One of the main threads running through our most-read stories of 2025—as much as ever in the medtech industry writ large—is that new technologies can make healthcare more accessible. And, when healthcare becomes more accessible, diseases lose.
The top half of our top 10 includes a slate of blood tests that aim to catch diseases like cancer and Alzheimer’s earlier as well as wearables designed to give the user a clearer picture into their everyday health. They all have yet to truly show they can make their marks in improving people’s lives—but their promise shows how patients can’t wait.
Our top story followed the FDA’s approval earlier this month of Cleveland Diagnostics’ next-generation blood test for prostate cancer, which aims to improve upon the standard PSA exam. The IsoPSA test looks for specific variants of the prostate-specific antigen protein tied to a higher risk of malignant disease, instead of charting total PSA increases over time.
The company, a Cleveland Clinic portfolio member, estimates that more than 1 million men undergo prostate biopsies annually, with as many as 75% coming back negative for high-grade cancer. IsoPSA has been on the market since 2020 as a lab-developed test, but the FDA’s green light means it can now be sold to labs nationwide as an in vitro diagnostic kit.
Story No. 2 tapped into the new Cancerguard blood test from Exact Sciences, which aims to spot the signs of more than 50 different types of malignancies. It doesn’t cover the more-common cases in the breast and prostate, but it includes aggressive diseases responsible for more than 80% of new diagnoses annually, such as cancers of the pancreas, ovaries, liver, lungs, esophagus and stomach.
Cancerguard’s long-awaited commercial launch in September came two months ahead of Abbott’s blockbuster $23 billion buyout offer for Exact Sciences, as the company looks to dive into cancer screening and precision oncology.
Coming in third was the FDA’s July clearance of the Hilo bracelet, marking the agency’s first for a cuffless blood pressure monitor. Developed by the Swiss company Aktiia, the Hilo uses optical sensors to capture continuous readings with monthly calibrations. The system previously obtained a CE mark approval in Europe, and Aktiia said the wristband will reach U.S. shores sometime in 2026.
Ranked fourth was Roche’s blood test for Alzheimer’s disease securing a U.S. green light. Developed in collaboration with drugmaker Eli Lilly, the Elecsys pTau-181 test aims to rule out the condition’s amyloid-related pathology among older adults showing the early signs of cognitive decline. Roche said bringing the test to its more than 4,500 instruments installed in the U.S. could help provide Alzheimer’s biomarker testing at the front lines of primary care.
Our fifth piece found the FDA’s de novo clearance of Biolinq’s painless and needle-free continuous glucose monitor. The Shine system, which also tracks activity and sleep, is studded with microsensors described up to 20 times shallower than the filament-based CGMs that breach the skin. For people with Type 2 diabetes that do not take insulin, the sensor is designed to provide a more qualitative view of glucose ranges and trends—with color-coded lights—instead of offering the typical quantitative measurements used to calculate doses.
And, sometimes those measurements can be wrong. Story No. 6 followed Abbott’s replacement of certain FreeStyle Libre 3 CGMs. In late November, the company reported hundreds of injuries and seven deaths outside the U.S. linked to incorrect readings that could prompt users to skip their insulin. Abbott said it fixed the issue after tracing a manufacturing defect to a single production line. Still, that amounted to about 3 million Libre 3 and Libre 3 Plus sensors distributed across the country; though, by that time, about half were expected to have either been used or past their expiration date.
At No. 7 came fellow CGM maker Dexcom, with a survey showing that healthcare providers ranked the impact of tech over new medications when it comes to Type 2 diabetes. Released during March’s International Conference on Advanced Technologies and Treatments for Diabetes in Amsterdam, the poll collected responses from more than 2,500 people in Germany, Italy, the Netherlands, Saudi Arabia, Spain and the U.K.—52% of healthcare providers said CGMs have more potential to help users manage their condition over the next 10 years, compared to 38% who listed the development of better or more effective drugs. In addition, about half said CGMs should become the standard of care regardless of whether a person is taking insulin.
Our eighth story also hails from earlier this month, with the FDA’s groundbreaking approval of its first at-home, device-based treatment for major depression. The brain stimulation headset developed by Flow Neuroscience was approved both as a standalone therapy and in combination with other medications. The company said about a third of that population does not see success with antidepressants and that many stop taking them due to certain side effects. A randomized, sham-controlled study showed 77% of users reporting symptom improvements in as little as three weeks.
No. 9 found the emerging field of renal denervation be accepted under hypertension guidelines. The publication from the American Heart Association and the American College of Cardiology updated recommendations from 2017 to include the single-shot procedure to burn out overactive nerves lining the blood vessels feeding the kidneys—following up on Medicare coverage proposals and transitional payments earlier this year for devices from Medtronic and Recor Medical.
Finally, story No. 10 saw BD bid farewell to its diagnostic and bioscience divisions as part of a long-term plan to reshape the company by the end of 2025. After parting ways with its diabetes franchise nearly three years ago—forming the independent spinout embecta—BD sold off its pair of units to Waters Corporation in a lab tools and testing deal worth $17.5 billion.
Medtech knows patients can’t wait, and we can’t wait to see what the new year brings.