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Diagnostics & Healthcare News

LifeScan Announces OneTouch Verio Reflect Meter U.S. Launch

LifeScan, a world leader in blood glucose monitoring and maker of the iconic OneTouch® brand, today announced the U.S. launch of OneTouch Verio Reflect®, the only meter with a Blood Sugar Mentor™ feature that gives people with diabetes personalized real-time guidance...

June 11, 2020

Diagnostics & Healthcare News

Nuvaira Announces FDA Breakthrough Designation for AIRFLOW-3 Pivotal Trial Device

Nuvaira, a developer of novel therapeutic strategies to treat obstructive lung diseases, has announced that its Nuvaira® Lung Denervation System has been designated as a Breakthrough Device by the U.S. Food and Drug Administration (FDA).  This program creates an expedited...

June 8, 2020

Diagnostics & Healthcare News

Noctrix Health granted FDA Breakthrough Device Designation for wearable Restless Legs Syndrome Therapy

Noctrix Health, Inc., a privately held medical device company announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its wearable NTX100 Neuromodulation therapy designed for the treatment of adults with primary moderate-severe Restless Legs Syndrome...

June 3, 2020

Diagnostics & Healthcare News

Senseonics Launches New Remote Monitoring App for Android Users in US

Senseonics Holdings, Inc. a medical technology company focused on the development and commercialization of the first and only long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today announced the launch of Eversense® NOW Remote Monitoring App for...

June 1, 2020

Diagnostics & Healthcare News

FDA Approves Emergency Use of A&R Tarpaulins’ Patient Isolation Transportation Unit (PITU) 

AR Tech, a division of A&R Tarpaulins Inc., an aerospace and medical equipment manufacturer, received emergency approval for the use of its Patient Isolation Transportation Unit (PITU) by the Food and Drug Administration. PITU is designed to temporarily isolate and transport...

May 21, 2020

Diagnostics & Healthcare News

New Ergotron CareFit Pro Medical Cart Improves Caregiver Comfort, Efficiency 

The new CareFit™ Pro Medical Cart from Ergotron can help improve caregiver comfort, streamline workflows and create better patient experiences. Developed based on years of research and insights from caregivers, CareFit Pro combines a highly mobile and adjustable design with a broad...

May 20, 2020

Diagnostics & Healthcare News

FDA and CDC Drawing Up Plan to Restart Routine Facility Inspections

Amid the coronavirus outbreak reaching pandemic level in March, FDA stopped routine inspections of domestic and international facilities. Under the revised policy, the agency would perform inspections seen as “mission critical” while relying on off-site monitoring and the commitment of...

May 14, 2020

Diagnostics & Healthcare News

Abbott Receives FDA Emergency Use Authorization for COVID-19 Antibody Blood Test on Alinity i System

Abbott announced today that the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the company’s SARS-CoV-2 IgG lab-based serology blood test on the Alinity™ i system. Abbott plans to ship nearly 30 million antibody tests globally in...

May 13, 2020

Diagnostics & Healthcare News

3M Awarded Department of Defense Contracts to Further Expand U.S. Production of N95 Respirators 

3M has been awarded two contracts through the U.S. Department of Defense in recent weeks to further expand U.S. production of N95 respirators in response to the COVID-19 outbreak. Beginning in January, 3M ramped up production of respirators and doubled...

May 7, 2020