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§ Private Profile · Los Angeles, CA, USA
Technology solutions provider streamlining medical device regulatory processes, automating inefficiencies for faster regulatory clearance.
Essenvia is a Los Angeles, California-based technology company that develops specialized software solutions to streamline complex regulatory compliance and submission processes for the medical device industry. The enterprise platform automates traditionally manual workflows associated with regulatory affairs, enabling medical device manufacturers to reduce administrative inefficiencies and achieve faster market clearance. Operating within the healthcare technology sector, the software is designed to manage the rigorous documentation requirements mandated by major regulatory bodies such as the FDA and EMA. To date, the organization has successfully assisted over 60 medical device companies in securing necessary regulatory approvals for more than 100 distinct healthcare products. While specific funding totals, valuation metrics, and institutional investor names remain undisclosed, the firm continues to focus on transforming medical device regulatory operations. Essenvia was established in 2018 by healthcare technologist Soumya Mahapatra and co-founder Basant Sahoo.
Essenvia has raised $4.7M across 3 funding rounds.
Essenvia has raised $4.7M in total across 3 funding rounds.
Essenvia has raised $4.7M in total across 3 funding rounds.
Essenvia's investors include Benhamou Global Ventures, Kwame Ulmer, Cyberstarts VC, First Rays Venture Partners, Plug & Play Ventures, StageOne Ventures, WestWave Capital, Amir Jerbi, Shlomo Kramer, Yevgeny Dibrov, Pasadena Angels, Rebright Partners.
Essenvia has raised $4.7M across 3 funding rounds. Most recently, it raised $4.0M Seed in May 2023.
| Date | Round | Lead Investors | Other Investors | Status |
|---|---|---|---|---|
| May 1, 2023 | $4M Seed | Benhamou Global Ventures, Kwame Ulmer | Cyberstarts VC, First Rays Venture Partners, Plug & Play Ventures, StageOne Ventures, WestWave Capital, Amir Jerbi, Shlomo Kramer, Yevgeny Dibrov, Pasadena Angels, Rebright Partners | Announced |
| Feb 1, 2021 | $500K Seed | — | Cyberstarts VC, First Rays Venture Partners, StageOne Ventures, Amir Jerbi, Shlomo Kramer, Yevgeny Dibrov | Announced |
| Jan 1, 2021 | $200K Seed | — | Cyberstarts VC, First Rays Venture Partners, StageOne Ventures, Amir Jerbi, Shlomo Kramer, Yevgeny Dibrov | Announced |
Essenvia is a MedTech software company that builds an AI-powered Regulatory Information Management (RIM) platform designed to streamline regulatory workflows for medical device companies throughout the product lifecycle.[1][2][5] It serves regulatory affairs teams at MedTech firms, solving the problem of complex, manual compliance processes by centralizing data, automating submissions (including FDA eSTAR), providing AI-driven regulatory intelligence, and accelerating global market access—reducing submission cycles by up to 3 months and enabling 70% faster submissions.[2][5] With over $9.53M raised, including a $4M seed VC-II round in 2023, Essenvia has supported 350+ submissions and brought 100+ new devices to market, demonstrating strong early growth momentum in the digital health space.[1][2][4]
Essenvia emerged from the need to modernize regulatory processes in MedTech, with founding dates cited variably as 2016, 2018, or 2020 across sources, but consistently operating as a US-headquartered firm in Los Angeles (Woodland Hills area).[1][2][3] The company was founded by innovators focused on expediting time-to-market for medical devices amid fragmented global regulations, evolving from early workflow automation tools to a comprehensive AI RIMS platform.[2][4][5] Pivotal early traction included a $4M pre-A round in May 2023 led by Wavemaker Partners and BGV, fueling platform enhancements, and real-world adoption like Terumo Medical Corporation's rapid 90-day rollout in 2025, highlighting its practical impact on regulatory teams.[4][5]
Essenvia rides the wave of digital transformation in MedTech regulatory affairs, where AI and automation address surging demands for faster global approvals amid stricter post-market surveillance and diverse regional rules (e.g., FDA, EU).[1][5] Timing is ideal as MedTech firms face submission delays costing revenue, with policies like timely adverse event reporting and global strategies amplifying the need for centralized platforms—Essenvia cuts these barriers, enabling 70% faster processes.[1][2] Market forces like rising device innovation (11,315+ digital health vendors) and AI adoption favor it, as seen in successes like Terumo's rollout, influencing the ecosystem by setting a standard for RIM tech that boosts compliance excellence and patient access to innovations.[1][5]
Essenvia is poised to dominate AI RIMS with its submission-speed focus, likely expanding via partnerships and deeper AI features amid 2025 regulatory shifts like enhanced post-market rules.[5] Trends like real-time intelligence across more countries and integration with QMS will shape its path, potentially scaling to enterprise MedTech giants and evolving influence through proven ROI—tying back to its core mission of accelerating life-saving devices to patients.[2][5]