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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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.  ...

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How digital therapeutics platforms are revolutionising health care delivery

17 February 2022 - With enormous advances in digital health innovation, we are quickly moving into an age where software platforms ...

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How is NICE supporting digital health technology developers?

10 February 2022 - From sensor-enabled glasses that facilitate self-management for major depression to devices that measure muscle performance to ...

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Blue Note Therapeutics receives breakthrough device designation for prescription only digital therapeutic for acute myeloid leukaemia

31 January 2022 - Blue Note Therapeutics, a prescription digital therapeutics company dedicated to easing the burden of cancer and improving ...

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Pear Therapeutics receives FDA breakthrough device designation for prescription digital therapeutic candidate to treat alcohol use disorder

22 November 2021 – Pear Therapeutics today announced that it has received breakthrough device designation from the U.S. FDA for ...

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Luminopia announces FDA approval of digital therapeutic that uses TV shows to improve vision in children with lazy eye

20 October 2021 - Luminopia One improves vision in children with amblyopia, the leading cause of vision loss in children, and ...

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Pear Therapeutics launches Pear Prescription Digital Therapeutics Digest, provides roadmap for payer coverage considerations

19 October 2021 - Pear Therapeutics, in collaboration with Avalere Health, today launched the Pear Prescription Digital Therapeutics Digest at ...

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Scotland is first country to offer free digital therapies to every adult

13 October 2021 - The Scottish Government has announced that all Scottish adults will now have access to "digital therapeutics" ...

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