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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 Approvals
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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

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

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

Artificial Intelligence Center To Offer Quality, Regulatory Solutions

In this Medtech Insight podcast, Xavier University's Marla Philips explains why the school is teaming up with IBM Watson Health to launch a Center for Artificial Intelligence. "Our mission is to provide artificial intelligence solutions. We will have free and open access for anyone to use so they can implement those solutions across the pharma and device industries, and FDA itself," she says. Also: will AI steal human jobs?

Quality Quality Control

Game On For Akili's Cognitive Control Tech

A digital video game developed by Akili Interactive Labs for treating cognitive disorders has demonstrated in a pilot study its ability to improve cognitive control test scores of neurotypical children and children with sensory processing dysfunction (SPD). The company is also anticipating a market launch of the device for pediatric attention deficit hyperactivity disorder in 2018.

Digital Health Neurology

Clinical Data Double-Boost Supports Medtronic's HeartWare Investment

Results of the LATERAL trial presented at the recent ISHLT conference show Medtronic's HVAD can be implanted safely through a thoracotomy procedure instead of the standard sternotomy approach, which is far more invasive. At the same meeting, subset data from the ENDURANCE trial confirms that the sickest heart-failure patients treated with HVAD have similar outcomes as less sick patients, and results of the ENDURANCE Supplement show that blood pressure management minimizes the risk of stroke with HVAD.

Cardiology Cardiovascular

OUS Approvals: Edwards And Trinity Lead Spring Surge

With 50 non-US approvals recorded by Medtech Insight in March, there were almost twice as many medical device approvals outside the US last month as in February and more than any month in the last year. Cardiovascular devices were in the lead, together with IVDs, and highlights on March's list include several new peripheral vascular technologies, including PQ Bypass' peripheral bypass system.

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