Blog
RSS FeedPosted by Michael Wonder on 17 May 2022
Dental AI start-up wins second FDA clearance to detect top oral diseases
16 May 2022 - The FDA has awarded dental AI start-up Overjet with landmark clearance to use its software to ...
Posted by Michael Wonder on 16 Nov 2021
FDA authorises marketing of virtual reality system for chronic pain reduction
16 November 2021 - The U.S. FDA today authorized marketing of EaseVRx, a prescription-use immersive virtual reality system that uses cognitive ...
Posted by Michael Wonder on 27 Oct 2021
FDA collaborates with Health Canada and UK’s MHRA to foster good machine learning practice
27 October 2021 - Today, the U.S. FDA, Health Canada and the United Kingdom’s MHRA jointly issued the “Good Machine Learning ...
Posted by Michael Wonder on 07 Oct 2021
The FDA should better regulate medical algorithms
7 October 2021 - Most do not require the agency’s approval, and those that do often don’t require clinical trials. ...
Posted by Michael Wonder on 16 Aug 2021
Artificial intelligence in medicine regulation
16 August 2021 - The International Coalition of Medicines Regulatory Authorities sets out recommendations to help regulators to address the ...
Posted by Michael Wonder on 04 Aug 2021
Abbott receives FDA clearance for its imaging technology using artificial intelligence for vessels in the heart
3 August 2021 - Ultreon 1.0 software, the first-of-its-kind imaging software, merges optical coherence tomography with the power of automation using ...
Posted by Michael Wonder on 21 Jun 2021
Sensome receives FDA breakthrough device designation for its AI powered stroke guidewire
21 June 2021 - Sensome announced today that it has been granted a Breakthrough Device designation by the Center of Devices ...
Posted by Michael Wonder on 06 May 2021
Viome receives FDA approval for its unique mRNA technology and AI platform to detect cancers
6 May 2021 - FDA breakthrough designation validates Viome's proprietary mRNA analysing technology and state of the art AI platform to ...
Posted by Michael Wonder on 09 Apr 2021
FDA authorises marketing of first device that uses artificial intelligence to help detect potential signs of colon cancer
9 April 2021 - Medical device aids clinicians in detecting potential irregularities during colon cancer screening and surveillance. ...
Posted by Michael Wonder on 23 Mar 2021
Optellum receives FDA clearance for the world’s first AI-powered clinical decision support software for early lung cancer diagnosis
23 March 2021 - Virtual Nodule Clinic empowers clinicians to make optimal clinical decisions in early-stage lung cancer diagnosis and is ...
Posted by Michael Wonder on 20 Mar 2021
FDA authorises first machine learning-based screening device to identify certain biomarkers that may indicate COVID-19 infection
19 March 2021 - Device may be used to identify biomarkers indicative of SARS-CoV-2 infection among certain asymptomatic individuals following a ...
Posted by Michael Wonder on 14 Jan 2021
FDA releases artificial intelligence/machine learning action plan
12 January 2021 - Today, the U.S. FDA released the agency’s first artificial intelligence/machine learning-based software as a Medical Device Action ...
Posted by Michael Wonder on 16 Jul 2020
Deep dive into big pharma AI productivity: one study shaking the pharmaceutical industry
15 July 2020 - The pharmaceutical business is perhaps the only industry on the planet, where to get the product from ...
Posted by Michael Wonder on 18 Feb 2020
Randomised clinical trials of artificial intelligence
17 February 2020 - As patient data are increasingly captured digitally, the opportunities to deploy artificial intelligence, especially machine learning, ...
Posted by Michael Wonder on 06 Jan 2020
Challenges to the reproducibility of machine learning models in health care
6 January 2020 - Reproducibility has been an important and intensely debated topic in science and medicine for the past few ...