Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 28 Feb 2019
First guidance on new rules for certain medical devices
28 February 2019 - EMA has published today the first of a series of guidance documents to help applicants prepare ...
Posted by Michael Wonder on 15 Feb 2019
FDA authorises first interoperable insulin pump intended to allow patients to customise treatment through their individual diabetes management devices
14 February 2019 - The U.S. FDA today permitted marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable ...
Posted by Michael Wonder on 22 Jan 2019
Statement from FDA Commissioner and Director of the Center for Devices and Radiological Health on latest steps to strengthen FDA’s 510(k) program for premarket review of medical devices
22 January 2019 - In 2018, the FDA’s Center for Devices and Radiological Health achieved several new milestones, including a ...
Posted by Michael Wonder on 17 Jan 2019
FDA issues letter about paclitaxel coated balloons and eluting stents
17 January 2019 - Today the FDA issued a letter to health care providers about a recent publication in the Journal ...
Posted by Michael Wonder on 18 Dec 2018
Statement from FDA Commissioner and Director of the Center for Devices and Radiological Health on new steps to promote innovations in medical devices that help advance patient safety
18 December 2018 - Spurring innovation of medical products so that patients can have access to safe, effective treatments that ...
Posted by Michael Wonder on 10 Dec 2018
The rise of use of medical devices force FDA to change the rules
9 December 2018 - A disruptive market of $410 billion until 2023, changes dramatically with the entrance of small and medium ...
Posted by Michael Wonder on 09 Dec 2018
Medical device price differentials in the U.S. and Europe – rethinking price regulation?
7 December 2018 - Recently, there has been a robust discussion of an October Trump administration proposal that Medicare pay for ...