Australian firm Seer Medical acquired FDA 510(okay) clearance for its at-home electroencephalograph (EEG) system Seer Dwelling that helps suppliers diagnose epilepsy.
Seer Dwelling’s EEG system allows sufferers to endure week-long research at residence. Sufferers put on a tool — the Seer Sense — round their shoulders with electrodes linked to the affected person’s cranium and chest to document mind (EEG) and coronary heart indicators (ECG). That knowledge is then wirelessly despatched to a close-by monitoring hub that shops it together with video footage synchronized to the EEG/ECG knowledge, which gives further context round physique motion artifacts.
Upon completion of the examine, the info collected is reviewed and annotated by a doctor who then produces a report for the referring physician.
Seer has offered diagnostic at-home monitoring providers in Australia since its launch in 2017, and acquiring 510(okay) clearance will permit the corporate to increase within the American market.
WHY IT MATTERS
Receiving an epilepsy diagnosis within the U.S. generally is a complicated course of. It usually requires docs to carry out a number of checks both in-office or at a hospital, and pinpointing the place the seizures begin within the mind might require a number of checks.
“Seer has demonstrated the effectiveness of ambulant diagnostic monitoring in our residence market of Australia. Now with this approval, we’re delighted to have the ability to supply a brand new pathway to prognosis for Individuals with epilepsy — one that doesn’t require a hospital keep and one that may give docs the info they should extra precisely diagnose and monitor neurological problems,” Dr. Dean Freestone, the corporate’s CEO and cofounder, stated in a press release.
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 rapidly. It not too long ago raised $50 million to help its ongoing business growth in emergency departments and intensive care items.
Within the distant monitoring area, quite a few firms are providing choices for seizure sufferers.
Embrace2 is a seizure monitoring wearable that has acquired FDA clearance and can be utilized by kids 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 acquired FDA 501(okay) clearance for in-hospital use of its REMI system in March 2021, however deliberate to increase into ambulatory and at-home care. February’s funding spherical can be used for the commercialization of its system and continued growth of its platform.
