EU Grants Marketing Approval to HiberGene December 19, 2016 The test can detect C. difficile in stool samples within an hour. Read More
HAS Grants Reimbursement to Theraclion December 16, 2016 The study has been approved to commence in 12 hospitals across France. Read More
FDA Approves Labeling Changes for Essure December 15, 2016 The complaint alleged that Bayer altered the medical records of clinical trial participants. Read More
FDA Awards Lumendi Marketing Clearance for DiLumen December 13, 2016 The device is a colonoscope accessory to aid in lesion treatment. Read More
Provision Healthcare Obtains FDA Clearance for SC360 Therapy System December 9, 2016 The device is a patient-bed scanning radiation system that treats cancer patients. Read More
FDA Expands Clearances for AMI’s TubeClear System December 9, 2016 The device is also cleared to clean clogged feeding tubes at a patient's bedside. Read More
Gordian Surgical Gets FDA Clearance for TroClose1200 December 9, 2016 The device opens and closes surgical procedures. Read More
EU Grants CE Mark to St. Jude Medical’s Full Body MR Conditional Labeling for the Proclaim Elite System December 8, 2016 The nerve-stimulating therapy device reduces chronic pain. Read More
Abiomed Receives Expanded FDA Approval for Heart Pump December 7, 2016 The heart pump stabilizes the heart by unloading the left ventricle. Read More
Medtronic Wins CE Mark Expansion for Endurant II/IIs December 7, 2016 The expansion includes a method used for implantation called ChEVAR. Read More
Invendo Medical Nabs CE Mark for Invendoscope SC200 December 6, 2016 The device is for single-use only. Read More
Voluntis Scores FDA Clearance and CE Mark for Insulia December 6, 2016 The company has developed an app that operates as a medical device to help monitor glucose levels. Read More