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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First guidance on new rules for certain medical devices

28 February 2019 - EMA has published today the first of a series of guidance documents to help applicants prepare ...

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FDA authorises first interoperable insulin pump intended to allow patients to customise treatment through their individual diabetes management devices

14 February 2019 - The U.S. FDA today permitted marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable ...

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Statement from FDA Commissioner and Director of the Center for Devices and Radiological Health on latest steps to strengthen FDA’s 510(k) program for premarket review of medical devices

22 January 2019 - In 2018, the FDA’s Center for Devices and Radiological Health achieved several new milestones, including a ...

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FDA issues letter about paclitaxel coated balloons and eluting stents

17 January 2019 - Today the FDA issued a letter to health care providers about a recent publication in the Journal ...

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Statement from FDA Commissioner and Director of the Center for Devices and Radiological Health on new steps to promote innovations in medical devices that help advance patient safety

18 December 2018 - Spurring innovation of medical products so that patients can have access to safe, effective treatments that ...

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The rise of use of medical devices force FDA to change the rules

9 December 2018 - A disruptive market of $410 billion until 2023, changes dramatically with the entrance of small and medium ...

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Medical device price differentials in the U.S. and Europe – rethinking price regulation?

7 December 2018 - Recently, there has been a robust discussion of an October Trump administration proposal that Medicare pay for ...

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FDA proposes improvements to the De Novo pathway for novel medical devices to advance safe, effective, and innovative treatments for patients

4 December 2018 - Today, the U.S. FDA published the De Novo Classification Proposed Rule, which if finalized, would establish procedures ...

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FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care

4 December 2018 - The U.S. FDA today took a significant step forward in driving the efficient development of novel diagnostic ...

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Statement from FDA Commissioner on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use 510(k) pathway

27 November 2018 - Earlier this week, the FDA announced new steps to modernise FDA’s 510(k) clearance pathway, used for ...

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The Implant Files: How the Therapeutic Goods Administration regulates medical devices

27 November 2018 - There is good reason why the building that houses Australia's powerful regulator of drugs and medical ...

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Statement from FDA Commissioner and Director of the Center for Devices and Radiological Health on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices

26 November 2018 - Forty-two years ago, Congress passed the law establishing the framework for evaluating the safety and effectiveness of ...

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