Floodlight™ MS
Support & Resources
Floodlight MS is a science-based smartphone app designed to inform clinical conversations and healthcare provider decisions by collecting objective data on patient function between clinic visits to see beyond the surface of living with MS.
Intended Use Statements
Floodlight MS Healthcare Professional’s Portal
The Floodlight Healthcare Professional’s (HCP) Portal is intended to display the results of various assessments from the Floodlight Mobile Application per end-user and for several users over time. The HCP is solely responsible for interpreting the results.
Floodlight MS Mobile Application
The Floodlight MS Mobile Application is intended to present various assessment modules to patients with multiple sclerosis and visualize the results of these assessments. The application is intended to send results from the assessment modules to a server in order to be visualized by qualified healthcare professionals (HCPs) on a portal. The application is also intended to receive responses from the user to questions related to their symptoms or person.
The Floodlight MS Mobile Application is not intended to interpret or analyze clinical laboratory test or other device data, results, or findings.
Floodlight MS Draw Shape Test
The Floodlight MS Draw Shape Test is intended to provide an objective measurement of hand function in patients 18 years of age and older with multiple sclerosis. The Floodlight MS Draw Shape Test is used by patients in their home environment, and the results are reviewable by the patient and exported to a qualified healthcare professional (HCP) for review. The patient is not intended to take action on the device output without consultation of a qualified HCP.
The Floodlight MS Draw Shape Test only provides objective measurements of hand function and does not provide an interpretation or a clinical implication of the measurements. The Floodlight MS Draw a Shape Test should only be used as an adjunctive tool for measuring hand function and is not intended to be used as a stand-alone diagnostic device nor to identify the presence or absence of clinical diagnoses.
Floodlight MS Pinching Test
The Floodlight MS Pinching Test is intended to provide an objective measurement of hand function in patients 18 years of age and older with multiple sclerosis. The Floodlight MS Pinching Test is used by patients in their home environment, and the results are reviewable by the patient and exported to a qualified healthcare professional (HCP) for review. The patient is not intended to take action on the device output without consultation of a qualified HCP.
The Floodlight MS Pinching Test only provides objective measurements of hand function and does not provide an interpretation or a clinical implication of the measurements. The Floodlight MS Pinching Test should only be used as an adjunctive tool for measuring hand function, and is not intended to be used as a stand-alone diagnostic device nor to identify the presence or absence of clinical diagnoses.
Floodlight MS U Turn Test
The Floodlight MS U Turn Test is intended to provide an objective measurement of gait and dynamic balance in patients 18 years of age and older with multiple sclerosis. The Floodlight MS U Turn Test is used by patients in their home environment, and the results are reviewable by the patient and exported to a qualified healthcare professional (HCP) for review. The patient is not intended to take action on the device output without consultation of a qualified HCP.
The Floodlight U Turn Test only provides objective measurements of gait and dynamic balance and does not provide an interpretation or a clinical implication of the measurements. The Floodlight U Turn Test should only be used as an adjunctive tool for measuring gait and dynamic balance, and is not intended to be used as a stand-alone diagnostic device nor to identify the presence of absence of clinical diagnoses.
Floodlight MS 2-Minute Walk Test
The Floodlight™ MS 2MWT is intended to provide an objective measurement of gait in patients 18 years of age and older with multiple sclerosis. The Floodlight™ MS 2MWT is used by patients in their home environment, and the results are reviewable by the patient and exported to a qualified healthcare professional (HCP) for review. The patient is not intended to take action on the device output without consultation of a qualified HCP.
The Floodlight™ MS 2MWT only provides objective measurements of gait and does not provide an interpretation or a clinical implication of the measurements. The Floodlight™ MS 2MWT should only be used as an adjunctive tool for measuring gait and is not intended to be used as a stand-alone diagnostic device nor to identify the presence or absence of clinical diagnoses.
Floodlight MS Cognitive Test
The Floodlight MS Cognitive Test is intended as a cognitive assessment aid to determine the level of cognitive functioning in patients 18 years of age and older with multiple sclerosis. The Floodlight MS Cognitive Test is used by patients in their home environment, and the results are reviewable by the patient and exported to a qualified healthcare professional (HCP)for review. The patient is not intended to take action on the device output without consultation of a qualified HCP.
The Floodlight MS Cognitive Test only provides objective measurements of cognitive function and does not provide an interpretation or a clinical implication of the measurements. The Floodlight MS Cognitive Test should only be used as an adjunctive tool for measuring cognitive functions and is not intended to be used as a stand-alone diagnostic device nor to identify the presence of absence of clinical diagnoses.
Please see the user manuals on Floodlightms.com for directions on how to properly do the activities in the app.