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“During the grace period, if you fail to keep to the conditions, or if there is evidence of the devices not meeting the relevant safety requirements, we will withdraw the permission,” the agency said. Read More
Certain device manufacturers will be allowed to continue placing their products on the EU market while they deal with the unexpected withdrawal of a notified body, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced. Read More
Hahn said the agency will distribute information to developers on approval pathways, such as Emergency Use Authorization, which allows the use of unapproved medical products in public health emergencies. Read More
NGS diagnostics can help patients and physicians put together a personalized cancer treatment plan because of the clinical information they provide. Read More