Posts by rw-admin
Acuitive Technologies Wins FDAClearance for Tendon Interference Screw System
Acuitive Technologies announced last week that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the CITREFIX™ Knotless Suture Anchor System with CITREGEN™ material technology, a new generation bioresorbable synthetic polymer. The CITREFIX system is intended to assist the attachment of tissue to bone during orthopedic surgeries such as…
Read MoreCLEW Medical Receives FDA Clearance for AI-Based Software that Predicts Hemodynamic Instability
CLEW Medical, a leader in AI-powered predictive analytics, today announced that the U.S. Food and Drug Administration (FDA) has given 510(k) clearance and authorized the use of “CLEWICU,” CLEW’s artificial intelligence (AI) based ICU solution, to predict hemodynamic instability in adult patients. The clearance is the FDA’s first for such a device, and follows the…
Read MoreInovytec’s Small “Sparrow” Ventilators Receive FDA Clearance
Inovytec, an innovator of multi-functional and user-friendly critical medical devices, announced today that it was granted FDA 510(k) clearance to market and sell its Ventway Sparrow ventilators in the United States. The ventilators are already commercialized in Europe, Canada and Australia and undergoing registration procedures in other countries. The Ventway Sparrow transport and emergency ventilators are designed for mobility, high-performance…
Read MoreZimmer Biomet Spinning Off Spine & Dental Business
Zimmer Biomet (Formerly Known As Biomet Inc.) Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, announced its intention to spin off the Company’s Spine and Dental businesses to form a new and independent, publicly traded company (“NewCo”). The planned transaction will enhance the focus of both Zimmer Biomet and NewCo to…
Read MoreZAP Surgical Receives CE Mark Clearance for its ZAP-X Gyroscopic Radiosurgery Platform
ZAP Surgical Systems, Inc. today announced it has received CE mark clearance to the new EU MDR for its ZAP-X® Gyroscopic Radiosurgery® platform. The CE mark makes it possible for healthcare providers to begin treating patients with the ZAP-X system in the European Union. For select indications including many primary and metastatic brain tumors, stereotactic…
Read MoreFDA Clears MULTIX Impact C Ceiling-Mounted DR System
Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the MULTIX Impact C ceiling-mounted digital radiography (DR) system as well as the MULTIX Impact VA20, a new version of the established floor-mounted parent DR system. Economically priced, both systems expand access to high-quality imaging and enhance the patient experience. The MULTIX Impact…
Read MoreFDA Approves Boston Scientific’s Vercise Genus Deep Brain Simulation System
Boston Scientific Corporation has received U.S. Food and Drug Administration approval of its fourth-generation Vercise Genus Deep Brain Stimulation (DBS) System. The portfolio, approved for conditional use in a magnetic resonance imaging (MRI) environment, consists of a family of Bluetooth-enabled, rechargeable and non-rechargeable, implantable pulse generators (IPGs) that power Cartesia Directional Leads, designed to provide…
Read MoreMedtronic Wins FDA Approval for DiamondTemp Ablation System
Medtronic, the global leader in medical technology, today announced it has received U.S. Food and Drug Administration (FDA) approval of the DiamondTemp Ablation (DTA) system which treats patients with recurrent, symptomatic paroxysmal atrial fibrillation (AF) and who have been unresponsive to drug therapy. The DiamondTemp system is the first FDA-approved, temperature-controlled, irrigated radiofrequency (RF) ablation…
Read MoreFDA Approves Seno Medical’s Breast Lesion Diagnostic Technology
The Center for Devices and Radiological Health (CDRH) of the US Food & Drug Administration (FDA) has granted Texas-based Seno Medical Instruments, Inc. (Seno) premarket approval (PMA) for its groundbreaking diagnostic breast cancer imaging technology that helps physicians better differentiate between benign and malignant breast lesions. The company’s Imagio Breast Imaging System uses non-invasive opto-acoustic ultrasound…
Read MoreDePuy Synthes Receives 510(k) FDA Clearance for VELYS Robotic-Assisted Solution Designed for Use with the ATTUNE Total Knee System
Today, The Johnson & Johnson Medical Devices Companies announced that DePuy Synthes has received 510(k) clearance from the U.S. Food and Drug Administration for the VELYS Robotic-Assisted Solution designed for use with the ATTUNE Total Knee System and its cleared indications for use. It will become part of the broader VELYS Digital Surgery Platform of…
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