Bardy Diagnostics is expanding the home enrollment program for its cardiac patch monitor and won CE mark for a 14-day version of the device.
The Seattle, WA-based company said it was exploring more telehealth opportunities with Carnation Ambulatory Monitor (CAM) patch because of the rapidly evolving COVID-19 public health emergency. Typically, the CAM patch is applied to a patient in the clinic setting.
In a prepared statement Ken Nelson, chief commercial officer of Bardy Diagnostics said, “To help address the evolving needs of physicians and patients in this public health emergency, facilitate the rapid transition to telehealth for clinics around the country and to ensure uninterrupted access to our CAM patch, our team has worked around the clock to increase our manufacturing capacity and expand our internal business operations to enable patients to receive and apply our disposable, single-use CAM patch at home. The home application program eliminates the need for in-person patient and healthcare provider contact, reduces the potential for exposure to COVID-19, streamlines care, and allows healthcare personnel who are already resource-constrained to focus on other areas of critical need."
The patch won a nod from FDA in 2019 and a Health Canada clearance in February 2020.
Bardy’s CAP competes with iRhythm’s Zio XT. The San Francisco, CA-based company is currently in a partnership to develop products for Verily’s Study Watch, which recently won FDA clearance.
Bardy said that the clinical value of its P-wave centric detection technology was compared to iRhythm’s Zio XT patch and results were published in the American Heart Journal.
The study concluded the CAM Patch identified 40% more arrhythmias and resulted in better, more informed clinical decision-making in 41% of patients as compared to the iRhythm Zio XT patch.