Devices & Diagnostics

Boston Scientific starts Cognis clinical trial

Boston Scientific Corp. (NYSE:BSX) is looking to get back on its feet after a series of mis-steps for its cardiac defibrillator operations. The Natick, Mass.-based medical device maker enrolled the first patient in its MultiSense clinical trial, aimed at evaluating the use of multiple sensors with its Cognis cardiac resynchronization therapy defibrillators. Boston Scientific┬ásaid it […]

Devices & Diagnostics

Boston Scientific gets FDA OK to ship defibrillators

Boston Scientific Corp. (NYSE:BSX) has resumed U.S. shipments of its Cognis and Teligen defibrillators after federal regulators on Thursday cleared recent changes to the company’s manufacturing process. Boston Scientific on March 15 voluntarily suspended all domestic defibrillator sales and began a recall of devices not yet implanted after discovering it failed to submit the necessary […]

Devices & Diagnostics

Boston Scientific halts shipments over FDA filings

Boston Scientific Corp. (NYSE:BSX) is holding all shipments of its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators and pulling all inventory from the field after discovering that it missed a pair of filings with the Food & Drug Administration. The medical device-making giant said it failed to notify the FDA of two changes to […]