Blue Belt Earns CE Mark for Stride Knee System January 29, 2015 The system has been available in the U.S. since October. Read More
FDA Rejects Venaxis 510(k) for APPY1 Blood Test January 29, 2015 The test helps to identify children and young adults who are at low risk for appendicitis. Read More
Agilent’ Microarray Scanner Approved in China for In Vitro Diagnostics January 28, 2015 The system measures and compares DNA and RNA targets. Read More
FDA Approves PARI’s eRapid Nebulizer System for Cystic Fibrosis Drug Delivery January 28, 2015 The nebulizer can deliver Genetech’s Pulmozyme faster than conventional nebulizers. Read More
FDA Gives Nod to New Flexible Ablation Catheter from St. Jude January 28, 2015 The flexible catheter tip was designed to better conform to cardiac anatomy. Read More
AliveCor’s Atrial Fibrillation-Detecting Algorithm Gets CE Mark January 27, 2015 The algorithm, available via an app, will be marketed in the UK and Ireland. Read More
Bioceptive Gets FDA Nod for New Women’s Health Device January 27, 2015 The company’s suction cervical retractor replaces standard forceps. Read More
Nevro’s Spinal Cord Stimulation System Gets FDA Approvable Nod January 23, 2015 The system will receive PMA approval if the company meets certain conditions. Read More
MED-EL’s MRI-Safe Cochlear Implant Gets FDA Green Light January 23, 2015 The Synchrony will be available this spring. Read More
Medtronic Lands HDE Approval for Enterra II System January 23, 2015 The implantable system is used to treat chronic vomiting and nausea. Read More
BioStructures Cleared to Market Collagen Bone Graft January 22, 2015 The Silhouette Mineralized Collagen Scaffold graft supports bone bonding and healing. Read More
Hospira Launches Plum 360 Infusion System Following FDA Clearance January 22, 2015 The device is the latest in Hospira’s portfolio of infusion devices. Read More