Stryker (NYSE:SYK) said today it won FDA 510(k) clearance for its MultiGen 2 radiofrequency energy generator designed for RF ablation procedures. The newly cleared MultiGen 2 generator is designed with double the industry standard for power to achieve its target temperature faster with fewer errors and increased reliability and efficiency, the Kalamazoo, Mich.-based company said. “The […]
510(k)
DeviceTalks Q&A: Regulatory experts talk medtech policy
A panel of regulatory experts convened at DeviceTalks Minnesota this year to chat with MassDevice.com editor Sarah Faulkner. The group of regulatory experts included Danelle Miller, VP of regulatory policy & intelligence at Roche Diagnostics; Megan Brandt, VP of regulatory affairs and quality assurance at CHF Solutions (NSDQ:CHFS); and Mac McKeen, regulatory science fellow at Boston Scientific (NYSE:BSX). Faulkner: We […]
Cardiologs wins FDA 510(k) for ECG analysis platform
Cardiologs Technologies said today it won FDA 510(k) clearance for its Cardiologs ECG analysis platform designed to aid in the screening for atrial fibrillation and other arrhythmias. The platform is a cloud-based cardiac monitoring and analysis web service which uses artificial intelligence to analyze long-term ambulatory ECG monitoring recordings, the Paris-based company said. The system […]
K2M win FDA 510(k), CE Mark for Nile proximal fixation device
K2M (NSDQ:KTWO) said today it won FDA 510(k) clearance and CE Mark approval in the European Union for its Nile proximal fixation spinal system designed for proximal construct augmentation. The Nile system is designed to address complex spinal deformities and consists of bands and connectors to be used in conjunction with spinal rod constructs to attach to […]
Varian Medical wins FDA nod for Halcyon radiotherapy cancer treatment system
Varian Medical (NYSE:VAR) said today it won FDA 510(k) clearance for its Halcyon image-guided volumetric intensity modulated radiotherapy cancer treatment system. The Palo Alto, Calif.-based company said its Halcyon IMRT system features improvements that make it more comfortable for patients and streamline operator’s workflow, only requiring 9 steps from start to treatment, down from 30 steps […]
Spineology wins FDA nod for Rampart One lumbar interbody fusion system
Spinal tech developer Spineology said this week it won FDA clearance for its Rampart One anterior lumbar interbody fusion system. The St. Paul, Minn.-based company said the Rampart One is designed to minimize exposure and vascular retraction requirements associated with traditional anterior spine fusion procedure, and includes both standard and oblique interbody device footprints with integrated […]
K2M wins FDA nod for Capri 3D-printed corpectomy cage
K2M (NSDQ:KTWO) said today it won FDA 510(k) clearance for its Capri small 3D static corpectomy cage system, touing it as the 1st-to-market 3D-printed, FDA-cleared device of its kind. The newly cleared device is designed for stabilizing the thoracolumbar spine during vertebral body resections as a result of trauma or tumors, the Leesburg, Va.-based company said. […]
Philips wins FDA 510(k) for IntelliSpace Portal 9 informatics platform
Royal Philips (NYSE:PHG) said today it won FDA 510(k) clearance for its IntelliSpace Portal 9.0 clinical informatics platform and associated applications for radiology. The newly cleared platform now includes additional applications for longitudinal brain imaging and multi-modality tumor tracking, as well as lung nodule assessment, the company said. “Analytics applications optimized for clinical decision support and […]
Insulin assay from Ortho Clinical Diagnostics nabs FDA nod
Ortho Clinical Diagnostics said yesterday that its Vitros insulin assay and calibrators won 510(k) clearance from the FDA. The Raritan, N.J.-based company reported that the diabetes and pre-diabetes diagnostic test is slated to be commercially available in the 3rd quarter of this year. Get the full story at our sister site, Drug Delivery Business News.
Korea’s Wontech wins FDA nod for Picocare tattoo removal device
Korean aesthetic device company Wontech said today it won FDA 510(k) clearance for its Picocare picosecond laser device designed for tattoo removal. The Picocare is a picosecond Nd:YAG based laser designed to remove tattoos in various colors, selectively removing pigment particles to minimize skin tissue damage. “Picocare has received a lot of praise for successfully […]
7 medtech stories we missed this week: June 23, 2017
From Guardant suing Foundation Medicine to Interson receiving 510(k) clearance for ultrasound probes, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Guardant levels false advertising suit against Foundation Medicine Guardant Health announced in a June 22 press release that it has filed a lawsuit against Foundation Medicine […]