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Intelesens announced that its wearable vital signs monitor zensor obtained 510(k) clearance from the FDA for use in monitoring patients outside of hospital. Stephen Henderson, commercial manager for the company, stated that the clearance "brings a step closer the promise of preventative, predictive and protective technology, enabling clinicians proactively to help safeguard the quality of the life patients have yet to live."
Henderson further noted that in addition to gaining access to the US market, the clearance "enables us to target those emerging markets looking to embrace innovative new healthcare technology immediately, in order to avoid some of the pitfalls that established healthcare delivery systems have encountered."
According to Intelesens, the zensor system "facilitates real-time monitoring of ECG (electrocardiogram), heart rate, respiration rate and motion," adding that "it also features the storage of diagnostic quality ECG over a monitoring period of 168 hours." Specifically, the miniaturised device clips on to a disposable adhesive electrode array to track "a range of out of normal vital signs, transmitting information wirelessly to a remote server," the company added.
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