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Please note this is an extract of the original bulletin.

Rubidium (Rb82) Generator approved as a diagnostic tool for people with heart disease

Page summary:
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (6 March 2024) approved the Rubidium (Rb82) Generator (RUBY-FILL) as a diagnostic tool for imaging of the heart, to evaluate blood flow and aid in the diagnosis or assessment of suspected or known coronary heart disease.

Change made:
First published.

Piflufolastat approved as diagnostic tool for adults with prostate cancer

Page summary:
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (6 March 2024) approved the medicine piflufolastat (18F) (Pylclari) as a diagnostic tool for people with suspected or known prostate cancer.

Change made:
First published.

Medical devices given exceptional use authorisations during the COVID-19 pandemic

Page summary:
List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation.

Change made:
Updated List of medical devices given exceptional use authorisations and List of medical devices that are no longer covered by an exceptional use authorisation.

 

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