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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

Diagnostics & Healthcare News

Pennsylvania-based Highmark Inc. Joins Theranica’s Coverage with Evidence Program for Nerivio® Drug-Free Migraine Treatment Device

Theranica, a prescribed digital therapeutics company developing advanced neuromodulation devices for migraine and other pain conditions, announced that Highmark Inc. (Highmark), one of America’s leading health insurance organizations and an independent licensee of the Blue Cross Blue Shield Association, will conduct...

December 12, 2022

Diagnostics & Healthcare News

Promising Remote Patient Monitoring solution, Polso, Achieves 1st FDA Clearance

ChroniSense Medical Ltd. took a step towards its vision of transforming chronic care management with Polso™, the company’s Remote Patient Monitoring (RPM) solution, achieving 510(k) clearance from the U.S. Food and Drug Administration (FDA). Initial indications include monitoring of blood...

December 8, 2022

Diagnostics & Healthcare News

Hemosonics Awared FDA 510(k) Clearance for Quantra® Hemostasis System with QSTAT® Cartridge

HemoSonics, LLC, a leading medical device company delivering individualized diagnostic solutions for Patient Blood Management (PBM), announced that it has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. “The...

December 1, 2022

Diagnostics & Healthcare News

Elemental Machines Raises $41M in Series B Funding to Fuel Growth

Elemental Machines, a developer of the LabOps Intelligence Platform for labs around the world, has raised $41 million in a Series B funding round led by Sageview Capital and co-led by Omega Venture Partners, with continued participation from Gutbrain Ventures and Digitalis...

November 17, 2022