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FDA

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

Phillips-Medisize has announced the groundbreaking of a new manufacturing facility in the St. Croix Meadows development in Hudson, Wisconsin. Read more

North America

We quite often hear that the medical device sector isn’t about revolution but evolution. But does it really matter? And does that detract from some of the innovative and groundbreaking products on the market? Read more

Opinion

The FDA has released a statement discussing its efforts to strengthen the agency’s medical device cybersecurity program as part of its mission to protect patients. Read more

Devices

The FDA will hold a meeting next year to assess the safety of breast implants, following concerns that they are linked to an increased chance of autoimmune diseases occurring in implant patients. Read more

Devices

From 25-27 September, at the NEC, Birmingham, TCT Show will bring the 3D printing community together under one roof. Our sister title, MTI, caught up with Dan O’Connor, head of content, TCT Group to find out what’s in store for the 2018 edition. Read more

News

To help streamline regulatory processes for medical devices across the world, the FDA has decided to replace its current system with ISO 13485, the organisation has announced. Read more

News

Reece Armstrong looks into Netflix's latest documentary, The Bleeding Edge and examines the FDA's regulatory approvals for medical devices and why it needs to change. Read more

Opinion

The first generic version the EpiPen has been approved by the FDA. Read more

Devices

The first non-radioactive device for tracking lymphatic nodes in patients with breast cancer has received premarket approval (PMA) from the FDA. Read more

Devices

After years of controversy, Bayer has decided to stop selling its Essure birth control device in the US, equating the decision to a decline in sales. Read more

Devices

Medtronic has received FDA approval for a device designed for a less invasive approach for patients with advanced heart failure. Read more

Devices

The FDA has approved Medtronic’s Infuse(TM) Bone Graft in new spine surgery indications. Read more

News

The FDA has released two documents finalising both the methods medical device and drug makers should take when communicating to payors, and how they should stay consistent with FDA labelling. Read more

News

Diabetes technology company Eversense has announced that its Continuous Glucose Monitoring (CGM) system has been approved by the FDA. Read more

Devices

The FDA has released an updated model of its software pre-certification pilot to help guide streamline the approval process for companies develop digital health solutions. Read more

News

The FDA has launched an Innovation Challenge in an attempt to combat the opioid epidemic currently facing the US. Read more

News