Category: FDA

ImmunoCAP Specific IgE alpha-Gal Allergen Component Test is the most widely used specific IgE blood test, and its use is documented in more than 6,000 peer-reviewed publications.

Designed for use in blood donor and plasma centers, as well as large reference laboratories, the PK7400 Automated Microplate System offers the industry's highest throughput for a single analyzer in its class and is now available in countries across Europe, Canada and the United States.

This technology, which is also available on the Vantage Galan 3T MR system and across a majority of Canon Medical’s CT product portfolio, uses a deep learning algorithm to differentiate true signal from noise so that it can suppress noise while enhancing signal, forging a new frontier for image reconstruction.

"The clinical experience of people with cancer who have contracted COVID-19 is an essential resource that can help the medical community better understand the impact of the disease in this population.

The next-generation WATCHMAN FLX™ LAAC Device is indicated to reduce the risk of stroke in patients with non-valvular atrial fibrillation (NVAF) who need an alternative to oral anticoagulation therapy by permanently closing off the left atrial appendage – the area of the heart where stroke-causing blood clots commonly form in NVAF.

“A range of stakeholders have expressed interest in development of drugs that contain cannabis and compounds found in cannabis. Recent legislative changes have also opened new opportunities for cannabis clinical research. As that body of research progresses and grows, the FDA is working to support drug development in this area.

As a result of the challenges presented by the COVID-19 public health emergency, the FDA is extending its enforcement discretion policy which will provide manufacturers and potential sponsors an additional six months to determine if they need to submit an Investigational New Drug (IND) or marketing application and, if such an application is needed, to prepare and submit the application, as appropriate.

The TiN coated humeral heads and glenospheres are identical to the current humeral heads and glenospheres that we offer but with the TiN coating applied.

An EUA to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to four individual swab specimens collected under observation. The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples.