FDA continues to take steps to fulfil its commitment to strengthen and modernise the 510(k) medical device program

19 September 2019 - The U.S. FDA today announced that, as a first step toward implementation of the recently established Safety ...

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FDA continues steps to promote innovation in medical devices that help advance patient safety through the Safer Technologies Program

18 September 2019 - Today, the Food and Drug Administration issued draft guidance titled “Safer Technologies Program for Medical Devices,” ...

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Greg Hunt's medical deals come back to bite him

11 September 2019 - Health minister Greg Hunt’s efforts to rein in growth in private health insurance premiums looks like ...

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FDA provides transparency and clarity on the Humanitarian Device Exemption pathway, helping bring more life-saving medical devices to patients in need

5 September 2019 - Today, the U.S. FDA issued a final guidance, Humanitarian Device Exemption (HDE) Program, to provide updated ...

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Aust stent costs five times higher than NZ

23 August 2019 -FactCheck Investigation: Do heart stents cost Australian private health funds five times more than they cost in ...

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'Remove rugs from aged care' to reduce health insurance costs, report says

22 August 2019 - The medical devices industry is pushing back against further reforms to lower the cost of hip ...

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Moving from substantial equivalence to substantial improvement for 510(k) ddevevices

29 July 2019 - Medical devices have been receiving more public attention and scrutiny in recent years because of safety problems. ...

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Aptar’s nasal unidose device approved by US FDA for first needle-free rescue treatment for severe hypoglycaemia

25 July 2019 - AptarGroup today announced that its Unidose Powder System was recently approved by the U.S. FDA for an ...

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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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