RSS

FDA

ClevelandClinicstent.jpg

Cleveland Clinic

Patient-specific airway stents developed by Cleveland Clinic physician Tom Gildea have been cleared by the Food and Drug Administration (FDA). Read more

North America

Our editor Laura Hughes highlights her five must-read articles for this week. Read more

News

The Food and Drug Administration (FDA) has published a final list that exempts certain class I and class II medical devices from 510(k) premarket review. Read more

News

Our editor Laura Hughes highlights her five must-read articles for this week. Read more

News

A Senate vote result of 72-18 sees Stephen Hahn confirmed as the next Food and Drug Administration (FDA) commissioner. Read more

North America

Our editor Laura Hughes highlights her five must-read articles for this week. Read more

News

A report published by the International Consortium of Investigative Journalists (ICIJ) has revealed more women than men have been injured by a medical device. Read more

News

Ethylene oxide is commonly used to sterilise medical devices. However, recently the levels of ethylene oxide, which is classed as a carcinogen, have been found to be too high at some sterilisation facilities, resulting in closure of the plants. Read more

North America

Our editor Laura Hughes highlights her five must-read articles for this week. Read more

News

Stephen Hahn, managing director of the MD Anderson Cancer Center has been appointed as the next Food and Drug Administration (FDA) commissioner by President Donald Trump. Read more

North America

Our editor Laura Hughes highlights her five must-read articles for this week. Read more

News

There are fears the closure of two medtech sterilisation plants could result in years of nationwide shortages for a number of surgical kits and implantable medical devices. Read more

North America

OraSure Technologies has seen its OraQuick Ebola Rapid Antigen Test approved for use by the Food and Drug Administration (FDA). Read more

News

The FDA has requested the recall of Allergan’s Biocell textured breast implants and tissue expanders as a result of the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) with these devices. Read more

News

Medical Plastics News editor Laura Hughes discusses how to ensure regulations are respected. Read more

North America

Phillips-Medisize has announced that its Little Rock, Arkansas facility is now fully compliant with the Current Good Manufacturing Practice (CGMP) regulations enforced by the Food and Drug Administration (FDA). Read more

North America

The Food and Drug Administration (FDA) has stopped Boston Scientific and Coloplast from selling the surgical mesh for the repair of organ prolapse within the United States. Read more

North America

The first foot and ankle implant made from PEEK-OPTIMA HA Enhanced has been cleared by the Food and Drug Administration (FDA). Read more

North America

As the pre-filled syringe market increasingly takes on digital health components it is important to think about the human factors validation strategies companies should consider. A post-conference workshop will provide an overview on this. Read more

North America

Concerning reports about potential mortality rates caused by paclitaxel-coated devices have been raised by the FDA. Read more

Devices