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, CMS Parallel Review Program To Be Made Permanent December 21, 2016 The agencies learned two primary lessons from the pilot program. Read More
Multi-Part Device Labeling, Other Issues Dog UDI Rule December 21, 2016 There has been some confusion about who is actually responsible for UDI. 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
$11.5 Million Raised for EU Device Startups December 19, 2016 MD Start II will continue to incept, finance, and develop startup companies. 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
Circulatory Technology Hit With Form 483 for Improper Reporting, Evaluations December 19, 2016 The company failed to submit an MDR report within 30 days of becoming aware of a device that had malfunctioned. Read More
FDA Announces Unchanged Final Guidance for IDEs for Neurological Diseases December 19, 2016 The guidance aims to help weigh the risks of medical devices for neurological conditions. Read More