Blog
RSS FeedPosted by Michael Wonder on 14 Jul 2019
How the FDA uses science to speed medical device innovation
11 July 2019 - The MDDT program streamlines the medical device development and review process. ...
Posted by Michael Wonder on 05 Jul 2019
Device for preventing and relieving pain of cluster headaches approved by NICE in draft guidance
5 July 2019 - A handheld device that delivers a small electric current has been recommended by NICE for the prevention ...
Posted by Michael Wonder on 23 Jun 2019
Statement on agency’s efforts to increase transparency in medical device reporting
21 June 2019 - In the spirit of promoting public transparency, the U.S. Food and Drug Administration’s Center for Devices ...
Posted by Michael Wonder on 22 Jun 2019
Delayed patient access to innovative medical technologies in South Korea: a lead-time analysis of reimbursement coverage determinations
20 June 2019 - Timely access to innovative medical technologies driven by accelerated patient access pathways can substantially improve the health ...
Posted by Michael Wonder on 08 Jun 2019
FDA permits marketing of first medical device for relief of pain associated with irritable bowel syndrome in patients 11-18 years of age
7 June 2019 - The U.S. FDA today permitted marketing of the first medical device to aid in the reduction ...
Posted by Michael Wonder on 04 Jun 2019
Consultation on draft guideline on quality requirements for medical devices in combination products
3 June 2019 - EMA has released a draft guideline on the quality requirements for medical devices in human medicines ...
Posted by Michael Wonder on 23 May 2019
FDA permits marketing of first diagnostic test to aid in detecting prosthetic joint infections
23 May 2019 - Today, the U.S. FDA permitted marketing of the Synovasure Lateral Flow Test Kit as an aid for ...
Posted by Michael Wonder on 02 May 2019
FDA advances the science of patient input by seeking specific feedback on patient preferences that may impact regulatory decisions on medical devices
2 May 2019 - The U.S. FDA today opened a docket to receive input from stakeholders on a new priority ...
Posted by Michael Wonder on 29 Apr 2019
FDA approves device to help increase access to more lungs for transplant
26 April 2019 - The U.S. FDA today approved a device, called Xvivo Perfusion System with Steen Solution Perfusate, that can ...
Posted by Michael Wonder on 23 Apr 2019
FDA permits marketing of first medical device for treatment of ADHD
19 April 2019 - The U.S. FDA today permitted marketing of the first medical device to treat attention deficit hyperactivity disorder. ...
Posted by Michael Wonder on 15 Apr 2019
FDA approves PureTech’s obesity device Plenity
15 April 2019 - The FDA has approved PureTech Health’s ‘space occupying’ device Plenity as a new prescription treatment for ...
Posted by Michael Wonder on 08 Apr 2019
NICE encourages use of greener asthma inhalers
8 April 2019 - People with asthma will be helped to choose the inhaler that is best for them, and best ...
Posted by Michael Wonder on 21 Mar 2019
FDA approves new device for treating moderate to severe chronic heart failure in patients
21 March 2019 - The U.S. FDA today approved the Optimizer Smart system for treating patients with chronic, moderate-to-severe heart failure ...
Posted by Michael Wonder on 17 Mar 2019
Statement from FDA Commissioner and Director of the Center for Devices and Radiological Health on efforts to evaluate materials in medical devices to address potential safety questions
15 March 2019 - We’re in an unprecedented era of innovation in medical devices with advances in materials science that ...
Posted by Michael Wonder on 15 Mar 2019
Health Canada begins release of clinical data on drugs and devices
14 March 2019 - Health Canada launched two public databases on Wednesday as the first step in making clinical information ...