Medical device startups from the last five years, by category. FDA status comes from the clearance tracker where an applicant matches; funding figures are public numbers only. Cybersecurity is listed first because every submission now needs one.
Section 524B made cybersecurity a premarket requirement for every cyber device. These are the companies that do the testing, the SBOMs, the threat models and the postmarket monitoring for device makers who do not have a security team.
Continuous security testing and vulnerability management for medical device manufacturers, sold as a subscription rather than a one off penetration test. Sponsors the cybersecurity desk and the Section 524B templates on this site.
Provides asset discovery and risk management for IoMT, IoT and OT devices, including vulnerability prioritization, device patching and segmentation orchestration. Founded by Shankar Somasundaram, who previously ran IoT security at Symantec.
Consultancy that handles premarket cybersecurity for device makers: penetration testing of hardware, firmware, apps and cloud, plus threat modeling, SBOMs and the documentation that goes into 510(k), De Novo and PMA submissions. Founded by Christian Espinosa.
Runs a risk management network that health systems use to assess vendors, products and medical devices, covering third-party, enterprise and AI governance risk. The vendor catalog covers tens of thousands of products, so device makers are assessed through it.
Runs a platform that inventories connected medical and IoT devices on hospital networks, then tracks their vulnerabilities, flags threats and supports network segmentation. Customers include RWJBarnabas Health and several NHS trusts.
Analyzes device firmware and binaries to generate SBOMs and find vulnerabilities, and automates the security evidence manufacturers file for FDA and other regulators. Serves medical device, automotive, energy and industrial makers.
Sells software and services that medical device manufacturers use to handle product security: SBOM and vulnerability management through Helm, encryption and key management through Guardian, plus threat modeling and premarket submission support.
Provides device cybersecurity services across the product lifecycle: threat modeling, penetration testing, SBOMs, vulnerability scanning and postmarket plans for regulatory submissions. In March 2026 it launched BRIDGE, a platform for passing security advisories from manufacturers to hospitals. Led by CEO Michelle Jump.
Sells embedded runtime protection and observability for connected devices, using integrity verification built into device firmware rather than a network agent. Medtronic is a named customer.
Structural heart, electrophysiology, vascular access and cardiac monitoring.
Neuromodulation, brain-computer interfaces, stroke and neurodiagnostics.
Assays, point-of-care testing, sequencing and lab instruments.
Software as a medical device, AI decision support and digital therapeutics.
Surgical robots, navigation, instruments and energy devices.
Implants, biologics, spine hardware and sports medicine.
Ultrasound, MRI, CT, optical imaging and image analysis.
CGM, insulin delivery and metabolic monitoring.
Ventilation, sleep apnea, airway and pulmonary devices.
Patches, wearables, home monitoring and hospital-at-home hardware.
Fertility, maternal health, pelvic and breast health devices.
Tumor treatment, ablation, radiation and cancer detection devices.
Eye, ear, nose and throat devices and implants.
Dental implants, aligners, imaging and chairside tools.
Exoskeletons, prosthetics, physical therapy and assistive devices.
Pumps, injectors, inhalers and combination products.
Endoscopy, incontinence, kidney and gastrointestinal devices.
Consultancies, test labs, CROs and submission specialists that serve device startups.
Contract manufacturers, components, materials and packaging.
Builds PlaqueIQ, FDA-cleared software that quantifies plaque composition from coronary CT angiography, and a BioIntegrated FFR-CT product under FDA review.
Builds the Op.n surgical platform, which combines 2D and 3D imaging, navigation and robotic guidance for spine and orthopedic procedures, and is open to third party implants and applications. Enovis agreed to acquire the company in September 2026.
Builds Aletta, an autonomous robotic blood-draw device that images the vein, inserts the needle and collects the sample. CE-marked in Europe; FDA granted De Novo authorization in August 2026.
Makes the Minima Stent System, a balloon-expandable growth stent for pulmonary artery stenosis and coarctation of the aorta in neonates and infants. Approved under PMA P240003 in August 2024.
Jupiter Endovascular builds the Vertex catheter system, which uses pressurized transforming fixation to hold position in the pulmonary arteries for clot removal.
Builds self-balancing walking exoskeletons for rehabilitation clinics and for personal use by people with spinal cord injury.
Makes a flexible nitinol intramedullary implant for long-bone fracture fixation in adults and children. Cleared under K250316 in October 2025 and in a controlled alpha launch.
Developing a non invasive brain stimulation device patients can use at home, in FDA pivotal trials for major depressive disorder with pilot work in Alzheimer's and Parkinson's disease.
Enovis signed a binding offer on September 1, 2026 to acquire Grenoble surgical robotics company eCential Robotics for 155 million euros, plus up to 35 million euros in milestone payments. The deal is expected to close at the end of 2026.
Resmed completed its $340 million acquisition of Noctrix Health on June 1, 2026. Noctrix makes Nidra, a wearable nerve stimulation device for restless legs syndrome that FDA authorized through De Novo DEN220059 in 2023.
MedTech Innovator named 65 companies to its 2026 accelerator cohort on May 27, 2026, drawn from 1,835 applicants. The cohort competes for $800,000 in non-dilutive prizes across finals in Boston in October and San Diego in November.
Stryker agreed on April 13, 2026 to acquire Amplitude Vascular Systems, then disclosed in a May 11 SEC filing that the deal is worth up to $835 million: about $435 million in cash plus up to $400 million in milestones. The Waltham company's Pulse IVL system is still investigational.
Johnson & Johnson agreed on April 27, 2026 to acquire Atraverse Medical, the Cardiff by the Sea company behind the Hotwire radiofrequency guidewire for left-heart access. Terms were not disclosed and the deal was expected to close in the second quarter of 2026.
Sight Diagnostics dismissed its roughly 20 remaining employees in April 2026, ending a 15-year run that raised about $124 million. Its OLO blood count analyzer had FDA clearance under K190898 and K211840.
Tulyp Medical came out of stealth on November 3, 2025, announcing an FDA 510(k) submission for a pressure-driven perfusion system after a first-in-human leg artery bypass case. The Paris company was built inside Sofinnova's MD Start accelerator.
Samay agreed to develop small airway disease algorithms for its Sylvee wearable chest sensor under a paid deal with Italian drugmaker Chiesi, reported October 9, 2025. Chiesi funds the model work and a pilot study, with results expected by April 2026, and takes no equity.
Listing is editorial and does not imply endorsement. Companies are added from FDA filings, funding announcements, accelerator cohorts and reader tips. To add or correct a listing, send it in.
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