Category: FDA

Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.

RapidAI Secures FDA Clearance for...

May 6, 2024

“We are pleased to expand our stroke AI imaging portfolio, the broadest in the industry, to include this new module. With AngioFlow™ by RapidAI, we can now support stroke AI imaging along the entire patient pathway, from the initial non-contrast CT scan all the way to the interventional suite,” said Karim Karti, CEO of RapidAI. “Already registered and used in Japan and Europe, we believe this technology will make a significant difference in the lives of U.S. stroke patients.”

Intuity Medical’s POGO Automatic ®,...

May 2, 2024

Recognized by healthcare professionals for its user-friendly design which can improve testing compliance, POGO Automatic is endorsed as the ideal solution for many diabetes patients by Rosemarie Lajara, MD, an endocrinologist with Southern Endocrinology & Diabetes Associates, P.A. in Plano, Texas

RapidAI Secures FDA Clearance for Perfusion Imaging in the Angiography Suite

May 6, 2024

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

July 24, 2020

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.

July 23, 2020

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.

July 23, 2020

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.

July 23, 2020

Vantage 1.5T MR System Receives FDA Clearance for AI-Based Image Reconstruction Technology Announces Canon Medical Systems USA

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.

July 22, 2020

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.

July 22, 2020

FDA Approves Next-generation WATCHMAN FLX LAAC Device Announces BSX

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.

July 21, 2020

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.

July 21, 2020

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.

July 20, 2020