Australian firm Seer Medical obtained FDA 510(ok) clearance for its at-home electroencephalograph (EEG) system Seer Residence that helps suppliers diagnose epilepsy.
Seer Residence’s EEG system permits sufferers to endure week-long research at house. Sufferers put on a tool — the Seer Sense — round their shoulders with electrodes related to the affected person’s cranium and chest to document mind (EEG) and coronary heart alerts (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 offers 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 supplied diagnostic at-home monitoring companies in Australia since its launch in 2017, and acquiring 510(ok) clearance will enable the corporate to broaden within the American market.
WHY IT MATTERS
Receiving an epilepsy analysis within the U.S. generally is a advanced course of. It usually 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 house 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 info 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 lately raised $50 million to help its ongoing industrial enlargement 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 obtained 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 obtained FDA 501(ok) clearance for in-hospital use of its REMI system in March 2021, however deliberate to broaden 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.