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Philips Respironics has initiated a voluntary worldwide recall of about 600 Trilogy ventilators due to a potentially defective component on the power management board. Read More
Four patients died after switching to a new form of controller for Thoratec’s HeartMate II Left Ventricular Assist System, the company revealed in a Tuesday recall announcement, adding the deaths did not involve a product malfunction. Read More
Just over a quarter of adverse incidents reported by devicemakers to the UK’s Medicines and Healthcare products Regulatory Agency in 2012 were submitted online, compared with nearly 90 percent of user-generated reports, the agency says. Read More
Devicemakers should take steps now to secure a production account for submitting electronic Medical Device Reports, ahead of an Aug. 14, 2015 deadline for compliance with mandatory eMDRs. Read More
It appears highly likely that the European Parliament won’t finalize the proposed medical device and IVD regulations before May elections, a lawyer familiar with the legislation says. Read More
Four patients died after switching to a new form of controller for Thoratec’s HeartMate II Left Ventricular Assist System, the company revealed in a Tuesday recall announcement, adding the deaths did not involve a product malfunction. Read More
Devicemakers should take steps now to secure a production account for submitting electronic medical device reports ahead of an Aug. 14, 2015 deadline for compliance with mandatory eMDRs. Read More