Karl Hoelper
Soapbox

Realizing RFID’s Potential in Healthcare: Tackling Closed-Loop System Hurdles

By Karl Hoelper

…as “RFID tracking systems set up within a company. Since the tracked item never leaves the company’s control, it does not need to worry about using technology based on open…

…as “RFID tracking systems set up within a company. Since the tracked item never leaves the company’s control, it does not need to worry about using technology based on open…

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FDA Issues Updated Draft Guidance on Use of Real World Evidence

By MedTech Intelligence Staff

…lieu of some premarket data, consistent with FDA’s policy on balancing premarket and postmarket data collection Stakeholders may submit comments under docket number FDA-2023-D-4395 at www.regulations.gov by February 20, 2024….

…lieu of some premarket data, consistent with FDA’s policy on balancing premarket and postmarket data collection Stakeholders may submit comments under docket number FDA-2023-D-4395 at www.regulations.gov by February 20, 2024….

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Crossing the eSTAR Chasm- The First MedTech Benchmark Report on FDA's 510(k) eSTAR Mandate

Crossing the eSTAR Chasm – The First MedTech Benchmark Report on FDA’s 510(k) eSTAR Mandate

By Essenvia

In this groundbreaking report, Essenvia shines a first-ever light on regulatory professionals’ preparedness, benchmarks, and best practices for embracing eSTAR and overcoming the challenges MedTech companies face in adopting the…

In this groundbreaking report, Essenvia shines a first-ever light on regulatory professionals’ preparedness, benchmarks, and best practices for embracing eSTAR and overcoming the challenges MedTech companies face in adopting the…

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Dhaval Shah
MEDdesign

Navigating Global Regulations for SaMD

By Dhaval Shah

…outcomes. Operational efficiency: Medical software automates tasks and streamlines workflows, freeing up staff time to focus on patient care. Ensuring regulatory compliance and safety: Medical software must adhere to strict…

…outcomes. Operational efficiency: Medical software automates tasks and streamlines workflows, freeing up staff time to focus on patient care. Ensuring regulatory compliance and safety: Medical software must adhere to strict…

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AdvaMed Announces New Board Chair and Medical Imaging Division

By MedTech Intelligence Staff

…outcomes. We need policies that keep pace with innovation, while fostering the highest ethical standards that improve patient access to the best care possible. With the promise of artificial intelligence…

…outcomes. We need policies that keep pace with innovation, while fostering the highest ethical standards that improve patient access to the best care possible. With the promise of artificial intelligence…

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FDA Announces New Genetic Metabolic Advisory Committee

By MedTech Intelligence Staff

…fields and have experience interpreting complex data. The committee will also include a consumer representative and an industry representative. Non-Federal members of this committee will serve either as special government…

…fields and have experience interpreting complex data. The committee will also include a consumer representative and an industry representative. Non-Federal members of this committee will serve either as special government…

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Caroline Irungu

Ask the Expert: Digital Continuity – Strategies for Product Recall Resilience

…outline a framework to help practitioners assess the relevance and adequacy of completed V&V activities to establish credibility of a computational model. Intelligent computational modeling can also be extended to…

…outline a framework to help practitioners assess the relevance and adequacy of completed V&V activities to establish credibility of a computational model. Intelligent computational modeling can also be extended to…

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