Canadian medical device company ClaroNav said yesterday it won FDA 510(k) clearance for its NaviENT surgical navigation system designed for endoscopic sinus surgery and skull base surgery, with plans to launch in the coming months. The NaviENT is designed as an image-guided surgical navigation system to help otolaryngology-specific surgeons identify anatomic structures in transnasal interventions […]
510(k)
FDA details possible regulatory paths for Strata Sciences Optimal Dosing Tech
Strata Skin Sciences (NSDQ:SSKN) said this week it received a response letter from the FDA concerning possible 510(k) clearance paths for its Optimal Dosing Technology initially designed for treating psoriasis, vitiligo and other skin conditions. The Horsham, Penn.-based said the federal watchdog proposed 2 alternative paths, the 1st of which would require a clinical trial to […]
GE Healthcare wins FDA nod for mammography system with patient controlled compression
GE Healthcare (NYSE:GE) said yesterday it won FDA 510(k) clearance for its Senographe Pristina Dueta, which it claims is the 1st patient-assisted mammography device that allows women to control their own compression during the examination. With the system, the woman undergoing the exam can control the application of compression on their breasts to minimize perceived pain […]
NuVasive wins FDA nod for redesigned Magec system
NuVasive Inc. (NSDQ:NUVA) said today it won FDA 510(k) clearance for its redesigned Magec magnetically controlled growth modulation system. The San Diego, Calif.-based company’s Magec system uses magnetic technology and adjustable growth rods to treat early-onset scoliosis, and features the company’s Reline small stature system. The Reline small stature platform is a pediatric deformity fixation system which […]
Janssen’s respiratory panel wins 510(k) clearance
Johnson & Johnson (NYSE:JNJ) subsidiary Janssen Diagnostics said today that it won 510(k) clearance from the FDA for its Idylla respiratory panel. The diagnostic test, developed in partnership with Biocartis Group, helps physicians identify viral respiratory infections, including infection from respiratory syncytial virus and influenza virus. Get the full story at our sister site, Drug Delivery […]
Adherium wins 510(k) clearance for smart inhaler monitoring device
Adherium Ltd. (ASK:ADR) said today that it won 510(k) approval from the FDA for its inhaler monitoring device, SmartTouch for Symbicort. The device was cleared for use with AstraZeneca‘s (NYSE:AZN) Symbicort aerosol inhaler. The Melbourne, Australia-based company’s product installs directly onto a patient’s inhaler to monitor and boost medication adherence. Get the full story at our sister […]
CSA Medical wins another FDA expansion for TruFreeze cryotherapy
Endoscopic cryo-ablation company CSA Medical said today it won expanded FDA 510(k) clearance for its TruFreeze spray cryotherapy system, now cleared for use on patients with Barrett’s esophagus with low grade dysplasia. With the clearance, the device is now approved for both low and high grade dysplasia as well as malignancies, the Boston-based company said. “Over the […]
Dextera Surgical wins expanded FDA nod for MicroCutter 5/80 stapler
Dextera Surgical (NSDQ:DXTR) said today it won expanded FDA 510(k) clearance for its MicroCutter 5/80 stapler and associated reloads, now cleared for open solid organ parenchymal dissection techniques. The new clearance covers use on organs including the liver, kidney, pancreas and spleen, the Redwood City, Calif.-based company said. “The small size and large degree of articulation […]
Smiths Medical wins 510(k) approval for wireless ambulatory infusion pump
Smiths Medical said yesterday that it won 510(k) clearance from the FDA for its CADD-Solis wireless ambulatory infusion pump. The device can connect wirelessly with Smiths’ PharmGuard Server infusion management software, enabling clinicians to deploy updates and drug libraries to all pumps simultaneously, as well as remotely manage device performance and monitor drug dosing. Get the […]
FDA clears Danaher’s Leica Microsystem’s FL560 cerebrovascular fluorescence microscope filter
Danaher‘s (NYSE:DHR) Leica Microsystems said yesterday it won FDA 510(k) clearance for its FL560 fluorescence microscope filter designed for visualizing cerebrovascular blood flow when used in conjunction with dye fluorescein. The filter is designed to be integrated into a M530 OH6 neurosurgical microscope to provide real-time, high-contrast visualization of cerebral anatomy in native color and […]
FDA approves Malin’s Hourglass peripheral embolization plug
Irish life sciences company Malin Corp said today it won FDA 510(k) clearance for its Hourglass peripheral embolization plug. The company said the Hourglass plug is designed to be deployed over-the-wire for peripheral embolization procedures, and can provide immediate occlusion with a single integrated device. “This is the 1st integrated, over-the-wire device designed for peripheral […]