Elucid raises $55M Series D with FFR-CT 510(k) under FDA review
Elucid closed a $55M Series D on September 2, 2026, backed by a fourth public medtech strategic, IAG Capital Partners and Elevage Medical Technologies. Total funding for the Boston company reaches about $185M as its BioIntegrated FFR-CT 510(k) sits under FDA review.
Every 510(k) clearance and original PMA approval from the last 12 months, with panel, product code and applicant, matched against the startup directory. 3,145 decisions on file, newest Aug 16, 2026.
BUILD YOUR SUBMISSION
Six stages, from “does Section 524B apply” to the metrics you report after clearance, every requirement cited to FDA’s February 3, 2026 guidance.
The same gaps recur across premarket and postmarket review. Here is the deficiency language reviewers actually send, paired with what the guidance says closes each one.
PathwayThe pathway decides your evidence, your timeline and your fee. Here is how the three fit together, the FY2027 numbers, and the small business determination that cuts a 510(k) fee by three quarters.
ResourcesThe eSTAR checklist, cover letter, substantial equivalence table, predicate log, Pre-Sub package, threat model, SBOM report and the rest, in editable Word and Excel.
THE FRONT
FDA cleared Wandercraft's Eve exoskeleton (K260381) on August 3, 2026, for adults with spinal cord injury at any level to walk hands-free at home. The Paris company, which raised a $75M Series D in June 2025 with Renault Group and Bpifrance, plans a U.S. launch on September 17.
Series BMeduloc closed a $4M Series B led by GenHenn Capital on August 6, 2026. The West Chester, PA company's nitinol Intramedullary Fracture Fixation System, cleared under K250316 in October 2025, enters a controlled alpha launch this month.
MDUFAFDA published fiscal year 2027 medical device user fee rates on July 30, 2026, effective October 1. The standard 510(k) fee rises to $28,653 and the small business rate to $7,163, while the establishment registration fee climbs to $13,785 with no small business discount.
De NovoFDA granted Caristo Diagnostics a De Novo (DEN250042) for CaRi-Heart on July 28, 2026, creating a new class of predictive indicator for long-term cardiovascular outcomes. The Oxford spinout's software quantifies coronary inflammation from routine coronary CT angiography and reports a 10-year cardiac mortality risk.
SeedAurenar closed an oversubscribed $5.7M seed round on July 28, 2026, co-led by the AHA's Go Red for Women Venture Fund and Solas BioVentures. Its V-Link ear-worn vagus nerve stimulator for vasospasm after subarachnoid hemorrhage got FDA Breakthrough designation on June 30.
PMAFDA granted premarket approval to Freenome's SimpleScreen CRC (P250029) on July 24, 2026, a blood-based colorectal cancer screen for average-risk adults 45 and older. The approval earns Freenome a $100M milestone from Abbott, which holds exclusive U.S. commercial rights, three days after the company began trading on Nasdaq.
NOTABLE DECISIONS
| Decision | Number | Device | Applicant | Panel | Code |
|---|---|---|---|---|---|
| Aug 12, 26 | K262399510(k) | Millipede System | Perfuze, Ltd. | Cardiovascular | NRY |
| Aug 11, 26 | K261398510(k) | Dexter L6 System | Distalmotion SA | General, Plastic Surgery | SDD |
| Aug 4, 26 | K261523510(k) | Vertex Thrombectomy System | Jupiter Endovascular | Cardiovascular | QEW |
| Aug 3, 26 | K260381510(k) | Eve | Wandercraft SAS | Physical Medicine | PHL |
| Jul 28, 26 | DEN250042510(k) | CaRi-Heart | Caristo Diagnostics , Ltd. | Cardiovascular | SIU |
| Jul 27, 26 | K261105510(k) | Powered Aventus Thrombectomy System | Inquis Medical | Cardiovascular | QEZ |
| Jul 24, 26 | P250029PMA | SimpleScreen CRC | Freenome, LLC | Medical Genetics | PHP |
| Jul 22, 26 | K261113510(k) | Op.n Spine Navigation and Robotic Guidance | Ecential Robotics | Neurology | OLO |
A working directory of medical device startups from the last five years, by category, with FDA status and funding where it is public.