FDA Clears Siemens Healthineers’ Magnetom Vida 3T MRI System June 16, 2017 The scanner is equipped with BioMatrix technology. Read More
FDA Broadens Rules on Humanitarian Device Exemptions to Reflect Cures Act June 15, 2017 Makers of humanitarian use devices may apply for an exemption from the effectiveness requirement. Read More
Skyline Medical Acquires CE Mark for the Streamway System June 15, 2017 The device is an automated, direct-to-drain fluid disposal system. Read More
OBP Medical Gains Sure-Scope Regulatory Approval in Australia June 15, 2017 Sure-Scope is a disposable, one-piece laryngoscope with integrated LED light source. Read More
Hologic Receives Expanded FDA Clearance for Cynosure's SculpSure June 15, 2017 SculpSure utilizes a selective wavelength laser that targets fat cells under the skin. Read More
10 FDA Answers on ‘Driving a Culture of Quality for Devicemakers’ June 14, 2017 CFQ program and its influence on quality for device manufacturers. Read More
FDA Will Issue Tougher Validation Requirements for Reusable Devices June 14, 2017 The CDC linked cases of multi-drug resistant bacteria to duodenoscopes in 2013. Read More
FDA Grants Clearance to QT Ultrasound for Breast Imaging Device June 14, 2017 The breast scanner is not intended as a replacement for screening mammography. Read More
FDA Clears Interson’s Ultrasound Array Probes June 14, 2017 Interson provides a portable ultrasound device. Read More
Biocartis Wins CE Mark for IVD Test for Lung Cancer June 13, 2017 The test allows the detection of 51 EGFR mutations directly from one slice of FFPE tissue. Read More
SI-Bone, Inc. Gains FDA Clearance of the iFuse-3D Implant June 13, 2017 The device has a fenestrated design and enhanced porous surface that resembles the trabecular structure of cancellous bone. Read More
Techlab Wins FDA Clearance for E. Histolytica Quik Chek Device June 13, 2017 The assay specifically detects pathogenic E. histolytica. Read More