Did you know that Software as a Medical Device (SaMD) can peer into the inner workings of the brain to help diagnose and treat concussions, sleep disorders and strokes? In Orthogonal’s quest to create the Ultimate Running List of all FDA-cleared SaMD, this article takes a look at 10 neurology SaMD cleared by the FDA from 2012 to 2022.
With 562 entries so far, Orthogonal estimates that our list of SaMD may only be ~10% complete at this point. Help us improve our list by sharing any SaMD you are aware of using this form or by emailing us at [email protected].
2012 – Stereotactic surgery planner: Praezis Plus
Company: Tatramed
Decision Date: May 24th, 2012
FDA Summary: K110644
Source: YouTube
The Praezis Plus system from Tatramed is software that aids in planning intracranial stereotactic surgeries such as biopsies and treatment of lesions. It helps physicians to select stereotactic trajectory positions by visualizing the entry and exit points of the stereotactic needle on a digitized CT scan or MRI.
2014 – Assessing cognitive baseline: BNA Analysis System
Company: Firefly Neuro
Decision Date: July 25th, 2014
FDA Summary: K121119
Source: Firefly Neuro
The BNA Analysis System from Firefly Neuro (formerly ElMindA) is software that analyzes electroencephalograms (EEGs) using evoked response potentials to capture differences between the patient and an age-matched reference group. The resulting composite score helps physicians understand the patient’s current cognitive state, with subsequent test results indicating how receptive the patient is to treatment.
2015 – Neurosurgical treatment aid: BrightMatter Planning Software
Company: Synaptive Medical
Decision Date: April 2nd, 2015
FDA Summary: K142024
Source: Synaptive Medical
The BrightMatter Planning Software from Synaptive Medical, later renamed Modus Nav, is used for pre-operative planning of neurosurgical treatments based on image-guided surgical systems. The software visualizes diagnostic images of the skull in 2D and 3D to help surgeons develop a treatment plan for neuronavigational procedures.
2016 – Neurocognitive function test: ImPACT
Company: ImPACT Applications
Decision Date: August 22nd, 2016
FDA Summary: DEN150037
Kids taking the ImPACT test. Source: ImPACT
ImPACT is a computerized neurocognitive test battery that aids in the detection and management of a concussion. The test measures aspects of neurocognitive function like reaction time, memory and spatial processing speed to assess the impact of a concussion on the patient. ImPACT’s target audience includes sports organizations and school districts that want to capture a cognitive baseline for their athletes/students as well as detect concussions early to help mitigate negative repercussions.
2017 – Sleep study analyzer: EnsoSleep
Company: Ensodata
Decision Date: March 31st, 2017
FDA Summary: K162627
Source: Sleep Review
EnsoSleep from Ensodata analyzes physiological signals measured in a sleep test to evaluate a patient for sleep and respiratory sleep disorders. This device aims to streamline the time physicians spend on scoring sleep tests by integrating with both home sleep tests and laboratory polysomnographic devices.
2018 – Reviewing EEG signals: Natus NeuroWorks
Company: Natus
Decision Date: March 14th, 2018
FDA Summary: K180421
Source: Natus
Natus’ Neuroworks EEG Software collects, displays, reviews and analyzes physiological signals found within EEGs. Its algorithms mark EEG recordings for signs of seizures and spikes and help physicians make informed treatment decisions.
2018 – Seizure detection software: Encevis
Company: AIT Austrian Institute of Technology
Decision Date: April 19th, 2018
FDA Summary: K171720
Source: Encevis
Encevis from AIT Austrian Institute of Technology is a software platform viewing and analyzing EEG data for seizure activity. This software’s capabilities include seizure detection, spike detection, artifact reduction and source localization.
2020 Therapeutic video game: EndeavorRx
Company: Akili Interactive
Decision Date: June 15th, 2020
FDA Summary: DEN200026
Source: Akili
EndeavorRx from Akili is a Digital Therapeutic (DTx) used to improve attention function in kids with ADHD through a video game experience. Combining art, music, storytelling and reward cycles, EndeavorRx delivers stimuli tailored to the needs of individual patients to keep them engaged with the treatment.
2021 – 3D brain anatomy visualizer: SureTune4
Company: Medtronic
Decision Date: August 23rd, 2021
FDA Summary: DEN210003
Source: Medtronic
SureTune4 from Metronic is a visualization tool that aids in planning the programming of deep brain stimulation. The device combines MRI, CT and Medtronic’s proprietary O-arm images into 2D projections and 3D reconstructions of a patient’s specific brain anatomy. Based on the projection and reconstruction, the software can suggest electrode configurations, placement of leads and potential stimulation settings.
2022 – AI sleep disorder algorithm: Somnometry
Company: Neumetry
Decision Date: September 21st, 2022
FDA Summary: K221179
Source: Neumetry
Somnometry from Neumetry is a AI/Machine Learning algorithm that automatically scores sleep study results to aid in the diagnosis of sleep and respiratory-related sleep disorders. The algorithm analyzes polysomnography signals recorded during sleep studies to detect disordered breathing events such as obstructive apneas.
Conclusion
The high number of De Novo (DEN) clearances on this list point to how SaMD can bring innovation to neurological care. We anticipate that advancements in AI and Machine Learning algorithms will continue to push the envelope on methods for diagnosing, monitoring and treating neurological, spinal cord and nerve conditions.
This selection of SaMD was taken from Orthogonal’s Ultimate Running List of every FDA-cleared SaMD. Even with over 500 SaMD cataloged, our journey to record all SaMD on the market in the U.S. is far from over. Help us complete our list by filling out this form or emailing us at [email protected].
Randy Horton
Randy Horton is Chief Solutions Officer at Orthogonal, a software consulting firm that improves patient outcomes faster by helping MedTech firms accelerate their development pipelines for Software as a Medical Device (SaMD), digital therapeutics (DTx) and connected medical device systems. Orthogonal makes that acceleration happen by fusing modern software engineering and product management tools and techniques (e.g., Agile, Lean Startup, User-Centered Design and Systems Thinking) with the regulated focus on device safety and effectiveness that is at the heart of MedTech.
Horton serves as Co-Chair for AAMI’s Cloud Computing Working Group, as well as AAMI CR:510(2021) and the in-process Technical Information Report #115, all of which address how to safely move medical device computing functions into the cloud. He is a frequent speaker at conferences and webinars, including events hosted by AdvaMed, AAMI, HLTH, RAPS and the Human Factors and Ergonomics Society (HFES).
