Morph DNA BioCardia has announced that the FDA has granted 510(k) clearance for the Morph DNA deflectable guide catheter, which is used to guide the Helix biotherapeutic delivery system during CardiAMP cell therapy delivery in the heart. The Morph DNA deflectable guide catheter, a press release reports, is designed to enhance procedural [...]
Helix BioCardia has announced the renewal of the CE mark for its Helix biotherapeutic delivery catheter and Morph universal deflectable guide catheter—both are used in the delivery of biotherapeutics to the heart. A press release reports that the CE mark renewal enables BioCardia to continue supporting partners conducting biotherapeutic clinical trials outside [...]
Avance BioCardia has announced the US commercial availability of its Avance bi-directional steerable introducer sheath for introducing various cardiovascular catheters into the heart, including via the left side of the heart through the interatrial septum. The product became available in late September. A press release reports that the Avance device addresses the [...]
BioCardia has announced that the European Patent Office has issued the Company Patent No: 3063172 for “methods of measuring potential for therapeutic potency and defining dosages for autologous cell therapies.” A press release reports that BioCardia’s new patent is for a diagnostic approach for patient selection that identifies a specific biomarker signature in a [...]