Please contact Sales at: (212) 520-2765 or email PharmaNewsSales@informa.com
Latest From Cardima, Inc.
Although ANG-3777, partnered with Vifor, missed its primary endpoint in cardiovascular surgery patients at risk for acute kidney injury, the companies will consider a path forward based on a renal events measure.
With more data submitted to CDRH, FzioMed and the device center have agreed to postpone a planned June 10 dispute-resolution panel meeting on the firm’s previously rejected PMA for the Oxiplex spine surgery gel.
FDA has officially scheduled the first meeting of its Medical Devices Dispute Resolution Panel in more than seven years to assess the case of FzioMed Inc.’s PMA for the Oxiplex gel for lumbar spine surgery. An ophthalmic devices panel has been set for a new corneal implant, and more regulatory news.
FDA granted FzioMed’s petition for an independent review of its Oxiplex gel PMA by the Medical Devices Dispute Resolution Panel in response to FzioMed’s November 2012 petition. The agency deemed the device, intended for use in spine surgery, as “not approvable” in 2008.
- Implantable Devices
- Radiofrequency Devices
Surgical Equipment & Devices
- Minimally or Less Invasive