RSS

FDA

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

The FDA has approved the world’s smallest mechanical heart valve designed for mitral or aortic valve replacement in babies and toddlers. more

News

Medical devices company, Sky Medical Technology has gained FDA 510(k) clearance for its geko medical device for treating pre and post-operative oedema in the US. more

News

Digital health company DarioHealth has been granted pre-market notification clearance for the Lightning-enabled version of its Blood Glucose Monitoring system, enabling the use of the Dario app on the latest iPhones. more

News

An integrated continuous glucose monitoring (iCGM) system for measuring sugar levels in children and diabetic adults has been given approval by the FDA. more

Devices

The FDA’s Center for Devices and Radiological Health (CDRH) is working on new industry policies and regulations for medical device cybersecurity, 3D-printing and artificial intelligence (AI), according to Regulatory Focus. more

News

An additive manufacturing company has been announced as the first in the world to receive clearance for software intended for 3D printing anatomical models for diagnostic use. more

Technology

The FDA is considering changes to the way it regulates pathways for software used as a medical device (SaMD), according to law firm, Dentons. more

News

Find out what's on at Extractables & Leachables US 2018 conference taking place May 7-9, at the Hyatt Regency Bethesda more

News

MPN takes a look at some the biggest medical device recalls that have taken place over the recent years. more

Devices