Sky Medical Technology said yesterday that it received FDA 510(k) clearance for its Geko electrostimulation device for preventing venous thrombosis. The Daresbury, England-based company’s Geko device is designed to stimulate the calf muscles to increase blood flow in the deep veins of the calf, preventing venous thrombosis in non-surgical patients at risk for venous thromboembolism. […]
Think Surgical wins FDA clearance for TSolution One robot-assisted total knee device
Think Surgical said yesterday that it won 510(k) clearance from the FDA for its TSolution One robot-assisted total knee replacement device. The TSolution One system uses Fremont, Calif.-based Think Surgical’s 3D pre-surgical planning workstation and computer-assisted Active robot. It won CE Mark approval in the European Union for total knees in December 2017. “We are […]
Dexcom wins FDA clearance for G6 Pro CGM
Dexcom (NSDQ:DXCM) said today that it won 510(k) clearance from the FDA for its G6 Pro continuous glucose Monitor for diabetic patients ages ages two years and up. The San Diego-based company said the G6 Pro is designed to measure glucose data in real time over 10 days in either “blinded” or “unblinded mode,” depending on […]
FDA clears new drill for Neocis Yomi robot-assisted dental surgery device
Neocis said yesterday that it received FDA 510(k) clearance for a new robot-assisted drill to be used with its Yomi dental surgery system. The Miami-based company said the clearance will lead to an easier workflow and provide enhancements to the surgeons’ drilling experience. Yomi won FDA clearance in March 2017 for dental implant procedures, becoming […]
FDA IDs first devices for expedited 510(k) clearance review
The FDA has released draft guidances for the first four types of devices it will evaluate under its expedited Safety and Performance-Based Pathway to 510(k) clearance. They are: Conventional foley catheters. Cutaneous electrodes for reporting purposes. Orthopedic non-spinal metallic bone screws and washers. Spinal plating systems. Developers of these types of devices will no longer […]
FDA clarifies refuse-to-accept policy for 510(k) applications
The FDA has updated its final guidance on its “refuse-to-accept” policy for 510(k) submissions. The guidance includes detailed checklists for devices that applicants want to be considered for traditional, abbreviated or special 510(k) clearance. The agency said it will respond to applications within 15 calendar days from submission and will notify applicants if information is […]
Wallaby Medical wins FDA nod, CE Mark for Avenir neurovascular coil
Wallaby Medical announced yesterday that it won FDA 510(k) clearance and CE Mark approval in the European Union for its Avenir coil system for intracranial aneurysms and other neurovascular abnormalities. The Laguna Hills, Calif.-based company also said it inked an exclusive distribution deal with Phenox for the commercialization of Avenir in the U.S. and Europe. […]
FDA clears GE Healthcare X-ray algorithms
GE Healthcare said today that it has received FDA 510(k) clearance for its AI algorithms embedded in a mobile X-ray device. The mobile X-ray device was built in collaboration with the University of California San Francisco using GE Healthcare’s Edison platform. The AI algorithms, which the company calls Critical Care Suite, are designed to reduce […]
Masimo wins expanded clearance for O3 oximetry device
Masimo (NSDQ:MASI) said today that its O3 regional oximetry device has been cleared for three additional indices — delta cHb, delta HHb, and delta O2Hb. These indices provide clinicians with greater visibility into changes in the underlying oxyhemoglobin and deoxyhemoglobin components used to calculate cerebral oxygen saturation, or rSO2, the Irvine, Calif.-based company said. The […]
Zimmer Biomet wins FDA clearance for Persona Revision Knee System
Zimmer Biomet (NYSE:ZBH) today announced it received FDA 510(k) clearance for its Persona Revision Knee System. The Warsaw, Ind.-based company plans to commercially launch the knee system in the U.S. over the next few weeks. Zimmer Biomet’s Persona knee system is designed to match a patient’s anatomy to offer a personalized fit in knee replacement procedures. […]
FDA clears Arthrosurface’s Boss toe implant
Arthrosurface said yesterday that it received FDA 510(k) clearance for its Boss toe fixation system, which the company believes will be commercially available at the end of the month. The Franklin, Mass.-based company said the Boss system is designed to improve stabilization in the first metatarsal with a distal bone void and to provide patients […]
- 1
- 2
- 3
- …
- 67
- Next Page »
MassDevice Network
@MassDevice
LinkedIn
YouTube