AliveCor said today that it won FDA clearance for its KardiaMobile 6L six-lead personal ECG device, touting it as the first device of its kind to win FDA clearance. The Mountain View, Calif.-based company said that the six-lead device features a design consistent with its existing KardiaMobile product, but features an additional two electrodes on the […]
FDA clears AliveCor’s KardiaMobile for bradycardia, tachycardia monitoring
AliveCor said yesterday that it won expanded FDA 510(k) clearance indications for its KardiaMobile personal ECG device, now cleared for detecting bradycardia and tachycardia. The Mountain View, Calif.-based company’s KardiaBand is a wrist-worn electrocardiogram device previously cleared to detect atrial fibrillation and normal sinus rhythm. “No other consumer ECG device in the world, can tell […]
Omron wins FDA nod for combined blood pressure monitor, EKG
Omron Healthcare (TYO:6645) has won FDA 510(k) clearance for its Blood Pressure Monitor + Echocardiogram device, according to a recently posted FDA release. The device, which was developed in collaboration with AliveCor, allows users to monitor both high blood pressure and atrial fibrillation, which the company said are critical risk factors for stroke. The newly cleared […]
Owens & Minor taps former Thermo Fisher CCO Pesicka as prez, CEO | Personnel Moves – February 27, 2019
Owens & Minor (NYSE:OMI) said this month that it named former Thermo Fisher Scientific chief commercial officer Edward Pesicka as its new prez & CEO, effective March 4. Pesicka will replace interim prez & CEO Robert Sledd, who will continue to serve as board chair, the Richmond, Va.-based company said. Prior to his position as chief […]
ReShape Lifesciences CEO Gladney to resign | Personnel Moves – January 29, 2019
ReShape Lifesciences (NSDQ:RSLS) said yesterday that its prez & CEO Dan Gladney will resign from his positions with the company, effective March 31. Gladney will remain with the company as board chair, San Clemente, Calif.-based ReShape Lifesciences said. The company’s board of directors said they will immediately begin to look for a replacement, according to an […]
AliveCor lands $20m loan from Oxford Finance
AliveCor landed a $20 million loan from Oxford Finance, the investment firm said today. Alexandria, Va.-based Oxford, which specializes in life-science and healthcare plays, said the senior secured loan are earmarked for working capital as Mountain View, Calif.-based AliveCor looks to expand the footprint of its mobile ECG devices. AliveCor makes the KardiaBand, a wrist-worn device […]
AliveCor app matches ECG in signaling certain heart attacks
An international study has found that AliveCor’s smartphone app has nearly the same accuracy as a standard 12-lead ECG in monitoring heart activity and determining if someone is having an ST-segment elevation myocardial infarction (STEMI). The study led by researchers from the Intermountain Medical Center Heart Institute in Salt Lake City followed 204 patients with chest […]
FDA hopes new disruptive wearables will lead to ‘universal digital future in healthcare’
The FDA is hopeful that devices like the new Apple (NSDQ:AAPL) Watch, which is designed to provide on-the-spot electrocardiogram tests and detect atrial fibrillation, will lead to a “reimagination of healthcare delivery,” according to a recent post from agency head Dr. Scott Gottlieb, but whether having that data will improve overall health has yet to be […]
FDA grants breakthrough designation to AliveCor’s KardiaK hyperkalemia software
AliveCor said this week it won breakthrough device designation from the FDA for its KardiaK software platform intended to screen for hyperkalemia, or elevated levels of blood potassium, without the need for drawing blood. The Mountain View, Calif.-based company said the KardiaK system uses a proprietary deep neural network intended to detect hyperkalemia using data from […]
AliveCor touts high precision AF detection, AI-powered hyperkalemia detection in KardiaBand studies
AliveCor this week announced results from two studies of its Apple (NSDQ:AAPL) smartphone-connected KardiaBand personal electrocardiogram device, touting the bands ability to detect atrial fibrillation and its ability to detect high potassium levels. Results from the studies, which were presented this week at the American College of Cardiology’s 67th Annual Scientific Session, provide more support to the […]
ACC ’18 Roundup: Abbott releases long-term HeartMate 3 data
Abbott (NYSE:ABT) touted two-year data yesterday from its trial designed to compare the company’s HeartMate 3 left ventricular assist device to its HeartMate 2 device in patients with advanced heart failure. Data from the study were published in The New England Journal of Medicine and presented at the American College of Cardiology’s 67th Annual Scientific Session. More […]
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