Health
CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.
COVID-19 Testing System Disrupted Resulting from Roche’s Supply Chain Glitch
Roche, a Swiss pharmaceutical company, was hit today (10/7) with a glitch that disrupted one of its warehouses. This interruption caused one of their main receivers, Britain’s National Health Service, to delay the reporting of nearly 16,000 positive COVID-19 tests....
COVID-19 Antibody Treatment Expansion Following Safety Clearance
GlaxoSmithKline (GSK) and Vir Biotechnology are partnering to conduct trials on an antibody for COVID-19 treatment. The clinical trial will include 1,300 patients globally and a control group receiving a placebo. Various other companies, Regeneron for instance, have...
Nvidia Building Britain’s Most Powerful Supercomputer to Combat COVID-19
Nvidia, a chip industry giant from the U.S., announced today (10/5) that they will be building a supercomputer called Cambridge-1 which will channel artificial intelligence technologies to help researchers find solutions to urgent medical challenges such as COVID-19....
Despite Advisory Committee’s Approval, FDA Rejects Mesoblast’s Ryoncil
Today (10/2) the U.S. Food and Drug Administration (FDA) announced the rejection of Ryoncil, a treatment for steroid-refractory acute graft versus host disease (SR-aGVHD) in pediatric patients. For patients with the most aggressive form of SR-aGVHD, the mortality rate...
Safety Report Review Calls for More Thorough Adverse Event Reporting by FDA
According to an analysis published in JAMA Internal Medicine, almost half of the Medical Device Reports (MDRs) were directly from the Medical Device Safety Communications (MDSC) sent by the U.S. Food and Drug Administration (FDA). From this report, it was more clear...
What’s So Special About Life Science Translation?
The life science industries are highly regulated for good reason. Without proper guidelines and control mechanisms to ensure safety and quality, dangerous products could be marketed to unassuming customers, making life science translation a necessity for global...
Premier Holographic Cardiac Ablation System by SentiAR Cleared by FDA
Today (9/30) the U.S. Food and Drug Administration (FDA) granted clearance for leading visualizations for surgical procedures provider, SentiAr’s holographic cardiac ablation system Command EP. This will be the first holographic guidance system to be used in an...
CMS Issues Guidance to Expedite COVID-19 Testing Certification
On Friday (9/25), the Centers for Medicare & Medicaid Services (CMS) published a revised guide to expedite the process in which laboratories receive approval for COVID-19 testing. To aid in combatting the novel virus, the CMS program’s goal is to eliminate the lag...
Hologic Receives FDA Emergency Use Approval for COVID-19 Test
Today (9/28), Hologic received emergency use authorization (EUA) from the FDA for their testing kit for individuals with no symptoms of COVID-19. The CDC recently rescinded their statement saying that asymptomatic people did not need to be tested for COVID-19 and...
Pre-Market Testing Guidance Pilot Program Released by FDA
The FDA is implementing a body of accredited testing facilities to streamline the medical device testing process internationally. The agency has released final guidelines for the program today (9/25) outlining the steps medical device companies must take in order to...
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