Blog
RSS FeedPosted by Michael Wonder on 17 Apr 2018
FDA medical device safety action plan now available
17 April 2018 - FDA's vision to protect patients and promote public health. ...
Posted by Michael Wonder on 12 Apr 2018
FDA finalises guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests
12 April 2018 - The agency is leveraging new tools and policies to advance the creation of innovative genetic and genomic-based ...
Posted by Michael Wonder on 11 Apr 2018
FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems
11 April 2018 - The U.S. FDA today permitted marketing of the first medical device to use artificial intelligence to detect ...
Posted by Michael Wonder on 10 Apr 2018
FDA clears first contact lens with light-adaptive technology
10 April 2018 - The U.S. FDA today cleared the first contact lens to incorporate an additive that automatically darkens the ...
Posted by Michael Wonder on 07 Apr 2018
Why Trump’s tariffs could raise the cost of a hip replacement
6 April 2018 - Pacemakers and artificial joints. Defibrillators. Dental fillings. Birth-control pills and vaccines. All are made in China, ...
Posted by Michael Wonder on 27 Mar 2018
FDA authorises first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices
27 March 2018 - The U.S. FDA today permitted marketing of the Dexcom G6 integrated continuous glucose monitoring (iCGM) system for ...
Posted by Michael Wonder on 08 Mar 2018
23andMe granted first FDA authorisation for direct-to-consumer genetic test on cancer risk
6 March 2018 - Authorisation allows 23andMe to report on BRCA1- and BRCA2-related genetic risk for breast, ovarian and prostate cancer. ...
Posted by Michael Wonder on 06 Mar 2018
FDA authorises, with special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes
6 March 2018 - Test only reports 3 out of more than 1,000 known BRCA mutations and negative result doesn’t rule ...
Posted by Michael Wonder on 28 Jan 2018
Transparency and dermatologic device approval by the US Food and Drug Administration
24 January 2018 - What post-approval changes occur to Class III dermatologic devices approved by the US FDA via the ...
Posted by Michael Wonder on 16 Jan 2018
Statement from FDA Commissioner in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review
16 January 2018 - To encourage innovation and provide patients with access to the latest safe and effective medical technologies, we ...
Posted by Michael Wonder on 14 Jan 2018
Can your hip replacement kill you?
13 January 2018 - When Stephen Tower’s right hip gave out in 2006, he asked his surgeon to implant an ...
Posted by Michael Wonder on 14 Dec 2017
New steps to facilitate beneficial medical device innovation
14 December 2017 - In recent days, the FDA has committed to several new policies that will modernise the agency’s approach ...
Posted by Michael Wonder on 12 Dec 2017
Bringing early feasibility studies for medical devices back to the United States
12 December 2017 - Ten years ago, when medical device manufacturers wanted to gain early clinical experience with their new devices ...
Posted by Michael Wonder on 04 Dec 2017
Statement by FDA Commissioner on FDA ushering in new era of 3D printing of medical products; provides guidance to manufacturers of medical devices
4 December 2017 - The agency is the first in the world to provide a comprehensive technical framework to advise manufacturers ...
Posted by Michael Wonder on 01 Dec 2017
FDA announces approval, CMS proposes coverage of first breakthrough-designated test to detect extensive number of cancer biomarkers
30 November 2017 - Agencies’ parallel review process makes test for efficient identification of multiple targeted therapy options available to health ...