LED Medical Diagnostics (TSX:LMD) said today its subsidiary LED Dental won FDA 510(k) clearance for its Tuxedo digital intraoral radiography system. The Atlanta, Ga.-based company’s Tuxedo imaging platform consists of an intraoral sensor and image management software, and is designed as a digital replacement for analog dental film. “We’re excited about bringing our own digital intraoral […]
510(k)
Xtant Medical wins FDA nod for spinal laminoplasty system
Xtant Medical said today its X-Spine Systems subsidiary won FDA 510(k) clearance for its Xspan laminoplasty fixation system designed for use in the lower cervical and upper thoracic spine. Spinal laminoplasty is a surgical procedure designed to remove pressure from the spinal cord through the restructuring of the lamina through a window or opening to allow […]
Tenex Health wins 510(k) for TX2 MicroTip
Tenex Health said today it won FDA 510(k) clearance for its TX2 MicroTip designed to treat tendinosis of the shoulder and hip. The Lake Forest, Calif.-based company said that the new TX2 MicroTip is 2 inches longer than the previous TX1 incarnation, allowing for easier access to both the shoulder and hip. “The TX System […]
Fortimedix seeks FDA clearance for single-port surgery device
Netherlands-based medical device company Fortimedix Surgical said today it submitted an application for FDA 510(k) clearance for its FMX314 single-port surgery device. The company said its FMX314 is the “world’s 1st” single-port surgery solution compatible with standard 15mm laproscopic trocar. The device “closely mimicks” conventional multi-port laparoscopy to allow surgeons to comfortably perform procedural steps, […]
ACell wins 510(k) for modified MicroMatrix
ACell said today it won additional FDA 510(k) clearance for its MicroMatrix device allowing the use of the device in conjunction with Cytal wound matrix or Cytal burn matrix devices. The MicroMatrix is a micronized particulate form of ACell’s Urinary Bladder Matrix designed to cover the wound bed in normal or irregular wounds, the Columbia, […]
InfoBionic wins 510(k) for next-gen MoMe Kardia cardiac monitor
Digital health startup InfoBionic said today it won FDA 510(k) clearance for its MoMe Kardia wireless cardiac remote monitoring system designed to aid in the diagnosis of cardiac arrhythmias. The next-generation MoMe Kardia is a 3-in-1 single piece device that acquires and stores ECG and motion data and transmits them through the company’s cloud-based MoMe […]
CardiacAssist wins 510(k) for TandemLung
CardiacAssist said today it won FDA 510(k) clearance for its TandemLung oxygenator designed to operate as an artificial lung by infusing oxygen and removing carbon dioxide from the blood. The Pittsburgh, Penn.-based company said the TandemLung is designed so it can be used along with its TandemHeart blood pump, and combined the devices “represent a leap […]
Life Spine wins FDA 510(k) for Prolift interbody fusion system
Life Spine said Tuesday it won FDA 510(k) for its Prolift expandable interbody fusion system. The Hunley, Ill.-based company’s Prolift system is all titanium and designed to restore disk height, in-situ, for minimally invasive posterior lumbar interbody fusion procedures, transforaminal lumbar interbody fusion procedures and oblique approaches, the company said. “The Prolift Expandable Interbody System […]
Parker Hannifin wins FDA nod for Indego exoskeleton
Parker Hannifin Corp said today it won FDA clearance for its Indego exosekelton designed to allow patients with spinal cord injuries to stand and walk for both clinical and personal use. The Cleveland, Ohio-based company said the approval came based on the largest exoskeleton clinical trial conducted to date in the U.S. The Indego is […]
Aurora Health Care touts role in clearance of cardiac mapping system
Aurora Health Care Systems today touted the FDA Clearance of APN Health‘s Navik 3D Cardiac mapping system, originally developed by Aurora Health cardiac electrophysiologist Dr. Jasbir Sra at Aurora St. Luke’s Medical Center and the Aurora Research Institute. The system from Pleasanton, Calif.-based APN Health is designed to give operating electrophysiologists or cardiologists real-time 3D […]
Visunex Medical wins FDA nod for infant visual imaging system
Fremont, Calif-based ophthalmic information system developer Visunex Medical said it won FDA 510(k) clearance for its PanoCam Pro Wide-field Imaging System designed for imaging newborn infants. The PanoCam Pro is a wireless imaging system deisgned to help detect external, anterior and posterior segment vision disorders in newborns, which the company says may have long term […]