Iradimed Corporation Scores FDA Clearance for MRI Compatible IV Infusion Pump December 21, 2016 The compatible device delivers fluids during MRI procedures. Read More
FDA Grants Marketing Clearance to Cepheid’s Next-Generation Test for MRSA Colonization December 21, 2016 Xpert MRSA NxG is a molecular test that delivers results in about an hour. Read More
FDA and Health Canada Approve OneTouch Vibe Plus Insulin Pump December 20, 2016 The device is an insulin pump and a glucose monitoring system. Read More
Anika Therapeutics Scores CE Mark for Tendon-Injury Treatment December 20, 2016 Orthovisc-T is administered via injection into the site of injury. Read More
Foundation Medicine Garners FDA Approval for Companion Device for Rubraca December 20, 2016 The device is a tissue-based, genomic assay. Read More
FDA Grants Marketing Clearance to SalutarisMD’s RBS System December 20, 2016 The SMD-Sr90-DA RBS device is indicated for episcleral brachytherapy. Read More
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