A connected medical device is a device that transmits and receives health data wirelessly — typically over Bluetooth, WiFi, or cellular networks — to support diagnosis, treatment, monitoring, or remote patient management. Connected medical devices include continuous glucose monitors (CGMs), wearable cardiac monitors, smart inhalers, connected blood pressure cuffs, implantable neurostimulators, and pulse oximeters that integrate with mobile apps and clinician dashboards.
Connected medical devices form the backbone of the Internet of Medical Things (IoMT) — a global market valued at USD 77.49 billion in 2025 and projected to reach USD 1,906.70 billion by 2034, according to Fortune Business Insights. Growth is driven by rising chronic disease prevalence, aging populations, and the growing capabilities of consumer platform sensors to capture clinical-grade data.
This guide covers what connected medical devices are, how they communicate, the categories they fall into, applications across 12+ chronic conditions, and the FDA regulatory framework that governs them.
What Is a Connected Medical Device?
A connected medical device is a device that uses wireless networking — most commonly Bluetooth, Bluetooth Low Energy (BLE), WiFi, or cellular — to transmit medical data to other devices, mobile applications, cloud platforms, or healthcare provider systems. The defining feature is data exchange: a connected medical device is not a device that happens to be used in medicine, but a regulated medical device whose clinical function depends on, or is meaningfully enhanced by, the data it transmits or receives.
Connected Medical Devices vs Consumer Connected Devices
Not every connected device used in healthcare is a connected medical device. The line is drawn by the FDA — and it depends on intended use. Devices that diagnose, treat, monitor, or mitigate a medical condition are subject to the FDA medical device regulations. Devices that support general wellness, fitness, or a healthy lifestyle without making clinical claims (consumer fitness trackers, sleep monitors marketed as wellness tools, basic step counters) are typically not regulated as medical devices, even when used by patients with medical conditions.
The distinction matters for development. FDA-regulated connected medical devices must be built in accordance with medical device quality and software standards, including IEC 62304 (software lifecycle), ISO 14971 (risk management), and ISO 13485 (quality management system). Consumer connected devices have no such requirement, but they cannot make clinical claims either.
Categories of Connected Medical Devices
Connected medical devices fall into several functional categories:
- Remote Patient Monitoring (RPM) devices collect physiological data from a patient in their home or daily environment and transmit it to a clinical care team. Examples: connected blood pressure cuffs, weight scales, pulse oximeters, glucose meters.
- Wearable medical devices are worn on the body to continuously monitor vital signs, movement, and other physical traits. Examples: continuous glucose monitors (CGMs), wearable cardiac event monitors, smartwatches with FDA-cleared ECG, and pregnancy contraction monitors.
- Implantable connected medical devices are surgically placed in the body and communicate with external apps or receivers controlled by the patient or clinician. Examples: implantable cardioverter defibrillators (ICDs), spinal cord stimulators, vagus nerve stimulators, deep brain stimulators.
- Smart drug delivery devices dispense medication and connect to apps or platforms that track adherence and dosing. Examples: insulin pumps, smart inhalers, connected injection pens, ingestible sensor pills.
- Connected diagnostic devices perform clinical-grade measurements at home or at the point of care and transmit results to clinicians. Examples: connected thermometers, otoscopes for telehealth, home ECG devices, smart stethoscopes.
- Connected EHR-integrated platforms aggregate data from multiple connected medical devices and feed it into electronic health records (EHRs). These themselves function as connected medical devices and inherit the regulatory requirements of the data flowing through them.
How Connected Medical Devices Communicate?
Connected devices typically communicate through one of four channels.
Radio Frequency
For many years, the only way for connected devices to transmit data was via radio frequency. These devices require a special transmitter that connects to the internet. The device transmits its information wirelessly to the transmitter via radio waves when within range. The transmitter then shares the information with the care team via the Internet.
Bluetooth
Many connected devices today utilize Bluetooth technology to communicate. Bluetooth connections allow them to share data over a short distance with a connected platform. This is typically an application on a smartphone or tablet, but Bluetooth can also be used between medical devices, such as insulin pumps and glucose monitors.
Wi-Fi
More recently, connected devices have been designed to use Wi-Fi to communicate. These devices have the added advantage of accepting large amounts of data from connected platforms and devices. Typically, these smart devices can be remotely updated and can access and store data in the cloud.
Cellular (4G/5G)
Modern connected medical devices increasingly use cellular networks (4G LTE and 5G) for direct cloud communication, bypassing the need for a paired smartphone or local WiFi. Cellular connectivity is particularly common in remote patient monitoring devices used by elderly patients or in low-connectivity environments. The trade-off is recurring connectivity costs — cellular devices typically include data plans baked into the manufacturer’s pricing model.
The Internet of Medical Things (IoMT) Market
The Internet of Medical Things (IoMT) is the network of connected medical devices, healthcare IT systems, and clinical software that exchange health data over wireless networks. According to Fortune Business Insights, the global IoMT market was valued at USD 77.49 billion in 2025 and is projected to reach USD 1,906.70 billion by 2034, growing at a CAGR of 44.22% during the 2026–2034 forecast period. North America held the largest share at 28.99% in 2025.
Growth is driven by rising chronic disease prevalence, aging populations, the expansion of reimbursement frameworks for remote patient monitoring, and the growing capabilities of consumer platform sensors to capture clinical-grade data. Within the IoMT market, the largest segments are remote patient monitoring, connected diabetes management, wearable cardiac monitoring, and connected drug delivery — all of which benefit from continuous data that measurably improves outcomes.
Connected Medical Devices in Chronic Disease Care
Connected medical devices have changed chronic disease care most where continuous data improves outcomes — in conditions where treatment decisions benefit from frequent measurement, where patient adherence is critical, and where early detection of decompensation prevents hospitalization. The 12 therapeutic areas below are where the impact has been clearest, with examples of devices currently on the market or in late-stage development.
Diabetes
One of the greatest examples of connected device advancements is in the world of diabetes. What started out as insulin pumps receiving readings wirelessly from blood glucose meters has expanded into highly intelligent, interconnected systems that use pumps, meters, and continuous glucose monitors (CGMs) to automatically adjust insulin rates to keep blood sugar within range.
Developers continue to build on this interconnected web of treatment tools. Current research is focused on enabling people living with diabetes to use pictures they take on their phones to calculate meal boluses, which are automatically communicated to their pumps and integrated with CGM data. Other companies are working on connected wearables that track body movement and use behavior analysis to automatically bolus for meals whenever the user eats.
Hypertension
Nearly half of all American adults suffer from hypertension. Advancements in connected devices and associated mobile applications are helping them better manage this condition and avoid serious, costly comorbidities. Connected home blood pressure cuffs allow doctors to track patient progress from afar, while connected mobile apps help patients stay on top of their medications, graph blood pressure readings throughout the day, and detect abnormal heart rhythms.
Advancements in the works aim to transform simple wearables, such as smartwatches, into connected blood pressure monitors for continuous data input.
Epilepsy
There are a variety of nonmedical connected devices on the market used to detect and alert to seizure activity. These include wearables like smartwatches, mattress sensors, and infrared cameras. There are also some options available and in development that utilize implanted devices to stimulate the vagus nerve or specific areas of the brain to reduce seizure activity.
Mental Health
Mental illness takes many forms, and so must the connected devices used to help treat and support patients. To track medication adherence, one company has developed pills with sensors in them that trigger a smartphone-connected patch worn on the skin whenever the medication is ingested.
Other projects look to use biofeedback to warn patients and their caregivers of potential problems. One such connected device uses pulse and other vitals to trigger soothing vibrating pads worn on the wrists anytime anxiety is detected. Others use integrated data from multiple devices to send warnings of oncoming episodes.
Irritable Bowel Syndrome
Connected wearable devices have helped researchers identify abnormalities in gastrointestinal nerve function in people suffering from IBS. In terms of treatment, one approved option features a device worn around the ear that sends mild electric impulses to cranial nerve bundles to reduce pain associated with abdominal discomfort.
Pregnancy and Childbirth
Advancements in supporting women through pregnancy and childbirth revolve around wearables that make the entire process more transparent and safer for the baby and the mom. For pregnancy, one team has developed wearable patches that track the baby’s development while also monitoring the environment for potential exposures. Other patches have been created specifically to monitor for contractions and help expectant mothers differentiate between Braxton hicks and the real thing.
In the delivery room, old, clunky, uncomfortable monitors are being replaced by wireless connected patches that monitor the baby while allowing the mom to move freely. Much of the same technology is being used to monitor newborn vitals. These patches and wraps connect to phone and tablet applications to alert caregivers to potential problems with oxygen saturation, pulse, and temperature.
Cystic Fibrosis
There are many opportunities for connected medical device use in diagnosing and treating cystic fibrosis, some of which are already available, while others are still in development. One such device that has shown promise for early diagnosis is a wearable that monitors sweat salt levels to identify CF before clinical symptoms appear. Another device focuses on early detection of pulmonary exacerbations in people with CF, giving care teams valuable time to respond and reduce damage.
Aging, Hormones, and Metabolic Changes
Aging is a chronic condition we all experience. With it come changes in hormone levels and metabolic rate. Various connected devices have been developed to help monitor the aging process and treat changes that may become problematic.
For women, many hormone monitoring devices are available to help users through the stages of menopause. Insertable hormone detectors connect to mobile apps to provide users with real-time information on hormone changes throughout the month and from month to month. Others connect to at-home blood test meters that measure hormones, keeping patients and doctors in the loop.
Older adults are at a greater risk of developing diabetes and other metabolic disorders. CGMs marketed for non-diabetics help detect blood sugar changes early so patients can make changes to their diet and routine that will be effective for their bodies. Many wearable devices focus on encouraging exercise and stress reduction using step counters, heart rate monitors, and blood pressure monitors to reduce metabolic risk.
Alzheimer’s Disease
Current work in the realm of connected devices for those suffering from Alzheimer’s disease is centered around wearable devices that can help detect the disease before clinical symptoms become obvious and wearables to keep early sufferers independent for longer. The former uses sensors, connected tracking devices, and applications to monitor movement, cognitive functions, memory, and sleep, detecting important changes. The latter uses activity trackers to encourage movement and exercise and AI-enabled devices to aid in communication and cognitive tasks.
Migraines and Chronic Pain Conditions
Drug-free methods for pain management have recently evolved from traditional Eastern medicine to high-tech connected devices. Many of these utilize nerve or neurostimulation to interrupt pain-processing pathways in the brain. Some take on a simple, wearable design, including hats with neuromodulation devices built into the band that help fight migraines and chronic pain and reduce stress.
More invasive applications include implanted devices that work with a wireless remote or phone app to provide electrical stimulation to counteract pain signals. These devices can be implanted in the spinal cord or, more recently, within the dorsal root ganglia.
Asthma and COPD
Inhalers have long been the preferred method of treatment for asthma and COPD. But these devices are often misused or underutilized by patients. Smart inhalers aim to change these trends. These new connected devices communicate with a smartphone app to track when, where, and how often the inhaler is used. Some can also remind patients of missed doses and warn them if they leave the house without their inhaler.
Highly integrated apps can use local weather forecasts, allergen counts, and pulse oximeters to help the user treat before breathing problems occur. Some specialty-connected inhalers can double as lung testing devices and record data in the associated application.
Chronic Kidney Disease
Treating patients with chronic kidney disease remains an area with many opportunities. These patients frequently struggle with complications from their condition that would benefit from close monitoring. Smartphone applications integrated with smart scales, blood pressure cuffs, and pulse oximeters could help patients keep a closer eye on fluid retention and worsening complications.
Integrating a CGM with this type of app would be imperative, given how many people living with diabetes suffer from kidney problems. People with CKD often experience heart failure and heart attacks, making wearable ECG monitors another obvious device to incorporate.
Multiple Sclerosis
Multiple sclerosis is the most common autoimmune disease to affect the central nervous system. Smart devices have long been helpful for people suffering from the condition, but only recently have connected medical devices been used to treat the disease itself.
Researchers have developed a promising connected neuro-electrostimulation system. The system delivers low-frequency electrical stimulation to specific clusters of damaged neurons in the brain to promote repair. The pulses are generated by an implant and controlled by a connected wireless phone app. Other possible treatment and supportive care devices include motion sensors used to track changes in walking impairment, falls, fatigue, and sleep quality.
Parkinson’s Disease
Parkinson’s disease is another neurological condition that is just beginning to benefit from advancements in connected devices. Many of these focus on tracking symptom progression using wearables that sense changes in gait and movement. Actual treatment options appear to be a ways off, but will likely include neurological stimulation devices and connected applications.
FDA Regulation and Cybersecurity for Connected Medical Devices
Connected medical devices that diagnose, treat, monitor, or mitigate a medical condition are regulated by the FDA in the United States and by equivalent national regulators internationally. The regulatory pathway depends on the device’s risk class, intended use, and whether a substantially equivalent predicate device exists.
Premarket Pathway
Most connected medical devices enter the U.S. market through a 510(k) premarket notification, which requires demonstrating substantial equivalence to a legally marketed predicate device. Novel low- to moderate-risk devices use the De Novo classification pathway. High-risk devices requiring clinical trial data use Premarket Approval (PMA). Connected medical devices that include software components — which are most of them — are also regulated under IEC 62304 software lifecycle standards.
Cybersecurity Requirements
Since 2023, FDA premarket submissions for connected medical devices that address cybersecurity must include detailed cybersecurity documentation under section 524B of the Federal Food, Drug, and Cosmetic Act. Required content includes a Software Bill of Materials (SBOM), threat modeling, vulnerability assessment, and a plan for monitoring and addressing post-market vulnerabilities. The FDA published expanded cybersecurity premarket guidance in 2023 and continues to evolve expectations as connected devices proliferate. Devices that fail to meet cybersecurity submission requirements face refusal-to-accept (RTA) decisions — meaning the submission doesn’t even progress to substantive review.
Developing a Connected Medical Device
Connected medical device development requires both hardware engineering and regulated software engineering — and the integration between them is where most projects struggle. The hardware side handles sensors, power, connectivity radios, and physical safety. The software side handles data acquisition, processing, transmission, security, and the regulatory documentation that makes the whole system FDA-submittable.
Software for connected medical devices must meet IEC 62304 software lifecycle requirements, ISO 14971 risk management, and FDA cybersecurity premarket standards — all developed within an ISO 13485 quality management system. For most hardware-focused medical device companies, building this software stack from scratch isn’t realistic. Most successful programs partner with a specialist software firm whose development process is already aligned to the regulatory framework.
Frequently Asked Questions About Connected Medical Devices
What is a connected medical device?
A connected medical device is a medical device that transmits or receives health data wirelessly — typically over Bluetooth, WiFi, or cellular networks — to support diagnosis, treatment, monitoring, or remote patient management. Examples include continuous glucose monitors (CGMs), wearable cardiac monitors, smart inhalers, connected blood pressure cuffs, and implantable neurostimulators.
What is the Internet of Medical Things (IoMT)?
The Internet of Medical Things (IoMT) is the network of connected medical devices, healthcare IT systems, and clinical software that exchange health data over wireless networks. According to Fortune Business Insights, the global IoMT market was valued at USD 77.49 billion in 2025 and is projected to reach USD 1,906.70 billion by 2034, growing at a CAGR of 44.22%.
What categories do connected medical devices fall into?
Connected medical devices fall into six main categories: remote patient monitoring (RPM) devices, wearable medical devices, implantable connected devices, smart drug delivery devices, connected diagnostic devices, and EHR-integrated platforms. Each category has distinct regulatory considerations and development requirements.
Are connected medical devices regulated by the FDA?
Yes. Connected medical devices that diagnose, treat, monitor, or mitigate medical conditions are regulated by the FDA in the United States. Most enter the market through 510(k) premarket notification; novel devices use the De Novo pathway; high-risk devices use Premarket Approval (PMA). Since 2023, all FDA submissions for connected devices with cybersecurity considerations must include detailed cybersecurity documentation under section 524B of the FD&C Act.
What’s the difference between a connected medical device and a consumer connected device?
The difference is intended use. Connected medical devices are intended to diagnose, treat, monitor, or mitigate medical conditions and are regulated by the FDA. Consumer connected devices (fitness trackers, basic step counters, wellness apps) are not intended to make clinical claims and are typically unregulated. The same physical hardware can be one or the other depending on how the manufacturer markets it.
How long does it take to develop a connected medical device?
Connected medical device development typically takes 18 to 36 months from concept to FDA clearance, depending on risk class, regulatory pathway, and whether the team is building from scratch or working from a regulated software foundation. Software-only SaMD products on the 510(k) pathway often complete faster (12–18 months); novel hardware-software combinations using De Novo or PMA can take longer.
Build Connected Medical Device Software With a Specialist Partner
Connected medical device software is what Sequenex builds every day. Every project is engineered under IEC 62304 within our ISO 13485-certified QMS, with ISO 14971 risk management running in parallel and FDA cybersecurity documentation produced as the engineering work happens — so submission week is paperwork, not a fire drill. Our team has decades of experience across diabetes care, biosensors, CGM, cardiac monitoring, and connected drug delivery.
Whether you’re a hardware company building software for the first time or a software company moving into regulated connected devices, we can help.
