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Diagnostics & Healthcare News

Ad Astra Diagnostics Files 510(k) for QScout™ Hematology Analyzer

Ad Astra Diagnostics (AAD), developer of rapid diagnostic systems, announced that it has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its QScout RLD rapid-result hematology system intended to report white blood cell count, neutrophil-to-lymphocyte ratio, and...

March 30, 2023

Diagnostics & Healthcare News

NanoVibronix Announces Positive Results from Independent Product Trial of UroShield for Patients with a Spinal Cord Injury

NanoVibronix, Inc., (NASDAQ: NAOV) (the “Company”), a medical device company utilizing the Company’s proprietary and patented low intensity surface acoustic wave (SAW) technology, today announced the positive evaluation results for its UroShield device, presented at a recent medical conference by...

March 14, 2023

Diagnostics & Healthcare News

Candela Introduces the New FDA-Cleared Profound Matrix™ System

Candela, the leading provider of energy-based solutions worldwide, and the pioneer of the first and only long-pulse radiofrequency (RF) microneedling device, announces the launch of the all-new Profound Matrix™ system. Designed to correct, maintain, and restore skin at various stages...

February 6, 2023

Diagnostics & Healthcare News

RefleXion Receives FDA Clearance for SCINTIX Biology-Guided Radiotherapy; Cutting-edge Treatment Applicable for Early and Late-stage Cancers

RefleXion Medical, a therapeutic oncology company, announced the U.S. Food and Drug Administration (FDA) has granted the first marketing clearance for its SCINTIX™ biology-guided radiotherapy, a cutting-edge treatment applicable for early and late-stage cancers. The company will host a live-stream event...

February 3, 2023

Diagnostics & Healthcare News

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...

January 18, 2023

Diagnostics & Healthcare News

Micronoma 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...

January 11, 2023

Diagnostics & Healthcare News

VERO 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...

January 10, 2023

Diagnostics & Healthcare News

Burning 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...

January 3, 2023

Diagnostics & Healthcare News

Visby 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...

January 3, 2023