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FDA Committee Befuddled by Data Discrepancies on Paclitaxel Devices

FDA concluded that there is a signal associated with an increase in mortality through five years of paclitaxel-coated devices as compared to non-coated devices. The agency was not, however, able to attribute this increased risk to a specific cause.

Survey Says: Fragmented Processes and System Silos are Hurting Clinical Trials

The Veeva 2019 Unified Clinical Operations Survey looked at the concerns of 461 clinical operations professionals from around the world.

Supplier Stories for the Week of June 16

Here’s what was new in the world of medical device suppliers during the week of June 16.

Large Financing Round Breathes New Life into Acutus’ AcQMap

The Carlsbad, CA-based company raised $100 million from a Series D Equity round and $70 million from a credit facility.

Look Out Mako, Here Comes Rosa

An industry analyst expects Zimmer Biomet's Rosa Knee robotic system to represent a formidable competitor to Stryker's Mako Knee after the Rosa Knee's full launch later this year. However, both Mako and Rosa have their strengths and weaknesses, and neither is clearly superior, the analyst said.

Ra Goes the Distance with Dabra in New Clinical Study

The Carlsbad, CA-based company is conducting the RESULTS study, which will gather data for its Dabra Excimer Laser System for two years, post-treatment of peripheral artery disease.

Vending Machine Keeps Spinal Implants at the Ready

Xenco Medical’s customizable machines can dispense prepackaged sterile kits with implants and instruments and help manage inventory.

Bursting Balloon Problem Prompts Cook to Recall Catheters

No deaths or injuries have been reported, but Cook Medical has received multiple complaints of balloons bursting below the rated burst pressure on its Advance Enforcer 35 Focal Force PTA Balloon Catheters manufactured with specific balloon material lots.