FDA Clears b-One Ortho Total Hip System September 21, 2018 The system will have a limited U.S. launch in the first half of 2019. Read More
Inui Health’s Smartphone Device for Urine Testing Gains Approval September 20, 2018 The device allows users to instantly see their test results. Read More
Cepheid Fingerstick HCV Test Gains CE Mark September 20, 2018 It can detect a wide range of virus genotypes in approximately one hour. Read More
Korea’s Hironic Laser Acne Device Approved September 20, 2018 The device can treat skin conditions such as acne and acne scars, and encourage skin rejuvenation. Read More
FDA Clears Angiography Module for Spectralis Imaging Devices September 19, 2018 The module allows physicians to gain better insight into ocular abnormalities. Read More
Contego Cleared for Carotid PTA Balloon System September 19, 2018 Its embolic protection filter can be adjusted in vivo for differing patient anatomies. Read More
SpineVision’s Spinal Deformity Correction System Gains CE Mark September 18, 2018 The system is used to treat spinal deformities that cause severe pain, neurological problems and spine curvature greater than 50 degrees. Read More
FDA Approves Olympus’ Biopsy Needle September 18, 2018 The device allows for faster pathological diagnosis of tissue collected during surgery. Read More
Staar Surgical’s Implantable Collamer Lens Cleared by FDA September 18, 2018 Nearsighted patients between 21 and 45 years of age are the ideal candidates. Read More
SpineVision Receives FDA Clearance, CE Mark for Interbody Cage September 18, 2018 The cage’s titanium surface promotes connection between bone and cage. Read More
Philips Gains CE Mark for Beltless Maternal Monitoring Device September 17, 2018 The device features a single patch and reusable pod that are placed on the mother’s belly to capture critical parameters. Read More
FDA Approves Device for Treatment of Acute Coronary Artery Perforations September 17, 2018 The agency granted the approval through the humanitarian device exemption pathway. Read More