FDA

FDA Updates Breakthrough Devices Guidance Focused on Health Equity

…by disparities in health and health care, as well as how the FDA discloses the Breakthrough status of designated devices once they receive marketing authorization. “The FDA is committed to…

…by disparities in health and health care, as well as how the FDA discloses the Breakthrough status of designated devices once they receive marketing authorization. “The FDA is committed to…

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Renato Rjavec

Preparing for a Data-first Regulatory World

By Renato Rjavec

…and of pre-built dashboards, too. Reporting & Analytics: From Standard Dashboards to AI-assisted Discovery As basic data interrogation becomes more commonplace and comfortable, teams will need to be able to…

…and of pre-built dashboards, too. Reporting & Analytics: From Standard Dashboards to AI-assisted Discovery As basic data interrogation becomes more commonplace and comfortable, teams will need to be able to…

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J&J Abiomed Logos

Johnson & Johnson to Expand Cardiovascular Segment with Abiomed Acquisition

By MedTech Intelligence Staff

Johnson & Johnson has entered into a definitive agreement to acquire Abiomed, developer of breakthrough heart, lung and kidney support technologies, for approximately $16.6 billion. The transaction—expected to be completed…

Johnson & Johnson has entered into a definitive agreement to acquire Abiomed, developer of breakthrough heart, lung and kidney support technologies, for approximately $16.6 billion. The transaction—expected to be completed…

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BlackHägen facility

BlackHägen Design Expands Its MedTech Research and Design Capabilities

By MedTech Intelligence Staff

…In its announcement, the company noted that considering user needs early on in design development is essential, particularly as the devices must compensate for users of varying experiences. To meet…

…In its announcement, the company noted that considering user needs early on in design development is essential, particularly as the devices must compensate for users of varying experiences. To meet…

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FDA

FDA Updates Guidance on Deficiencies in Accordance with Least Burdensome Provisions

…2023 Through Fiscal Year 2027 Commitment Letter. In addition, the guidance describes suggested formats for FDA staff to communicate deficiencies, and for industry to use for responses to such requests,…

…2023 Through Fiscal Year 2027 Commitment Letter. In addition, the guidance describes suggested formats for FDA staff to communicate deficiencies, and for industry to use for responses to such requests,…

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Veeva Logo

Veeva Introduces MedTech-Specific Vault CRM

By MedTech Intelligence Staff

…application built for medtech sales teams, key account managers and medical affairs professionals. Built on the Veeva Vault Platform, Vault CRM allows companies to bring together commercial functions across sales,…

…application built for medtech sales teams, key account managers and medical affairs professionals. Built on the Veeva Vault Platform, Vault CRM allows companies to bring together commercial functions across sales,…

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Tim Brown

Bridging the Design Development and Quality Management Chasm

By MedTech Intelligence Staff

…use cases that we’re starting to see, especially on the design side of things, are with the computer-aided design (CAD) models. For example, if a component of the project is…

…use cases that we’re starting to see, especially on the design side of things, are with the computer-aided design (CAD) models. For example, if a component of the project is…

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LaĂ­s Junqueira
Soapbox

Nudging Towards Safer Decision Making

By LaĂ­s Junqueira

…choice architecture encourages you to make a certain decision, the option to follow through with the prompt is still yours to make. A clinician’s immediate environment and choice architecture should…

…choice architecture encourages you to make a certain decision, the option to follow through with the prompt is still yours to make. A clinician’s immediate environment and choice architecture should…

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Jenna Wagner
Soapbox

Life Sciences Labeling for Patient Safety

By Jenna Wagner

…supply chain requirements can be complex. Enterprise labeling systems can equip medical device companies with the tools to make compliant labeling accurate, efficient and scalable.   References: [1] https://teklynx.com/en/support/learn/media-library/case-studies/top-clean-injection?utm_source=medtech_intelligence&utm_medium=media_relations&utm_campaign=life_sciences  …

…supply chain requirements can be complex. Enterprise labeling systems can equip medical device companies with the tools to make compliant labeling accurate, efficient and scalable.   References: [1] https://teklynx.com/en/support/learn/media-library/case-studies/top-clean-injection?utm_source=medtech_intelligence&utm_medium=media_relations&utm_campaign=life_sciences  …

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Critical Manufacturing and Dataworks

Critical Manufacturing Partners with Dataworks To Enhance CSA Support

By MedTech Intelligence Staff

companies to take a more automated approach using computer system assurance (CSA). We are in a strong position to support companies in achieving the huge benefits this has to offer.”…

companies to take a more automated approach using computer system assurance (CSA). We are in a strong position to support companies in achieving the huge benefits this has to offer.”…

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