From Medizone’s evaluation deal to Advantis Medical Imaging getting CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Medizone inks AsepticSure evaluation deal with commercial cleaning products maker Innovasource Medizone announced in a March 22 press release that it has signed a product evaluation agreement with […]
510(k)
MIS device startup Human Xtensions wins FDA nod for HandX device
Minimally invasive surgery device start up Human Xtensions said today it won FDA 510(k) clearance for its HandX device. The HandX device is a light-weight, handheld device designed to translate a surgeon’s natural hand motions into more complex movements inside the patient, the Israel-based company said. The device is part of a series of electromechanically-simplified […]
UroViu wins FDA nod for disposable diagnostic cytoscope
UroViu said yesterday it won FDA 510(k) clearance for its Uro-V single-use diagnostic cytoscopic system designed to visually assess the urethra and urinary bladder in instances of suspected pathology or dysfunction. The Bellevue, Wash.-based company’s newly cleared Uro-V device is a self-contained single-use diagnostic cytoscope designed for female diagnostic cytoscopy. The system is designed to […]
7 medtech stories we missed this week: March 16, 2018
From Intricon expanding its manufacturing space to Arthrex signing a global distribution deal, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Intricon expands medical footprint Intricon announced in a March 13 press release that it has signed a 5-year lease that will secure 30,000 sq. ft of manufacturing […]
Philips wins FDA nod for ProxiDiagnost N90 radiography-fluoroscopy system
Royal Philips (NYSE:PHG) said today it won FDA 510(k) clearance for its ProxiDiagnost N90 digital radiography-fluoroscopy system. The newly cleared system is designed to perform both nearby fluoroscopy and digital X-rays to support more efficient room utilization and improve workflows, the Amsterdam-based company said. Philips said that the ProxiDiagnost N90 is designed to provide enhanced, high-quality images […]
FDA clears DxNow’s sperm separation device
Medical device developer DxNow said today it won FDA 510(k) clearance for its ZyMōt ICSI and ZyMōt multi sperm separation devices designed for use in assisted reproductive technology procedures. The newly cleared devices from the Gaithersburg, Md.-based company are designed for preparing motile sperm from semen for use in the treatment of infertile couples by […]
TSO3 wins expanded FDA nod for Sterizone VP4 sterilizer
TSO3 (TSE:TOS) said late yesterday it won expanded FDA 510(k) clearance for its Sterizone VP4 sterilizer, clearing a new feature of the system that the company claims can improve installation of the device and reduce oxygen supply requirements. The company’s Sterizone VP4 is a low-temperature sterilization system which uses dual-sterilants of vaporized hydrogen peroxide and ozone for […]
CereMetrix wins FDA nod for neuroimaging analytics platform
CereHealth subsidiary CereMetrix said yesterday it won FDA 510(k) clearance for its CereMetrix Silver neuroimaging analytics and quantification platform designed to detect, quantify and analyze brain function. The CereMetrix Silver image viewer is designed to analyze brain images from positron emission tomography, single-photon emission computerized tomography, magnetic resonance imaging and computed tomography scans, the Denver-based […]
Panther Orthopedics wins FDA nod for Puma flexible fixation device
Panther Orthopedics said today it won FDA 510(k) clearance for its Puma implantable flexible fixation device. The newly cleared device from the San Jose, Calif.-based company is now indicated for syndesmosis fixation, hallux valgus reconstruction and tarsometatarsal fixation. The system allows for a 2.8 mm pilot hole to preserve bone tissue and comes in a […]
Orthofix wins FDA, CE Mark for next-gen PhysioStim bone-growth stimulator
Orthofix (NSDQ:OFIX) said today it won FDA approval in the US and CE Mark approval in the European Union for its next-gen PhysioStim bone growth stimulator devices. The device is designed as a non-surgical treatment option for patients with a nonunion fracture in an extremity with no visible signs of healing, using pulsed electromagnetic field signals to […]
Stryker wins FDA nod for Tritanium TL fusion cage
Stryker (NYSE:SYK) said today it won FDA 510(k) clearance for its 3D-printed Tritanium TL curved posterior lumbar cage designed for use in lumbar fixation procedures. The newly cleared cage is a hollow implant consisting of solid and porous structures built using the company’s AMagine proprietary additive manufacturing techniques, the Kalamazoo, Mich.-based company said. The system consists of […]