Why these 10 medical device makers are the most innovative in the world

Thanks to AI, we’re in the midst of an unprecedented technology boom. The medical devices industry hasn’t been left out of it.

Among the 10 Most Innovative Companies in the medical device field, several have leveraged AI to make diagnosis and treatment easier. This includes an AI platform from Heartflow that creates a 3D diagram of the heart and allows clinicians to diagnosis coronary artery disease. Sprint Ray used AI to make it easier for dentists to print teeth on demand, reducing patient wait times.

AI isn’t a prerequisite for innovation, though. HistoSonics is taking a technology we’ve long used—ultrasound—and deploying it to destroy liver tumors, while Xenco Medical’s device is helping shave time off spine surgeries and recovery time. And Cala Health has made it easy for facilities of any size to offer minimally invasive surgery, even bringing its technology to space. Read about all the honorees below.

1. HistoSonics

For channeling sound to destroy liver tumors

Some liver-cancer patients faced limited options because traditional treatments such as surgery or radiation and chemotherapy might damage healthy tissue. Minnesota-based HistoSonics has pioneered a groundbreaking way to treat tumors noninvasively: histotripsy. Histotripsy uses focused ultrasound waves to mechanically liquify cancerous tissue. Its precision allows doctors to target diseased tissues with significant accuracy.

Founded in 2009, the company received FDA clearance in October 2023 for its Edison histotripsy system for liver-tumor treatments. The therapy costs $17,500 on average and is covered by Medicare. The company’s clinical studies show it’s 95.5% effective at treating tumors, with a complication rate of 6.8%. In 2024, HistoSonics treated nearly 1,000 patients.

The HistoSonics clinical education team trained nearly 100 physicians and their teams on how to target and destroy tumors in 2024, and received more than 50 orders for the device. Eight of 10 top U.S. cancer centers have purchased the Edison, and the company closed a $102 million Series D this year. The company is now starting to investigate other uses for the Edison. It’s enrolling patients in kidney and pancreas studies, and it is looking at how it might be used to treat thyroid and breast cancer.

Read more about HistoSonics, honored as No. 37 on Fast Company’s list of the World’s 50 Most Innovative Companies of 2025.

2. Heartflow

For using AI to help doctors get a full picture of patients’ hearts

Over the past century, coronary artery disease has been a leading cause of death among Americans. Currently it impacts 18 million adults. Coronary artery disease is caused by plaque building up in the arteries that supply blood to the heart, restricting blood flow. However, current diagnostic methods are not reliable. In up to 30% of cases, traditional diagnostic measures miss existing plaque buildup, and in more than 50% of cases, traditional diagnostic measures will say there’s a problem when there’s none.

California-based Heartflow has built an AI-powered platform that shows doctors a full picture of a patient’s heart health so they can diagnose and manage coronary artery disease. In 2024, Heartflow’s newest plaque analysis feature turned its platform into the only diagnostic tool that offers a full view of a patient’s coronary artery disease burden. This includes a 3D model of the heart with cross-sectional color-coded images of the different plaque types present. One study shows that Heartflow’s technology is 95% accurate compared to gold-standard invasive imaging. Heartflow also launched a registry that will collect treatment data from clinicians using its plaque analysis feature in order to understand the impact of its technology and how clinicians are using it.

Heartflow’s platform is currently used in 84% of the top 50 heart hospitals in the U.S. As of 2024, Heartflow had been used to screen more than 400,000 patients.

3. ROMTech

For using remote monitoring to keep patients connected to their doctors during surgery recovery

At the moment, the U.S. is in the midst of a worsening physical therapist shortage. Physical therapy is crucial for restoring strength and range of movement after an orthopedic surgery. It can also reduce the need for prescription painkillers and allow patients to recover more quickly with fewer complications. For heart surgery patients, it can help reinflate the lungs and clear them of phlegm as well as promote blood flow. Yet, currently fewer than 25% of cardiac patients complete rehabilitation programs.

Connecticut-based ROMTech, founded in 2013, has developed the PortableConnect, a telemedicine rehabilitation cycle. The cycle features a screen that displays a custom app that allows patients to connect remotely with clinicians and record their progress. A wearable can be attached to the patient’s leg to track their range of motion. Going forward, ROMTech is preparing to launch in the cardiac field and it’s conducting pilots in assisted-living and long-term care. ROMTech is also exploring applications for dialysis, diabetes, rheumatoid arthritis, and oncology patients.

To date, more than 98,000 patients have successfully completed rehabilitation programs on the PortableConnect, saving an average of $2,460 compared to the cost of traditional physical therapy. ROMTech is continuing to see tremendous growth: In 2024, it tripled the number of Veterans Affairs agencies it works with, bringing the total to 40. Meanwhile, the number of doctors prescribing the PortableConnect increased by 36% over the past year.

4. Xenco Medical

For giving patients a way to regenerate bones and recover safely

Spinal surgery recovery can take up to a year, and physical therapy plays a key role in patient outcomes—but not all patients follow through with a PT regimen. To remedy that, Xenco Medical is bringing together surgery and recovery via its FDA-cleared TrabeculeX Continuum. Launched in January 2024, the continuum includes Xenco’s TrabeculeX Bioactive Matrix—a biomaterial designed to help with bone generation that eliminates the need for bone harvesting from other parts of a patient’s body, saving about 35 minutes per surgery. Post-op, patients are onboarded into the TrabeculeX Recovery app, which allows clinicians to remotely monitor their pain, posture, and motion to identify the best PT exercises. Since its launch, the TrabeculeX Continuum has been used in 52 hospitals across the U.S. to treat 2,684 patients, who have used the app for an average of 11 minutes a day over 90 days.

5. SprintRay

For making full smiles possible on a faster timeline

Traditionally, it can take weeks to make a dental crown or a prosthetic. However, SprintRay is leading the charge to allow dentists to use images of a patient’s tooth to print crowns and prosthetics in their office. In 2024, the California-based company released a host of innovations to make 3D printing in dental offices easier. It launched SpringRay AI Studio, an AI-assisted design software that lets dentists create designs for crowns and bridges.

It also released NanoCure, which lets dentists cure dental appliances, as well as two printing devices: the Pro 2 Dental 3D Printer and the Midas Digital Press. The Pro 2 allows dentists to print dentures, night guards, retainers, and dental models in their offices. The Midas lets dentists print crowns, inlays, and veneers in 10 minutes. In dentistry, highly filled composite resins are the gold standard for durability; however, these resins are extremely viscous, making them difficult for a 3D printer to handle. The Midas solves this problem by using sealed capsules that force the resin to move through pressurized chambers.

In 2024, SprintRay sold more than 7,000 devices, and it has a 53% market penetration rate. It increased its reach by 50% over 2023 and benefited nearly 600,000 patients. In 2024, dentists printed 95,000 crowns, 143,000 implant dentures, 131,000 removable dentures, and 197,000 night guards using SprintRay’s products.

6. Cala Health

For scaling its tremor device with the patients who need it most

Almost 10 million Americans live with essential tremors, a neurological condition that causes the hands and limbs to shake uncontrollably. This makes completing everyday tasks such as eating and drinking or writing a struggle, which, in turn, can lead to anxiety and depression. However, medications for essential tremors often come with strong side effects such as erectile dysfunction, fainting, and nausea.

Cala Health has created a watchlike device, the Cala kIQ, that treats hand tremors with transcutaneous afferent patterned stimulation (TAPS) therapy. TAPS therapy senses a patient’s tremor patterns and creates a personalized electrical signal pattern that counteracts the tremors. The Cala kIQ delivers these signals to the patient’s brain by stimulating nerves on the patient’s wrist. TAPS therapy was cleared by the FDA in 2018, and the Cala kIQ received FDA clearance in 2022.

In an efficacy study of more than 1,200 patients, 89% of participants saw their tremors improve by an average of 64%. About 62% of patients said they were able to reduce their medication after using Cala Health’s solution or planned to consult their doctor about reducing medication. In 2024, the Californian company received Medicare coverage for all f50 states.

Today, the Cala team are working on understanding whether TAPS therapy can be used to treat other diseases. While they’re still looking for answers, investors are clearly intrigued: In December 2024, the company raised $50 million.

7. Medtronic

For harnessing electric fields to heal hearts

Atrial fibrillation is one of the most undertreated heart rhythm disorders. It’s caused by irregular electrical signals that lead to an irregular heartbeat. It impacts more than 60 million people across the globe and can get progressively worse over time, increasing a patient’s risk of heart failure or stroke. For years, doctors have treated atrial fibrillation with ablation, which uses hot or cold energy to create scars on the heart tissue that block faulty signals. However, this can cause collateral damage to the heart.

In December 2023, Medtronic was the first company to receive FDA clearance for a new atrial fibrillation treatment, it’s PulseSelect pulsed field ablation system. Pulse field ablation, a phrase coined by a Medtronic scientist, uses electrical pulses to destroy the heart tissue that causes the irregular heartbeat without damaging other surrounding structures. In October 2024, Medtronic followed up with another FDA clearance for its Affera Mapping and Ablation System with Sphere Catheter. The Affera includes a mapping feature that identifies which heart tissue to target for treatment. It can also switch between using pulse field energy or radio frequency energy, and it eliminates the need to use more than one catheter, which leads to a more efficient, safer process. As of the end of 2024, more than 20,000 patients had been treated with PulseSelect. Currently, Medtronic’s cardiac ablation solutions is a billion-dollar business and on track to double in size.

8. Virtual Incision

For taking minimally invasive surgery to new frontiers

Minimally invasive surgery, which involves very small incisions, is great for patients. It results in less pain, fewer complications, and a shorter recovery time. However, roughly 90% of the operating rooms in the U.S. still lack access to technology that makes minimally invasive surgery possible.

Virtual Incision has created MIRA, the first miniaturized robotic surgical system for minimally invasive surgery. While many surgical robots require a dedicated mainframe and operating room, the approximately 2-pound MIRA can be used as a stand-alone device for smaller facilities or within an existing mainframe system. In February 2024, the Nebraska-based company received FDA approval to market MIRA for adults who need colectomies. Colectomies are one of the most complex abdominal procedures, and nearly half are still being performed as open surgery.

In addition, Virtual Incision took MIRA to space. In February 2024, the company developed a space version of MIRA and sent it to the International Space Station. Six surgeons based on earth were able to direct the space MIRA, and they successfully simulated surgical maneuvers such as grasping and cutting.

Closer to home, in July 2024, Virtual Incision launched an international study evaluating MIRA’s ability to handle gynecological procedures. At the end of that month, MIRA successfully completed a hysterectomy at Geneva University Hospitals in Switzerland. While the study is still ongoing, in time the company hopes to get clearance for MIRA to do gynecological procedures.

9. Bruin Biometrics

For helping detect bedsores in patients regardless of skin color

Bedsores, also known as pressure ulcers, fly under the radar but impact 2.5 million patients a year and can prolong hospital stays or result in follow-up visits. Patients with darker skin are especially vulnerable—they are at a 60% greater risk for bedsores and are more likely to die from them.

To help identify bedsores as they form, Bruin Biometrics developed the Provizio SEM Scanner, which measures moisture levels below the skin’s surface—an early marker of cell death. This helps clinicians detect bedsores up to five days before they appear visually, giving clinical teams more time to prevent and treat them. According to studies, the scanner reduces bedsores by up to 100% for patients of all skin tones, helping reduce the higher rate of pressure ulcers among patients of color.

In 2024, Bruin was able to bring the scan to more patients when the FDA acknowledged that below-skin moisture is equivalent to the early stages of a bedsore. The company also earned a dedicated Medicaid and Medicare billing code for the procedure—one of only 40 new codes issued by the Center for Medicare and Medicaid Services in 2024. So far, Bruin has scanned 1 million patients and prevented 50,000 pressure injuries.

10. Elixir Medical

For creating a biodegradable stent that dissolves when its job is done

Coronary artery disease is a leading cause of death around the world. In the 1980s, researchers developed stents—small pieces of metal that can hold open an artery. However, these can lead to scar tissue that will close up the artery again. The current standard of care for treatment was developed in 2003 and involves using drug-eluting stents. These stents are coated with medication and reduce the chances of scarring. However, for every year the drug-eluting stent is in place, there is a 2% to 3% chance it will cause complications for the patient, and this is cumulative—within five years of a stent procedure, 20% of patients will run into a complication.   

In search of a better solution than stents, Elixir Medical has developed the DynamX, which has three helical strands linked together. It is coated in a biodegradable polymer that releases a medication for three months that helps the vessel heal. After six months, the polymer is absorbed by the body and the DynamX’s helical strands unlock and separate, allowing the blood vessel to move and function normally. Cleared for use in Europe, DynamX made strides toward use in ththe United States in 2024 while demonstrating its efficacy abroad. Elixir received the FDA’s breakthrough device designation for two uses—the DynamX BTK System, which treats narrowed or blocked blood vessels below the knee, and the DynamX Sirolimus-Eluting Coronary Bioadaptor System, which treats heart disease.

In the fall of 2024, a study published in The Lancet showed that patients in Sweden with acute coronary artery disease who were treated with Elixir’s DynamX system showed significant reduction in adverse outcomes after six months—including death from cardiovascular causes, myocardial infarction, and repeat procedures for the same issue—compared to stents from other companies.

In the past year, thanks to DynamX’s growth, Elixir Medical doubled the number of patients it treated.

Explore the full 2025 list of Fast Company’s Most Innovative Companies, 609 organizations that are reshaping industries and culture. We’ve selected the companies making the biggest impact across 58 categories, including advertising, applied AI, biotech, retail, sustainability, and more.

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