Seizure-Detecting Smart Watch Given FDA Approval
The FDA has recently approved Embrace, a smart watch designed to monitor epileptic patients for seizures, according to a press release. According to the press release, the device uses machine learning to monitor patients for dangerous seizures, including grand mal or generalized tonic-clonic seizures. These seizures cause loss of consciousness and can cause a state of confusion in patients for periods of time after they finish. Embrace is said to allow medical professionals to gain information about when seizures happen with higher accuracy than was previously available and can also alert caregivers when patients are having seizures. During a seizure, the watch vibrates, LEDs light up, and an alert is sent via Bluetooth to the patient’s smartphone. An app on the phone can then send a distress signal via text or phone call to one or more caregivers.
The device was previously approved by the European Medical Agency in April 2017. According to articles, the technology was originally developed at MIT in 2007 and was funded by a successful crowdfunding campaign in 2014, which netted the maker, Empatica, more than $800,000. Embrace went on sale shortly after that campaign and has been available commercially but was not previously available as a medical device in the U.S.
The FDA’s approval was reportedly based on a clinical trial of 135 patients over 272 days. Each of the patients had epilepsy and were simultaneously monitored by EEG and using Embrace. The trial recorded over 6500 hours of data, including 40 seizures, which Embrace detected with 100% accuracy.
Matteo Lai, Co-Founder and CEO of Empatica, touted Embrace’s design and functionality, saying “We wanted to design the world’s first medical device that could win a design award, while being used as a lifesaving product.” Embrace is said to be the first smart watch to be approved by the FDA for neurological monitoring.
Nestlé Continues Medical Industry Expansion
Nestlé Health Science S.A. recently announced that it will acquire Manchester, England-based Phagenesis Ltd. in a staged acquisition.
Nestlé Health Science S.A., a subsidiary of Nestlé S.A., is the owner of more than a dozen nutritional supplement brands. It has previously invested in several businesses that develop solutions for nutrition- and digestion-related disorders and diseases.
Phagenesis is the developer of the Phagenyx®, a device designed for the treatment of dysphagia, the inability to safely swallow. Phagenesis explains that the device aims to restore neurological control of swallowing lost due to stroke by delivering Pharyngeal Electrical Stimulation (PES). According to Phagenesis, electrical stimulation of the pharynx induces a new part of the brain to assume control of such lost swallowing function.
The Phagenyx® product includes a treatment catheter and a base station. The catheter carries two electrodes, which deliver the PES, and is designed to be introduced through the nose. The catheter can optionally accommodate a feeding tube. The catheter is connected to the base station, which controls the amount of stimulation delivered and stores the patient’s treatment information. Phagenyx® is currently undergoing clinical evaluation. While the device received its CE mark in 2012, it has yet to be approved for use in the US by the FDA.
According to its press release, Nestlé Health Science’s acquisition of Phagenesis will start with an upfront payment followed by milestone-based payments contingent upon successful completion of Phagenyx’s® European and US development programs.
The acquisition was announced on the same day former Fresenius Medical Care CEO Ulf Mark Schneider joined Nestlé S.A. In June 2016, Nestlé announced Mr. Schneider’s appointment to the position of CEO, which will become effective on January 1, 2017.
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