VoluMetrix's NIVA|HF for heart failure patients designated as breakthrough device by U.S. FDA

15 June 2021 - NIVA|HF is an investigational device designed to monitor the venous waveform, a novel physiologic signal, in heart ...

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Medtronic announces FDA approval of its next generation recharge-free spinal cord stimulation platform

10 June 2021 - Vanta implantable neurostimulator offers up to 11 year battery life and personalised pain relief. ...

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CyMedica Orthopedics announces FDA clearance for IntelliHab, a novel drug free, non-invasive modality for treatment of knee osteoarthritis pain

9 June 2021 - CyMedica Orthopedics today announced the U.S. FDA has cleared the submission of its latest technology for ...

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Ibex granted FDA breakthrough device designation

9 June 2021 - Ibex's Galen AI powered platform is recognised by the FDA as breakthrough technology with the potential to ...

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Glaukos Announces Australia’s TGA regulatory approval for Preserflo MicroShunt

8 June 2021 - Glaukos Corporation today announced that the TGA has granted regulatory approval for the Preserflo MicroShunt intended for ...

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Alpha Tau receives breakthrough device designation from the FDA for Alpha DaRT

8 June 2021 - Alpha Tau Medical is pleased to announce that it has received a breakthrough device designation for Alpha ...

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Proposed refinements to the regulation of personalised medical devices

7 June 2021 - Regulatory changes introducing a new framework for the regulation of personalised medical devices commenced on 25 ...

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FDA authorises marketing of diagnostic aid for autism spectrum disorder

2 June 2021 - Today, the U.S. FDA authorised marketing of a device to help diagnose autism spectrum disorder.  ...

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BrainSee novel software is breakthrough for non-invasive detection and monitoring of Alzheimer’s disease at the early stage of mild cognitive impairment

28 May 2021 - Darmiyan’s AI solution reliably guides physicians on prognosis and clinical management of mild cognitive impairment patients. ...

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FDA grants breakthrough device designation for smart orthopaedic implants

28 May 2021 - Intelligent Implants has announced today that its SmartFuse system has received breakthrough device designation by the ...

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FDA grants Micro Interventional Devices breakthrough device designation for the MIA-T percutaneous tricuspid annuloplasty system

27 May 2021 - Micro Interventional Devices has received breakthrough device designation from the U.S. FDA for its MIA-T percutaneous ...

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FDA announces draft guidances to help increase transparency, assist reporting and timely completion for certain medical device studies after FDA approval or clearance

26 May 2021 - Today, the U.S. FDA issued two guidances regarding the surveillance of certain medical devices. ...

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Medical device regulation comes into application

26 May 2021 - The medical device regulation, which was adopted in April 2017, changes the European legal framework for medical ...

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Woebot Health receives FDA breakthrough device designation for post partum depression treatment

26 May 2021 - WB001 is the first digital therapeutic designed to reduce the burden of post partum depression. ...

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Varian receives FDA breakthrough device designation for its cardiac radioablation system for treatment of refractory ventricular tachycardia

26 May 2021 - Varian's CRA system has been designated a "breakthrough device" by the FDA because of its potential to ...

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