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 […]
AngioDynamics starts postmarket study
AngioDynamics (NSDQ:ANGO) announced today that it launched a postmarket study of its Auryon atherectomy system for treating lesions in patients with peripheral artery disease (PAD). The Auryon atherectomy system, previously known as the Eximo B-Laser, is a wavelength laser technology platform that AngioDynamics acquired in October 2019. The system is designed to treat de novo, re-stenotic […]
LumiThera closes second Series C financing round
LumiThera announced today that it closed the second tranche of its Series C financing round with more than $10 million raised. The photobiomodulation (PBM) treatment developer earmarked the proceeds from the funding round for further clinical testing and commercialization of its Valeda light delivery system for treating dry age-related macular degeneration (AMD). LumiThera’s Valeda system […]
Polyganics’ Liqoseal sealant patch wins CE mark approval
Polyganics announced that it is initiating the European launch of its Liqoseal dural sealant patch after it won CE Mark approval. The Groningen, The Netherlands–based company’s Liqoseal dural sealant patch is designed to reduce cerebrospinal fluid (CSF) leakage following elective cranial surgery. Liqoseal’s European approval follows the Encase I clinical trial, which revealed an absence […]
CryoLife to begin investigational trial on using aortic valve without warfarin
CryoLife Inc. (NYSE:CRY) announced that it had its investigational new drug application accepted by the FDA for a clinical trial to observe whether the On-X mechanical aortic valve can be maintained on apixaban instead of warfarin. The On-X aortic valve is the first mechanical aortic heart valve to win FDA and CE Mark approval for labeling […]
Report: Mayo Clinic to try Corindus telestenting
Mayo Clinic researchers this spring plan to try out Corindus’ telestenting technology — which Mayo officials think could improve care in the rural hospitals in their network, according to a report in the Star Tribune of Minneapolis. Corindus told MassDevice‘s sister site Medical Design & Outsourcing in 2018 that the company had a partnership with […]
Could an algorithm improve breast cancer treatment?
A study from researchers at Penn Medicine revealed that MRI and an algorithm-based field of medicine called radiomics could help characterize the heterogeneity of cancer cells in a tumor and allow for better understanding of the causes and progression of individual diseases. The study, published in Clinical Cancer Research, examines radiomics, which uses algorithms to extract […]
Adagio Medical starts iCLAS AFib trial
Adagio Medical announced that it enrolled the first patient in its iCLAS investigational device exemption clinical trial for assessing the treatment for persistent atrial fibrillation. The iCLAS is a low-temperature intelligent continuous legion ablation system. The FDA-approved study has the goal of evaluating the safety and efficacy of the system in PsAF to support pre-market approval […]
iRhythm touts AFib study
iRhythm Technologies (NSDQ:IRTC) announced that it is participating in a new Bristol-Myers Squibb–Pfizer (NYSE:PFE) Alliance study for reducing stroke by screening for undiagnosed atrial fibrillation in elderly individuals. The goal of the “Guard-AF” study is to determine if earlier detection of AFib can impact the rate of stroke through screening previously undiagnosed people who are at least […]
Dyve Biosciences wins FDA nod for Phase 2 transdermal drug delivery trial
Dyve Biosciences received FDA clearance to begin a Phase 2 study of its DYV-700 transdermal therapeutic for the treatment of acute gout pain. Thousand Oaks, Calif.-based Dyve said it plans to begin the Targets study in the first quarter of 2020. It is slated to be a double-blind, placebo-controlled, randomized clinical trial to evaluate the […]
- 1
- 2
- 3
- …
- 182
- Next Page »
MassDevice Network
@MassDevice
LinkedIn
YouTube