USA – FDA Authorizes Software that Can Help Identify Prostate Cancer

Today, the U.S. Food and Drug Administration authorized marketing of software to assist medical professionals who examine body tissues (pathologists) in the detection of...

USA – FDA OKs new pathology AI software, launches AI-enabled device database

The US Food and Drug Administration (FDA) has authorized software designed to help pathologists detect prostate cancer in digitally scanned slides from prostate biopsies....

France – La FDA se réorganise et crée un  »bureau de la transformation numérique »

PARIS (TICpharma) - La Food and drug administration (FDA) américaine a annoncé le 15 septembre une réorganisation de ses services pour ''donner la priorité...

USA – FDA outlines safety and performance-based criteria for facet screw systems and denture...

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Monday issued two draft guidances outlining the performance criteria...
U.S. FDA Approves TherapeuticsMD's Menopause Drug

USA – Vagal nerve stimulator for stroke rehab nabs FDA nod

The first-ever vagal nerve stimulation system for chronic ischemic stroke rehabilitation has received approval through the US Food and Drug Administration’s (FDA’s) most stringent...

USA – FDA updates safety communication for robotically assisted surgical devices used in mastectomy

The safety and effectiveness of robotically assisted surgical devices has yet to be established in the prevention and treatment of breast cancer, according to...
Coronavirus delays many FDA foreign inspections

USA – FDA affirms increased risk with pelvic mesh products

The US Food and Drug Administration (FDA) announced on Monday that its review of final results from postmarket surveillance of transvaginal mesh devices meant...

USA – Update: Check first with FDA regarding their current availability to review a...

In recent years, the US Food and Drug Administration has strongly encouraged medical device manufacturers to submit human factors (HF) validation test protocols for...

USA – Update: FDA is not accepting human factors validation test protocols for review...

In recent years, the US Food and Drug Administration has strongly encouraged medical device manufacturers to submit human factors validation test protocols for agency...

USA – Proposed US FDA program targets medical device supply chain shortages

A new program proposed by the US Food and Drug Administration would bolster domestic supply chains for medical devices during public health emergencies, but...

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