HistoSonics announced today that its Edison histotripsy system for noninvasively destroying liver tumors has secured early, limited U.K. market access. According to the Plymouth, Minnesota–based medtech company, the Medicines and Healthcare Products Regulatory Agency in Britain granted controlled early limited market access under an Unmet Clinical Need Authorisation available through the U.K.’s Innovative Devices Access […]
United Kingdom
AstraZeneca vaccine recipients in U.K. will wait up to 12 weeks for second dose
An inexpensive COVID-19 vaccine from AstraZeneca (LON:AZN) — now authorized in the U.K. — could go on to become the most widely used in the world. It is inexpensive and easy to produce. But a major hurdle that could slow its rollout in the U.K. after yesterday’s approval is the question of how to best […]
Here’s how the UK will regulate medical devices after Brexit
The United Kingdom issued an outline of how it intends to regulate medical devices beginning in 2021 after Brexit. From Jan. 1, 2021, the responsibilities for the UK medical devices market that are currently governed by the European Union (EU) will be taken over by the Medicines and Healthcare products Regulatory Agency (MHRA), the guidance said. […]
