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The UK’s Medicines and Healthcare products Regulatory Agency released final recommendations from the Mesh Oversight Group, which concluded hospitals need to improve their processes for tracking data and patients need to be better informed about potential risks of pelvic mesh devices. Read More
Boston Scientific sent out an alert when one of its pacemakers, the S-ICD device, “delivered an atypical amount of energy” after environmental radiation corrupted its memory, preventing S-ICD arrhythmia detection/treatment and ultimately causing the patient’s death. Read More
The FDA updated the status of a voluntary field removal notice for Penumbra’s 3D revascularization device, designating it as a Class I recall. Read More
Companies will need to report within 48 hours from discovery if a medical device sold in Malaysia presents a serious threat to the public health according to new requirements released by Malaysia’s Medical Device Authority. Read More