Partner
I have led or supported FDA strategy and submissions for 51+ medical devices, most AI-enabled, since co-founding Innolitics in 2012, across 510(k), De Novo, Breakthrough, Q-Sub, and deficiency responses. My work spans radiology AI (CADe, CADx, CADt, quantitative imaging), cardiac and neuro imaging software, dental AI, LLM and foundation model devices, and I have managed or contributed to 65 Innolitics projects. FDA's public clearance letters for AI Metrics (K202229, 2020) and Medweb's Lightning Viewer (K242362, 2024) name me as the sponsor's correspondent. I presented at FDA's first Digital Health Advisory Committee meeting on generative AI in November 2024, I have published 78 articles on innolitics.com, and I built fda.innolitics.com, our public FDA device search tool.
Partner
I have led or supported FDA submissions for 40+ diagnostic devices since 2012, across 510(k), De Novo, Q-Sub, and PCCP, including cleared 510(k)s for Echo IQ and Prenuvo. I co-founded Innolitics in 2012 and was the named FDA contact on Echo IQ's EchoSolv AS (K241245, 2024) and Prenuvo Body Composition (K242825, 2025); in 2026 I helped GuideAI Health clear a vascular occlusion triage CADt 510(k) without a pre-submission. My work spans radiology AI (CADt, CADe, CADx, quantitative imaging), ECG and signal analysis software, and SaMD cybersecurity across 65 Innolitics projects, and I write our long-form guides on FDA software regulation, cybersecurity, SBOMs, pre-subs, PCCPs, and De Novo requests. I hold biomedical engineering degrees from Boston University (M.S.) and UT Austin (B.S.) and run Innolitics with Yujan, my old friend and business partner.
Director of Regulatory Affairs
I bring 13 years in medical devices and 30+ FDA 510(k) clearances, leading 510(k), De Novo, and Q-Submission strategy for AI/ML SaMD, IVDs, and surgical tools. As Director of Regulatory Affairs at Innolitics, I lead 510(k), De Novo, and Q-Submission strategy for AI/ML SaMD, IVDs, implants, dental and surgical planning software, reprocessed and electromechanical devices, and surgical tools, and FDA clearance letters for Heartvue.ai, Biotics, Zeto, and USA Therm name me as correspondent. I am an ISO 13485 Lead Auditor and have taught AAMI's 510(k), De Novo, and Lead Auditor courses since 2019.
Director of Engineering
I've built, documented, and secured FDA-regulated SaMD for 15+ devices over the past 10 years, spanning radiology, digital pathology, radiation oncology, and non-invasive diagnostics. I've served as a fractional CTO for clients and grown engineering teams to support and maintain cleared devices in the post-market phase. As Director of Engineering, I lead our engineering team at Innolitics while still actively architecting and building software. Notable projects include Mobius3D (K191761, cleared 2019), AI Metrics (K202229, cleared 2020) and Neosoma (K252922, cleared 2025). I'm fluent in Python, Rust, TypeScript, and C/C++, and have extensive experience in medical imaging, cloud architecture, full-stack web, AI/ML applications, and embedded medical devices. I hold a BS in Biomedical Engineering from UT Austin.
Principal Regulatory Specialist
I spent 22 years at FDA's CDRH working 510(k), PMA, De Novo, and IDE pathways, directed more than 150 Advisory Committee meetings, and oversaw all six CDRH advisory committees. I oversaw all six CDRH advisory committees, trained the center's Designated Federal Officers, prepared both FDA review teams and sponsors for panel, and served as Designated Federal Officer for FDA's first Digital Health Advisory Committee meeting on generative AI in 2024. At Innolitics I bring that reviewer-side view to regulatory strategy, Q-Subs, 510(k) and De Novo submissions, and hold responses for software and AI/ML devices.
Principal Regulatory Specialist
Over 15 years I have taken 9 devices building them from ideas on a whiteboard through FDA and CE clearance, and now work on 510(k), De Novo, and pre-sub strategy for AI SaMD at Innolitics. I have helped clients raise $22mn in grants and $25mn in seed capital. On an engagement I own product, regulatory, and reimbursement together: I set the claims, design the validation study, run the pre-sub, and carry the 510(k) or De Novo through FDA questions with CMS coverage in view from day one. I developed the firmware and co-authored the 510(k) for a bedside device data platform cleared in 2011/2013 and deployed to 5,000 beds across 12 health systems, led product for the 2008T BlueStar hemodialysis machine cleared in 2018, and won FDA agreement on validation designs for five AI imaging devices, saving one client over $400K. At Innolitics I work on 510(k)s for CT coronary calcium and body composition AI, a De Novo for an AI guided exercise therapy SaMD, and AI/ML pre-sub strategy for a teleradiology group. I hold an MS in Electrical Engineering from the University of Pennsylvania, five global patents, and a Stanford AI in Healthcare certificate, and I judge for MedTech Innovator and the CES Innovation Awards.
Principal Regulatory Specialist
As a former FDA acting branch chief and lead medical device reviewer with nine years at CDRH, I advise 17 AI/ML SaMD projects across De Novo, 510(k), and IDE pathways. At Innolitics I guide founders and funded AI/ML device companies through classification, Pre-Sub responses, and submission strategy. Before Innolitics I was Senior Director of Regulatory Affairs and Quality Assurance at ConvaTec and Senior Vice President of Regulatory Affairs at AscentX Medical, worked at St. Jude Medical, and founded FDA Blueprint and Mr. Regulatory, helping [X] startups win IDE approvals and 510(k) clearances. I teach Regulatory Submissions for Medical Devices at UC San Diego Extended Studies, presented at RAPS Convergence 2024, and am a founding member of the Kidney Health Initiative. I hold a Master of Mechanical Engineering from Johns Hopkins University and a BSE in Biomedical Engineering from Case Western Reserve University.
Principal Regulatory Specialist
I recently retired from Johnson & Johnson where I specialized in PMA class 3 orthopedic implantables. I have achieved more than 70 FDA 510(k) clearances over 30 years, including 14 Special 510(k) clearances and 4 Breakthrough Device Designations. I led an engineering team in the commercialization of a revolutionary medical device for staging blood cancers in which we won a Silver Award for Medical Device Innovation in 2001. In addition, I advised an AI/ML startup for over 10 years from inception to a successful acquisition for over 100 million dollars. I have advised on 2 projects which led to MRI’s being used during brain surgeries and being placed near the Neonatal ICU. During the Pandemic, I obtained an Emergency Use Authorization from the FDA and later obtained the 510(k), with clinical data from the Mayo Clinic, for a therapeutic medical device to help patients recover from COVID. When the remote work revolution became a reality, I established a successful side-hustle which led to over 80k dollars in earnings and top rate status because a the magnitude of positive customer feedback. Currently, I am a mentor and lecturer for the Master’s Program at a world renowned university. I have survived 9 face-to face FDA Inspections (survival = no Warning Letter). Yearly, I donate a percentage of my time Pro Bono to advance medical device technologies which are worthy and will make a difference. I hold RAC, ASQ Certified Quality Engineer, and ASQ Certified Medical Device Auditor credentials.
Director of Business Development and Growth
I launched Innolitics' first two Business Wire press releases in one week in 2026: an FDA Breakthrough Device partnership with BEACON-Neuro.AI and Heartvue's 510(k) clearance, turned around in 3 days. Since joining Innolitics in April 2025 I have run our marketing: the AI/ML device recap newsletter, Google Ads campaigns, the SIIM26 conference materials, and the 2026 website revamp. I also lead hiring, screening and scheduling interviews for regulatory affairs, AI/ML, and medical device software roles. Before Innolitics I spent over 10 years in healthcare business development, care navigation, behavioral health, and telemedicine, and co-founded MatrixMD, which built tablet-based patient check-in and intake for clinics.
Physician Engineer
In under two years at Innolitics I helped six AI/ML imaging devices reach FDA 510(k) submission, after clearing my own Class II radiation therapy device in 2024. I earned my PhD in biomedical engineering and my MD at Wake Forest, trained in radiation oncology at the University of Miami, spent five years as an assistant professor of radiation oncology at the University of Cincinnati, and then built and cleared my own deformable image registration software as a startup CTO, publishing the method in Physics in Medicine & Biology in 2019. At Innolitics I work the seam between clinic, code, and FDA: study design, standalone and MRMC performance testing, pre-submissions, FDA orientation meetings, and deficiency responses for imaging AI in radiology, oncology, and dentistry. I spoke at RSNA 2025 on taking a device from bench to bedside.
Director of Admin/Finance
A theoretical physicist with three years in EdTech and three-plus years of operations and project management, I have run admin and finance at Innolitics since June 2024. In 2023 and 2024 I co-wrote Innolitics' own ISO 13485 quality system with the regulatory team, drafting the CAPA and management review procedures and the clause 6 through 8 justifications. I sit on the weekly leadership and sales team meetings, so budgets, invoicing, and contract terms for your engagement run through me. Before Innolitics, I trained as a theoretical physicist and spent over three years in operations and project management.
Senior Software Engineer I
Since 2021 at Innolitics I have written software and submission documentation for 510(k), De Novo, and IDE packages across 13 client projects and managed three of them. On an engagement I write the code, the IEC 62304 design and verification records, and the cybersecurity files (SBOM, architecture views, security risk management) that FDA reviewers read, then cut the signed releases. I built a DICOM worklist and PACS export application that made one client its first sale after integrating with the VA VistA PACS, and I led a four year image processing pipeline that now processes experiments more than 10x faster. I wrote Innolitics' guide to integrating with the VA VistA PACS and hold a B.S. in Applied Mathematics from the Colorado School of Mines, magna cum laude. I work in Python, MATLAB, TypeScript, and AWS, and I keep the client in the loop while I run down the hard bug.
Senior Software Engineer II
Since 2025 I have supported 11 medical device cybersecurity engagements and 3 FDA submissions, two 510(k)s and one De Novo, with threat models, SBOMs, and penetration tests. Before that I spent 2 years maintaining the Varian Mobius 3D radiotherapy QA system and 10 years at an aerospace firm, including DO-178C software for an FAA-certified helicopter cockpit instrument. My deliverables follow the FDA premarket cybersecurity guidance, ANSI/AAMI SW96, and AAMI TIR57: threat models, security risk assessments, SBOMs, and penetration tests of web, mobile, and firmware attack surfaces.
Senior Software Engineer I
I have 13 years of experience in medical imaging AI/ML, 12 publications, and have contributed to four FDA 510(k) clearances for AI/ML-enabled SaMD. At Innolitics, I specialize in statistical analysis, MRMC clinical validation studies, and regulatory documentation for CADe/x and SaMD devices. Previously, I conducted PET/CT radiomics research at the University of Iowa and led software development at a medical AI startup, helping bring a device from concept through FDA clearance.
Senior Software Engineer II
Deep learning for imaging is my specialty: CT, X-ray, and otoscopy algorithms since 2017, an FDA cleared coronary calcium product, a RadUnity 510(k) amendment, and PhotoniCare's otitis media detector. At Innolitics I have contributed to 14 projects for 9 medical device clients since 2023 and led 7 of them as project manager, including PhotoniCare's otitis media detection algorithm from digital otoscopy and a real-time tympanic membrane segmentation MVP. Earlier, at National Jewish Health and Imbio, I wrote 510(k) documentation and co-authored a 2019 Radiology paper on deep learning classification of emphysema at CT and an International Forum of Allergy and Rhinology paper on automated sinus opacification quantification. I am currently supporting verification and validation for a De Novo AI/ML chest X-ray SaMD and cybersecurity documentation for a 510(k).
Senior Software Engineer II
I hold a PhD in applied mathematics, 3 lung CT publications, and have significantly contributed to multiple imaging AI/ML 510(k) submissions to FDA, 2 cleared. The most recent, Heartvue.ai, was cleared in 5.5 months, and included performance evaluation strategy and plan for 20 ML models and a PCCP. Before that, I led development of RadUnity's web DICOM ingestion and routing platform through its 2024 510(k) clearance. I maintain pylidc, an open-source Python library for the LIDC lung CT dataset. I build across the stack: from algorithm and ML engineering to data engineering to full web stacks to desktop C++ applications.
Senior Software Engineer I
At Innolitics since 2024, I have supported four device programs under IEC 62304, from a Class III IVD PMA submitted in 2026 to a Class II embedded Qt device. I build Qt/C++ desktop and embedded applications, including a DICOM image-analysis app for a quantitative CT product and the UI for a Class II device, and I have worked on four device programs at Innolitics since 2024. I hold a BS in Computational Biomedical Engineering from UT Austin and am completing an MS in Computer Science at Georgia Tech.
Medical Device AI/ML Engineer
I spent five years building HL7 interfaces to Epic, Athena, Veradigm, and eCW, and now write the performance evaluation plans and pipeline code behind AI/ML 510(k) submissions at Innolitics. On an engagement I write the performance evaluation plan, the algorithm development plans, and the device output inventory that an FDA reviewer will read, then build and test the pipeline code behind them. In 2026 I drafted the performance evaluation plan and centerline development reports for a coronary CT analysis device preparing a 510(k) after its FDA Pre-Sub, and I shipped 14 features (DICOM de-identification, upload telemetry, database backups, offline in-browser de-id) to a research hospital's clinical trial imaging portal, including the verification test record its sponsor's auditor requested. I hold an MS in Computer Science from Georgia Tech, a BS in Aerospace Engineering from UCF, and the InterSystems HL7 Interface Specialist certification, and I presented healthcare interoperability work at HIMSS 2026 and cardiac arrest prediction from EKG data at InterSystems READY 2026. Improving patient health at scale is the mission I signed up for.
Senior Software Engineer I
In 4 years of FDA-regulated device software I have carried a 510(k) AI-enabled SaMD to clearance and now support De Novo and 510(k) submissions for AI/ML SaMD at Innolitics. I led the PCCP implementation inside the QMS for controlled post-market model updates, and wrote the requirements, architecture, ISO 14971 risk management, and V&V documentation under IEC 62304 and ISO 13485. At Innolitics I work on De Novo and 510(k) submissions for AI/ML SaMD, including retrieval-augmented and foundation-model systems, from Pre-Sub strategy through verification and validation. I hold a bioengineering degree from the University of Colorado Denver.
Intern Engineer
I study data science at UC Irvine and, since June 2026, have audited 2 client 510(k) eSTAR packages and completed 6 features for Innolitics' submission software. My work covers eSTAR metadata parsing, the submissions interface, and the image and LaTeX equation transcription pipeline. I am a data science student at UC Irvine, based in the Bay Area.
Senior Medical Device Software Engineer
I authored the 510(k) that cleared eye-tracking neuro-diagnostic software in 2018 (K181025), co-invented four US patents, and co-authored sixteen PubMed papers on oculomotor testing and brain-computer interfaces. At Neuro Kinetics I was lead developer and project manager for the VEST eye-tracking platform, owning design controls, verification and validation, IEC 62304 documentation, and the ISO 13485 quality system, and I led the company's pre-submission meeting with FDA. I am co-inventor on four US patents for concussion screening and neurological rehabilitation and co-author of sixteen PubMed-indexed papers on brain-computer interfaces, oculomotor testing, and concussion. I hold a PhD in Neuroscience from the University of Pennsylvania and an MS in Mathematics and Computer Science, and I write Python, C++, and LabVIEW. At Innolitics I help clients take software-driven devices from design input through verification, cybersecurity documentation, and submission.
Senior Regulatory Affairs Specialist
I have led or supported 15+ FDA 510(k) clearances — primary correspondent on 8 — including a Special 510(k) cleared in 29 days and AI/ML-enabled SaMD for CT, MRI, and dental radiography. Since joining Innolitics in February 2023, I have project-managed 13 client engagements and personally led six clearances through FDA review: BodyCheck's CT Cardiomegaly (K232613), Radical Imaging's FlexView Diagnostic DICOM viewer (K233226), Smile Dx's dental CADe (K242437), GECHO contrast-echocardiography analysis software (K250120), Neosoma's brain-metastasis segmentation software (K252922), and AdvaHealth Solutions' AdvaView radiological image-processing software (K262449). I advise on complex strategies with little established precedent including generative AI (LLM and VLM) devices, Device versus Non-Device CDS determinations, non-device classifications, and premarket submission exemptions; for small and large, domestic and foreign, multidisciplinary teams; have drafted De Novo and Breakthrough Device submissions. I co-authored The Ultimate 510(k) Checklist on the Innolitics blog and hold a B.S. in Biomedical Engineering from UT San Antonio.
Admin Assistant
Five years in executive assistant, operations, and marketing roles at four companies preceded Innolitics, where since October 2024 I handle statements of work and project tracking for 510(k) engagements. I run the semiannual performance review cycle, onboard new hires, and organized the 2026 team retreat, and I have supported [sensitive: 13 client accounts across 17 projects] since joining. I hold a Master of Mathematics from Kyiv National University (2025) and a bachelor's degree in marketing and PR, and I bring five years of operations and administrative experience working in English, Ukrainian, and German.
Sales Manager
Have an AI SaMD and no regulatory plan? I am usually your first call at Innolitics, scoping 510(k), De Novo, Breakthrough Device Designation, and Pre-Sub engagements since August 2025. From 2020 to 2025 I sold into pharmaceutical and medical device manufacturers, managing a $24.5M territory and a $30M pipeline across GLP-1, oral solid dose, vaccine, and medical device products. I hold a Lean Six Sigma Green Belt. I am usually the first person you talk to at Innolitics, and I stay in the client channel after the SOW is signed.
Associate Quality/Regulatory Specialist
I submitted three 510(k)s in my first year at Innolitics, including Zeto's New Wave EEG system (K260455), which FDA cleared in 30 days with no hold. I have advised on and managed a variety of regulatory engagements, including Breakthrough Device Designation, De Novo, 510(k) submissions, and supported five Pre-Submissions through their FDA meetings. My experience covers a diverse range of medical technologies, including EEG, dental AI, radiology, mental health, surgical guidance, and other AI/ML-enabled software as a medical device. I also serve as project manager, coordinating cross-functional teams, client deliverables, and FDA-facing activities. I hold a BS in Biomedical Engineering from the University of Texas at Austin.
Associate Quality/Regulatory Specialist
Since joining Innolitics in November 2025 I have managed 13 regulatory engagements across 510(k), De Novo, and Pre-Sub pathways, submitting 2 510(k)s and 2 Pre-Subs in 2026. Before Innolitics I ran quality and regulatory for a neuromonitoring SaMD company, where I built an eQMS to 21 CFR 820, ISO 13485, and IEC 62304, authored 35+ technical documents, and led ISO 14971 risk management. At Innolitics I have managed 13 regulatory engagements, including a De Novo for an AI/ML SaMD and Deep Reasoning AI's regulatory strategy, and I hold BS and MS degrees in Biomedical Engineering from Drexel. Outside work I play basketball and squash and hunt down the best happy hours in any city I visit.
Associate Quality/Regulatory Specialist
At Innolitics, I manage regulatory engagements across the 510(k), De Novo, and Pre-Sub pathways. I have prepared four FDA Pre-Submissions and drafted a Breakthrough Device Designation request, usability engineering files, and risk analyses for AI/ML software devices. I also co-authored Innolitics’ published analysis of FDA clearance pathways for whole-slide imaging AI algorithms. Before joining Innolitics, I helped startups develop and launch cutting-edge medical technologies, including supporting a De Novo submission through FDA authorization and an IDE submission, establishing a device manufacturing line and production processes, and building quality management systems and design and development files from the ground up in alignment with 21 CFR Part 820 and ISO 13485. I hold ISO 13485 Lead Auditor and IEC 62304 certifications and earned a bachelor’s degree in Biomedical Engineering with a minor in Neuroscience from Drexel University.
Senior Regulatory Affairs Specialist
If your AI/ML SaMD has no predicate, I have run the De Novo path, pre-sub through eSTAR, submitted in under three months, backed by 10 years of 510(k) work. Since joining in May 2026 I have led 8 Innolitics engagements spanning 510(k), De Novo, pre-submissions, an IDE, and QMS audits, and contributed to 5 more. Before Innolitics I consulted at Medical Device Academy, and have three 510(k) clearances in gynecology and urology in the FDA database under my name. I hold a Pharmacy degree and a Masters in Regulatory Affairs (Medical Devices) & I am a certified ISO 13485 Lead Auditor. I have handled AINN responses, SIR meetings, and FDA inspection readiness, and have helped founders and C-suite teams pick the pathway that fits their timeline and budget.
Senior Regulatory Affairs Specialist
Over 5+ years leading FDA submissions I have taken a SaMD through 510(k) clearance (K222359), Health Canada licensing, and CE marking, and led 5+ MDSAP and ISO 13485 audits. I hold RAC-Devices, P.Eng, and ISO 13485 Lead Auditor credentials, have led 5+ MDSAP, ISO 13485, and MDR audits, and speak at RAPS Convergence, RAPS Euro Convergence, and INCOSE on AI/ML SaMD regulatory strategy, PCCPs, and GMLP. At Innolitics I manage FDA Pre-Submissions and 510(k) programs for AI/ML SaMD clients, including a completed Pre-Sub for Apellai. I do this work because safety-critical software reaching patients matters, and the best part is digging into a team's hardest problems together.
AI/ML Regulatory Engineer
I helped build two AI models, one at 93% recall on pancreatic whole slide images, one predicting rupture on a 1,065-patient brain AVM registry, and now support 510(k) submissions. I earned an M.S.E. in biomedical engineering from Johns Hopkins in 2026 with a focus on AI in healthcare, and I joined Innolitics as an AI/ML Regulatory Engineer to carry clinical AI from validated prototype to FDA clearance. I currently contribute to a 510(k) submission for a medical image viewing device. Before Hopkins I built a healthcare chatbot with retrieval-augmented generation as a data scientist at Mindsprint and did wet-lab immuno-oncology research at Harvard Medical School and Brigham and Women's Hospital, so I can hold both the clinical and the engineering side of a regulatory conversation.
Medical Device Cybersecurity Specialist
As a medical device cybersecurity specialist, I have supported over 20 FDA 510(k) clearances, including AI and SaMD submissions. I bridge engineering and regulatory teams on submissions and align processes with FDA QMSR. I have 2.5 years in medtech cybersecurity; before that I supported hospital EMR infrastructure.
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