Cardima, Inc.
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Latest From Cardima, Inc.
The New Generation Of Investor: Creating Value From Diamonds In The Rough
Debbie Dumont, co-founder of Bioqube Ventures, and one of In Vivo’s Rising Leaders, talks about the company’s investment model, Europe’s translational challenges, and aligning passion and purpose to find ultimate fulfilment.
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.
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.
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.
Company Information
- Industry
-
Medical Devices
- Implantable Devices
- Radiofrequency Devices
-
Surgical Equipment & Devices
- Minimally or Less Invasive
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