Dive Brief:
- Verily, Alphabet's life sciences unit, announced Friday that its Study Watch has received FDA 510(k) clearance as a Class II medical device for its on-demand electrocardiogram (EKG) feature.
- The Study Watch is a prescription-only device that can record, store, transfer and display ECG rhythms. The device is indicated for use by healthcare professionals, adult patients with known or suspected heart conditions and health-conscious individuals, Verily, a division of Google parent Alphabet, said in a blog post.
- The FDA approval could introduce some competition to Apple Watch, whose EKG feature was cleared for over-the-counter use in September.
Dive Insight:
The Study Watch, first launched in April 2017, already has been used by thousands of participants in clinical trials run by Verily and its partners. Efforts include the Project Baseline mobile app to build a database of biometric data, Aurora study of post-traumatic stress and two studies on Parkinson's Disease. The company said it is collecting and organizing many types of health data, from biometric data such as EKG to genomic and proteomic data to traditional clinical data such as electronic health records and medical images.
With its EKG feature, Verily sees a role for the Study Watch in tackling heart disease with additional research focused on cardiovascular health. It has competition from Apple, which announced FDA approval in September of an EKG monitor embedded in its latest Apple Watch. Apple's app is indicated for over-the-counter use.
An EKG measures the electrical activity of the heart and can assist in diagnosing a range of heart conditions. Verily said the Study Watch can take an on-demand, single-lead EKG. Gaining FDA clearance for the EKG feature will support both population-based research and individual patients' clinical care, the company said.
"Receiving this clearance showcases our commitment to the high standards of the FDA for safety and effectiveness and will help us advance the application of Study Watch in various disease areas and future indications," Verily said.
Verily just raised $1 billion in a new funding round it intends to use for strategic partnerships, global business opportunities and potential acquisitions. Other projects to date range from investments in population health tools and precision medicine to surgical robotics and sensor technologies. In December, Verily partnered with Walgreens on a medication adherence pilot project. The two companies also plan to work with virtual diabetes clinic Onduo to help people with Type 2 diabetes manage their disease.
