Our eSTAR interface is changing the game on FDA 510(k) submissions

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Our eSTAR interface is changing the game on FDA 510(k) submissions

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Our eSTAR interface is changing the game on FDA 510(k) submissions

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Our eSTAR interface is changing the game on FDA 510(k) submissions

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Press Release

Press Release: What Lies Ahead for US MedTech? New Essential Industry Report Offers Peek

May 2, 2024

Press Release

Press Release: What Lies Ahead for US MedTech? New Essential Industry Report Offers Peek

May 2, 2024

Press Release

Press Release: What Lies Ahead for US MedTech? New Essential Industry Report Offers Peek

May 2, 2024

Press Release

Press Release: What Lies Ahead for US MedTech? New Essential Industry Report Offers Peek

May 2, 2024

For Immediate Release / May 2, 2024

Contact: Shawn M. Schmitt / shawn@essenvia.com / +1 305-240-9339

“2024 State of US MedTech Regulation” is Latest Insightful Report From Essenvia

LOS ANGELES – Now that the MedTech industry has 2023 in its rear-view mirror, it’s ready to tackle fresh, oncoming challenges head-on. With its brand-new “2024 State of US MedTech Regulation” report, Essenvia has pinpointed eight specific hurdles that many medical device manufacturers will have to jump in the coming years. They include:

  • Adapting to regulatory changes with a focus on digital health

  • Increased emphasis on digital transformation and artificial intelligence (AI) integration

  • Greater investment in AI and machine learning (ML) technologies

  • Rapid adoption of eSTAR for Food and Drug Administration (FDA) regulatory submissions

  • Leveraging real-world evidence (RWE) for regulatory and market access strategies

  • Embracing Breakthrough Device Designation and expedited submission pathways

  • Heightened focus on cybersecurity

  • Strategic planning for decentralized clinical trials (DCTs)

Through its novel report, Essenvia urges industry to proactively embrace these challenges by investing in innovative technologies, adapting to regulatory evolutions, and prioritizing cybersecurity activities to protect the data of patients and providers.

“The future of medical devices is bright, but it is vital for industry leaders to stay informed and engaged in the ongoing changes and needs for MedTech regulation,” says Soumya Mahapatra, Essenvia’s CEO and a coauthor of the “2024 State of US MedTech Regulation” report. “It is also vitally important for industry as a whole to collaborate with policymakers, insurers, and health systems to make sure tech advancements are safe and accessible to patients in a timely manner and lead to equitable healthcare outcomes, which is something everyone should be striving for.”

And for those who want to look back at the previous year, Essenvia’s report does that, too. The “2024 State of US MedTech Regulation” offers a unique look at 2023 and dissects the recent US regulatory landscape, and includes data culled from FDA databases, industry experts, and other stakeholders.

** Join Essenvia CEO Soumya Mahapatra and VP of Regulatory Affairs Dhriti Roy on May 16 at noon EST for a FREE, informative MedTech Intelligence webinar that will walk through key findings of the “2024 State of US MedTech Regulation” report. REGISTER FOR THIS FREE WEBINAR NOW! **


Founded in 2018, Essenvia is a MedTech RIM platform that gives you the tools you need to manage regulatory workflows across the total product lifecycle, accelerate global market access, and generate exponential business value. Learn more about what Essenvia can do for your MedTech company at Essenvia.com.