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FDA

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? 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. 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. 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. 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. 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. more

Opinion

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

Devices

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

Devices

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

Devices

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

News

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

News

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

News

The FDA has granted pre-market approval to a new device used used to help control certain types of bleeding in the gastrointestinal (GI) tract. more

Devices

FDA experts discussed regulatory considerations for orthopaedic sensing, measuring and advanced reporting technology (Smart) at the organisation’s latest public workshop. more

News

The time has come to take note of the female-focussed healthtech hitting the market, says Lu Rahman. more

Opinion

The FDA has announced that it is working towards new frameworks for enhancing medical device safety. more

Devices

In an attempt to inform women about the potential dangers of the Essure device, the FDA has issued an order restricting the sale and distribution of the device. more

Devices