Diagnostics & Healthcare News

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 to help them take action to maintain and/or improve control.  The OneTouch Verio Reflect meter…

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 pathway for prioritized FDA review of devices that have potential to provide more effective treatment…

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 (RLS) who are refractory to medications. RLS is the second most common sleep disorder in…

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 Android Operating System. “Now more than ever, the world relies upon remote methods of contact…

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 patients with confirmed or suspected COVID-19 infection. “PITU is a game changer in this fight…

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 feature set to help caregivers be efficient and comfortable in their jobs. The cart also…

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 companies to quality in the absence of in-person regulatory oversight to maintain standards during the…

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 across its ARCHITECT® and Alinity i™ platforms and will have capacity for 60 million tests in…

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 its global output to 1.1 billion per year – including 35 million N95 respirators per…

Pulmonx Corporation, a commercial-stage medical technology company that provides a minimally-invasive treatment for patients with severe emphysema, announces a $66 million financing led by Ally Bridge Group, a leading global life science investor. The financing also attracted new investors Adage Capital Management, HealthQuest Capital, Partner Fund Management, and Rock Springs Capital, as well as existing…