From Cytosorbents opening a new U.S. manufacturing facility to DyAnsys received FDA clearance for a wearable to treat opioid withdrawals, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Cytosorbents opens new U.S. manufacturing facility CytoSorbents announced in a June 12 press release that it has opened a new […]
LivaNova wins FDA nod for Memo 4D mitral annuloplasty ring
LivaNova (NSDQ:LIVN) said today it won FDA 510(k) clearance for its Memo 4D semi-rigid mitral annuloplasty ring, and said that the device has been used in its first commercial procedure. The Memo 4D mitral annuloplasty ring is a next-generation device designed for treating patients with mitral regurgitation, and is available in sizes from 24 mm to […]
OptoVue wins FDA nod for AngioAnalytics tech
Ophthalmological-focused developer Optovue said yesterday it won FDA 510(k) clearance for its AngioAnalytics optical coherence tomography angiography blood vessel measurement tech designed to aid in managing disease that cause progressive blindness. The Fremont, Calif.-based company said it also won clearance for its 3D projection artifact removal software, designed to improve OCTA image quality to allow for accurate […]
OrthoSensor wins FDA nod for Verasense knee system
OrthoSensor said today it won FDA 510(k) clearance for its Verasense sensor-assisted device designed to be used with Zimmer Biomet‘s (NYSE:ZBH) Persona knee system during total knee replacement procedures. The newly cleared Verasense device uses advanced sensors and wireless connectivity to analyze knee balance and improve outcomes during total knee procedures using the Persona knee system, […]
FDA clears Edap’s Focal One prostate treatment
Edap (NSDQ:EDAP) said yesterday it won FDA 510(k) clearance for its Focal One device designed for prostate tissue ablation procedures. The French company’s Focal One device uses both magnetic resonance and 3D biopsy data, alongside real-time ultrasound imaging, to allow urologists to view 3D images of the prostate while using high intensity ultrasound to ablate the […]
7 medtech stories we missed this week: June 8, 2018
From Royal Philips receiving FDA clearance to NeuroPace launching its epilepsy treatment device, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Philips’s Ingenia Elition 3.0T MR scanner Royal Philips announced in a June 5 press release that it has received FDA 510(k) clearance for its Ingenia […]
Camber Spine wins FDA nod for combining existing tech
Camber Spine Technologies has won 510(k) clearance from the FDA to market its ENZA-A Titanium Anterior Lumbar Interbody Fusion (ALIF) system, which leverages two of its existing technologies. The new device borrows from the Wayne, Penn.-based company’s first-generation ENZA, which has dual-grip anchor technology, and from its Spira line, which use spiral support arches to […]
FDA clears Insulet’s Omnipod Dash insulin management system
Insulet (NSDQ:PODD) said today that the FDA granted 510(k) clearance to its Omnipod Dash insulin management system. The system wirelessly connects the company’s Personal Diabetes Manager with its tubeless, waterproof insulin pump. The PDM calculates how much insulin should be administered using blood glucose readings from the Contour Next One blood glucose meter. Altogether, the system […]
Pursuit Vascular wins expanded indication for antimicrobial device
Pursuit Vascular (Maple Grove, Minn.) today announced that it has won FDA clearance for a broader indication of its ClearGuard HD antimicrobial caps. The new indication for the caps — used as an antimicrobial device for catheter-based dialysis patients — includes reduction in the incidence of central-line associated bloodstream infection in hemodialysis patients with central venous […]
BrainCool wins FDA nod for IQool Warm temp regulation system
European medical device developer BrainCool said today it won FDA 510(k) clearance for its IQool Warm System with indications for thermal regulation to cool and rewarm adult patients. The Swedish company said the newly cleared next-gen temperature regulation system is designed for temperature management with a focus on the head and neck, thighs and torso. The system […]
Lumendi wins FDA nod for DiLumen IS endoscopic scissors
Lumendi said today it won FDA 510(k) clearance for its DiLumen IS endolumenal interventional scissors, now indicated for cutting, dissecting and cauterizing tissue within the digestive tract during endoscopic procedures. The Westport, Conn.-based company touted the sterile, single-use disposable, monopolar electrosurgical device as the fourth it’s developed, and said that it and its recently cleared DiLumen […]
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