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The FDA said it had received medical device reports of early SVD with the Trifecta valves, which show a peak time to SVD of three to four years after implant.
Abbott has issued an advisory to customers warning of potential early structural valve deterioration (SVD) of its Trifecta Valve and Trifecta Valve with Glide Technology (GT) bovine heart valves, occurring five years or less after being implanted.
On the website GoodRx, a two-pack of Viatris’ branded EpiPen can cost more than $635, while a generic version costs anywhere from $100 to more than $280.
The German-based certification organization DEKRA has temporarily suspended the CE certificates for Getinge’s HLS and PLS life support sets effective March 1 due to noncompliance with the EU’s Medical Device Directive.
The FDA explains the types of modifications to a diagnostic ultrasound device for which the agency does not intend to enforce the requirement for a new 510(k) filing, in a final guidance released yesterday — one of six newly released guidances from the agency related to imaging solutions and lasers.
The U.S. Supreme Court has refused to review a $302 million judgment levied against Johnson & Johnson (J&J) by California for misrepresenting the risk of its pelvic mesh products in marketing materials.
President Biden has upheld the U.S. International Trade Commission’s final determination that Apple infringed on AliveCor’s wearable electrocardiogram device, keeping alive a limited exclusion order and a cease and desist order on Apple to cease importing certain versions of its watches.
Having solid design and process verification baked into the product lifecycle is a challenge for devicemakers as it calls for effective collaboration between separate units, according to one medical device quality and regulatory expert.