25 impressive medical device startups to watch in 2026
As history has shown, it only takes one ground-breaking medtech startup to change a product category forever.
Back in 2006, serial entrepreneur Steve Kelly partnered with MIT researchers to take an anti-bleeding gel product to market. The biodegradable gel was a significantly better option for many hemostat applications compared to alternatives like bandages, surgical clamps and tissue adhesives - and today, topical hemostatic agents are considered the most effective and safe way to stop bleeding in many patients and conditions.
With the medtech industry predicted to generate over 600 billion dollars in revenue in 2026, medical technology companies as a whole show no signs of slowing down in their extraordinary innovative growth.
Take a look at this list of medtech companies on the move in 2026 and get inspired in your own pursuit of medical device greatness!
Table of Contents
- Top medical device companies in 2026
- Our list of the top 25 best medical device companies in 2026
- CergenX
- ComeBack Mobility
- ThinkBio.AI
- Boston Micro Fabrication
- Polycarbin
- ABLE Human Motion
- Garwood Medical Devices
- Parasym Health
- HemoSonics
- CMR Surgical
- EvoEndo
- Francis Medical
- Healthy.io
- InVivo Bionics
- Axion BioSystems
- Béa Fertility
- Flow Neuroscience
- Synchron
- Shockwave Medical
- SimBioSys
- Ibex
- BiVacor
- Hemotune
- xCures
- Enable Injections
- Join the list of successful medical device companies
RELATED READING: FDA medical device classifications explained
Top medical device companies in 2026
Cutting-edge medtech companies have a few factors in common, according to McKinsey research.
They all have an idea that can provide consistently superior experiences to all users and stakeholders, including patients, caregivers and clinicians. They also 'reimagine processes to dramatically reduce costs and accelerate decision-making'. The most successful medical technology companies manage to get closer to the patient by providing an innovation that’s better, cheaper, safer and more convenient.
In order to make an impact in an extraordinarily competitive and highly regulated market, medtech companies need to achieve velocity in their early stages to provide proof of concept, secure funding and demonstrate clinical safety for regulatory approval.
There’s no room for mistakes or delays in the hyper-competitive world of medical device companies. A strong baseline of compliance is crucial from day one to ensure there are no barriers to obtaining FDA approval or a CE/UKCA mark.
The following 25 medical device companies have caught our eye for their impressive devices, from digital health tools to AI-powered diagnostics.
RELATED READING: 5 secrets to securing medical device venture capital in 2026
Our list of the top 25 best medical device companies in 2026
1.CergenX
We always have a soft spot for our customers when we make these lists, and one of them, CergenX, is doing great things.
Their AI-powered EEG neurotech platform, Wave, delivers critical early detection of brain injury risk for newborn babies.
2025 saw them use our medtech quality and compliance software to secure Breakthrough Designation from the FDA and get accepted into the FDA's Total Product Lifecycle Advisory Program (TAP), making 2026 their year to kick on and hit new heights.
2. ComeBack Mobility
Ukraine-based ComeBack Mobility wants to make it easy for patient care teams to monitor progress of the entire rehabilitation process after a leg injury.
Their Smart Crutch Tips measure how much weight a patient puts on their leg as they use crutches. Too much weight on their leg, and the crutch tips provide instant feedback so the patient can adjust accordingly. The crutch tips also pair with an app where patients can track their weight-bearing progress.
With this data, healthcare providers can advise the patient on the best rehabilitation plan so that they heal quickly and correctly. They can also send new rehab advice straight to the patient through the mobile app.
CEO Ilya Popov, the co-founder of ComeBack Mobility, was inspired to create this tool after going through his own injury. He raised the seed round of funding himself during the COVID-19 lockdown and gave an interview about maintaining a medical device startup during wartime.
3. ThinkBio.AI
It wouldn't be a 2026 medtech innovation list without AI, and ThinkBio.AI embodies the industry's dramatic shift towards a new age of artificial intelligence.
From an AI agent that analyzes and revives failed clinical trials, to in silico patient simulations, their suite offers faster, more targeted and more data-rich biopharma innovation than ever before.
Plus, they care about the delicate intersection of AI and GxP environments: their AI Judge governance platform keeps AI-backed decision-making transparent, compliant and accurate.
4. Boston Micro Fabrication
When we think of medical devices and how they’re built, 3D printing isn’t necessarily the first thing that comes to mind. But Boston Micro Fabrication is at the cutting edge of an exciting development in how life-saving devices are prototyped and created.
With the news that the FDA is pivoting away from animal testing towards 3D organoids, and with the growing need to produce miniature, intricate and high-quality devices at speed, BMF’s nanometer-precise microArch 3D printing technology is opening the door to new possibilities - allowing the rapid production of equipment like stents, endoscopes, and even needles.
A BMF-built catheter recently featured in a nature.com scientific report, delivering 183x higher drug concentrations for liver cancer treatment than would otherwise have been possible.
5. Polycarbin
Life sciences use a lot of plastic, between syringes, DNA extraction kits, and more. In fact, over 12 billion pounds of scientific plastic waste is produced each year, according to Polycarbin, and its goal is to put a stop to that.
Founded by two friends who left medical school to start the company, Polycarbin remanufactures laboratory equipment, such as pipette tips, from post-consumer lab plastic.
The company helps labs reduce carbon emissions and also provides ways to recycle plastic waste.
Its mobile app gives scientists data about reducing their waste, lets them schedule recycling pickup, and more. Labs can also order recycled equipment from Polycarbin. In 2024 it raised $2 million in seed funding, per Crunchbase.
6. ABLE Human Motion
ABLE is a Barcelona-based medical device startup and the world’s first manufacturer of robotic exoskeletons for individuals with disabilities.
The award-winning start-up studied the human gait extensively to create a product that allows wheelchair users to stand up, walk and sit down without any assistance. The battery-powered 8 kg exoskeleton has parameters for smart device configurations, which can allow for remote monitoring by physical therapists and physicians.
The lower-body exoskeleton is the first home-use product for individuals with lower-limb paralysis. In mid-2021, they obtained ISO 13485 certification for their exoskeleton.
It launched in Europe in 2023.
7. Garwood Medical Devices
Garwood Medical is an advanced medtech startup based in Buffalo, NY, with a mission of improving clinical outcomes for infections and wound healing.
Garwood’s products include the BioPrax™, a minimally invasive device designed to prevent biofilm infections on prosthetic knee implants by using electrodes to prevent microbe growth. It was granted Breakthrough Device designation by the FDA in 2019.
The company began human clinical trials in 2023.
8. Parasym Health
Parasym is a UK-based medical device start-up that provides neurostimulation products for patients with inflammatory disorders and chronic pain.
Its first product uses micropulses of electrical current to target the vagus nerve through an ear clip electrode. The Parasym Device is currently CE-marked and has been designated a non-significant risk (NSR) by the FDA.
In 2022, the company completed a clinical trial that revealed promising results for patients dealing with cardiac inflammation and potential heart failure.
With big plans in the pipeline for 2026, they're one to watch.
9. HemoSonics
If you’ve ever seen a medical drama, you know how intense it gets when a patient is bleeding and doctors have to act fast.
But in real life, understanding why someone is bleeding — and how best to stop it — isn’t always straightforward. That’s where HemoSonics comes in.
HemoSonics provides a solution for doctors to get a clear picture of how a patient’s blood is clotting. Instead of waiting for slow lab results or guessing which blood products to give, doctors can now make informed decisions in real time, right at the bedside.
In 2026, HemoSonics is addressing one of the most critical gaps in patient care: the need for fast, accurate, and actionable blood clotting data during surgery, in the ICU, and at the point of trauma.
10. CMR Surgical
Surgical robots!
CMR Surgical took more venture capital funding than any other medical device company in 2021, raising over $600m.
That's testament to the extraordinary potential of its Versius robot, an electronic helper in the operations room that can never slip or waver mid-surgery.
Versius has helped more than 5,000 surgeries so far, from thoracic to gynecological.
11. EvoEndo
Qualio customer EvoEndo is pushing to 'evolve unsedated endoscopy' with its innovative 3.5mm gastroscope that can be inserted through the mouth or nose.
Patients no longer need to be anesthetized or sedated for their upper digestive tracts to be examined.
EvoEndo won the 2022 MedTech Innovator Execution Award, closing out a highly successful year that saw them secure 510(k) clearance and over $8m of Series A funding.
12. Francis Medical
Prostate cancer kills about 35,000 American men every single year.
Francis Medical's transurethral ablation device uses water vapor to overheat and kill cancer cells in the prostate while leaving healthy cells untouched.
The company plans to expand product usage to tackle kidney and bladder cancer in the near future.
13. Healthy.io
Medtech companies don't always need to produce and distribute millions of new devices to make their mark.
Israeli software company Healthy.io works with what you've already got, turning your smartphone camera into an FDA-approved test-at-home kit for UTIs, open wounds and more.
The company has grown 300% since 2017 and shows no signs of slowing down, with partnerships with Johns Hopkins, the British NHS and more building steam.
14. InVivo Bionics
This Norwegian medical device company turned to Qualio in 2021 to help them build their quality management system from the ground up on their route to the European market.
Their innovative pressure microsensor, less than 1mm across, sits within the bladder and relays real-time information via the cloud to help treat patients with urinary dysfunction.
A shrewd electronic quality management system (eQMS) investment has effectively doubled their speed to market, making their rapid and quality-centric push to market one to watch this year!
15. Axion BioSystems
Understanding how cells interact is a critical cornerstone of modern life science, and Axion BioSystems is right at the confluence of live-cell analysis and next-generation technology.
Axion’s Maestro and Multiwell medtech products are helping to unlock the secrets of cellular behavior and allow the tracking of the health and function of thousands of cells at once, in real time.
16. Béa Fertility
The struggle to conceive a child can be a stressful and upsetting experience for couples.
This medical device company launched the world's first at-home intracervical insemination kit to some early adopters in mid-2023, allowing hopeful parents to increase their chance of pregnancy for a fraction of the cost of IVF and without ever leaving the bedroom.
17. Flow Neuroscience
Can depression be physically treated like a cut or infection?
This Swedish medical device company thinks so. Their Flow headset uses transcranial direct current stimulation (tDCS) to treat depression without drugs or side effects.
83% of users reported results in the first three weeks.
18. Synchron
Brain computers sound like the stuff of science fiction.
But this Brooklyn-based start-up recently secured an FDA IDE for its stentrode, the first commercial implantable brain computer interface to do so.
Synchron are undergoing clinical trials this year, with the ambitious goal of mapping all 400 miles of the brain's blood vessels and 'unlocking the natural highways of the brain' with digital technology.
19. Shockwave Medical
Sound waves are already used to break down kidney stones.
This medical device company wants to retarget that technology towards calcified artery blockages, with its intravascular lithotripsy (IVL) device sidestepping the current risks of physical artery unblocking.
With balloons and drills also used to break down artery plaque, Shockwave's device was approved in 2021 by the FDA as a safer alternative.
Now in its second year of marketization, Shockwave makes our list of medical technology companies to watch this year.
20. SimBioSys
This Qualio customer is developing an SaMD platform to revolutionize 'computational oncology'.
By digitally modelling cancer behavior, including tumor growth and medicinal impact, SimBioSys' device will unlock precise, pre-simulated cancer care that saves lives.
The company has a wide range of regulatory targets to hit, from 510(k) clearance to MDSAP, ISO 13485 and IEC 62304 accreditation.
Their eQMS upgrade in 2022 allowed them to build a market-ready quality system in just 90 days, positioning themselves for blistering take-off and more market success this year.
21. Ibex
Founded in 2016, Ibex aims to provide accurate, timely and personalized cancer diagnoses using AI medtech technology.
They secured $55m of Series C funding in 2023, and their AI-powered pathology platform is reshaping breast, prostate and gastric cancer diagnostics and making a significant impact on patient outcomes.
One to watch in 2026.
22. BiVacor
The exciting days of fully artificial hearts could be almost upon us.
This Texan medical device company has raised over $22m of funding and went into clinical trials last year.
Magnetic levitation and centrifugal pumps give the device a single moving part with no mechanical wear. BiVacor's heart promises an operational life of a decade and complete takeover of cardial function from patients' failing hearts.
While we anticipate it'll be another couple of years before we see the device in the market, 2026 could be the year the company grabs the headlines on the final lap of its journey to market approval and real day-to-day product usage.
23. Hemotune
This Swiss medical device company is working on magnetic blood purification.
Magnetic beads in the bloodstream bind to pathogens, toxins, antibodies and cytokines, then pull them out of the blood as it passes through a dialysis machine.
Hemotune promises a complete 3-part 'hemosystem' to revolutionize blood treatment for septic shock, infections and autoimmune diseases.
24. xCures
xCures is an SaMD start-up that provides an advanced algorithmic AI platform connecting cancer patients to targeted oncology treatment.
The American medical device company wants to end the traditional challenges blocking cancer patients in need from clinical trial access.
Their AI engine matches patients with the most suitable of the 9000 different cancer treatment options currently available, including experimental treatments passing through clinical trials - then liaises with trial providers, predicts the outcome and secures treatment.
xCures set the stage for accelerated market success with their eQMS partnership with Qualio, making them one to watch for 2026!
25. Enable Injections
The final medical device company on our list, based in Ohio, wants to lift drug delivery to the next level.
Their enFuse on-body disc is filled with the therapeutic of choice, then attached to the skin with an adhesive before a small unseen needle emerges beneath for drug delivery.
The patient simply conceals the delivery disc beneath their clothes while the drug is administered. The disc is designed to be lightweight, comfortable and flexible, and should be welcome news for trypanophobes around the world.
With patents secured in 2022 and over $215m of financing under their belt, Enable Injections are well on their way to making a serious mark in the medical device world.
Join the list of successful medical device companies
All of the medical device start-ups on our list began by recognizing a real problem or gap in current treatment options, then applying cutting-edge technology to make a difference.
These medtech companies represent our hope for a better future in healthcare: one filled with less pain, more mobility and fewer deaths and injuries. We can’t wait to see what these start-ups do next!
Qualio's quality and compliance software for medical device companies positions companies like yours for maximum success: accelerated time to market, stronger and more cost-effective processes, and unshakeable quality and compliance.
Book a demo with us to see how it works!
