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FDA

To help streamline regulatory processes for medical devices across the world, the FDA has decided to replace its current system with ISO 13485, the organisation has announced. more

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Reece Armstrong looks into Netflix's latest documentary, The Bleeding Edge and examines the FDA's regulatory approvals for medical devices and why it needs to change. more

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The first generic version the EpiPen has been approved by the FDA. more

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The first non-radioactive device for tracking lymphatic nodes in patients with breast cancer has received premarket approval (PMA) from the FDA. more

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Medtronic has received FDA approval for a device designed for a less invasive approach for patients with advanced heart failure. more

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Scalp cooling technology provider Paxman has gained FDA clearance for an expanded indication of its system in the US, the company has announced. more

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The FDA has launched an Innovation Challenge in an attempt to combat the opioid epidemic currently facing the US. more

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The FDA has granted pre-market approval to a new device used used to help control certain types of bleeding in the gastrointestinal (GI) tract. more

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On day one of Med-Tech Innovation Expo, Ken Block, president and founder of Ken block Consulting will discuss recent drafts and final FDA guidance on a variety of topics. more

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Digital health company DarioHealth has been granted pre-market notification clearance for the Lightning-enabled version of its Blood Glucose Monitoring system, enabling the use of the Dario app on the latest iPhones. more

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Google is partnering with connected products designer Flex on a cloud-based platform for medical device analytics. more

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One-day event in March aims to support medical device manufacturers through the implementation. more

Features

A doctor in the US has been suspended after allegedly reusing disposable single-use anal catheters, according to the news site, NJ. more

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Provider of respiratory monitoring technology PMD Solutions has been selected to join the NHS Innovation Accelerator Programme. more

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The FDA has issued new guidance on the use of 3D printing in response to the technology’s growing adoption by the healthcare industry. more

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The first medical device accessory for the Apple Watch has been approved for use by the FDA. more

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The FDA has approved a medical device system that can make small adjustments to intraocular lens’ power, potentially giving patients better vision when not using glasses. more

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A new robotically-assisted surgical device (RASD) that can help with minimally invasive surgery has been cleared by the FDA. more

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Last month Puerto Rico was devastated by hurricane Maria which wiped out much of the island’s infrastructure and killed 51 people. Most of the island is still without power and basic services are in dire need. more

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