Biocardia Inc. said an independent data safety monitoring board has found there are no safety concerns for the first 10 patients treated in the phase III Cardiamp cell therapy trial. The San Carlos, Calif.-based company’s ongoing multicenter, double-blind, randomized, sham-controlled trial is expected to enroll 260 patients at up to 40 centers across the U.S. and will continue as planned.

Biocardia Inc. said an independent data safety monitoring board has found there are no safety concerns for the first 10 patients treated in the phase 3 Cardiamp cell therapy trial. The San Carlos, Calif.-based company's ongoing multicenter, double-blinded, randomized, sham-controlled phase 3 trial is expected to enroll 260 patients at up to 40 centers across the U.S. and will continue as planned.

Abbott Laboratories Inc. has received FDA approval for the Freestyle Libre Flash glucose monitoring system as a replacement for blood glucose monitoring (BGM). The draw behind the Abbott Park, Ill.-based company's Freestyle Libre Flash is it eliminates the need for routine finger sticks. The Freestyle Libre system reads glucose levels through a sensor that is worn on the back of the upper arm for up to 10 days.

W. L. Gore & Associates Inc. has completed enrollment for the pivotal phase of its ASSURED study. This IDE trial is evaluating the Flagstaff, Ariz.-based company's Cardioform ASD occluder for the interventional closure of atrial septal defects (ASDs) sized 8 to 35 millimeters. Gore also recently reported the publication of data from the REDUCE clinical trial that could lead up to the FDA granting approval for patent foramen ovale (PFO) indication for the Cardioform septal occluder.

Boston Scientific Corp. has received a nod from the FDA for its high-voltage MR-safe labeling of the Resonate family of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems. The MR labeling indication comes about three months earlier than expected for the Marlborough, Mass.-based company. Boston Scientific said the favorable regulatory decisions were based on clinical results of the 500-patient ENABLE MRI trial, which was completed earlier this year.

Stryker Corp. has picked up a nod from the FDA to market the Tritanium C anterior cervical cage, an interbody fusion technology intended for use in the cervical spine. With this clearance, the Kalamazoo, Mich.-based company takes a deeper dive into the 3-D printing market.