Medical Device & 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

Having a DCES on staff helps, but virtual options are also effective

2,000 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.

Reflow Medical's Spur Stent System gains FDA clearance, offering treatment options for chronic limb-threatening ischemia with its retrievable design.

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

A new study outlines how AI might support eVisits. Patients are on board, as long as doctors remain in the driver’s seat.

Company expects to submit to FDA in 2026

GlobalData report says hospitals may be accelerating purchases of certain medical devices

Mark Daly of Digital Diagnostics joins the show to discuss AI diagnostic tools.

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.

Atia Vision's OmniVu lens system promises a breakthrough in cataract surgery with enhanced vision restoration.

U.S. tariffs are disrupting European medtech growth, forcing firms to adapt supply chains and prioritize cost optimization amid rising challenges and uncertainties.

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.

Medtech CEO warns senate that tariffs could undermine health care and innovation