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X-trodes swings FDA 510(k) clearance for at-home electrophysiological system

Israel-based patient monitoring firm, X-trodes has announced that its Smart Skin solution designed to expand access to at-home care has been granted US Food and Drug Administration (FDA) 510(k) clearance.

The company has said that its X-trodes System M, a wireless wearable designed to assist with advanced electrophysiological monitoring, is able to track several biopotential signals ranging from brain activity to cardiac monitoring to eye movement.

Described as a smart skin system, the device has been available for researchers for some time in measuring electrophysiological signals outside of laboratory settings, with X-trodes saying that it now intends to further validations for a wide range of clinical use cases, with an initial focus on the cardiovascular and sleep monitoring markets. It follows after X-trodes had previously been granted a €5.2m ($5.6m) award from the European Innovation Council Accelerator (EIC).

Speaking with Medical Device Network, X-trodes CEO Ziv Peremen, said: “These days we use electrophysiology in many applications, more than 100 of them, most of them are measured using equipment that was developed up to eight or nine years ago. They were cumbersome and costly and probably the most bothersome issue is the fact that they would need to be measured within a clinic or lab.

“At X-trodes we have developed this unique solution to increase the feasibility of taking this kind of technology out of clinics and measuring it outside the clinic, in an at-home environment.”

Peremen elaborated on how the X-trodes System M comes in the form of a skin patch and contains electrodes able to measure multi-modality electrophysical activity and is designed to produce readable results across numerous settings.

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Expanding on the benefits of at-home care, Peremen added: “The current technology is using rigid electrodes that need to be attached to the body and depending on what test you take you may have to spend hours, days, or nights in a clinical setting. It is uncomfortable to spend a night in someone else’s bed in a clinic.

“It’s not only a big issue for the patients but it is an issue for the health system. You need real estate, you need trained technicians to set it up, it is costly, and I think the most disturbing issue, is the fact that most electrophysiology tests are currently unavailable. You would have to go to a sleep clinic and often these are hours away from the patient.”

A GlobalData report found that in 2019 the market for remote patient monitoring sat at a value of around $600m, with that value estimated to rise to $760m by 2030. At the same time, the market for remote patient monitoring and telehealth apps has been on the rise.

Elsewhere in the field of remote patient monitoring Canadian company, Momentum Health received 510(k) clearance from the US FDA for its Momentum Spine app, designed to remotely monitor postural asymmetries.

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