Data

Key Barriers to RWD Adoption

By MedTech Intelligence Staff

…the results of a recent survey commissioned by Komodo Health and conducted by Frost & Sullivan. The survey, which was conducted anonymously among 300 professionals across Commercial, Health Economics and…

…the results of a recent survey commissioned by Komodo Health and conducted by Frost & Sullivan. The survey, which was conducted anonymously among 300 professionals across Commercial, Health Economics and…

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Vladimir A. Makatsaria

Makatsaria Takes Helm as CEO of LivaNova

By MedTech Intelligence Staff

LivaNova, a global medical technology company, announced that Vladimir A. Makatsaria will be the company’s Chief Executive Officer (CEO) and a member of the Board of Directors, effective March 1,…

LivaNova, a global medical technology company, announced that Vladimir A. Makatsaria will be the company’s Chief Executive Officer (CEO) and a member of the Board of Directors, effective March 1,…

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ISO_13485

FDA Adopts ISO 13485 with QMSR Final Rule

By MedTech Intelligence Staff

The FDA has issued the Quality Management System Regulation (QMSR) Final Rule. The QMSR rule emphasizes risk management activities and risk-based decision making and aims to reduce regulatory burdens on…

The FDA has issued the Quality Management System Regulation (QMSR) Final Rule. The QMSR rule emphasizes risk management activities and risk-based decision making and aims to reduce regulatory burdens on…

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FDA Elevates Office of Strategic Partnerships and Technology Innovation to CDRH Super Office

By MedTech Intelligence Staff

…understanding, drive synergy, advance best practices and innovate regulatory approaches to provide efficient and least burdensome oversight for digital health products while meeting FDA standards for safe and effective products….

…understanding, drive synergy, advance best practices and innovate regulatory approaches to provide efficient and least burdensome oversight for digital health products while meeting FDA standards for safe and effective products….

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DiMe Logo

DiMe Convenes Industry Leaders to Streamline Commercialization of Digital Health Products

By MedTech Intelligence Staff

…to successful commercialization of high-value, evidence-based DHPs, addressing the top priority reported by industry leaders in DiMe’s recent Digital Health Industry Regulatory Needs Assessment: to align best practices between regulatory…

…to successful commercialization of high-value, evidence-based DHPs, addressing the top priority reported by industry leaders in DiMe’s recent Digital Health Industry Regulatory Needs Assessment: to align best practices between regulatory…

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Dhaval Shah

Care Beyond Walls: Six Digital Trends Shaping Health Care in 2024

By Dhaval Shah

…and operational outcomes. For example, health IT CRM systems can help healthcare leaders elevate their value chain and enhance data cycle management and interoperability while maintaining compliance. AI-powered clinical decision…

…and operational outcomes. For example, health IT CRM systems can help healthcare leaders elevate their value chain and enhance data cycle management and interoperability while maintaining compliance. AI-powered clinical decision…

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Clinical Evaluation

Role of Clinical Evaluation Report Consultants

By Anushree Singh

…requirement. A CER Consultant is a specialized professional who assists manufacturers in the preparation of their CERs, ensuring compliance with regulatory guidelines. These consultants possess in-depth knowledge of the regulatory…

…requirement. A CER Consultant is a specialized professional who assists manufacturers in the preparation of their CERs, ensuring compliance with regulatory guidelines. These consultants possess in-depth knowledge of the regulatory…

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European Union Flag

European Commission Proposes Extension for EU IVDR Compliance

By MedTech Intelligence Staff

On January 23, the European Commission put forth a proposal that would extend the deadline for compliance with EU In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions. The…

On January 23, the European Commission put forth a proposal that would extend the deadline for compliance with EU In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions. The…

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