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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

Diagnostics & Healthcare News

Nipro introduces SURDIAL™ DX Hemodialysis System to U.S. Market

Nipro Medical Corporation (Nipro), a leading manufacturer and supplier of renal, vascular, and medical-surgical products, announced the commercial launch of SURDIAL™ DX Hemodialysis System to the U.S. SURDIAL™ DX is a state-of-the-art hemodialysis system designed to create an optimal dialysis...

March 29, 2022

Diagnostics & Healthcare News

Fresenius Kabi Receives FDA 510(k) Clearance for Wireless Agilia® Connect Infusion System with Vigilant® Software Suite-Vigilant® Master Med Technology

Fresenius Kabi, a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition, announced it has received 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) for its wireless Agilia® Connect Infusion System which includes...

March 14, 2022

Diagnostics & Healthcare News

Valencia Technologies Gains FDA Approval of eCoin® Therapy to Treat Urinary Urge Incontinence

Valencia Technologies Corporation, a privately held company, announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of its eCoin® leadless tibial neurostimulator for the treatment of urinary urge incontinence (UUI), which affects over 60% of patients...

March 2, 2022

Diagnostics & Healthcare News

Medtronic to Acquire Intersect ENT for $1.1B

Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced that it has entered into a definitive agreement with Intersect ENT (NASDAQ: XENT), a global ear, nose, and throat (ENT) medical technology leader dedicated to transforming patient care, in...

August 8, 2021

Diagnostics & Healthcare News

Dexcom Wins FDA Nod for Real-time APIs, Allowing Third-party Developers Access to CGM Data

Dexcom’s Partner Web Application Programming Interfaces (APIs) were cleared by the FDA, allowing approved third-party developers to connect to the continuous glucose monitoring data of Dexcom users. Developers can integrate CGM data with their applications, diabetes management systems or devices through...

July 18, 2021

Diagnostics & Healthcare News

Cognoa Receives FDA Marketing Authorization for First-of-its-kind Autism Diagnosis Aid

Cognoa, a pediatric behavioral health company developing diagnostic and therapeutic solutions for children living with behavioral health conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted the company’s De Novo classification request for its autism diagnosis...

June 6, 2021

Diagnostics & Healthcare News

empowerDX At-Home COVID-19 Testing Kit Receives EUA For Children Three Years And Older

Clinical Enterprise, Inc. d/b/a empowerDX, today announced its at-home COVID-19 testing kit received FDA-emergency use authorization for children three years and older. The direct-to-consumer company, owned by Eurofins Scientific, is the first to receive an EUA for an at-home PCR nasal test...

May 23, 2021

Diagnostics & Healthcare News

Neurolutions Receives FDA De Novo Market Authorization for IpsiHand Robotic Stroke Rehab System

Neurolutions, Inc., a medical device company developing and commercializing a first-of-its-kind device leveraging brain-computer interface (BCI) technology for upper extremity chronic stroke rehabilitation, announced today that the U.S. Food and Drug Administration (FDA) granted De Novo market authorization for its...

May 9, 2021