Posts by rw-admin
FDA Clears Cytovale’s® IntelliSep® Sepsis Test, First in a New Class of Emergency Department-Focused Diagnostic Tools
Cytovale®, a medical diagnostics company focused on advancing early detection technologies to diagnose fast-moving and immune-mediated diseases, announced today that its IntelliSep® test has received U.S. Food and Drug Administration (FDA) 510(k) clearance to aid in the early detection of sepsis for the approximately 30 million adult patients with signs and symptoms of infection who present…
Read MoreHip Innovation Technology Announces Initiation of FDA Approved Investigational Device Exemption Study
Hip Innovation Technology, LLC (HIT), a medical device company developing innovative orthopaedic device solutions to advance the quality of life and quality of care for patients, is pleased to announce the first U.S. implantation of the HIT Reverse Hip Replacement System (Reverse HRS), under an FDA approved Investigational Device Exemption (IDE). The IDE Study is…
Read MoreMedcura Receives Breakthrough Device Designation for its LifeGel™ Absorbable Surgical Hemostat
Medcura, Inc., a medical device company dedicated to transformatively improving the management of surgical bleeding, announces that the U.S. Food and Drug Administration (FDA) has granted the coveted Breakthrough Device Designation for its LifeGel™ Absorbable Surgical Hemostat. LifeGel™ is the first and only hemostatic agent to receive Breakthrough Device Designation seeking a new and highly…
Read MoreMicronoma Receives FDA Breakthrough Device Designation for OncobiotaLUNG, A Novel Liquid Biopsy Assay for Lung Carcinoma Detection
Micronoma, the first biotech company offering early cancer detection with a microbiome-driven liquid biopsy platform, announced that its OncobiotaLUNG assay received the Breakthrough Device Designation from the Food and Drug Administration (FDA). As a result, Micronoma can expect continued guidance and prioritized reviews from the agency of its upcoming clinical trial and concomitant pre-market approval…
Read MoreVERO Biotech Receives FDA Approval of its Third Generation Tankless Inhaled Nitric Oxide Delivery System
VERO Biotech Inc., a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, announced FDA approval of the newest generation of its tankless inhaled nitric oxide (iNO) delivery system. The Third Generation GENOSYL® Delivery System – developed for respiratory therapists by respiratory therapists – has new features that are expected to deliver three key benefits…
Read MoreLydus Medical Announces FDA Clearance of Vesseal™, The Microvascular Anastomosis Aid Device for Small Arteries
Lydus Medical is pleased to announce that the Vesseal™ has received FDA clearance 510(k). The Vesseal™ is a microvascular anastomosis suture deployment system, for standardized omni-vessel anastomoses, enabling simple, fast, safe, and effective procedures. An anastomosis is one of the most complicated steps of microvascular surgery and fundamental to the success of these demanding surgical interventions. Varied clinical…
Read MoreABM Respiratory Care Announces the FDA Clearance of the Biwaze Clear System
ABM Respiratory Care, a medical technology company focused on developing and globally commercializing novel integrated airway clearance and ventilation solutions, announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the BiWaze® Clear System. This new airway clearance system helps patients clear their airways as well as prevent or treat atelectasis by using Oscillating Lung…
Read MoreImperative Care Announces FDA Clearance and Initial Cases of Zoom RDL, the First Stroke-Specific Radial Access Platform for Mechanical Thrombectomy
Imperative Care, Inc., announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its Zoom™ RDL Radial Access System, the company’s latest innovation in elevating stroke care and the first radial access platform developed specifically for ischemic stroke treatment. Zoom RDL is the newest addition to Imperative Care’s Zoom Stroke Solution™, the company’s ischemic stroke…
Read MoreBurning Rock Received FDA Breakthrough Device Designation for its OverC™ Multi-Cancer Detection Blood Test
Burning Rock, a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, announced that its OverC™ Multi-Cancer Detection Blood Test (MCDBT) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA), which is the third of its kind globally. Under the FDA’s Breakthrough…
Read MoreVisby Medical™ Receives FDA Emergency Use Authorization for Respiratory Health Test for use in CLIA waived settings
Visby Medical™ announced that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for its Respiratory Health point of care test. The Visby Medical Respiratory Health Test is a fast, polymerase chain reaction (PCR) device that detects and differentiates between upper respiratory infections caused by Influenza (Flu) A & B, and SARS-CoV-2 (COVID-19). Visby Medical has…
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