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In addition to acquiring the product and handling the customer, devicemakers need to incorporate some key steps into their investigations into serious or critical complaints. For instance, the quality department should always receive a notice of critical complaints and be involved in the investigation. Read More
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
RIGImmune announced its acquisition of Subintro, a move the company says is focused on development of intranasal delivery of RIGImmune’s stem-loop RNA antivirals and vaccines to treat and prevent respiratory diseases caused by RNA viruses such as COVID-19, influenza, RSV and rhinoviruses. Read More
Inadequate device history records (DHRs) and other deficiencies landed Xintec, also known as Convergent Laser Technologies, a Form 483 after an inspection of its Alameda, Calif., facility. 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
An effective strategy to maintain compliance with the EU Medical Device Regulation (MDR) requires systems to monitor key factors and take appropriate actions in the face of changing instruments. In essence, an ideal strategy for regulatory compliance should include nine key steps. The two most important? The implementation of a monitoring plan and establishment of monitoring sources. 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