Zilia announced today that it received FDA 510(k) clearance for its Ocular FC retinal camera for non-invasive ocular assessments. Quebec City, Canada-based Zilia designed the Ocular FC system for assessing ocular biomarkers. The company believes it could “transform the diagnosis and management of ocular diseases,” according to a news release. It said the FDA clearance […]
510(k)
FDA clears oral device for severe sleep apnea from Vivos Therapeutics
Vivos Therapeutics (Nasdaq:VVOS) announced today that the FDA cleared its removable CARE oral devices for treating severe obstructive sleep apnea (OSA). The CARE (complete airway repositioning and/or expansion) line includes the flagship DNA, mRNA and mmRNA oral appliances. Littleton, Colorado–based Vivos says its clearance makes it the first company bringing a clear alternative to CPAP […]
FDA clears on-device triage algorithms for critical care from GE HealthCare
GE HealthCare announced today that the FDA granted 510(k) clearance to its Critical Care Suite 2.1 with a pneumothorax (PTX) algorithm. The industry-first clearance allows the suite to detect, notify and triage the diagnosis of PTX. Chicago-based GE HealthCare’s updated algorithm expands the suite’s on-device triage capabilities, according to a news release. It provides immediate […]
FDA clears Masimo W1 medical watch
Masimo has received FDA 510(k) clearance for its medical watch for both over-the-counter and prescription use. The FDA clearance is the latest good news for Masimo, which has been making headway in its patent battle with tech giant Apple. MASI shares were up more than 1% to $94.75 apiece by midday trading today on the […]
NeuroOne expects FDA nod for neuro ablation tech next year
NeuroOne (Nasdaq:NMTC) announced today that it responded to FDA questions regarding the 510(k) submission of its OneRF ablation system. Eden Prairie, Minnesota–based NeuroOne submitted OneRF for FDA clearance in June. It’s the company’s first therapeutic device. The technology uses already-implanted sEEG electrodes to record brain activity and enable the ablation of nervous tissue. It connects […]
FDA clears Corin Group’s Apollo surgical robot platform
Corin Group announced today that it received FDA 510(k) clearance for its Apollo robotic-assisted surgical platform. The Cirencester, UK-based company also picked up clearance for the ApolloKnee software application. Corin Group says it marks “a significant industry milestone” in its commitment to advancing total joint replacement surgery. Apollo, which features BalanceBot technology, builds upon a […]
FDA clears non-invasive insomnia-treating device from Neurovalens
Neurovalens announced today that the FDA granted clearance to its Modius Sleep device for treating chronic insomnia. Belfast, Northern Ireland-based Neurovalens develops non-invasive neurotechnology. The company took part in the MedTech Innovator Accelerator program last year. Neurovalens designed Modius to deliver non-invasive electrical stimulation to key areas of the brain and nervous system. It eliminates […]
FDA clears iPhone app for the Insulet Omnipod 5
Insulet announced today that the FDA granted 510(k) clearance for its Omnipod 5 App for iPhone. Clearance makes Insulet the only company offering a tubeless, automated insulin delivery (AID) system with full control from a compatible Android and iOS smartphone. The company first launched the system, compatible with Android devices, in August 2022. Chief Technology […]
Interventional Systems wins new FDA nod for surgical robot with CT guidance
Interventional Systems announced today that the FDA granted a new 510(k) clearance for its Micromate surgical robot system. The new clearance enables U.S. marketing for percutaneous procedures using computed tomography (CT) optical navigation. These include biopsies and ablations for diagnosing and treating conditions in the chest, abdomen and musculoskeletal structures. Interventional Systems said the clearance […]
FDA clears next-gen image-guided therapy tech from GE HealthCare
GE HealthCare announced today that the FDA granted 510(k) clearance to its Allia IGS Pulse system. The latest addition to GE HealthCare’s image-guided system (IGS) offerings features a new imaging chain. GE HealthCare says it engineered this feature to provide exceptional imaging at the right dose. This enables visible impact in complex cardiology interventions regardless […]
FDA clears DePuy Synthes TriLeap plating system for foot and ankle surgeries
DePuy Synthes, the orthopedic device business of Johnson & Johnson , has won FDA 510(k) clearance for its TriLeap lower extremity anatomic plating system. The company said it designed the TriLeap system to address the intricate needs of orthopedic surgeons and foot and ankle specialists. As conditions like bunions become more prevalent —with Cleveland Clinic […]
