Veranex Acquires Fusion Biotec
The acquisition expands Veranex’s footprint for product design engineering services across the U.S., with combined company offices now in the Eastern, Central, and Western regions
Tag Archives: diagnostics
Lace To Helm New RQM+ Reimbursement Division
“We are honored to have Dr. Lace, who is widely recognized as one of the industry’s most trusted reimbursement experts, leading our new division. He will also support all our services as our CMO.”
WHO Convenes Panel to Identify Priority Pathogens for Research and Oversight
More than 300 scientists will consider the evidence on over 25 virus families and bacteria—as well as “Disease X” (an unknown pathogen that could cause a serious international epidemic)—and recommend a list of priority pathogens that need further research and investment.
The Real Impact of IVDR on Clinical Evidence Requirements
One of the biggest stumbling blocks for manufacturers, particularly those with legacy devices, is clinical evidence under IVDR. Carlos Galamba, former technical reviewer and current VP of Intelligence and Innovation at RQM+, discusses the challenges and opportunities of the more stringent evidence requirements facing diagnostics developers.
American Health Care Has a Diagnostics Problem
The key priority for any healthcare system should be the well-being of patients. At present, the U.S. healthcare system is failing to target low-hanging fruit that could help drive better results for patients, and—by catching illnesses earlier—ultimately lower the cost of our healthcare system.
European Commission Adopts Common Specifications for High-Risk Diagnostics
The specifications set uniform and rigorous benchmarks for tests across the EU, with the goal of clarifying the requirements for market actors and protecting EU patients.
Risk of False Results with Certain Prenatal Genetic Screening Tests
FDA has issued a safety communication to alert patients and healthcare providers about the dangers of inappropriate use of NIPS tests.
Optical Detection Systems for Microfluidic Applications: Designs, Imaging Techniques, and Deciding Which Optical System to Use
This article discusses simple optical designs and common imaging techniques used in microfluidic enabled platforms. It will also suggest key elements to consider when deciding which optical set-up to employ for a given microfluidic application.
COVID-19 Detection Kits Remain Key Tools in Pandemic Response
Diagnostic advances bode well for the imminent expansion of the global COVID-19 detection kits market, which is expected to be worth $8 billion by 2027.
How Large-Scale Genomics Is Helping the War Against COVID-19 and Beyond
Greater use of next generation sequencing can better prepare the world for future diseases and accelerate the adoption of precision care.
