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Cardima, Inc.

http://www.Cardima.com

Latest From Cardima, Inc.

Angion’s HGF Mimetic Fails Second Phase II Study, But Not Shuttered Yet

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.

Clinical Trials Drug Approval Standards

FzioMed Oxiplex Dispute Panel Postponed So CDRH Can Review More Data

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.

Medical Device Regulation

Regulatory Roundup: FDA Panels; Proteomics; Experiential Learning; 510(k)s

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.

Medical Device Regulation

FzioMed Gets Second Chance For Oxiplex Gel PMA With Dispute Resolution Panel

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.

Medical Device Regulation
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  • Medical Devices
    • Implantable Devices
    • Radiofrequency Devices
    • Surgical Equipment & Devices
      • Minimally or Less Invasive
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