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Following 45 reports of serious adverse events, the FDA is cautioning healthcare providers about using a SentreHeart device in a procedure intended to prevent strokes. Read More
Malaysia’s Medical Device Authority has extended the application deadline for medical device manufacturers to register their products in that country. Read More
The FDA is giving labelers of intraocular lenses the green light to restart submissions to the Global Unique Device Identification Database after extending the deadline by one year over data concerns. Read More
Top FDA officials last week listened to stakeholder feedback on what has worked well and what can be improved in the Medical Device User Fee Amendments. Read More
Public Citizen has filed a petition urging the FDA to rescind its approval of the Seprafilm bioresorbable membrane, which is used to prevent postoperative adhesions, citing adverse patient events, including at least 21 deaths. Read More
India’s National Pharmaceutical Pricing Authority is asking several orthopedic implant manufacturers to provide details on cost increases that potentially may violate drug pricing laws. Read More
Starting in 2016, medical devicemakers supplying or manufacturing products in Ireland would be subject to a proposed fee-based system to cover the cost of the Health Products Regulatory Authority’s market surveillance activities. Read More