BioCardia (NSDQ:BCDA) said today that it submitted an application for FDA 510(k) clearance for its Avance steerable introducer intended for introducing cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The San Carlos, Calif.-based company said the Avance device uses new technology developed for the company’s Morph line of […]
Google taps ex-Geisinger CEO Feinberg to lead consolidated Google Health biz | Personnel Moves – November 14, 2018
Google (NSDQ:GOOG) has picked up former Geisinger Health CEO David Feinberg to lead its fragmented health divisions under the Google Health moniker, according to a recent CNBC report. The tech giant had been searching for a head for several months, with artificial intelligence head Jeff Dean heavily involved in the process, according to the report. Other […]
BioCardia touts preliminary data from heart failure trial
BioCardia (OTC:BCDA) touted data today from the first 10 patients treated in its Phase III CardiAmp heart failure trial. The company’s investigational therapy uses a patient’s bone marrow cells to trigger the body’s natural ability to heal itself, according to BioCardia. These data are the first to be published from any pivotal trial of a stem […]
Report: Amazon adds MGH cardiologist Majmudar | Personnel Moves – August 21, 2018
Amazon (NSDQ:AMZN) has picked up well-known cardiologist Dr. Maulik Majmudar for a new role within the company as it looks to continue its foray into healthcare, according to a recent CNBC report. The announcement was made by Majmudar himself on Twitter, according to the report, though he did not state what his specific role within the […]
BioCardia wins FDA nod for chronic myocardial ischemia pivotal trial
The FDA has approved a trial to test BioCardia‘s (OTC:BCDA) CardiAMP cell therapy in chronic myocardial ischemia patients with refractory angina. The San Carlos, Calif.-based company could enroll up to 343 patients in the pivotal trial, which is designed to support benefit claims for the cell therapy product without the need for a second confirmatory trial. […]
BioCardia files 2nd FDA IDE bid for CardiAMP chronic myocardial ischemia, refractory angina study
BioCardia (NSDQ:BCDA) said today it filed for a second FDA investigational device exemption to launch a trial of its CardiAMP cell therapy of chronic myocardial ischemia and refractory angina as it seeks a second indication. The San Carlos, Calif.-based company’s CardiAMP therapy uses autologous cells to treat chronic myocardial ischemia, and is designed to stimulate the […]
BioCardia treats 10-patient cohort in late-stage heart failure trial
BioCardia (NSDQ:BCDA) said today that it finished treating a 10-patient cohort in its pivotal Phase III CardiAmp heart failure trial. The company reported that it expects a review of the 30-day outcomes for this cohort in the third quarter of this year. Get the full story at our sister site, Drug Delivery Business News.
BioCardia, Johns Hopkins treats first patient with CardiAmp cell therapy in Phase III trial
Johns Hopkins, the Maryland Stem Cell Research Fund and BioCardia (NSDQ:BCDA) said today that the 1st patient has been treated in a pivotal Phase III trial of the CardiAmp cell-based therapy for the treatment of ischemic heart failure. The investigational therapy was designed to deliver a dose of a patient’s own bone marrow cells directly […]
BioCardia launches pivotal trial for CardiAmp heart failure treatment
BioCardia (NSDQ:BCDA) initiated its CardiAmp pivotal trial this week to evaluate its cell therapy at 40 clinical sites across the U.S. The pivotal trial is a part of the company’s efforts for premarket approval, as regulated by the FDA’s Center for Biologics Evaluation and Research division. Get the full story at our sister site, Drug Delivery […]
BioCardia closes Tiger X Medical merger
BioCardia said today it closed its merger with Tiger X Medical (OTC:CDOM), with the combined company retaining the BioCardia name and “BCDA” ticker. San Carlos, Calif.-based BioCardia said it converted all outstanding convertible promissory notes into shares of common stock before the merger, putting approximately $25 million in cash in their packets before the payment of […]
Opko Health gets in on BioCardia after merger with Tiger X Medical
BioCardia said today that Opko Health (NYSE:OPK) agreed to pick up a “significant” stake in its business after a merger with Tiger X Medical (OTC:CDOM). The new company will keep the BioCardia name and the development program for its CardiAMP cell therapy for heart failure patient’s who’ve had a heart attack. Stem cells derived from the bone marrow of […]
MassDevice Network
@MassDevice
LinkedIn
YouTube