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Diagnostics & Healthcare News

Pulmonx Secures $66M in Financing to Support Commercial Acceleration of the Zephyr Valve System, a Minimally-Invasive Treatment for Severe Emphysema 

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...

May 7, 2020

Diagnostics & Healthcare News

TruMed Systems, Inc. Announces Launch of the AccuShelf Total Practice Inventory Management System, to Complement the AccuVax Vaccine Storage and Handling Solution

AccuShelf makes inventory control simple, from tracking of receiving items, to patient administration. The system utilizes an all-in-one touch screen PC system with an integrated biometric reader and a wireless barcode scanner to capture and record every medication dose with...

May 6, 2020

Diagnostics & Healthcare News

Cerus Corporation Announces FDA Approval for INTERCEPT Blood System for Plasma with Alternate Plastic Disposable Kits

Cerus Corporation (Nasdaq:CERS) announced today FDA regulatory approval for manufacture of INTERCEPT plasma with a new, alternative plastic disposable kit. The planned conversion to these new kits is part of the Company’s ongoing strategy to enhance its global supply chain...

May 4, 2020

Diagnostics & Healthcare News

Molekule Launches New Commercial Product, Air Pro RX, with FDA 510(k) Class II Medical Device Clearance

Molekule, the leader in reinventing air purification, today announced that the U.S. Food and Drug Administration (FDA) cleared the 510(k) premarket notification for its new medical-grade air purifier, Air Pro RX, classifying it as a 510(k) Class II Medical Device. The Molekule Air...

April 29, 2020

Diagnostics & Healthcare News

ZEUS Scientific Announces New Rapid SARS-CoV-2 Antibody Test

ZEUS Scientific announces today the submission for an Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for its rapid, in vitro diagnostic test for the qualitative detection of IgG and/or IgM antibodies to the SARS-CoV-2 (novel 2019 Coronavirus)....

April 22, 2020

Diagnostics & Healthcare News

New Renewable Energy Agreements To Reduce Boston Scientific Carbon Footprint By Half

Boston Scientific Corporation (NYSE: BSX) has signed a virtual power purchase agreement (VPPA) that represents the largest step the company has taken to achieve its goal of global carbon neutral manufacturing and distribution by 2030. The agreement, with Clearway Energy Group,...

April 22, 2020

Diagnostics & Healthcare News

Brainlab Announces CE Mark for ExacTrac Dynamic Patient Positioning and Monitoring 

Brainlab, the digital medical technology company, today announced CE Mark (Conformité Européenne) approval for ExacTrac® Dynamic, the company’s next generation patient positioning and monitoring system. The new system offers never-before-seen, high-speed thermal surface tracking technology combined with an update of ExacTrac X-ray...

April 21, 2020

Diagnostics & Healthcare News

Vent Multiplexor Receives FDA Emergency Use Authorization for Crisis Care Co-Ventilation During COVID-19 Pandemic

Vent Multiplexor, LLC and Yale New Haven Hospital announced today that the Food and Drug Administration has granted Emergency Use Authorization for the Vent Multiplexor, a life-saving emergency rescue device developed by Vent Multiplexor LLC in collaboration with Yale New...

April 20, 2020

Diagnostics & Healthcare News

FDA Encourages Recovered Patients to Donate Plasma for Development of Blood-Related Therapies

As part of the all-of-America approach to fighting the COVID-19 pandemic, the U.S. Food and Drug Administration has been working with partners across the U.S. government, academia and industry to expedite the development and availability of critical medical products to...

April 16, 2020