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 ...

Read more →

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 ...

Read more →

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. ...

Read more →

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 ...

Read more →

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 ...

Read more →

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, ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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. ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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.  ...

Read more →