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United Kingdom

HistoSonics Edison system gains early market access in the UK

May 29, 2025 By Chris Newmarker

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 […]

Filed Under: Featured, Oncology, Regulatory/Compliance, Robotic-Assisted, Ultrasound Tagged With: histosonics, HistoSonics Inc., United Kingdom

AstraZeneca vaccine recipients in U.K. will wait up to 12 weeks for second dose

December 31, 2020 By Brian Buntz

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 […]

Filed Under: Featured, Pharmaceutical, Regulatory/Compliance Tagged With: AstraZeneca plc, coronavirus, COVID-19, COVID-19 vaccine, Medicines and Healthcare Products Regulatory Agency, Oxford University, United Kingdom

Here’s how the UK will regulate medical devices after Brexit

September 2, 2020 By Sean Whooley

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. […]

Filed Under: Business/Financial News, Featured, Regulatory/Compliance Tagged With: CE Mark, Medicines & Healthcare products Regulatory Agency (MHRA), United Kingdom

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