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Cardiovascular / Cardiology
Cagent Vascular Announces FDA 510(k) Clearance for Balloon Catheter
Cagent Vascular (Wayne, PA), a developer of serration technology for vessel dilatation in cardiovascular disease interventions, announces FDA 510(k) Clearance of its Serranator® PTA Serration Balloon Catheter for treating below-the-knee (BTK) lesions. The Serranator device is the first and only...
April 28, 2020
Biologics, Wound Care, Infection Prevention
HealthySole HOME Approved to Keep Your Home Safe From COVID-19
Researchers have proven a device using ultraviolet light technology can neutralize the COVID-19 virus and other infectious diseases on the soles of shoes by more than 99.5 percent, according to a new study. The device, called HealthySole® PLUS, is being introduced...
April 28, 2020
Cardiovascular / Cardiology
FDA Grants ALung Emergency Use Authorization (EUA) to the Hemolung Respiratory Assist System (RAS) for the Treatment of COVID-19 
ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced that the Food and Drug Administration (FDA) has granted the Company Emergency Use Authorization (EUA) designation to the...
April 27, 2020
Orthopedics and Spine
FDA grants Carmell Therapeutics Expedited Review for CT-101, Bone Healing Accelerant 
Carmell Therapeutics, a pioneer in the development and commercialization of innovative Plasma-based Bioactive Materials (PBMs) to accelerate bone and soft tissue healing, announced that the U.S. Food and Drug Administration (FDA) last week has granted Fast Track designation for the...
April 27, 2020
Cardiovascular / Cardiology
AliveCor and OMRON Announce Global Strategic Alliance for Comprehensive Remote Cardiovascular Monitoring
AliveCor, a leader in personal ECG products, and OMRON Healthcare, Co., Ltd., a global leader in personal heart health and wellness technology, today announced a global, strategic alliance that combines AliveCor’s ECG technology with industry-leading blood pressure devices from OMRON to...
April 23, 2020
Biologics, Wound Care, Infection Prevention
Sterilucent Granted Emergency Use Authorization to Reprocess Respirators
The U.S. Food and Drug Administration has granted Sterilucent, Inc. (Minneapolis, MN), an Emergency Use Authorization to allow the emergency use of the Sterilucent™ HC 80TT Vaporized Hydrogen Peroxide Sterilizer for decontaminating single-use compatible N95 and N95-equivalent respirators. Test results...
April 23, 2020
Imaging Visualization & Navigation
Olympus Launches EVIS X1, its Most Advanced Endoscopy System to Date
Olympus Corporation (President: Yasuo Takeuchi) today announced the launch of EVIS X1, its most advanced endoscopy system to date. The new system is to improve outcomes from disorders of the stomach, colon, and oesophagus, as well as from bronchial diseases,...
April 23, 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
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