The system aims to address underlying chronic cough and issues with mucus production and clearance in chronic bronchitis.

The U.S. Food & Drug Administration issued select updates to premarket cybersecurity guidance on March 13, including who is required to comply, the types of devices that fall under certain agency ...

Please provide your email address to receive an email when new articles are posted on . The FDA has granted premarket approval to Sequana Medical’s alfapump implantable device for the treatment of ...

Merit Medical Systems, Inc. announced that its WRAPSODY® Cell-Impermeable Endoprosthesis has received premarket approval from the FDA, allowing for commercialization in the U.S. starting in 2025. This ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

The Food and Drug Administration published guidance for medical device manufacturers that describes how the benefits and risks of certain medical devices are considered during the pre-market review.

Spectral Medical and partner Vantive are ploughing ahead with an application for the approval of their endotoxic septic shock therapy after it exceeded expectations in a Phase III trial. In topline ...

The majority of cardiovascular devices with Class I recalls from the US Food and Drug Administration made it to market without appropriately rigorous premarket clinical testing, a new analysis has ...

A study of 25 high-risk medical devices approved for use on children showed that 84 percent of those devices approved by FDA since 2008 had not been tested on any child under 18 years of age before ...