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Boston Scientific’s Sentinel cerebral protection system did not meet the primary endpoint in a large randomized trial since “the data demonstrated a non-significant trend towards a lower rate of stroke in patients treated with the Sentinel device,” the company said in a presentation at the Transcatheter Cardiovascular Therapeutics annual scientific symposium in Boston, Mass. Read More
An FDA inspection of Stuart, Fla.-based Powers Medical Devices found that the company had not been doing internal audits, according to a Form 483 the agency issued to the company. Read More
Insulin and intrathecal pain pumps, intracardiac defibrillators, mobile cardiac telemetry and pacemakers are among the devices “susceptible to cyber attacks,” according to a new FBI statement that cites a recent healthcare cybersecurity analyst’s report. Read More
Carryover funds and an undisclosed contingency plan will keep the FDA’s user fee program in motion even if Congress misses the Sept. 30 deadline for reauthorizing the Medical Device User Fee Amendment (MDUFA V), said FDA’s Jeff Shuren at the recent annual meeting of the Regulatory Affairs Professionals Society (RAPS) in Phoenix. Read More
FEMSelect’s EnPlace meshless pelvic floor ligament fixation system had positive results in a four-year prospective follow-up study of 14 patients, the company said in a Tuesday statement. Read More
An experimental radiotracer known as [18F]flurpiridaz has met its two primary endpoints of exceeding a 60 percent threshold for both sensitivity and specificity in detecting coronary artery disease (CAD), according to the sponsors, GE Healthcare and Lantheus. Read More
Manufacturers ready to establish a risk-based framework for computer software assurance throughout the software’s lifecycle now have a clearer place to start. Read More
OssView, medical diagnostic software that calculates bone microstructural deterioration, has received Breakthrough Device Designation from the FDA, according to developer CurveBeam AI of Hatfield, Penn. The designation will give the investigational software a prioritized 510(k) application review. Read More
Political pressure and internet-bred conspiracy theories have eroded one of the FDA’s prime functions — the communication of scientific truth, FDA Commissioner Robert Califf said at the annual meeting of the Regulatory Affairs Professional Society (RAPS) taking place in Phoenix, Ariz. this week. Read More