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 […]
510(k)
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 […]
Cardiovascular Systems touts OrbusNeich coronary balloon FDA nod
Cardiovascular Systems (NSDQ:CSII) said today that the FDA granted 510(k) clearance to the OrbusNeich‘s 1mm Sapphire II Pro coronary balloon. St. Paul, Minn.-based Cardiovascular Systems touted the newly cleared product as the first and only 1mm coronary balloon available in the US. “Offering the Sapphire II Pro 1.0mm coronary balloon—the smallest, FDA-cleared coronary balloon on the market—is […]
Europe’s new MDR: Is it as scary as you might think?
The European Union’s regulation of medical device appears to be increasing under the new Medical Device Regulation (MDR) going into effect, while U.S. FDA is easing off. In many ways, the E.U. and the U.S. are going in opposite directions when it comes to medical device regulation, said Michael Drues, a regulatory consultant based outside […]
7 medtech stories we missed this week: March 2, 2018
From InspireMD’s new distribution deals to Kelynium’s distribution deal with a mystery partner, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. InspireMD inks distribution deals in Greece, Caribbean InspireMD announced in a March 1 press release that it has signed exclusive distribution agreements with T-Vascular IKE Medical Supplies […]
Axiostat is India’s first entry on the U.S. hemostat market
Indian medical device maker Axio Biosolutions became the first Indian company with a wound care product cleared by the FDA, according to a press release from the company posted yesterday. The federal watchdog granted 510(k) clearance to Axio’s Axiostat chitosan hemostatic dressing, which is cleared as an over-the-counter product to stop external bleeding. The dressing […]
FDA clears Access Vascular’s HydroPICC catheter
Access Vascular said today that its HydroPICC catheter has won 510(k) clearance from the FDA. The peripherally-inserted central catheter is designed with Access Vascular’s proprietary bulk-hydrophilic material, which the company touted as “the ideal material for long-term implantable vascular access devices.” “The FDA clearance of the HydroPICC catheter is an important milestone for Access Vascular […]
Corindus wins FDA 510(k) PVI indication for CorPath GRX
Corindus Vascular Robotics (OTC:CVRS) said today it won FDA 510(k) clearance for its CorPath GRX system, now indicated for use in peripheral vascular interventions. The Waltham, Mass.-based company touts the CorPath system as the first and only FDA-cleared robotic device cleared for both percutaneous coronary interventions and peripheral vascular interventions. “My colleagues and I have seen first-hand […]
Electrocore wins FDA nod for GammaCore acute migraine treatment indication
Electrocore said today it won FDA 510(k) clearance for its GammaCore device, expanding indications to include the acute treatment of pain associated with migraines in adult patients. The Basking Ridge, N.J.-based company’s GammaCore device is a non-invasive, hand-held vagus nerve stimulation device designed for the reduction of pain. The system is intended to be applied to […]