In-Vitro Production Radiology 
pharmaphorum
OCTOBER 5, 2022
It has been shown in vitro to cover all major influenza A strains that have arisen since the 1918 ‘Spanish flu’ pandemic and is designed as a universal prophylactic for influenza A. VIR-2482 is an investigational intramuscularly administered influenza A-neutralising mAb.
FDA Law Blog
AUGUST 18, 2024
De Novos now play an important role in product advancement. By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Gibbs — In 1997, Congress wisely amended the Federal Food, Drug, and Cosmetic Act (FDCA) by adding Section 513(f)(2) to establish the De Novo process. Each of these De Novos can represent a clinical advance.
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XTalks
JULY 10, 2024
The US Food and Drug Administration (FDA) has granted marketing authorization to Cepheid for its groundbreaking Xpert HCV test and GeneXpert Xpress System, marking a significant advancement in the diagnosis and treatment of hepatitis C virus (HCV). About 80 percent of acute cases are asymptomatic.
XTalks
JULY 13, 2022
The Minuteful Kidney test kit is delivered to the patient’s home and is made up of all these things needed for in vitro home ACR testing: A urine collection cup. Some factors that can increase the risk of CKD include diabetes, hypertension, cardiovascular disease, smoking, obesity and a family history of kidney disease. Healthy.io Healthy.io
pharmaphorum
OCTOBER 4, 2022
On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criterion 1. Criterion 2.
FDA Law Blog
DECEMBER 11, 2023
However, this prediction is unfounded, because it assumes that there is an existing classification regulation and/or product code for 90% of currently available LDTs. Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ).
XTalks
JUNE 12, 2023
In Medtronic’s annual report, CEO Geoff Martha attributes their success in this area to their comprehensive suite of products and solutions, which equip clinicians with the tools necessary for optimal atrial fibrillation care. Note: When it comes to companies that report in foreign currencies, the conversion to U.S.
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