The FDA grants a breakthrough device designation to the MIScoli, an innovative vertebral body tethering device to treat idiopathic scoliosis

18 June 2021 - Spinologics announced today that the U.S. FDA has granted the company a breakthrough device designation for its ...

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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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Novartis prostate cancer drug receives U.S. FDA breakthrough designation

17 June 2021 - Swiss drugmaker Novartis has received breakthrough therapy designation from the U.S. FDA for an experimental treatment ...

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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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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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Protagonist Therapeutics receives FDA breakthrough therapy designation for rusfertide in polycythemia vera

3 June 2021 - Designation further validates registrational path for rusfertide in polycythemia vera and facilitates potentially expedited development and review. ...

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Janssen announces U.S. FDA breakthrough therapy designation granted for teclistamab for the treatment of relapsed or refractory multiple myeloma

1 June 2021 - U.S. milestone follows EMA PRIME designation for this BCMA bi-specific antibody for the treatment of relapsed or ...

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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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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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Unity HA awarded breakthrough device designation for implantable neurostimulation technology to treat cluster headache pain

25 May 2021 - Unity HA announced today that the U.S. FDA has granted breakthrough device designation to the Pulsante SPG ...

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Spinal Stabilization Technologies earns FDA breakthrough designation for PerQdisc nucleus replacement system for degenerative disc disease

25 May 2021 - Spinal Stabilization Technologies announced today that it has earned the CE Mark and the FDA's breakthrough ...

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Verastem Oncology receives breakthrough therapy designation for VS-6766 with defactinib in recurrent low grade serous ovarian cancer

24 May 2021 - Results of early trial demonstrate 70% overall response rate in patients with KRAS mutant tumours, 44% ...

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