Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 04 Dec 2018
FDA proposes improvements to the De Novo pathway for novel medical devices to advance safe, effective, and innovative treatments for patients
4 December 2018 - Today, the U.S. FDA published the De Novo Classification Proposed Rule, which if finalized, would establish procedures ...
Posted by Michael Wonder on 04 Dec 2018
FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care
4 December 2018 - The U.S. FDA today took a significant step forward in driving the efficient development of novel diagnostic ...
Posted by Michael Wonder on 27 Nov 2018
Statement from FDA Commissioner on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use 510(k) pathway
27 November 2018 - Earlier this week, the FDA announced new steps to modernise FDA’s 510(k) clearance pathway, used for ...
Posted by Michael Wonder on 27 Nov 2018
The Implant Files: How the Therapeutic Goods Administration regulates medical devices
27 November 2018 - There is good reason why the building that houses Australia's powerful regulator of drugs and medical ...
Posted by Michael Wonder on 26 Nov 2018
Statement from FDA Commissioner and Director of the Center for Devices and Radiological Health on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices
26 November 2018 - Forty-two years ago, Congress passed the law establishing the framework for evaluating the safety and effectiveness of ...