medical device guru

Cardiovascular / Cardiology

FDA Clears Numares Health Cardiovascular Diagnostic Test and Core Technology Platform

The US Food and Drug Administration has cleared a Numares Health test, the AXINON® LDL-p Test System, as a new tool physicians can use to measure lipoproteins for patients at risk for cardiovascular disease. Currently, Numares is the only company...

July 25, 2023

Diagnostics & Healthcare News

Magnus Medical Announces First Participants Treated in Study Using SAINT Neuromodulation System for Major Depression

Magnus Medical, Inc., a medical device company and developer of brain stimulation technology for the treatment of neuropsychiatric disorders, today announced that the first participants have been treated in the Open Label Optimization (OLO) Clinical Trial evaluating the effectiveness of...

July 24, 2023

Surgery and Surgical Robotics

UroMems Announces First-Ever Smart Artificial Urinary Sphincter Implant in a Female Patient

UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-ever implant of the UroActive™ smart, automated artificial urinary sphincter (AUS) in a female patient. This milestone indicates a new...

July 21, 2023

Imaging Visualization & Navigation

MediView Receives FDA 510(k) Clearance for XR90 Augmented Reality-Based Visualization and Navigation Platform

MediView XR, Inc., a leading clinical augmented reality med-tech company, announced today it received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for its XR90 augmented reality-based surgical visualization and navigation platform. XR90 is intended to be used...

July 20, 2023

Surgery and Surgical Robotics

Francis Medical Announces First Patient Treated in VAPOR 2 Pivotal Study for Water Vapor Ablation of Prostate Cancer

Francis Medical, Inc., a privately held medical device company developing an innovative and proprietary water vapor ablation therapy for the treatment of prostate, kidney, and bladder cancer, today announced the first patient has been treated in the company’s VAPOR 2...

July 19, 2023

Diagnostics & Healthcare News

FDA Clears ReddyPort® Non-Invasive Ventilation Device

ReddyPort announced today that the US Food and Drug Administration (FDA) granted 510(k) premarket clearance for the ReddyPort elbow device used in non-invasive ventilation (NIV). “ReddyPort’s patented elbow is central to the eco-system we are building to help mitigate clinical...

July 18, 2023

Orthopedics and Spine

WillowWood Launches Fiberglass Meta® Shock X

Building on the success of META® Shock X, WillowWood launches the Fiberglass META® Shock X. The revolutionary META® feet combine responsive energy return with balance, stability, and impact protection. All META® feet feature the industry’s first unibody platform, free of...

July 17, 2023

Biologics, Wound Care, Infection Prevention

Allosource Receives FDA 510(K) Clearance for Aceconnex™ Pre-Sutured Fascia for Hip Labral Reconstruction and Augmentation

AlloSource®, one of the largest allograft providers creating innovative cellular and tissue products to help surgeons heal their patients, today announced the U.S. Food and Drug Administration’s 510(K) clearance of AceConnex Pre-Sutured Fascia for hip labral reconstruction and augmentation. This...

July 14, 2023

Cardiovascular / Cardiology

AccurKardia’s AccurECG™ Analysis System Receives FDA 510(k) Clearance

AccurKardia, a medical technology company delivering clinical-grade ECG interpretation software, announced today that its flagship product, the AccurECG™ Analysis System (“AccurECG” or the “System”), has been granted FDA 510(k) clearance. AccurECG™ is a cloud-based, device-agnostic and fully automated electrocardiogram (ECG) interpretation software...

July 12, 2023