FDA Clears Innovasis’ Lateral Interbody Fusion Device June 27, 2019 The company said it expects to launch the product in the United States in the third quarter of 2019. Read More
European Commission Approves Opioid Dependence Implant June 27, 2019 The subdermal implant delivers buprenorphine at a continuous rate for six months. Read More
NeuMoDx Launches HBV and HCV Assays in Europe June 26, 2019 The reagents do not need to be refrigerated. Read More
Viveve Earns FDA Clearance for Collagen Builder June 26, 2019 The system uses a small probe that emits cryogen-cooling and radio waves to spur the production of new collagen. Read More
FDA Clears Allergan’s Magnetic Muscle Stimulator June 25, 2019 The CoolTone technology is intended for use by plastic surgeons. Read More
Lucid Diagnostics Earns 510(K) Clearance for Esophageal Cell Collector June 25, 2019 The device is an alternative to sponge-on-a-string devices used to gather esophageal cells. Read More
Avioq’s HIV Assay for Reactive Samples Gains CE Mark June 25, 2019 The test confirms the presence of HIV-1 or HIV-2 antibodies in specimens that were repeatedly reactive during diagnostic screening. Read More
Quidel Earns 510(k) Clearance for Triage TOX Drug Screen June 21, 2019 The company is optimistic that the assay will boost its Triage sales and create further growth for its MeterPro instruments. Read More
RYAH Medtech Gains CE Mark for Dry Herb Vaporizer June 21, 2019 The device is able to stay clean by using RYAH cartridges that prevent material from coming into direct contact with the heating chamber. Read More
J&J Subsidiary Gains FDA Clearance for Surgicel Applicators June 20, 2019 Surgicel is used to control hemorrhage when other techniques don’t work. Read More
Philips Earns Premarket Approval for Defibrillators June 20, 2019 The HeartStart Home defibrillator is the only AED specifically indicated for use at home. Read More
Gel-E Nabs FDA’s Breakthrough Designation for Bleeding Control Foam June 20, 2019 The device lowers the risk of limb loss or death. Read More