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FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products

The FDA first warned about some of the methanol-containing hand sanitizers being sold in retail stores and online in June.

Zebra Medical Vision Secures its First FDA Clearance in Oncology, Boosting Early Detection of Breast Cancer in Mammograms

This latest clearance makes Zebra Medical the first AI startup with six FDA clearances across three different modalities under its belt. In initial testing Zebra-Med conducted, a number of cases which were originally missed were alerted by Zebra Medical’s ‘HealthMammo’ algorithm and the patients were recalled and confirmed

Vesta™ RF Cannula Receives FDA Clearance

Vesta™ RF Cannula was developed to provide our customers and their patients a high quality and cost-effective RF cannula to treat pain in clinical scenarios where our Nimbus® RF Multitined Expandable Electrode, that provides a large volume lesion for the treatment of pain, is not indicated. 

U.S. FDA Approves Kite’s Tecartus™

The approval of this one-time therapy follows a priority review and FDA Breakthrough Therapy Designation and is based on results of ZUMA-2, a single-arm, open-label study in which 87 percent of patients responded to a single infusion of Tecartus, including 62 percent of patients achieving a complete response

EVA15 Insufflator and Smoke Evacuation System Receives FDA Clearance Annouces Palliare

EVA15 is a novel insufflator designed to meet the demanding insufflation requirements of endoscopic and robotic surgery, while offering integrated surgical smoke evacuation capability, filtering the hazardous smoke particles produced during laparoscopic surgery and removing them from the operating room.

ImmunoCAP Specific IgE alpha-Gal Allergen Component Test Receives FDA Clearance

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.

Beckman Coulter’s PK7400 Automated Microplate System Receives 510(k) FDA Clearance

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.

FDA In Brief: Findings from Real-World Data Study Reveal Higher Risk of Hospitalization and Death Among Cancer Patients with COVID-19, Underscore Health Disparities

"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.

FDA Issues Draft Guidance to Encourage Cannabis-Related Clinical Research

“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.

FDA Extends Enforcement Discretion Policy for Certain Regenerative Medicine Products

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.

FX Solutions [FX Shoulder, Inc.] Receives FDA 510k Clearances for TiN Coated Humeral Heads and Glenospheres

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.

Coronavirus (COVID-19) Update: FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing

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.

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