Blog
RSS FeedPosted by Michael Wonder on 24 Jan 2024
FDA's ISTAND Pilot Program accepts submission of first artificial intelligence based and digital health technology for neuroscience
23 January 2024 - FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research recently accepted a ...
Posted by Michael Wonder on 11 Oct 2023
FDA establishes new advisory committee on digital health technologies
11 October 2023 - Today, the US FDA announced the creation of a new Digital Health Advisory Committee to help ...
Posted by Michael Wonder on 12 Jun 2023
One stop shop for AI and digital regulations for health and social care launched
12 June 2023 - A new online advice service to help the NHS and wider care system adopt and make ...
Posted by Michael Wonder on 28 Mar 2023
'To develop digital health, separate insurance coverage system needed’
28 March 2023 - The Government needs to establish a separate reimbursement registration frame for digital treatment devices that secure ...
Posted by Michael Wonder on 27 Mar 2023
FDA outlines plan for digital health technologies for clinical trials
24 March 2023 - The US FDA plans to hold at least one public meeting and release several guidances on digital ...
Posted by Michael Wonder on 01 Mar 2023
Eight digitally enabled therapies to treat depression and anxiety in adults conditionally recommended by NICE
1 March 2023 - Eight digital enabled therapies to treat depression and anxiety disorders in adults have been conditionally recommended by ...
Posted by Michael Wonder on 11 Feb 2023
Digital health predictions: uncertainty will trigger innovation in 2023
7 February 2023 - It was an interesting year for digital health. ...
Posted by Michael Wonder on 09 Feb 2023
Digital mental health tech for children and young people recommended by NICE in first rapid healthtech guidance
8 February 2023 - Four digital technologies that can help children and young people with mild to moderate symptoms of anxiety ...
Posted by Michael Wonder on 06 Jan 2023
Pear Therapeutics and Spero Health to expand access to prescription digital therapeutics for people in recovery across multiple locations and states
4 January 2023 - Spero Health, one of the nation’s largest office-based outpatient opioid treatment providers for individuals in recovery, to ...
Posted by Michael Wonder on 18 Dec 2022
Click Therapeutics receives FDA breakthrough device designation for prescription digital therapeutic to treat episodic migraine
16 December 2022 - Click Therapeutics today announced that it has received breakthrough device designation from the US FDA for ...
Posted by Michael Wonder on 20 Oct 2022
How digital health innovators can successfully navigate evolving FDA regulations
19 October 2022 - In the rapidly changing landscape of digital health, innovation has often outpaced regulations, especially for novel ...
Posted by Michael Wonder on 10 Oct 2022
Mental health funding of £1.8 million welcomed by NICE and MHRA to explore regulation of digital mental health tools
10 October 2022 - NICE and the MHRA have been awarded £1.8 million funding by Wellcome over three years to explore ...
Posted by Michael Wonder on 29 Aug 2022
Amazon versus Apple: only one will rewrite the rules of health care
29 August 2022 - Big tech has had a surprisingly small impact on U.S. healthcare, so far. ...
Posted by Michael Wonder on 20 Aug 2022
Regulatory considerations to keep pace with innovation in digital health products
19 August 2022 - Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital ...
Posted by Michael Wonder on 16 Aug 2022
Visibly becomes first FDA cleared online vision test in the United States
16 August 2022 - Visibly is excited to announce that, as of 12 August 2022, it has received 510(k) clearance ...