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Diagnostics & Healthcare News
U.S. FDA Grants PAVmed Subsidiary, Lucid Diagnostics, Breakthrough Device Designation for its EsoGuard Esophageal DNA Test 
PAVmed Inc., a highly differentiated, multiproduct medical device company, today announced that the Company’s majority owned subsidiary, Lucid Diagnostics Inc. (“Lucid”), has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its EsoGuard™ Esophageal DNA Test...
February 27, 2020
Diagnostics & Healthcare News
ReadCoor, Inc. Unveils True Spatial Sequencing Platform to Drive Groundbreaking Insights into Immuno-oncology, Neuroscience, and Infectious Disease 
ReadCoor, Inc., a company leading true multi-omic spatial sequencing, today unveils its first product line, including multi-omic spatial sequencing assays and the RC2 instrument. The platform is powered by ReadCoor’s proprietary FISSEQ (Fluorescent in situ Sequencing) technology, which combines the massive multiplexity of next-generation sequencing (NGS)...
February 24, 2020
Diagnostics & Healthcare News
ImmunoPrecise Launches Coronavirus Vaccine and Therapeutic Antibody Program
ImmunoPrecise Antibodies Ltd (the “Company”), a provider of best-in-class therapeutic antibody discovery capabilities for the global industry, announces its commitment to the development of innovative vaccines against the new coronavirus originating in Wuhan, China (SARS-CoV-2) as well as coronavirus-neutralizing antibodies, addressing both prophylactic...
February 20, 2020
Diagnostics & Healthcare News
Flowonix Receives FDA Approval to Market Prometra II Pump for use with Intrathecal Baclofen
Flowonix Medical, Inc. today announced United States Food and Drug Administration (FDA) approval to market the Prometra II Programmable Pump System for use with intrathecal baclofen. Flowonix introduced the Prometra II 40mL pump to the US market in November 2019, providing...
February 20, 2020
Diagnostics & Healthcare News
Baxter and COSMED Announce U.S. FDA 510(k) Clearance of Q-NRG+ Indirect Calorimetry Device 
Baxter International Inc. (NYSE: BAX), a global leader in clinical nutrition, today announced the U.S. Food and Drug Administration (FDA) clearance of Q-NRG+, a metabolic monitoring device utilizing indirect calorimetry (IC) technology. IC is considered the “gold standard”1  to accurately measure...
February 17, 2020
Diagnostics & Healthcare News
Carelight Introduces Line Of FDA-Cleared Light Therapy Devices
CareLight Solutions is proud to now be offering a complete line of industry-leading Light Therapy products to the public. Inspired by Nobel Prize-winning science, Light Therapy devices are backed by years of scientific research and are FDA-cleared to reduce pain...
February 17, 2020
Diagnostics & Healthcare News
Intuitive Acquires Orpheus Medical to Expand Informatics Platform for Hospitals
Intuitive, a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, announced it has acquired privately held Orpheus Medical to deepen and expand its integrated informatics platform. Orpheus Medical provides hospitals with information technology connectivity, as...
February 11, 2020
Diagnostics & Healthcare News
Serenno Medical Introduces Novel Device for Continuous Automatic Monitoring of Kidney Function of Hospitalized Patients
Serenno Medical, developer of medical devices for patient monitoring in a hospital setting, reveals Sentinel™, a novel, robust device for automatic monitoring and detection of kidney damage in hospitalized patients. The Sentinel device is a continuous urine output monitor that measures...
February 5, 2020
Diagnostics & Healthcare News
Amid Coronavirus Outbreak, FDA and Industry Seek Roadmap for Emergency Diagnostics 
Just as some manufacturers hasten to make tests available for the novel Wuhan coronavirus, FDA will convene with industry representatives Monday in hopes of developing a better “roadmap” for how diagnostics are evaluated during and potentially after emergencies. The workshop...
February 3, 2020
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