Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 08 Aug 2022
Pear Therapeutics and SelectHealth announce coverage to provide access to FDA authorised prescription digital therapeutic for the treatment of opioid use disorder
8 August 2022 - SelectHealth teams with Pear to provide its members with covered access to Pear’s innovative prescription digital therapeutic, ...
Posted by Michael Wonder on 04 Aug 2022
Pear Therapeutics and Cove Behavioral Health to provide patients access to prescription digital therapeutic for the treatment of opioid use disorder
3 August 2022 - Pear Therapeutics announced today that Cove Behavioral Health will provide access to Pear’s FDA authorised PDT reSET-O ...
Posted by Michael Wonder on 15 May 2022
Digital health devices must prove a benefit to get reimbursement
13 May 2022 - Digital health care companies should prove that their devices can improve the quality of patient care ...
Posted by Michael Wonder on 19 Apr 2022
iHealthScreen announces TGA approval for iPredict automated AI system for early diagnosis of diabetic retinopathy, age-related macular degeneration and glaucoma suspect
19 April 2022 - iHealthScreen is the first company in the USA to receive a CE certification, Australian Health approval, and ...
Posted by Michael Wonder on 13 Apr 2022
Pear Therapeutics receives safer technologies program designation from FDA for product candidate to treat acute and chronic pain
13 April 2022 - Pear Therapeutics today announced it has received safer technologies program for medical devices designation from the ...
Posted by Michael Wonder on 04 Apr 2022
Digital Medicine Society launches toolkit to support reimbursement for new drugs developed using digital outcomes
4 April 2022 - New essential resources ensure that patients will benefit without delay following regulatory acceptance of digital outcomes. ...
Posted by Michael Wonder on 30 Mar 2022
FDA officials aim to stop misuse of the term ‘digital biomarker’
29 March 2022 - While a lot of researchers claim they are capturing digital biomarker data, they may in fact be ...
Posted by Michael Wonder on 03 Mar 2022
Digital Therapeutics should be regulated with gold standard evidence
28 February 2022 - There is enormous growth in the digital health sector, illustrated by huge capital investment, and a massive ...
Posted by Michael Wonder on 02 Mar 2022
DynamiCare Health digital therapeutic receives FDA breakthrough device designation for treatment of smoking during pregnancy
23 February 2022 - If approved, DynamiCare’s DCH-001 would become the first prescription treatment for smoking cessation demonstrated to be safe ...
Posted by Michael Wonder on 21 Feb 2022
Apple iPhone game changing new health feature cleared by FDA, coming in weeks
20 February 2022 - A new app is coming this spring which will be game changing for diabetes care. ...