Digital imaging solutions company Visaris Americas said yesterday it won FDA 510(k) for its portfolio of software, flat panel detectors and various hardware offerings. The company’s central Avanse technology is designed to integrate with latest-generation flat panel detectors, which Visaris said enables facilities to transition to a single software platform to reduce cost and training […]
510(k)
Visunex wins FDA 510(k) for Panocam LT
Fremont, Calif-based ophthalmic information system developer Visunex Medical said it won FDA 510(k) clearance for its Panocam LT wide-field imaging system for newborns. The PanoCam LT is a small wireless imaging system designed to detect external, anterior and posterior segment vision disorders that could have long-term effects on children’s vision, the company said. “We are […]
Spectranetics wins 510(k) clearance for laser atherectomy cath
Spectranetics (NSDQ:SPNC) said yesterday it won FDA 510(k) clearance for its next-generation Turbo-Power laser atherectomy catheter for treating in-stent restenosis. The Turbo-Power laser catheter treats at the tip and debulks lesions in a single step with remote automatic rotation for accurate directional control, the Colorado Springs, Colo.-based company said. “Patients with ISR present the most […]
Perspectum Diagnostics wins FDA 510(k) for LiverMultiscan MR device
Perspectum Diagnostics said it won FDA 510(k) clearance for its LiverMultiscan MR imaging device designed to detect early liver disease. The LiverMultiScan uses quantitative MR methods and provides a highly detailed map of the whole liver for clinicians to identify regions of disease, the U.K.-based company said. Perspectum Diagnostics said the device is currently used […]
Si-Bone wins FDA 510(k) for iFuse sacroiliac joint system
Si-Bone said today it won FDA 510(k) clearance for its minimally invasive iFuse implant system designed for fusion of the sacroiliac joint. The device is cleared for treating certain disorders of the sacroiliac joint, and its indication includes a statement that treatments with the device “improved pain, patient function and quality of life at 12-months […]
Mauna Kea wins FDA 510(k) for Cellvizio
Mauna Kea (ENT:MKEA) said yesterday its Cellvizio confocal laser endomicroscopy platform won FDA 510(k) clearance for use during surgical procedures for treating multiple types of cancer. The Cellvizio device is designed for use in a variety of surgical procedures, providing real time visualization at the microscopic level, Mauna Kea said “This is a historic regulatory and business […]
Pryor Medical wins FDA 510(k) for aortic balloon catheter
Minimally-invasive vascular trauma focused Pryor Medical Devices said today it won FDA 510(k) clearance for its ER-Reboa balloon catheter designed to occlude the aorta. The ER-Reboa is San Antonio, Texas-based Pryor’s flagship product, designed to occlude large vessels using a balloon for treating traumatic injuries, specifically by the critical care and emergency medicine community. “We […]
Qualcomm’s Capsule wins FDA nod for patient monitoring system
Qualcomm (NASDAQ: QCOM) medical data management subsidiary Capsule Tech said it received FDA 510(k) clearance for its SmartLinx Vitals Plus patient monitoring system. The SmartLinx system integrates remote monitoring of patient vital signs and clinical patient documentation into a single platform as part of Capsule’s broader SmartLinx medical device information system. “Today’s patient bedside is crowded with […]
Orfit wins CE Mark, FDA 510(k) for immobilization system
Orfit said today it won FDA 510(k) clearance and CE Mark approval in the European Union for its HP Pro Solution immobilization system for use during proton therapy treatments. The system is designed for use during proton therapy procedures for the brain, head and neck, and can be used with Orfit’s Nanor immobilization masks. “Ensuring […]
Osprey rises on FDA 510(k) for DyeVert
Osprey Medical (ASX:OSP) said it received FDA 510(k) clearance for its DyeVert contrast modulation system, sending shares of the company to a nearly 2-month high. The DyeVert system automates contrast modulation during manual dye injections, self adjusting for catheter and contrast types without requiring user adjustments, Osprey said. “With FDA Clearance of our DyeVert System, […]
FDA clears CareStream’s Vue Motion on desktop, tablets
CareStream Health said yesterday it won FDA 510(k) clearance for its Vue Motion universal viewer system designed for the diagnostic viewing of electrocardiogram waveforms. The system is designed for clinicians, physicians and cardiologists to view ECG exams for patients with ST segment elevation myocardial infarction and other heart conditions and illnesses, the Rochester, N.Y.-based company […]