Emerging Technology

The FDA’s IDE approval allows Presidio to initiate a randomized, controlled trial in the United States and Australia to evaluate the safety and efficacy of its ULF neuromodulation technology

The novel test uses a machine learning algorithm and multiple cardiac protein markers to detect obstructive coronary artery disease through a simple blood draw.

Company eyes FDA clearance for expanding use of real-time navigation technology

Two thousand consumers offered their feedback on medical devices. Here are the findings.

Phillips Medisize announces its new TheraVolt connectors, enhancing EP device performance and integration for advanced cardiac treatments like pulsed field ablation.

Reports will assess providers' capabilities in digital engineering, product development, regulatory compliance, and post-market digital services, with a focus on addressing key challenges such as data interoperability and cybersecurity.

The selected startups represent the top 4% of nearly 1,500 applicants from around the globe and will participate in MTI’s flagship four-month program focused on de-risking innovation and fast-tracking market access in the U.S.

Openwater's portable stroke detection tool enhances EMS capabilities, improving rapid diagnosis and treatment for severe strokes in emergency settings.

Guardant Health's Shield multi-cancer screening test detects multiple cancer types with a single blood draw, promising early diagnosis for various cancers.

BiVACOR's magnetic artificial heart gains FDA Breakthrough Device status, promising a revolutionary solution for severe heart failure patients.

Moximed initiates a trial for its MISHA Knee System, an alternative treatment for knee osteoarthritis, promising pain relief and improved mobility.

Company expects to submit to FDA in 2026

Tenovi's new blood pressure monitor enhances stroke prevention by enabling early detection of hypertension and irregular heartbeats through remote patient monitoring.

Aptar Digital Health and AstraZeneca collaborate to revolutionize chronic kidney disease detection using AI algorithms in eye exams, enhancing early diagnosis.

ReGelTec's HYDRAFIL System offers a minimally invasive treatment for chronic low back pain, promising significant pain relief and improved function.

Fujirebio Diagnostics’ test, which received 510k clearance Friday, will “assist physicians and patients to obtain an AD diagnosis in early stages of the disease.”

The VivAer procedure offers lasting relief for nasal obstruction, transforming NAO treatment with its minimally invasive approach and impressive results.

Synchron integrates brain-computer interface technology with Apple devices, enabling thought-controlled access for individuals with motor impairments.

Veradigm leverages AI to enhance real-world evidence for GLP-1 drugs, revealing insights on patient adherence, side effects, and treatment outcomes.

AccurKardia's AccurECG wins "Best New Technology Solution for ECG," revolutionizing cardiac diagnostics with AI-driven, real-time ECG analysis for better patient outcomes.

Myomo's MyoPro 2x revolutionizes upper-limb paralysis treatment, enhancing independence with advanced myoelectric orthoses for improved user experience and clinical outcomes.

Results show that the system consistently achieves high stone-clearance rates across diverse patient populations and clinical settings—key factors in reducing repeat procedures.

CorWave advances heart failure treatment with a groundbreaking LVAD, showcasing promising preclinical results and paving the way for human trials.

MIT's CircTrek device revolutionizes health monitoring by detecting individual cells in real-time, promising personalized treatments and improved patient outcomes.

Ohio State researchers develop system that analyzes health by how they walk