significant progress for the first-ever complete PMTA submission for a standalone, interoperable, blockchain-enabled age-verification component. This technology is designed for universal integration across all Electronic Nicotine Delivery Systems (ENDS) devices.
IKE Tech's platform requires continuous, real-time identity verification, offering an unprecedented level of security against underage vaping, unlike traditional systems that verify age only at the point of purchase. The company has formally requested an expedited review, emphasizing the system's potential to significantly enhance public health.
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