FDA

FDA Issues Final Guidances on Postmarket Surveillance and Post-approval Studies

By MedTech Intelligence Staff

This month, the FDA issued two final guidances related to post-approval studies and postmarket surveillance of medical devices. Per the FDA announcement, these guidances are “intended to enhance patient safety…

This month, the FDA issued two final guidances related to post-approval studies and postmarket surveillance of medical devices. Per the FDA announcement, these guidances are “intended to enhance patient safety…

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Sean Smith

The Real Impact of IVDR on Clinical Evidence Requirements

By Sean Smith

…insufficient demonstration of clinical evidence. Subscribe to the MedTech Intelligence weekly newsletter to stay up to date on the latest news and information on medical device development and regulation. Clinical…

…insufficient demonstration of clinical evidence. Subscribe to the MedTech Intelligence weekly newsletter to stay up to date on the latest news and information on medical device development and regulation. Clinical…

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Whitehouse 2021

White Houses Releases AI Bill of Rights Blueprint

By MedTech Intelligence Staff

Against a backdrop of growing concern surrounding biased data and rights to privacy and informed consent, the White House has released the “Blueprint for an AI Bill of Rights” that…

Against a backdrop of growing concern surrounding biased data and rights to privacy and informed consent, the White House has released the “Blueprint for an AI Bill of Rights” that…

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Doctor on computer

AHRQ Announces Real World Data Competition for HCOs

By MedTech Intelligence Staff

…into AHRQ’s systematic review findings to improve healthcare practice. The top award winner could earn up to $200,000. In a news release outlining its goals and the application process, The…

…into AHRQ’s systematic review findings to improve healthcare practice. The top award winner could earn up to $200,000. In a news release outlining its goals and the application process, The…

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Mother child and doctor

Ethical Considerations for Children in Clinical Investigations: FDA Publishes New Draft Guidance

The FDA has published a new draft guidance that outlines its current views regarding ethical considerations for clinical investigations of medical products in children. The guidance seeks to balance the…

The FDA has published a new draft guidance that outlines its current views regarding ethical considerations for clinical investigations of medical products in children. The guidance seeks to balance the…

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FDA

FDA Announces Funding Opportunities for Medical Device Development Tools

By MedTech Intelligence Staff

The FDA Center for Devices and Radiological Health (CDRH) has announced new funding opportunities to support small businesses in developing innovative medical device development tools (MDDTs). The MDDT program was…

The FDA Center for Devices and Radiological Health (CDRH) has announced new funding opportunities to support small businesses in developing innovative medical device development tools (MDDTs). The MDDT program was…

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Veranex logo

Veranex Acquires Medidee

By MedTech Intelligence Staff

Veranex, a global, tech-enabled service provider dedicated to the medical technology industry, has acquired MedTech consultancy Medidee, headquartered in Lausanne, Switzerland. The acquisition will expand and strengthen Veranex’s regulatory affairs,…

Veranex, a global, tech-enabled service provider dedicated to the medical technology industry, has acquired MedTech consultancy Medidee, headquartered in Lausanne, Switzerland. The acquisition will expand and strengthen Veranex’s regulatory affairs,…

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MedExecWomen Panel on M&A

M&As: Maximizing the Partnership Process on Both Sides

By Leslie Storms, Kristine Ilaria, Martha Shadan

…then more serious steps to be taken before the final decision is made to merge. Subscribe to the MedTech Intelligence weekly newsletter to stay up to date on the latest…

…then more serious steps to be taken before the final decision is made to merge. Subscribe to the MedTech Intelligence weekly newsletter to stay up to date on the latest…

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FDA

FDA Issues Draft Guidance on Computer Software Assurance for Medical Devices

On September 12, the FDA issued a new draft guidance, which provides recommendations on risk-based assurance activities for computers and automated data processing systems that are used as part of…

On September 12, the FDA issued a new draft guidance, which provides recommendations on risk-based assurance activities for computers and automated data processing systems that are used as part of…

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Whitehouse 2021

Pres. Biden Issues Executive Order on Advancing Biotechnology and Biomanufacturing

By MedTech Intelligence Staff

On September 12, President Joe Biden issued an executive order, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.” The order outlines a “whole-of-government approach” to…

On September 12, President Joe Biden issued an executive order, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.” The order outlines a “whole-of-government approach” to…

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