Posts by cstephenson@legacymedsearch.com
FDA Clears CorNeat EverPatch, World’s First Non-degradable, Synthetic Tissue Substitute for Ophthalmic Surgery
CorNeat Vision’s EverPatch, a synthetic tissue substitute, has been granted 510(k) clearance by the US Food & Drug Administration (FDA). The CorNeat EverPatch is the first synthetic, non-degradable tissue-integrating matrix for use in ophthalmic surgeries. It is composed of a non-woven, polymer matrix which integrates with surrounding tissue and is intended to reinforce the sclera and…
Read MoreAvails Medical’s eQUANT™ System Submitted to FDA for 510(k) Clearance
Avails Medical, a pioneer in rapid, automated and fully electrical antibiotic susceptibility testing (AST) solutions announced today the submission of its eQUANTTM system for FDA 510(k) clearance. The eQUANT system provides a standardized inoculum (0.5 McFarland equivalent) directly from a positive blood culture, which is designed to be used with traditional automated AST systems and Disk…
Read MoreEndologix 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 patients with complex peripheral arterial disease (PAD). Over 8.5 million Americans are affected by PAD.…
Read MoreInnova 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 as the Laguna Thrombectomy System. “Removing clots quickly, safely, and in large volumes from the…
Read MoreArtelon, 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 ulnar collateral ligaments, spring ligaments, deltoid ligaments, and extra-articular ligaments in the ankle, knee, and…
Read MoreWaters 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 XS source with the Xevo TQ Absolute system and is five times more sensitive and five…
Read MoreTHINK 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 that assists surgeons in performing total knee replacement. Following a CT based three-dimensional surgical plan,…
Read MoreBiosency 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 pulmonary disease) exacerbations on average 3 days prior to hospitalisation in 86% of cases, with…
Read MoreiHealthScreen 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 refer them to a specialist (i.e., an ophthalmologist). Once high-resolution images of the patient’s eyes…
Read MoreCartessa 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 texture. Cartessa Aesthetics and its manufacturing partner, DEKA, have been at the forefront of skin…
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