BioTelemetry's (BEAT) MCOT Patch Approved by U.S. FDA

July 26, 2016 8:37 AM EDT

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BioTelemetry, Inc. (Nasdaq: BEAT) announced that it has received U.S. Food and Drug Administration (“FDA”) 510(k) clearance of its next generation Mobile Cardiac Outpatient Telemetry device, the MCOT™ Patch. The MCOT™ Patch is a four-lead, two-channel system which provides the same best in class technology as the current MCOT™, in a more convenient form factor. The MCOT™ devices, through the use of a proprietary algorithm, offer the most accurate remote arrhythmia detection available on the market.

The new device was developed in partnership with Belgium-based IMEC, a leading developer of nanoelectronics. The system also incorporates proprietary patch technology that the Company recently acquired from DELTA Danish Electronics, Light and Acoustic. The Company expects the MCOT™ Patch to be commercially available later this year.

Joseph H. Capper, President and Chief Executive Officer of BioTelemetry, commented: “We are extremely excited to announce this latest milestone in the evolution of our MCOT™ technology. Validated by numerous clinical publications and abstracts, MCOT™ is widely recognized among remote monitoring options as the “gold standard” in terms of sensitivity and accuracy in the detection of arrhythmias such as atrial fibrillation. The MCOT™ Patch incorporates this same unmatched detection capability into a light-weight, easy-to-use patch form factor, which we believe will lead to higher utilization. Moreover, due to its advanced capabilities and flexible design, our new sensor is also anticipated to have commercially viable applications in other areas of healthcare. The introduction of the new system demonstrates our ongoing commitment to reaching as many patients as possible with our life-saving technology and service.”



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