medical device guru

Surgery and Surgical Robotics

Endologix Receives FDA Approval of the DETOUR™ System to Treat Long Complex Superficial Femoropopliteal Lesions in Patients with PAD

Endologix LLC, a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, announced today that the U.S. Food and Drug Administration (FDA) has granted approval for the DETOUR System to treat...

June 9, 2023

Cardiovascular / Cardiology

Innova Vascular Earns FDA Clearance for Two New Thrombectomy Devices: Laguna Clot Retriever™ System and Malibu Aspiration Catheter™ System

Innova Vascular, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Laguna Clot Retriever™ System and its Malibu Aspiration Catheter™ System for use in the peripheral vasculature. The two new devices are collectively known...

June 7, 2023

Orthopedics and Spine

Artelon, Inc.’s FlexBand®, FlexPatch®, and FlexBand Plus® earn FDA Clearance for Ligament Reinforcement

Artelon Inc., announced today U.S. FDA 510(k) clearance of FlexBand®, FlexPatch®, and FlexBand Plus® for ligament repair surgery in addition to tendon repairs*. This new clearance expands the indications for these products to now include reinforcement of medial, lateral and...

June 6, 2023

Imaging Visualization & Navigation

Waters Takes Targeted, Quantitative Imaging to the Next Level with New DESI Source for the Xevo TQ Absolute System

American Society for Mass Spectrometry (ASMS) — Waters Corporation (NYSE:WAT) today launched the industry’s first targeted imaging mass spectrometer based on its Xevo™ TQ Absolute tandem quadrupole mass spectrometer, the most sensitive and compact mass spectrometer in its class. The new instrument combines the Waters™ DESI...

June 5, 2023

Surgery and Surgical Robotics

THINK Surgical Receives FDA 510(k) Clearance for TMINI Miniature Robotic System

THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that its TMINI™ Miniature Robotic System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The TMINI system includes a wireless robotic handpiece...

May 30, 2023

Diagnostics & Healthcare News

Biosency detects early COPD exacerbations thanks to Bora care®, a predictive digital medical device

The American Thoracic Society International Conference (ATS 2023) took place in Washington, D.C. from 19 to 24 May 2023. During the conference on 23 May, French MedTech Biosency unveiled its latest clinical results demonstrating the ability of its BVS3 technology to predict acute COPD (chronic obstructive...

May 26, 2023

Diagnostics & Healthcare News

iHealthScreen Inc. Announces FDA 510K Submission for iPredict™ AMD tool

iPredictTM AI Eye Screening System provides fully automated age-related macular degeneration (AMD) screening, including retinal imaging and immediate reporting of actionable results. Using the iPredictTM System, primary care and various specialty practices can accurately and efficiently screen people over 50 for AMD and...

May 24, 2023

Biologics, Wound Care, Infection Prevention

Cartessa Aesthetics Introduces Helix by DEKA, a Powerful Fusion of Skin Resurfacing Technology

In the growing category of non-invasive, energy-based aesthetic procedures, laser skin resurfacing occupies one of the largest shares. Laser resurfacing is an effective way to reduce the appearance of fine lines, wrinkles, scars, unwanted pigment, and improve skin’s tone and...

May 23, 2023

Imaging Visualization & Navigation

Orlucent Receives FDA Breakthrough Device Designation for Handheld Mole Imaging System

Orlucent, Inc., a company focused on clinical assessment of suspicious moles, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s Orlucent® Skin Fluorescence Imaging System. The Orlucent system is a handheld point-of-care...

May 22, 2023