As digital therapeutics (DTx) carve out their place in the medical device landscape, navigating the regulatory requirements remains one of the biggest hurdles. This is why guidance from experts like Lindus Health Adviser Acacia Parks PhD, MBA, RAC is so valuable! In a recent Q&A with Today's Medical Developments Magazine, Acacia shares critical insights for DTx developers, including: 🍊Why DTx require intensive clinical studies, even when similar products already have FDA clearance 🍊The importance of early and frequent FDA presubmission meetings 🍊How to approach novel regulatory pathways when blazing new trails Her advice? "Don't be afraid to talk to the FDA. Submit early and often!" Read the full article: https://lnkd.in/duVs5tfH #DigitalTherapeutics #DTx #FDA #ClinicalTrials #MedTech
Lindus Health
Research Services
Boston, Massachusetts 15,890 followers
We are the anti-CRO running radically faster, high-quality clinical trials for life science pioneers.
About us
Lindus Health is an anti-CRO running radically faster, more reliable clinical trials for life science pioneers. We do this thanks to a commercial model that aligns incentives (fixed-price quotes per study, with milestone-based payments), marrying a world-class clinical operations team with our AI-software platform, and access to 40 million Electronic Health Records. We handle the end-to-end execution of clinical studies, including design, patient recruitment, clinical data capture, monitoring and project management. We have helped over 40 sponsors run entire clinical studies across the US, UK, and Europe up to 72.9% faster than traditional CROs.
- Website
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https://www.lindushealth.com/
External link for Lindus Health
- Industry
- Research Services
- Company size
- 51-200 employees
- Headquarters
- Boston, Massachusetts
- Type
- Privately Held
- Specialties
- Trial Design, Recruitment, Trial Delivery, and Clinical Trials
Locations
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Primary
Get directions
145 Tremont St
Boston, Massachusetts 02111, US
Employees at Lindus Health
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Malcolm Fogarty
Global Growth & Scale-Up Leader | Lindus Health, GSK, Haleon, Heineken | Consumer & Health Innovation, Strategic Partnerships, Commercial GTM |…
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Gemma Harrison
VP of Engineering @ Lindus Health | Energetic, driven and collaborative software engineering leader, passionate about inspiring and promoting women…
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Rogier Van Willigen
Strategy & Operations Leader | FinTech | ex-Stripe, ex-Founder | INSEAD MBA
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Edna K.
Senior leader and innovator in clinical research operations, driving excellence in project execution.
Updates
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It’s London Life Sciences Week! 🧬 Don’t miss our Co-CEO Meri Beckwith November 19th at the Bench to Business Showcase in London on a panel with Benjamin Swerner (COO, Relation Therapeutics) and John Baker (CEO, IMU Biosciences) for an exciting discussion about the impact of #AI on biotech! Reserve your spot here: https://lnkd.in/dZ8-wuRQ
From lab benches to boardrooms, London’s innovators are shaping the future of global health.💡🧬 As part of our Bench to Business London Showcase, London's most promising early-stage life sciences companies are stepping into the spotlight at London Life Sciences Week. 🤝 Join us at the London Life Sciences Week Pavilion, 180 Studios on 19 November 2025, for a day dedicated to the early stage and scaleup companies ready for transforming science into real-world solutions. 🚀 Series A+ Pitches: Hear from London’s Series A+ trailblazers driving global growth and impact: ⚡Micrographia Bio ⚡Signatur Biosciences ⚡Epsilogen Ltd ⚡Echopoint Medical Ltd ⚡Hypervision Surgical ⚡Entia ⚡Charco 🌱 Seed to Series A Pitches: Meet the emerging innovators moving from lab to market and shaping the future of healthcare ⚡Axovia Therapeutics ⚡LIfT BioSciences ⚡MediSieve ⚡P.Happi® ⚡Genevation LTD ⚡Vivan Therapeutics ⚡Nilocas AI 🎙️And also hear from them: 💫 Dr Nara Daubeney PhD, CEO, Phaim Pharma Ltd 💫 Meri Beckwith, CEO, Lindus Health 💫 Dr Raj Mehta, CEO, Adendra Therapeutics 💫 Dr Shakiba Kaveh, CEO, Mitra bio 💫 Benjamin Swerner, COO, Relation Therapeutics 💫 Dr John Baker, CEO, IMU Biosciences 💫 Dr Christina Coughlin, CEO, Avacta Therapeutics Bench to Business Showcase is a rare opportunity for investors to connect with London’s most exciting early-stage ventures, explore scalable innovations, and discover high-potential opportunities backed by world-class science and leadership. 🔬 Come join us where breakthroughs meet business.
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We’re extremely grateful to have been listed in MedCity’s 2025 Life Sciences Companies to Watch. This recognition underscores our dedication to transforming the traditional CRO model with cutting edge technical innovations, patient first study designs, and delivering clinical trials for innovative medication at the highest quality and speed in the industry. Read the brochure to see our profile and the full list of teams pioneering changes in the healthcare industry: https://lnkd.in/eDX2PEND
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Does Wealth = Health? In Livelong Media™'s recent article, Lindus Health Medical Monitor Dr.Anita Phung shares why women are losing years from dismissive and inflexible healthcare. Anita’s expert recommendations for women to help take control of their health: 🧘🏻♀️Move your body 🥑Feed your gut 🧠Expand your knowledge Read more here: https://lnkd.in/df_GDBTS
Portfolio GP | Research Physician and Medical Monitor at Lindus Health | Pharmaceutical Medicine | Digital Health | Clinical Safety Officer | Health Optimisation
Grateful to be featured in the Livelong Newsletter discussing how healthcare barriers impact women's longevity ➡️ https://lnkd.in/epweR3QE My key message: accessible, flexible healthcare and foundational health habits - strength training, mobility work and metabolic health - can help level the playing field for women's healthspan. Thank you Tiffany Nieslanik!
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We’re a Rising Star! ⭐ Last Thursday, Hannah Gledhill, Chief of Staff and Program Operations Director, and Sarah (Craig) Moore, Associate Director of Clinical Operations, attended Deloitte’s Fast 50 awards ceremony, where Lindus Health was recognized as a rising star for our commitment and achievements in innovation. Thank you for having us - we had a blast! Read more here: https://lnkd.in/drGKKcd7
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We’re proud to share that Lindus Health has been recognized in Accel’s Globalscape Report in the Vertical AI category as one of the Top 100 Artificial Intelligence and Cloud companies to watch. The annual report highlights companies, technologies, and trends that are defining the next generation of innovation with #AI. 🔗 At Lindus Health, we’re using in-house technology and AI to reimagine clinical trials—making them faster, more efficient, and more accessible. Read the full report: https://lnkd.in/dEKE_fvc
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Last chance to sign up for our webinar tomorrow featuring Meri Beckwith and Malcolm Fogarty from Lindus Health, alongside Dr. Thomas Gurry, Co-Founder & CSO at myota. Our panel will explore how leading consumer health brands are building science-backed evidence, without pharma-scale timelines or budgets. You’ll learn: 🍊 How to make clinical evidence into your competitive edge 🍊 Smarter, pragmatic study designs that reflect real-world use 🍊 What “medical-grade evidence” really means for consumer health Save your seat today 👇 https://lnkd.in/d5a2ShCR #consumerhealth #clinicaltrials #consumerhealthCRO
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“People are validating health claims and checking side effects in real time — scanning barcodes, reading reviews, even asking AI." In the latest episode of Off Protocol, Meri Beckwith sits down with Malcolm Fogarty to explore how the consumer health landscape has evolved — and why brand trust now depends on transparency and scientific credibility as much as marketing. 🎧 Listen now on all major podcast platforms: https://lnkd.in/d9hfuJWv #podcast #consumerhealth #clinicalevidence #consumerhealthCRO
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Will we see you at Frontiers Health? Catch our Co-CEO Meri Beckwith on November 11 and 12 in Berlin, celebrating 10 years of health innovation at #FH25 - connect to discuss how Lindus Health is driving healthcare change with AI-enabled, faster, and more reliable clinical trials.
10 years. Countless breakthroughs. One unstoppable mission: shaping the future of health—together. Frontiers Health isn’t just about ideas—it’s about people, companies, and bold visions turning into reality. This 11–12 November in Berlin, we’re celebrating a decade of innovation, collaboration, and impact—with some of the most forward-thinking health companies joining us. Expect insights, cutting-edge solutions, and a glimpse into the future of #DigitalHealth, #DigitalTherapeutics, #HybridCare, #DTC, #AI, and personalized care. Two days. Infinite inspiration. Powerful networking. Hands-on sessions that spark the next big thing. This is where the future of health begins. Be there. Shape it. Lead it. 1000Farmacie Absci Aignostics ArcaScience Captain T Cell Caresyntax Click Therapeutics, Inc. Clue dacadoo Daye ETERNO HealthHero HelloBetter InsideTracker Lapsi Health Leafwell Lindus Health Nelly Solutions NeuroNation - Mind & Brain Health Technology Newel Health Numan One Health Biosensing Oviva Paginemediche Perfood Prenuvo Psyon Games S3 Connected Health SIME Diagnostics Sidekick Health Spectrum.Life Teladoc Health TESSAN Tonic Easy Medical Volv Global SA Wellster Healthtech Group YourCoach.Health #FrontiersHealth #FH25 #HealthInnovation
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A huge round of applause! 👏 This week, George Morriss, Lindus Health Director of Talent Acquisition (TA) was named in HIGHER Community’s #Talent100 list celebrating the most innovative and impactful TA leaders. As Co-CEO, Michael Young put it best, “We wouldn’t be where we are today without him.”
Grateful to be featured in the 2025 Talent100 List by HIGHER Community. Even more grateful to be part of an ambitious team at Lindus Health that has deep buy-in to building incredible talent density and delivering radically faster, more reliable clinical trials. The book showcases the full list of winners alongside strategies, insights, and journeys of those shaping the future of hiring. Download Talent100 here: https://lnkd.in/ebmugrcD #Talent100
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