Akili Interactive Labs, Inc.

Akili Interactive Labs, Inc. specializes in developing therapeutic software applications primarily focused on mental health and cognitive function. These devices are designed to be viewed on screens and are intended to enhance attention, executive function, and behavioral regulation. The company’s products fall under the category of mental health/function therapeutic software, which is a digital intervention used to support conditions like ADHD and related disorders.

Akili Interactive Labs, Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies these products as Class II medical devices, which means they undergo specific regulatory pathways, including the 510(k) clearance process and compliance with the Unique Device Identifier (UDI) system. This classification ensures that the devices meet established safety and performance standards before they are authorised for use.

Akili Interactive Labs, Inc.’s devices are listed in the FDA’s 510(k) registry and the Unique Device Identifier (UDI) system. These registries are part of the U.S. regulatory framework for medical devices, ensuring transparency and traceability. Listing in these systems confirms that the devices have undergone the necessary authorisation processes, such as the 510(k) clearance, to demonstrate compliance with FDA requirements.

Akili Interactive Labs, Inc.’s devices are classified as Class II medical devices by the FDA. This classification is determined based on the level of risk associated with the product. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness. The classification influences the regulatory pathway, such as the 510(k) process, which the company’s devices must follow to demonstrate compliance before they are authorised for market.