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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
The development of the product was funded by HHS’ Administration for Strategic Preparedness and Response as well as the Biomedical Advanced Research and Development Authority. Read More