New 510(k) boosts iRhythm, Verily efforts for AFib screening

The latest 510(k) clearance for the Verily Study Watch will further the efforts of the Google sister company and iRhythm Technologies (NSDQ:IRTC)  to improve atrial fibrillation treatment.
Verily — a life science company under Alphabet (NSDQ:GOOGL) — recently received an FDA 510(k) clearance to include an irregular pulse monitor in its Study Watch wearable.
“We’ve worked carefully to meet the FDA’s stringent requirements for medical devices, and with this new indication, will explore opportunities to leverage Study Watch as a measure of irregular pulse in clinical settings across our cardiovascular programs, including our collaboration with iRhythm,” Dr. William Marks, head of clinical science at Verily, said in a blog post yesterday.
San Francisco–based iRythm in September closed on a $115 million stock offering to help fund its partnership with Verily to develop AI-based screening, diagnosis and management technology for AF. Work is in the early stages as the two companies seek to boost screening, diagnosis and management of patients with AFib, according to Marks.
“Since announcing the collaboration in September, our product and engineering teams have begun work on technical integrations and exploring how we can leverage tools like Study Watch with ECG and Irregular Pulse Monitor and iRhythm’s Zio Service to support continuous monitoring, data analytics and cloud-based machine learning to monitor AFib,” Marks said.
Launched in April 2017, the Study Watch has found use among thousands of people participating in clinical trials, according to Verily. The company touts the Study Watch’s unobtrusive biosensing, which includes built-in biometric, environmental and movement sensors.
Pharmaceutical industry giants including Novartis, Otsuka, Pfizer and Sanofi formed a strategic alliance with Verily last year to develop patient-centered clinical research programs using Verily’s Project Baseline evidence generation platform and tools, including the Study Watch.
Original Article: (https://www.massdevice.com/new-510k-boosts-irhythm-verily-efforts-for-afib-screening/)