Emily Newton, Revolutionized Magazine

How to Thrive Amid the Shifting Sands of Medical Device Regulations

By Emily Newton

compliance. Anticipate New Needs and Concerns Given how quickly regulations shift, waiting until new laws emerge to adapt is no longer sufficient. Medical device businesses must prepare before rules take…

compliance. Anticipate New Needs and Concerns Given how quickly regulations shift, waiting until new laws emerge to adapt is no longer sufficient. Medical device businesses must prepare before rules take…

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AMA Logo

Physicians Enthusiastic but Cautious About Healthcare AI

By MedTech Intelligence Staff

…Intelligence Research surveyed 1,081 physicians in August 2023 to investigate the sentiment of practicing physicians regarding the increased usage of AI in health care. Among the key findings, the physician…

…Intelligence Research surveyed 1,081 physicians in August 2023 to investigate the sentiment of practicing physicians regarding the increased usage of AI in health care. Among the key findings, the physician…

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Regulations

Regulatory Advocacy: Amplifying Your Voice

By MedTech Intelligence Staff

…of stakeholders is beneficial, there are some instances where companies should approach the FDA on their own. “Once there is a formal comment process, companies need to follow the rules…

…of stakeholders is beneficial, there are some instances where companies should approach the FDA on their own. “Once there is a formal comment process, companies need to follow the rules…

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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 Logo

FDA Issues Updated Draft Guidance on Use of Real World Evidence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

…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 new mandate….

…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 new mandate….

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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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