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Australian firm Seer Medical obtained FDA 510(ok) clearance for its at-home electroencephalograph (EEG) system Seer Dwelling that helps suppliers diagnose epilepsy.
Seer Dwelling’s EEG system permits sufferers to bear week-long research at dwelling. Sufferers put on a tool — the Seer Sense — round their shoulders with electrodes linked to the affected person’s cranium and chest to report mind (EEG) and coronary heart indicators (ECG). That information is then wirelessly despatched to a close-by monitoring hub that shops it together with video footage synchronized to the EEG/ECG information, which gives extra context round physique motion artifacts.
Upon completion of the examine, the information collected is reviewed and annotated by a doctor who then produces a report for the referring physician.
Seer has supplied diagnostic at-home monitoring companies in Australia since its launch in 2017, and acquiring 510(ok) clearance will enable the corporate to develop within the American market.
WHY IT MATTERS
Receiving an epilepsy analysis within the U.S. could be a complicated course of. It typically requires docs to carry out a number of exams both in-office or at a hospital, and pinpointing the place the seizures begin within the mind might require a number of exams.
“Seer has demonstrated the effectiveness of ambulant diagnostic monitoring in our dwelling market of Australia. Now with this approval, we’re delighted to have the ability to supply a brand new pathway to analysis for Individuals with epilepsy — one that doesn’t require a hospital keep and one that may give docs the information they should extra precisely diagnose and monitor neurological problems,” Dr. Dean Freestone, the corporate’s CEO and cofounder, stated in an announcement.
THE LARGER TREND
Ceribell developed a fast response EEG system to assist diagnose neurological sufferers, which the corporate says additionally addresses the necessity to diagnose sufferers suspected of getting a seizure extra shortly. It not too long ago raised $50 million to assist its ongoing business growth in emergency departments and intensive care models.
Within the distant monitoring house, quite a few corporations are providing choices for seizure sufferers.
Embrace2 is a seizure monitoring wearable that has obtained FDA clearance and can be utilized by youngsters ages six and above.
In February 2022, Epitel, maker of a wearable EEG system for seizure detection, raised $12.5 million in Collection A funding. The platform obtained FDA 501(ok) clearance for in-hospital use of its REMI system in March 2021, however deliberate to develop into ambulatory and at-home care. February’s funding spherical could be used for the commercialization of its system and continued improvement of its platform.
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