Disclaimers

Lucid™ TCD

The Lucid TCD is a medical ultrasound system intended for use as an adjunct to the standard clinical practices for measuring and displaying cerebral blood flow velocity within the major conducting arteries and veins of the head and neck. Additionally, the Lucid TCD measures the occurrence of transient emboli signals within the bloodstream.

The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.

NovaBot™

The NovaBot when used with the Lucid TCD is a medical ultrasound device which assists the user in the setup and acquisition of cerebral blood flow velocity via the patient’s temporal windows. It is intended for use as an adjunct to standard clinical practices for measuring and displaying cerebral blood flow velocity and the occurrence of transient emboli within the bloodstream.

The NovaBot is intended to be used by healthcare professionals qualified by training in its safe and effective use. The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications and is not intended to be used inside the sterile field.

NovaGuide™

NovaGuide consists of the NovaBot and the Lucid TCD. It is intended for use as an adjunct to standard clinical practices for measuring and displaying cerebral blood flow velocity and the occurrence of transient emboli within the bloodstream. NovaGuide is intended to be used by healthcare professionals qualified by training in its safe and effective use. The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.

CAUTION: Federal (USA) law restricts this device to sale, distribution by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Lucid TCD is a new name for Lucid M1 with no significant differences in the product. NovaBot is a new name for NeuralBot with no significant differences in the product.

Lucid TCD 2.0, NovaBot, and NovaGuide are not licensed for sale in Canada.

NovaGuide View

NovaGuide View is a Medical Device Data System (MDDS) per 21 CFR 880.6310. Further, NovaGuide View is a non-device MDDS that contains software functions which only transfer, store and display medical device data or results. Per the FDA guidance on Medical Device Data Systems, Medical Image Storage Devices and Medical Image Communications Device (September 17, 2019), non-device MDDS are not devices under section 201(h) of the FD&C Act.

NovaGuide View is not offered for sale in Canada or the European Union.