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Clinical / R & D

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Inside The Spinal Cord: InVivo Therapeutics Looks To Reverse Injury, Leverage Regulatory Reforms

InVivo Therapeutics is looking to build on a breakthrough in understanding the pathophysiology of spinal cord injury to bring the first device to market for partially reversing the debilitating condition. The firm is dealing with a cautious FDA in its pivotal-trial development, but also looking to leverage a new US policy for humanitarian-use devices to expedite its path to market expansion.

Neurology Innovation Companies
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Clinical Trials

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Latest From Clinical Trials

Starts & Stops: ICS' Emblok Medtronic's Arctic Front, Abbott's Absorb, Boston Scientific's S-ICD

Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions each month. Over the last month, 31 new trials started, 25 trial were completed, one trial was "reinitiated," and six trials were terminated or suspended, according to meddevicetracker.

Clinical Trials Research & Development

Japan’s New 'Fast-Break Scheme' To Reduce Clinical Trial Burden For Medtech

Japan’s “fast-break scheme” is coming soon and will be the country’s fourth procedure for accelerating the approval of important medical devices.

Approvals Clinical Trials

Device Debuts: Tryton, Myriad Genetics, Integra Lifesciences, Acelity, And Toyota

This edition of device debuts highlights a wide variety of innovative devices introduced into commercial markets since the beginning of March, including a new stent for side-branch coronary interventions, an assay that identifies which breast-cancer patients do not need chemotherapy, a full ankle prosthesis, improvements to a negative-pressure wound therapy system, and a robotic system that helps paralyzed people learn to walk again.

Research & Development Clinical Trials
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New Technology

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Latest From Innovation

Emerging Markets Welcome Rise Of Robots, But UK Skeptical

New research from Pricewaterhouse Coopers finds that emerging economies are more willing to embrace the use of AI and robotics in health care, compared to Western European countries. The report – "What Doctor? Why AI and Robotics Will Define New Health" – surveyed more than 11,000 people from 12 countries across Europe, the Middle East and Africa. Among these countries, the UK proved to be the biggest skeptic.

Innovation Market Access

STAT-DX Aims To Take On Rival BioFire In Syndromic Testing

Barcelona start-up STAT-DX is gearing up to launch a new decentralized multiplex PCR system in the rapidly growing field of syndromic testing. The company, which will face larger rivals such as bioMérieux's BioFire, will unveil its new point-of-care platform at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), in Vienna from 22-25 April.

Infectious Diseases In Vitro Diagnostics

Start-Up Spotlight: Amniox Medical, Bringing The Benefits Of Amniotic Tissue To Ortho And Wound Care

Amniox Medical is developing biologics products for wound-healing and orthopedic applications based on technology that takes advantage of the unique anti-inflammatory and anti-scarring properties of human amniotic membrane and umbilical cord matrix.

Regenerative Medicine Wound Healing & Tissue Repair
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Approvals

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Latest From Approvals

Japan’s New 'Fast-Break Scheme' To Reduce Clinical Trial Burden For Medtech

Japan’s “fast-break scheme” is coming soon and will be the country’s fourth procedure for accelerating the approval of important medical devices.

Approvals Clinical Trials

Edwards Gets Early Present With FDA Clearance

While Edwards Lifesciences was hoping for a 510(k) clearance later in the year, the company got the greenlight to market its new hemodynamic monitoring system, HemoSphere, in the first quarter.

Cardiovascular Cardiology

ElectroCore's gammaCore Gets US Clearance For Cluster Headaches

The de novo clearance is the first US clearance for electroCore's non-invasive vagus nerve stimulation therapy. The company will market it through headache specialists as a non-pharmacological alternative to sumatriptan for patients with cluster headaches, which afflict about 350,000 people in the US.

Neurology Innovation
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