Camber Spine Technologies said today it won FDA 510(k) clearance from the FDA for its Spira open matrix anterior lumbar interbody fusion device. The Wayne, Penn.-based company said the Spira device consists of spiral support arches designed to increase fusion rates and stabilization. The company said the spiral support arches also decrease subsidence by load […]
510(k)
Stryker wins FDA nod for Serrato pedicle screws
Stryker (NYSE:SYK) said today it won FDA 510(k) clearance for its Serrato pedicle screw, designed for use in the non-cervical spine as part of its Xia 3 spinal system. The Serrato pedicle screws feature enhanced serrated cutting flutes, a dual-thread pattern with increased leads for rapid insertion and a buttress thread locking mechanism designed to reduce […]
ImpediMed shares rise on FDA nod for Sozo system
Australian medtech developer ImpediMed saw shares rise as much as 9.7% after it said it won FDA 510(k) clearance for its Sozo bioimpedance spectroscopy platform. The Sozo system is designed to non-invasively measure and monitor fluid status and body composition using the company’s L-Dex lateral lymphedema assessment system. “We are delighted to receive this FDA clearance […]
7 medtech stories we missed this week: August 11, 2017
From Xtant Medical’s 510(k) extension to Varian Medical’s distribution deal, here are seven medtech stories we missed this week but thought were still worth a mention. 1. FDA extends Xtant Medical’s 510(k) for Calix C spinal implant Xtant Medical announced in an Aug. 9 press release that the FDA has cleared its product line extensions […]
Renovis wins FDA nod for Tesera lumbar interbody fusion systems
Renovis Surgical Technologies said today it won FDA 510(k) clearance for its Tesera lumbar porous titanium interbody fusion systems. The Redlands, Calif.-based company said its newly cleared Tesera devices feature implants designed for direct posterior or transforaminal approaches, and includes straight and curved options in multiple heights, widths and lengths. The Tesera devices are produced […]
Mauna Kea wins FDA nod for CelioFlex Cellvizio miniprobes
Mauna Kea (ENT:MKEA) said today it won FDA 510(k) clearance for its CelioFlex UHD confocal miniprobes designed for use with its Cellvizio device in robotic-assisted surgery. The CelioFlex UHD probes are designed to provide visualization of body cavities, organs and canals during endoscopic, laparoscopic and robotic-assisted procedures, the Paris-based company said. “This new FDA clearance is […]
GE Healthcare wins FDA 510(k) for Signa Premier MRI
GE Healthcare (NYSE:GE) said today it won FDA 510(k) clearance for its Signa Premier wide bore 3.0 Tesla magnetic resonance imaging system. The company said the Signa Premier was the result of a 4-year collaboration with the National Football League and research institutions worldwide and integrated technology to aid in the detection of biomarkers for the potential […]
EDAP submits FDA 510(k) for Ablatherm Fusion HIFU device
Edap (NSDQ:EDAP) said this week it submitted an FDA 510(k) application for its next-gen Ablaterm Fusion device. The Lyon, France-based company’s next-generation Ablatherm Fusion is a robotic high-intensity focused ultrasound device designed to allow urologists to import pre-treatment diagnostic info, including MRI images and 3D biopsy maps, and merge them with live ultrasound images during prostate […]
Accuray wins FDA nod for iDMS data management system
Accuray (NSDQ:ARAY) said today it won FDA 510(k) clearance for its iDMS data management system designed for sharing data between the company’s treatment delivery platforms. The Sunnyvale, Calif.-based company said the iDMS system is designed to integrate data from its technology platforms, including the Radixact, TomoTherapy and CyberKnife systems, as well as the company’s Accuray Precision […]
Haemonetics wins FDA 510(k) for NexSys PCS plasmapheresis system
Haemonetics (NYSE:HAE) said today it won FDA 510(k) clearance for its NexSys PCS plasmapheresis system designed for collecting blood plasma. The NexSys PCS includes bi-directional connectivity to the Braintree, Mass.-based company’s NexLynk DMS donor management system, and allows for automated collection procedure programming and automated end of procedure documentation. “NexSys PCS is designed to increase productivity […]
7 medtech stories we missed this week: July 28, 2017
From Accenture’s AI-powered app to help the visually impaired to Rayovac getting clearance from Health Canada, here are seven medtech stories we missed this week but still thought were worth mentioning. 1. Accenture touts AI-powered app for visually impaired Accenture announced in a July 28 press release that it has developed an artificial intelligence–powered way to […]