The growing prevalence of chronic diseases like cancer and diabetes is driving increasing innovation in medical device technology. In 2024 alone, 30 new devices were approved by the US Food and Drug Administration (FDA).
Wearable medical devices and the use of artificial intelligence in medical technology are two key trends in this sector.
Investors who want exposure to this wave of growth may want to consider NASDAQ small-cap medical device stocks. Below is a list of the top NASDAQ medical device companies based on year-on-year gains.
All data was compiled on December 31, 2025, using TradingView’s stock screener, and the medical device makers listed below had market caps between US$50 million and US$500 million at that time.
1. MDxHealth (NASDAQ:MDXH)
Year-on-year gain: 50.86 percent
Market cap: US$173.24 million
Share price: US$3.50
MDxHealth is a commercial-stage precision diagnostics company specializing in molecular tests for urologic cancers, particularly prostate cancer, using genomic, epigenetic and exosomal technologies. Its US headquarters and operations are located in Irvine, California.
The company offers non-invasive and tissue-based diagnostic assays that run on standard PCR platforms.
In September, MDxHealth acquired Exosome Diagnostics from Bio-Techne (NASDAQ:TECH) for US$15 million, adding the ExoDx Prostate urine test to its portfolio. The deal also includes a CLIA-certified clinical laboratory and related assets. The deal is expected to generate over US$20 million in revenue in 2026.
2. KORU Medical Systems (NASDAQ:KRMD)
Year-on-year gain: 50.13 percent
Market cap: US$269.6 million
Share price: US$5.82
KORU Medical Systems develops and manufactures medical devices and supplies in the US and internationally, with a focus on mechanical infusion products. Its Freedom Syringe Infusion System first received FDA clearance in 1994.
Based on this system, its primary products include the Freedom60 and FreedomEdge syringe infusion systems, Precision Flow Rate Tubing and High-Flo Subcutaneous Safety Needle Sets.
KORU Medical Systems submitted a 510(k) premarket notification to the FDA on December 30, 2025, seeking clearance for its FreedomEdge system to deliver Phesgo — a HER2+ breast cancer targeted biologic — subcutaneously, targeting infusion centers to cut chair time and boost efficiency.
The company stated this is part of its strategy to expand the indications of FreedomEdge to the wider oncology infusion center market.
3. Vivani Medical (NASDAQ:VANI)
Year-on-year gain: 1.71 percent
Market cap: US$86.81 million
Share price: US$1.19
Vivani Medical is a clinical-stage biopharmaceutical company developing miniature, long-term subdermal drug implants using its proprietary NanoPortal technology to treat chronic conditions like obesity and type 2 diabetes.
Headquartered in Alameda, California, Vivani focuses on GLP-1 implants that provide steady drug release over six months to improve adherence and tolerability compared to daily pills or weekly injections.
In August, Vivani Medical reported positive Phase 1 results from its LIBERATE-1 trial of the NPM-115 exenatide implant, confirming safety and steady drug release for obesity treatment without major side effects.
The company plans to rapidly advance its NPM-139 semaglutide implant after it achieved preclinical results of sustained 20 percent weight loss. It is planning a Phase 1 clinical study in the first half of 2026.
Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.
