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
U.K. Issues Medical Device Alert for Smith & Nephew's Renasys Wound Care Device January 27, 2015 The device was pulled from the U.S. market last June. 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
Sorin Group Completes Enrollment of Perceval Valve IDE Trial January 26, 2015 The first patient had the valve implanted in 2013. Read More
Natus Medical Acquires Global Neuro-Diagnostics January 26, 2015 The deal adds neurodiagnostics to Natus’ portfolio of services. Read More
Invitae, Myriad Settle BRCA 1 and 2 Genetic Testing Lawsuit January 26, 2015 Myriad alleged that Invitae’s test infringed on its patents for BRCA 1 and 2 tests. 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
Vasomedical 483 Details Complaint, CAPA Issues January 23, 2015 Vasomedical received a four-observation Form 483 due to shortcomings in complaint reviews and other GMP slips. Read More