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Flexible endoscopes have topped ECRI Institute’s 2016 list of the top 10 health technology hazards, following a series of fatal infections associated with duodendoscopes that were inadequately reprocessed. Read More
Failure to conduct adequate investigations of complaints related to its volumetric infusion pumps and not providing corrective action documents are among the issues that have landed WalkMed Infusion an FDA warning letter. Read More
Failing to evaluate potential suppliers and making claims that its therapeutic massagers can help reduce cellulite and wrinkles have helped earn A-1 Engineering an FDA warning letter. Read More
The FDA is aiming to develop additional documents and policies to help investigators and devicemakers understand Critical to Quality factors. Read More
Boston Scientific is recalling 600 units of its RotaWire Elite guidewire and wireClip Torquer guidewire manipulation device, components of the Rotablator rotational atherectomy system, because they may break and separate, causing serious injury or death. Read More
FDA investigators conducting quality system inspections are becoming a more common sight at international facilities, according to new numbers unveiled last week by the agency’s device center. Read More
With an eye toward ensuring patient safety, Malaysia’s Medical Device Authority has provided its thinking on how companies should report incidents involving medical devices. Read More