iRhythm Technologies (Nasdaq:IRTC) announced today that it received FDA 510(k) clearance for its ZEUS (Zio ECG Utilization Software) system. ZEUS, produced in partnership with Google’s life sciences sister company Verily, combines deep-learned algorithms with iRhythm’s cardiac arrhythmia service, providing the AI algorithm component for the Zio Watch sensor-based wearable for non-invasive, clinical-grade, long-term continuous monitoring […]
Verily
iRhythm plans silent AFib screening pilots, high-level hires and Zio Watch evaluations
iRhythm Technologies (NSDQ:IRTC) has big plans for 2022 and its remote external electrocardiogram monitors as the medical device developer gears up for growth. President and CEO Quentin Blackford is looking to hire an international general manager among other roles in the coming months, he told Medical Design & Outsourcing after presenting at this month’s 2022 J.P. Morgan Healthcare Conference, […]
FDA rejects Verily’s smartwatch-based Parkinson’s exam
The FDA issued a letter to Google’s (NSDQ:GOOGL) Verily declaring that it will not accept a letter of intent for the company’s Parkinson’s exam. Verily submitted the LOI for drug development tool (DDT) for the virtual motor exam for Parkinson’s disease. The device measures a change in digitally assessed parameters of a subset of Parkinson’s disease […]
FDA grants Verily EUA for pooled COVID-19 testing
The FDA has granted Google’s (NSDQ:GOOGL) Verily emergency use authorization (EUA) for its pooled COVID-19 testing. In a letter to the company dated yesterday, the FDA confirmed the EUA status for the qualitative test for detecting nucleic acid from SARS-CoV-2 in respiratory specimens procured through nasal, mid-turbinate, nasopharyngeal and oropharyngeal swabbing. The test also can be […]
Verily launches clinical lab for COVID-19 testing
Google’s (NSDQ:GOOGL) Verily announced that it established a CLIA-certified lab to create additional lab capacity to support COVID-19 testing. The lab, at Verily’s San Francisco headquarters, is designed to support programs in the COVID-19 testing space as demand continues to increase while the pandemic goes on, including the company’s own return-to-work efforts for its own employees, […]
LivaNova adds Verily to depression study
LivaNova (NSDQ:LIVN) announced that it has added Google’s (NSDQ:GOOGL) Verily to its study of vagus nerve stimulation (VNS) therapy for difficult-to-treat depression (DTD). The Recover clinical will gather quantitative data on patient behavior using Verily’s technology and analytics. The data could help the researchers understand depressive episodes and the patient’s response to treatment. Study participants will […]
Verily, Santen do a JV for ophthalmological devices
Santen Pharmaceutical (OTC:SNPHY) and Verily, an Alphabet (NSDQ:GOOGL) company, announced that they are entering into a joint venture to focus on applying microelectronics and scalable digital technologies to ophthalmology. Osaka, Japan-based Santen and San Francisco-based Verily say they want to improve eye health globally. According to a news release, the joint venture is slated to combine […]
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 […]
FDA clears Verily Study Watch for additional capabilities
Verily, Google’s life science’s sister company under Alphabet (NSDQ:GOOGL), has received an FDA 510(k) clearance to include an irregular pulse monitor in its Study Watch wearable. The FDA announcement, last updated Jan. 20, did not include additional information. The agency cleared ECG capabilities on the Study Watch in January 2019. Launched in April 2017, the Study […]
Earlens to partner with Verily for next-gen Earlens hearing device
Earlens today said it entered a strategic agreement with Verily to develop next-generation capabilities for the Earlens Contact Hearing Solution. Earlens’s Contact Hearing Solutions directly activates the hearing system to deliver the broadest bandwidth in a nonsurgical hearing solution. It uses a small lens to vibrate the eardrum to replicate the natural hearing process. “Unlike […]
Verily hires former Tesla executive as CFO
Verily — Google’s life sciences sister company under Alphabet (NSDQ:GOOG) — has hired Tesla veteran Deepak Ahuja as its CFO, according to a report on CNBC. Ahuja previously served two stints as CFO at Tesla. He left Tesla in early 2019 and was serving as a senior advisor to Capricorn Investment Group, according to his LinkedIn […]