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 dwelling. Sufferers put on a tool — the Seer Sense — round their shoulders with electrodes linked to the affected person’s cranium and chest to file mind (EEG) and coronary heart alerts (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 supplies extra context round physique motion artifacts.
Upon completion of the research, 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 companies in Australia since its launch in 2017, and acquiring 510(ok) clearance will enable the corporate to increase within the American market.
WHY IT MATTERS
Receiving an epilepsy analysis within the U.S. generally is a complicated course of. It typically 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 could require a number of checks.
“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 provide a brand new pathway to analysis for People 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, mentioned 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 just lately raised $50 million to assist its ongoing industrial enlargement in emergency departments and intensive care items.
Within the distant monitoring area, 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 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 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.