NEC Display Solutions of America, a provider of commercial LCD display and projector solutions, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its MultiSync MD210C2 medical-grade monitor. The 21.3-inch, ...
Tags: NEC Display Solutions, Medicine
The US Food and Drug Administration (FDA) has given 510(k) clearance for the marketing of Iceland-based Kerecis' proprietary fish-skin, omega-3, tissue-regeneration product for treating chronic wounds in the US. The product known as ...
Tags: Kerecis, Fish-Skin treatment, chronic wounds, FDA
Vycor Medical (Vycor), a medical device company with a suite of FDA cleared products, announced the first release of its new "direct to the patient" saccadic eye training program to be marketed as NeuroEyeCoach. The company further ...
Tags: Vycor, NeuroEyeCoach, saccadic, release
US-based Fujifilm SonoSite has received 510(k) clearance from the US Food and Drug Administration (FDA) for its X-Porte ultrasound kiosk, a new generation of point-of-care ultrasound. This integrates advanced signal processing for ...
US-based EndoShape has received 510(k) marketing clearance from the Food and Drug Administration (FDA) for its Medusa vascular plug, designed for arterial and venous embolization in the peripheral vasculature. The FDA cleared the ...
Tags: EndoShape, clearance, FDA, Medusa vascular plug
NLT SPINE, a manufacturer of minimally invasive spine surgery products, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its generation 2.0 PROW FUSION and eSPIN lumbar interbody fusion products, which are ...
Tags: Espin Products, Medicine
Germany-based Raumedic has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its NEUROVENT-PTO device, a multimodal catheter for monitoring brain tissue oxygen partial pressure, intracranial pressure (ICP), and ...
Tags: Raumedic, Neurovent-PTO Device
NanoString Technologies, a provider of life science tools for translational research and molecular diagnostic products, has obtained the US Food and Drug Administration (FDA) 510(k) clearance for its Prosigna breast cancer prognostic gene ...
ICU Medical has received the US Food and Drug Administration (FDA) 510(k) clearance for its ChemoLock needlefree closed system transfer device (CSTD). The CSTD is approved for pharmacy applications (product code ONB), as well as patient ...
Tags: ICU Medical, FDA Approval
Medical devices developer Tissue Regeneration Systems has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its new Cranial Bone Void Filler product designed for repair of neurosurgical burr holes. The new ...
Boston Scientific has received the US Food and Drug Administration (FDA) approval for its IntellaTip MiFi XP catheter and 510(k) clearance for its Zurpaz 8.5F steerable sheath. The IntellaTip MiFi XP is a high resolution catheter that ...
Tags: Cardiac Devices, Drug
Denmark-based health care company Novo Nordisk has won US FDA 510(k) clearance for the insulin injection device, NovoPen Echo, combining half-unit dosing with a memory function to help patients manage their diabetes. Available to patients ...
Tags: Insulin Injection, Medicine
Clearance, an AngioDynamics company, has received the US Food and Drug Administration (FDA) 510(k) clearance for its BioFlo Port with Endexo technology, Clearance to the accumulation of platelets and thrombus. The BioFlo Port is a ...
Verizon, a US- based broadband and telecommunications company, has received the US Food and Drug Administration (FDA) 510(k) clearance for a cloud-based, remote patient-monitoring medical device called Converged Health Management. ...
Tags: Verizon, Patient-Monitoring Device
Quidel has won FDA 510(k) clearance for its Sofia hCG fluorescent immunoassay (FIA) for use on the Sofia Analyzer to detect elevated levels of human chorionic gonadotropin (hCG), an early indicator of pregnancy. The Sofia Analyzer and ...
Tags: Quidel, Fluorescent Immunoassay