How the FDA uses science to speed medical device innovation

11 July 2019 - The MDDT program streamlines the medical device development and review process. ...

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Device for preventing and relieving pain of cluster headaches approved by NICE in draft guidance

5 July 2019 - A handheld device that delivers a small electric current has been recommended by NICE for the prevention ...

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Statement on agency’s efforts to increase transparency in medical device reporting

21 June 2019 - In the spirit of promoting public transparency, the U.S. Food and Drug Administration’s Center for Devices ...

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Delayed patient access to innovative medical technologies in South Korea: a lead-time analysis of reimbursement coverage determinations

20 June 2019 - Timely access to innovative medical technologies driven by accelerated patient access pathways can substantially improve the health ...

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FDA permits marketing of first medical device for relief of pain associated with irritable bowel syndrome in patients 11-18 years of age

7 June 2019 - The U.S. FDA today permitted marketing of the first medical device to aid in the reduction ...

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Consultation on draft guideline on quality requirements for medical devices in combination products

3 June 2019 - EMA has released a draft guideline on the quality requirements for medical devices in human medicines ...

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FDA permits marketing of first diagnostic test to aid in detecting prosthetic joint infections

23 May 2019 - Today, the U.S. FDA permitted marketing of the Synovasure Lateral Flow Test Kit as an aid for ...

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FDA advances the science of patient input by seeking specific feedback on patient preferences that may impact regulatory decisions on medical devices

2 May 2019 - The U.S. FDA today opened a docket to receive input from stakeholders on a new priority ...

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FDA approves device to help increase access to more lungs for transplant

26 April 2019 - The U.S. FDA today approved a device, called Xvivo Perfusion System with Steen Solution Perfusate, that can ...

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FDA permits marketing of first medical device for treatment of ADHD

19 April 2019 - The U.S. FDA today permitted marketing of the first medical device to treat attention deficit hyperactivity disorder.  ...

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FDA approves PureTech’s obesity device Plenity

15 April 2019 - The FDA has approved PureTech Health’s ‘space occupying’ device Plenity as a new prescription treatment for ...

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NICE encourages use of greener asthma inhalers

8 April 2019 - People with asthma will be helped to choose the inhaler that is best for them, and best ...

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FDA approves new device for treating moderate to severe chronic heart failure in patients

21 March 2019 - The U.S. FDA today approved the Optimizer Smart system for treating patients with chronic, moderate-to-severe heart failure ...

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Statement from FDA Commissioner and Director of the Center for Devices and Radiological Health on efforts to evaluate materials in medical devices to address potential safety questions

15 March 2019 - We’re in an unprecedented era of innovation in medical devices with advances in materials science that ...

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Health Canada begins release of clinical data on drugs and devices

14 March 2019 - Health Canada launched two public databases on Wednesday as the first step in making clinical information ...

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