medical device guru

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

Diagnostics & Healthcare News

Eyenuk secures $26 Million Series A funding to accelerate global access to AI-powered eye-screening technology

Eyenuk, Inc., a global artificial intelligence (AI) digital health company and the leader in real-world applications for AI Eye Screening™ and AI Predictive Biomarkers™, announced it has secured $26 million in a Series A financing round, bringing the Company’s total...

October 20, 2022

Diagnostics & Healthcare News

Tasso+™ Device Earns FDA 510(k) Class II Medical Device Clearance

Tasso, Inc., the leading provider of convenient, clinical-grade blood collection solutions, announced that the U.S. Food and Drug Administration (FDA) has cleared its Tasso+™ lancet as a Class II medical device. The clearance allows the company to market and sell...

September 15, 2022

Diagnostics & Healthcare News

MedWand Solutions Receives FDA 510k Clearance

MedWand Solutions, Inc. is pleased to announce that the company’s groundbreaking MedWand device and VirtualCare ecosystem is commercially available to enable clinical exams with its comprehensive care solutions. Poised to transform the current capabilities of telemedicine, MedWand is offering various kits...

August 22, 2022

Diagnostics & Healthcare News

Cognito Therapeutics Announces Proprietary Gamma Sensory Stimulation for 6-Months Reduces White Matter Atrophy in Alzheimer’s Disease Patients

Cognito Therapeutics, announced that its proprietary gamma sensory stimulation at 40Hz over a 6-month period reduced white matter atrophy in the brain for patients with Alzheimer’s Disease, according to new data presented at the Alzheimer’s Association International Conference 2022. Alzheimer’s...

August 2, 2022

Diagnostics & Healthcare News

Alio Remote Monitoring Technology Receives First FDA 510(k) Clearance

Alio Inc., announced it received FDA 510(k) clearance for its remote monitoring system intended for use by healthcare professionals to intermittently collect physiological data in home use settings. Collected physiological data includes skin temperature, auscultation sound data and heart rate....

April 18, 2022