
Data from 30-patient study support FDA De Novo application as company highlights system performance in bariatric procedures





Data from 30-patient study support FDA De Novo application as company highlights system performance in bariatric procedures

Canadian medical device company Vena Medical completes seven neurosurgery cases at UTMB Health following recent FDA clearance.

What exactly are the steps for getting federal approval for new devices and technology?

New surgical stapling device designed to improve staple line integrity across a range of tissue thicknesses in open and laparoscopic procedures

Venture will combine implantable sensing tech with 3D-printed designs

A researcher in wearable medical technology describes technology that’s already helping patients and has room to grow.

The company’s device, a Class II prescription product, is positioned as a non-drug treatment for postmenopausal women with osteopenia

Under the program, eligible Medicare beneficiaries will be able to use WHOOP’s wearable device and data platform to receive continuous health monitoring, personalized insights and real-time coaching.

Device is intended for use in minimally invasive cardiac procedures that require access to the left atrium, a critical but technically challenging step in many structural heart and electrophysiology interventions.

As the medical device industry accelerates its transition to software-enabled, connected, and AI-driven technologies, the testing and validation landscape is undergoing a fundamental shift.

Device designed to deliver faster, more efficient ablation with improved usability

Device expands treatment options for high-risk patients with complex aortic conditions, reflecting broader advances in endovascular therapy

Device is intended to treat pain associated with hypertrophic bone growth, a common contributor to lumbar spinal stenosis

New device aims to address appointment delays, technologist shortages with simplified setup

Two-year TRISCEND II data show lower mortality, quality of life gains

System replaces handwritten labels with a barcode-scanning process that prints standardized, color-coded adhesive labels for infusion lines

The system is intended for use by trained health care professionals and integrates into existing clinical workflows without requiring changes to treatment planning systems or IT infrastructure.

Study shows improved handling, faster ablation times with smaller catheter design

The approval allows Seimens' systems to deliver low-dose radiation therapy to patients whose osteoarthritis has not responded to other medical treatments.

Neurostimulation system offers alternative for patients who fail standard therapies

LPP200 series features a 0.75-inch profile, representing what the company says is a significant advancement in power supply miniaturization for devices including patient monitors, displays and infusion pumps.

Bridging the gap between innovation and sustainable deployment in health care

First patient enrolled in clinical trial for novel biofilm treatment

Artificial intelligence-powered surgical robot designed to improve precision and reduce physical strain on surgeons performing urological procedures.

FDA-cleared app brings automated insulin delivery to Google Pixel, Samsung Galaxy smartphones