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Over the past week, the FDA issued draft guidance on advanced manufacturing technologies designation program and announced the establishment of a new advisory committee on genetic metabolic diseases. Read More
CDRH has teamed up with three more collaborative device initiatives, including an international effort to leverage the power of AI to improve medical device quality and patient health. Read More
Illumina announced that it has filed a draft notice to the Securities and Exchange Commission related to its potential divestiture of Grail, pursuant to an order Illumina received from the European Commission (EC) directing the company to divest Grail. Read More
This edition of Quick Notes looks across the pond at Europe’s new critical medicines list, reference labs for high-risk IVDs, guidelines for adverse reaction follow-ups and a tweaked website. Read More
Upcoming events in the coming weeks and months include two FDA advisory committee meetings; and MAGI 2024: The Clinical Research Conference in New Orleans. Read More
The law, slated to take effect Jan. 1, 2024, requires Colorado health insurers to cap the amount for an epi-pen at $60 for a two-pack of injectors. Read More
AdvaMed announced the establishment of a new medical imaging technology division that will advocate on behalf of large and small devicemakers, and is establishing itself as the new home for advocacy, supplanting the Medical Imaging & Technology Alliance (MITA), a division of the National Electrical Manufacturers Association. Read More
Getinge’s recall of its Cardiohelp for problems with its emergency drive has been identified by the FDA as a Class I recall — the most serious type of recall as use of these devices may cause serious injuries or death. Read More
HHS’s fall unified agenda of proposed rules for the FDA includes a new rule that revokes two old rules that have either been superseded or do not reflect current agency practice, the agenda says. Read More