Medtech & Devices

Unsafe medical devices allowed into global markets harm patients, investigation reveals

A global investigation has found that unsafe medical devices have caused 1.7 million injuries globally and almost 83,000 deaths in the last 12 years. According to The Implant Files, a year-long investigation of the manufacturers of devices by the International Consortium of Investigative Journalists (ICIJ), unsafe medical devices have been allowed into global markets as

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HIV Diagnosis Market Size, Share and Forecast to 2023

Request Free Sample Market Overview HIV diagnosis refers to the test performed to detect the presence of human immunodeficiency virus (HIV) in humans. HIV attacks the immune system targeting CD4 cells, also known as T cells. T-cells helps the immune system to fight against infections. HIV weakens the immune system of an infected individual by

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Guidewires Market Players are Investing in Developing Technologically Advanced and Innovative Products

Global guidewires market is forecasted to attain revenue of $1,126.5 million by 2023, according to P&S Market Research.The growth is led by favorable reimbursement scenario, increasing prevalence of chronic and lifestyle associated disorders, and growing demand for minimally invasive surgeries (MISs). Access Detailed Report Summary: https://www.psmarketresearch.com/market-analysis/guidewires-market On the basis of material type, the market has

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FDA’s Reworked Premarket Medical Device Guidance

The Food and Drug Administration’s recently issued draft document updating its premarket medical device cybersecurity guidance originally issued in 2014 contains several important provisions, says regulatory attorney Yarmela Pavlovic.”The 2014 guidance that FDA issued about premarket cybersecurity considerations was fairly sparse; it wasn’t particularly detailed,” Pavlovic notes in an interview with Information Security Media Group.

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Medical device management: The high cost of doing nothing

A typical hospital system has thousands of stationary and mobile medical devices on site and spends millions of dollars on maintenance, purchasing and leasing. Yet, despite the volume of devices, the investment and expense involved, healthcare organizations are overwhelmingly laggard in adopting effective medical device management likely because they dont realize the surprisingly high cost

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Amazon launches connected medical device brand focused on diabetes, cardiovascular disease

Developed with brand consultancy firm Arcadia Group, the Choice product line will kick off with app-connected blood glucose and blood pressure monitors sold directly to consumers. Amazons latest move into the healthcare arena will be focused on helping consumers manage their diabetes or cardiovascular conditions, according to an announcement from Arcadia Group, a brand consultancy

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FDA Calls for ‘Cybersecurity Bill of Materials’ for Devices

In addition to releasing the proposed guidance this week, the FDA announced a formalized agreement with the Department of Homeland Security to implement a new framework for greater collaboration between the two agencies for addressing cybersecurity in medical devices.”From my vantage point, it looks like everyone in the medical device security community is happy to

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FDA proposes updated cybersecurity recommendations to help ensure device manufacturers are adequately addressing evolving cybersecurity threats

Cybersecurity threats and vulnerabilities in todays modern medical devices are evolving to become more apparent and more sophisticated, posing new potential risks to patients and clinical operations, said FDA Commissioner Scott Gottlieb, M.D. The FDA has been working to stay a step ahead of these changing cybersecurity vulnerabilities, including engaging with external stakeholders. In this

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FDA to include cybersecurity bill of materials in medical device premarket guidance

As part of a series of announcements around medical device cybersecurity, FDA Commissioner Scott Gottlieb, M.D., said the agency plans to update premarket guidance in the coming weeks to recommend that manufacturers include a cybersecurity “bill of materials.” The agency also issued a new “playbook” for health systems responding to an attack.

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