The past year has proved that the long-standing way of thinking about medical devices as hardware—machines, implants, tools in surgeons’ hands—is obsolete.
The 10 most innovative companies in the medical device field are building ecosystems. Sensors feed algorithms, wearables pair with apps, and implants adapt in response to live biological signals within the body. At the center of these systems is data.
In today’s AI era, data has evolved from simple facts and figures into a dynamic tool for changing how and when care is delivered. A standard ECG becomes a window into future cardiac risk. A leg sleeve becomes a neuromuscular intelligence system. A defibrillator becomes an always-on safety net outside the hospital.
This year’s honorees share a common strategy: blending data and connectivity into traditional medical technology to make it more responsive, comfortable and scalable. Many are securing regulatory clearances not just for single devices, but for adaptive systems that improve over time.
These companies show that the category is redefining itself. What was once a hardware-driven industry is morphing into a platform business, where software updates, data streams, and an agile regulatory strategy matter as much as engineering. Read about all the honorees below.
1. Cresilon
For stopping bleeding—quickly
Tens of thousands of Americans die annually from bleeding injuries that could be survivable. Traditional methods like gauze packing and tourniquets have significant limitations. Packing gauze can be dangerous for first responders and painful for patients, while tourniquets can only be used for up to two hours before causing tissue damage.
Cresilon’s Traumagel offers a breakthrough solution. This hemostatic gel—roughly the color and texture of hummus—was cleared by the FDA in August 2024 and launched in January 2025. It stops bleeding in seconds when injected into wounds via syringe. Made from fungi- and algae-based polysaccharides, it creates a mechanical barrier that works regardless of a patient’s clotting ability. Unlike traditional methods, Traumagel is easily cleaned from wounds once treatment continues at a hospital.
Brooklyn-based Cresilon, led by CEO Joe Landolina (who created the earliest version at age 17 in his NYU dorm), now produces 10,000 units monthly. The product is used by over 125 trauma and EMS systems across 25 states, with Landolina reporting hundreds of lives saved. The company aims to scale production to 100,000 units per month by mid-2027, and is making inroads with military adoption.
Read more about Cresilon, No. 46 on Fast Company’s list of the World’s 50 Most Innovative Companies of 2026.
2. Element Science
For making a defibrillator into a wearable
For patients at risk of sudden cardiac arrest, continuous protection is everything. Element Science offers a wearable defibrillator and set of digital tools designed to keep these patients safe as they go about their daily lives.
The defibrillator patch, affixed to the torso with an adhesive, protects users by delivering a life-saving shock to the heart. Element obtained FDA approval for this first-of-its-kind device in May after completing a clinical study in which the system delivered multiple shocks that saved people’s lives. Its discreet design makes it far easier to wear consistently than traditional bulky defibrillators, which can improve patients’ adherence and reduce mortality rates.
Essentially, Element’s device brings hospital-grade defibrillation to patients wherever they are, without compromising their comfort or mobility.
The patient population that the company targets is a vulnerable one, too. It consists of individuals with life-threatening heart rhythms that could go amiss at any moment but who often struggle to use traditional, bulky defibrillators consistently. With its wearable defibrillator, Element is helping lay the groundwork for a new standard in cardiac care that makes life-or-death protection more practical and reliable.
3. EssilorLuxottica
For creating eyeglasses that correct nearsightedness
Eyewear has long been treated as a consumer accessory, but EssilorLuxottica is positioning it as a frontline health tool. Eye exams can reveal far more than vision loss—and the company is betting on its ability to unlock those findings at scale.
The company has moved quickly into wearable AI and is partnering with consumer brands people already trust and want to wear. Last year, it launched new Meta smart glasses with Ray-Ban and Oakley, each offering prescription-quality lenses alongside cameras, displays, audio and fitness tracking. EssilorLuxottica’s glasses can also address needs such as correcting nearsightedness or farsightedness, reducing eye strain through blue-light filtering and supporting multiple focal distances with progressive lenses.
The appetite for this technology is materializing quickly. EssilorLuxottica’s Ray-Ban Meta glasses are now the world’s top-selling AI glasses, with sales nearly tripling last year. The company is responding by ramping production capacity to as many as 10 million pairs.
Unlike startups building from scratch, EssilorLuxottica is evolving an existing global category. By layering AI, diagnostics and digital health capabilities onto its eyewear portfolio, the company is extending glasses beyond vision correction and into preventive health care.
4. Cionic
For giving people with mobility impairment assistive devices that fit seamlessly into their lives
Medical devices are no longer clunky pieces of equipment, with many evolving into discreet, everyday companions. That’s the case with Cionic’s devices, which blend wearable sensors and AI-powered electrical stimulation directly into clothing to benefit patients across more than 20 neurological conditions, including multiple sclerosis, cerebral palsy and stroke.
The company’s technology, worn as a leg sleeve, monitors movement in real time and delivers stimulation as needed. It gives people with mobility impairments immediate support as they move, quickly adapting to how they move across different speeds, surfaces and levels of muscle control. Unlike traditional assistive devices, it’s designed to feel more seamless and intuitive during neuromuscular rehab—like an extension of the body rather than external hardware.
In September, Cionic’s Neural Sleeve 2 became the only FDA-cleared device to activate muscle movement and relax muscle spasms at the same time. These indications reflect the company’s broader ambition to change how mobility care is delivered. By combining sensing, stimulation and software into a single wearable system, Cionic is carving out a category for one-size-fits-all mobility solutions.
Users have now walked more than 500 million steps in the sleeve, offering early evidence that mobility support can be both clinically rigorous and easily integrated into daily life.
5. Insightec
For finding an incisionless way to treat neurological conditions
Insightec, based in Haifa, Israel, makes medical devices that use focused ultrasound beams to treat conditions inside the body without making incisions. Its systems use MRI imaging to guide doctors, ensuring they know where they’re working to avoid damage to surrounding tissue. This method means that patients can receive treatment for disorders like essential tremor or tremors caused by Parkinson’s disease with fewer risks and faster recovery than traditional surgery.
In July 2025, the Food and Drug Administration approved the company’s Exablate Neuro platform for bilateral, focused treatment of Parkinson’s diseases. Insightec’s system enables treatment of both sides of the brain in a staged approach for Parkinson’s patients who have severe, medication-resistant motor systems.
Even before the system was approved, health insurer Aetna announced that it would be the first national insurer to cover focused ultrasound treatment for tremor-dominant Parkinson’s disease. Along with Aetna, focused ultrasound to treat essential tremor is now covered through Medicare in all 50 states.
As of late 2025, Insightec’s treatments—including the recently approved one—have been used in more than 25,000 procedures at some 200 facilities, and its surgical treatment has surpassed deep brain stimulation as the top treatment for essential tremor.
6. Uresta
For finding a nonsurgical way to give incontinent women control over their bladders
For millions of women, bladder leaks are a hidden but constant burden that disrupts their daily activities and confidence. Uresta has created a device that gives them discreet, effective control over this common condition.
Designed for at-home use, patients insert the small device — made of hypoallergenic medical-grade resin — vaginally to provide internal urethral support, blocking leaks caused by coughing, laughing, running, or lifting. It fills the gap between feminine pads and invasive surgery, offering proactive leak prevention without the risks or downtime of an operation. By shifting the focus from managing symptoms to stopping leaks at their source, Uresta is enabling women to manage their condition independently — removing the prescription requirements and in-office fittings that have been barriers to care.
The Canadian company entered the U.S. market last March and has already sold nearly 16,000 units in the country, generating close to $4 million in revenue. More than 33,000 women across North America have used Uresta’s device in the past two years, with 90% continuing use after 12 months, according to the company’s data.
This early success signals a broader movement in women’s health: the recognition that self-directed solutions can outperform legacy treatments — especially when they restore confidence and control in areas typically shaped by stigma and compromise.
7. Medtronic
For expanding the number of Parkinson’s patients who can benefit from deep brain stimulation
Medtronic is proof that massive companies can still be innovative. It may be the largest medical device firm in the world, but it continues to invest heavily in the AI, robotics and data-driven platforms needed to extend its reach well beyond traditional hardware.
Medtronic received a few new and expanded FDA clearances last year, most notably for its BrainSense adaptive deep brain stimulation system for Parkinson’s disease, which seeks to drastically improve the quality of life for Parkinson’s patients who don’t respond well to conventional deep brain stimulation.
Unlike traditional products that provide constant stimulation through an implanted device, Medtronic’s system modulates electrical signals in real time according to a patient’s brain activity. This personalized approach gives patients more control of their unique symptoms, as well as reduced side effects.
Medtronic has treated more than 40,000 patients with its deep brain stimulation system devices, including 1,500 using its new system—marking the largest launch of brain-computer technology ever.
The launch underlines Medtronic’s ability to pair novel science with global deployment. Through bringing this new form of treatment to thousands of patients, the company is making meaningful difference in daily comfort and independence for thousands of people.
8. Beacon Biosignals
For developing a headband that helps people gain insights into brain and sleep health
Sleep has become one of the most closely monitored parts of modern health, with millions of people tracking their nights in hopes of unlocking useful insights about their overall health. Beacon Biosignals is one of the digital health startups betting that AI can help translate raw sleep data into clearer signals about health and disease.
The company makes technology that analyzes brain signals, monitors sleep stages and detects neurological conditions, giving clinicians and researchers the data they need to assess patients’ brain function more accurately and efficiently.
The goal is to make brain monitoring more continuous and actionable. The ongoing flow of data can show how sleep affects a person’s cognitive performance, mood and disease progression over time, giving both patients and clinicians a clearer picture of brain health.
Beacon is broadening its pipeline from narcolepsy diagnostics to partnerships with pharmaceutical companies testing treatments for a wide range of neurological and sleep-related conditions. With more than $120 million in investor funding, the startup is strengthening its algorithms, adding physiological metrics to its platform and launching clinical studies aiming to make continuous brain monitoring a standard part of care.
9. Anumana
For getting AI-powered cardiology tools to Medicare patients for the first time
Despite decades of advances in cardiology, heart disease continues to kill more people than any other condition, often because it’s caught too late. Anumana’s AI seeks to tackle this issue by surfacing early, otherwise invisible markers of heart disease in standard electrocardiograms (ECGs)—turning one of medicine’s most common tests into a powerful early warning system.
The company, formed in 2021 as a joint venture between Mayo Clinic and health technology company nference, develops cardiac algorithms trained on large datasets. These algorithms connect ECG patterns with confirmed diagnoses, allowing the system to flag risk earlier and help guide follow-up testing and treatment.
To scale its reach, Anumana has cozied up to giants in the medtech and pharmaceutical industries, integrating its AI into widely used cardiac platforms through partnerships with larger players such as Pfizer, Philips, Boston Scientific, and Novartis.
The startup’s momentum picked up last year, when Anumana secured Medicare reimbursement for one of its algorithms—the first time an AI-powered ECG tool has been covered by a federal insurer. Backed by more than $150 million in funding, the company is now focused on expanding its pipeline of cardiac algorithms and deepening its capabilities across clinical settings.
10. RenovoRx
For finding a new route to target tumors with chemotherapy
Mountain View, California-based RenovoRx is focused on improving the delivery of cancer meds to tumors. It’s trans-artertial micro-perfusion (TAMP) therapy is designed to use arterial walls near the site of a tumor to administer treatment in a targeted way.
The central tool of this therapy is RenovoCath—a proprietary dual-baloon catheter system that the company launched at the end of 2024. Throughout 2025, RenovoCath reached 12 cancer centers, and as of February had been ordered by 33 more—generating more than $900,000 in revenue through Q3 of 2025 without a dedicated sales team.
As it has commercialized RenovoCath, RenovoRx has also been moving forward with Phase III trials evaluating the impact of TAMP delivery of pancreatic cancer treatment gemcitabine using RenovoCath in patients with locally advanced forms of the cancer.
Explore the full 2026 list of Fast Company’s Most Innovative Companies, 720 honorees that are reshaping industries and culture. We’ve selected the companies making the biggest impact across 59 categories, including advertising, applied AI, biotech, retail, sustainability, and more.