This year’s leading medical device makers run the gamut from improving medical procedures to better patient monitoring.
Explore the full 2022 list of Fast Company’s Most Innovative Companies, 528 organizations whose efforts are reshaping their businesses, industries, and the broader culture. We’ve selected the firms making the biggest impact with their initiatives across 52 categories, including the most innovative biotech, design, and consumer goods companies.
For the first time, Fast Company is honoring the Most Innovative Companies in Medical Devices this year, letting companies that are creatively using technology to improve patient care shine on their own, rather than as part of our broader Health list. From rethinking how to clear blocked arteries to treating sleep apnea with multidisciplinary teams, the 10 companies that populate this list have created devices that make big strides in improving how we tackle chronic disease, ensure hospital safety, and perform procedures.
Many of the companies on this list address chronic conditions, which the Centers for Disease Control and Prevention says affect 6 in 10 Americans, with 4 in 10 diagnosed with 2 or more. Notably, Vivos Therapeutics is forging a new path for people with obstructive sleep apnea that uses palate expanders and lower-jaw repositioning to eliminate the cause of the condition, rather than keeping them tethered to CPAP machines long-term.
Other honorees this year are focused on improving existing procedures with better tools or taking trusted technology and applying it in new ways. Ambu is expanding the list of procedures for which it provides single-use endoscopes, which reduces the risk of spreading infection inherent in reusable ones. On the surgical side, Bolder Surgical debuted a new line of tools for operating on vessels that make thermal sealing less likely to affect surrounding areas–a proposition so innovative, the company was snapped up by Hologic for $160 million.
In the hospital setting, VirtuSense Technologies is using AI to help predict when patients are at risk of a fall, and Xandar Kardian is rethinking how vitals are collected, using technology to make checking heart and respiratory rate possible without a wearable and without touching a patient.
These 10 companies are examples of how creative thinking in medical devices from innovative companies is saving lives and improving care.
For creating a toolkit for cardiac monitoring
When Biotricity founder Waqqas Al-Siddiq first conceived of his biotech startup, he wanted to give people with cardiac issues a tool to monitor their conditions.”Diabetics have a glucometer. Cardiac patients [had] nothing,” he says. But he quickly discovered that, to make accurate diagnoses, cardiologists themselves needed a better mechanism—a way to gather lots of data over time. So, in 2018, he introduced Bioflux, a wearable, 24/7 electrocardiogram that continuously collects and transmits cardiac data, with abnormalities monitored in real time by a call center. Today, more than 1,500 cardiologists use Bioflux, making it available to some 3 million patients. Biotricity is now making good on its original mission. In November, it released Bioheart, a direct-to-consumer, wearable EKG that pairs with a smartphone to help users better track their heart health. (The $199 device is available from a range of retailers, including Amazon.) “It gives you insight into your baseline, so that if it changes you’ll know about it,” Al-Siddiq says. “Then, when you go to the doctor, you’re coming in with long-term data.” The company also recently debuted its Biokit, which contains a connected thermometer, pulse oximeter, and blood pressure cuff, allowing patients to send even more information to their physicians.
2. SHOCKWAVE MEDICAL
For bringing good vibrations to heart procedures
Shockwave Medical’s intravascular lithotripsy (IVL) device—approved by the Food and Drug Administration in February 2021—takes the sonic technology used widely since the 1980s for breaking up kidney stones and repurposes it to safely remove calcified plaque from arteries. (Traditional plaque-removal approaches, like high-pressure balloons and atherectomy using a small drill, have potential issues that range from soft tissue damage to perforating the arterial wall.) Shockwave’s IVL device sonically breaks up the calcium, allowing the artery to expand with low pressure and a stent to be placed—good news for the 12,000 people in the United States who had an IVL procedure in the first six months after approval, and potentially good news for the roughly 333,000 people annually whose stent placements involve calcified heart disease.
For giving physicians a digital leg up in detecting arrhythmia
Even before Eko unveiled the second generation of its flagship AI-powered digital stethoscope/electrocardiogram, the DUO, in August, the company had had a big year. The company’s sales of its stethoscopes and smart assessment software to medical professionals tripled its 2020 revenue within the first six months of 2021, as it launched its Eko Connect telehealth platform for physicians and rolled out an educational app to help medical students and doctors better interpret heart and lung sounds. At the core of the company’s growth has been the Eko DUO stethoscope, which uses AI to help detect heart irregularities—and whose capabilities were backed up by a Journal of the American Heart Association article in May, which shared data demonstrating that the DUO showed 90% accuracy in detecting murmurs.
4. CLEANSPACE TECHNOLOGY
For giving healthcare workers a HALO of protection
The CleanSpace HALO respirator looks like something you’d see in the futuristic hospital of a sci-fi movie, but its technology is playing a critical role in keeping healthcare workers COVID-free in the present. Worn around the neck, CleanSpaceHALO is 40 times more effective at filtration than an N95 mask. And because it’s reusable and rechargeable, it also helps reduce waste generated by single-use masks. In 2021, HALO introduced an app to make it easier for healthcare workers to know the status of a given respirator—including battery level, fit check, and refresher instruction videos—which helped the company make big gains in its client base. HALO was being used in 20 hospitals at the start of fiscal 2021; by year’s end, it was in more than 850, and had entered more than 1,000 by the end of calendar year 2021. Above all, HALO works: Singapore’s Sengkang General Hospital implemented the devices before the pandemic. After caring for 748 COVID-19 patients over six months, none of the hospital’s workers came down with the virus.
5. BOLDER SURGICAL [NOW HOLOGIC]
For creating a microsurgical Swiss army knife
In laparoscopic surgery, closing vessels that have been worked on carries a certain set of risks. Smoke from thermal sealing can obscure surgeons’ views, and even damage adjacent structures. Bolder Surgical wanted to solve for this while reducing the need for instrument changing that can slow down procedures. The company’s CoolSeal Vessel Sealing portfolio includes the CoolSeal Trinity (a sealer, divider, and dissector) and the CoolSeal Reveal (an open sealer, divider, and dissector designed for otolaryngology, as well as head and neck procedures). Both are designed to minimize the instruments’ thermal footprints. CoolSeal’s launch in January 2021 garnered notice from clients and the wider industry—after a first half of 2021 that saw a 43% year-over-year lift in sales, Bolder Surgical was acquired by Hologic for $160 million, with its new parent looking to expand the CoolSeal suite and other products into use by OB/GYN specialists.
6. VIRTUSENSE TECHNOLOGIES
For keeping an eye on hospital patients
Between 700,000 and 1 million people fall every year in the hospital, according to numbers from the Agency for Healthcare Research and Quality. VirtuSense Technologieswants to bring that number as low as possible with its predictive, AI-powered VSTOne platform, which uses connected depth sensors and an algorithm to help predict when a patient is about to get out of bed—and to alert a nurse. Currently deployed in more than 40 hospitals across nearly 30 health systems after less than two years in business, VSTOne can identify that a patient wants to leave a bed 35 to 65 seconds before they get up with 95% accuracy. VirtuSense said data from its clients has shown a 95% reduction in false alarms and a 60% reduction in falls. Along with the fall-prediction capabilities, VTSOne brings wearable vitals sensors to hospitals, as well as a telehealth platform that connects patients with specialists and other members of their care team.
For scoping out a safer approach to endoscopy
Reusing endoscopes has always been a bit of a dicey proposition, given the potential for them to spread infection from one patient to the next. Single-use endoscopes have been a growing area of interest for medical professionals, and Ambu has been one of the pioneers in the field, growing its array of single-use scopes with two FDA approvals in 2021, as well a Health Canada Greenlight for a cystoscope. The U.S. products include VivaSight 2 DLT, a double-lumen tube for use in single-lung ventilation, and the aScope 4 Broncho Sampler Set, designed for bronchial wash and bronchoalveolar lavage procedures, including airway clearing and lung fluid samples. As Ambu looks to make inroads in ENT, urology, and gastroenterology, it’s targeting 20 product launches over the next 3 years while also aiming to cut its carbon emissions in half and partnering with Sharps Compliance to keep its scopes out of landfills.
8. XANDAR KARDIAN
For checking vitals without waking anyone up
In hospitals and long-term care situations, checking vitals is a necessary but monotonous task for healthcare workers—and something of an annoyance for patients, especially at night. Xandar Kardian’s solution is to use ultra-wideband impulse radar to continually monitor patient vitals without a wearable. Given its 510(k) clearance by the FDA in April, Xandar Kardian’s XK300 Autonomous Health Monitoring Solution can assess heart rate and respiratory rate and measure them against doctor-set thresholds to know when it needs to alert staff about changes. With 23 patents under its belt and growing partnerships with long-term care groups and hospitals, Xandar Kardian closed 2021 with a Series A funding round that brought in $10 million.
9. VIVOS THERAPEUTICS
For pioneering a collaborative approach to sleep apnea
Dentists and physicians don’t often work terribly closely, and if they do, it’s not on sleep disorders. The unlikely combination of all three is at the heart of Vivos Therapeutics, whose FDA-cleared device for treating sleep apnea engages doctors, who diagnose sleep apnea, and dentists, who provide patients with the Vivos Method—a treatment protocol that’s often combined with oral-appliance technology to treat dentofacial abnormalities, along with mild to moderate obstructive sleep apnea and snoring. And though the Vivos Method has more than 25,000 users, the company’s 2021 was focused on growing its reach with a new diagnostic technology called VivoScore, which uses a single-sensor ring recorder to assess sleep quality and help get patients started on treatment, which is more simple, unlike with CPAP machines and other approaches.
For expanding the scope of point-of-care ultrasound
In 2021, EchoNous introduced Lexsa, a 128-channel linear probe, that unlocked new and wide-ranging capabilities for its Kosmos AI-powered point-of-care ultrasound. With Lexsa, physicians have a new tool that is capable of high-level imaging of vascular structures, the musculoskeletal system, and nerves, making Kosmos a tool for guiding central line placement, nerve blocks, and injections into joints. Even before it built out Kosmos’s capabilities with Lexsa, the platform’s performance led a 500% year-over-year increase in global sales from 2020 to 2021, highlighting the appeal of a portable machine that carries the same imaging abilities as a cart-mounted ultrasound.