FDA grants breakthrough device designation to VR mental illness treatment

22 June 2022 - A British startup that uses virtual reality to help deliver cognitive behaviour therapy has been granted a ...

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MHRA joins international partnerships to set global standards for medicines and medical devices regulation

16 June 2022 - These are the International Medical Device Regulatory Forum, the International Council for Harmonisation of Technical Requirements for ...

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NICE’s early value assessment for medtech: panning for nuggets of innovation gold

15 June 2022 - The explosion in digital health products has left NHS commissioners wondering how they can possibly sift out ...

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FDA should step in to help spur AI/ML standards

13 June 2022 - The US FDA should support the burgeoning integration of artificial intelligence and machine learning in medical ...

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Revolutionary wearable ultrasound device gains FDA approval

26 May 2022 - ManaMed has been granted FDA approval on its latest orthopaedic recovery device, ManaSport. ...

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Bonesupport receives market authorisation for Cerement G in the US

18 May 2022 - BoneSupport today announced that the company has received market authorisation from the U.S. FDA, for the ...

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NeuroMetrix reports that Quell wearable neuromodulation device has received FDA de novo authorisation as first non-pharmacological treatment for fibromyalgia

19 May 2022 - NeuroMetrix today announced U.S. FDAde novo authorisation to market the Quell neuromodulation device as an ...

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Exactech announces FDA breakthrough device designation for JointMedica’s Polymotion hip resurfacing system

17 May 2022 - Exactech announced that the U.S. FDA has granted a breakthrough device designation for JointMedica’s Polymotion hip ...

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VenoStent technology receives breakthrough device designation by FDA

17 May 2022 - Designation to promote more rapid agency and market access for VenoStent. ...

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FDA grants breakthrough device designation to Remedee Labs for its groundbreaking endorphin stimulation solution for the management of fibromyalgia

12 May 2022 - On World Fibromyalgia Awareness Day (May 12), the French startup Remedee Labs is announcing that the FDA ...

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Wysa receives FDA breakthrough device designation for AI led mental health conversational agent

12 May 2022 - New peer-reviewed studies demonstrate efficacy in managing chronic pain, depression and anxiety ...

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Wearable technology promises to revolutionise health care

5 May 2022 - Do not let bureaucracy delay matters. ...

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FDA permits marketing for new test to improve diagnosis of Alzheimer’s disease

4 May 2022 - The U.S. FDA today permitted marketing for the firstin vitro diagnostic test for early detection ...

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New handbook on health economic assessments of medical devices

4 May 2022 - TLV performs health economic assessments of medical technology products at the request of the Medical Technology Product ...

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X-Therma receives FDA breakthrough device designation for XT-ViVo preservation solution and TimeSeal organ transport device

3 May 2022 - X-Therma announced today that the Center for Devices and Radiological Health of the FDA has granted ...

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