Avita Scores FDA EAP Designation for ReCell December 14, 2015 The device enables clinicians to rapidly regenerate healthy skin. Read More
EDAP’s Focal One Ultrasound Device Wins Russian Approval December 11, 2015 The robot-assisted device is designed for the focal therapy of prostate cancer. Read More
Medtronic Scores Additional Approvals for Infuse Bone Graft December 11, 2015 The product can now be marketed for use with certain spine implants. Read More
FDA Accepts Ocular Therapeutix’s NDA for Dextenza Drug-Device Combo December 9, 2015 The combination is designed for the treatment of ocular pain after ophthalmic surgery. Read More
Stimwave Wins FDA Clearance for Spinal Cord Stimulation System December 9, 2015 The wireless, micro-technology neuromodulation system features eight-electrodes placed near surrounding nerves. Read More
Dignitana Receives FDA Clearance to Market DigniCap Cooling System December 9, 2015 The system is a cooling cap to reduce hair loss in female breast cancer patients being treated with chemotherapy. Read More
Medtronic Receives Approval for Full-Body MRI Deep Brain Stimulation Neurostimulator December 9, 2015 The approved full body MRI and higher power limits enable improved image quality and faster scan times. Read More
FDA Grants 510(k) Clearance to Cepheid for Xpert Flu+RSV Test December 8, 2015 The test is approved for use on the GeneXpert Xpress System. Read More
FDA Clears RevMedX’s Wound Dressing for Civilians December 8, 2015 The dressing was previously only approved for military use. Read More
Allurion Technologies Wins CE Mark for Elipse Gastric Balloon December 8, 2015 The swallowable balloon fills the stomach and assists patients in feeling full and eating less. Read More
FDA Grants 510(k) Clearance to Qfix for Encompass SRS Immobilization System December 7, 2015 The device is cleared for sub-millimeter immobilization to treat multiple lesions with a single isocenter. Read More
ExThera Medical to Start Clinical Trials of Seraph December 7, 2015 The device will treat dialysis patients with Staphylococcus aureus and MRSA bloodstream infections. Read More