The Hidden Crisis Within Today’s Healthcare Crisis

The Healthcare Crisis of today – or, perhaps more accurately, over the past two years — has been never-ending waves of COVID-19 variants.  With “Alpha” starting in 2019 to the current “Omicron” & “BA.2” mutations, our hospital systems have been stretched to the breaking point.  This crisis has forced administrators to deal with huge patient…

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Thirdwayv Applauds Insulet’s FDA Clearance for the World’s First Tubeless Automated Insulin System with Smartphone Control

Congratulations to Insulet and all the kids who will sleep better now after the company  announced FDA clearance of its Omnipod® 5 Automated Insulin Delivery System for people with type 1 diabetes aged 6 years and older. It is the first and only tubeless automated insulin delivery (AID) system in the US with compatible smartphone…

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FDA Cybersecurity Playbook is out – so what?

The FDA’s long-awaited playbook on cybersecurity for medical devices is out, and while it covers critical topics related to preparedness and response, we hope it’ll soon be followed by efforts that focus on threat prevention.  The Playbook thoughtfully covers fundamental concerns for Healthcare Delivery Organizations  (HDOs) in managing cyber attacks on Healthcare and Public Health infrastructure…

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Don’t get nicked by “Z-Shave”

While malware hacks such as WannaCry, Fancy Bear and Petya get widespread news coverage, Z-Shave “Man in the Middle” attacks could be much more relevant to the world of IoT.  As Catalin Cimpanu writes in this article, the Z-Shave vulnerability could impact more than 100 million devices that use the Z-Wave wireless protocol! The Z-Shave attack exploits the fact that two wireless “Things” that are designed to talk to each other never…

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FDA Releases Statement on its Medical Device Safety Action Plan

  On April 17, FDA Commissioner Scott Gottlieb released a statement regarding the agency’s latest efforts to enhance and modernize its approach to medical device safety and innovation. Aimed at protecting patients and promoting public health, the Medical Device Safety Action Plan outlines how the agency will encourage innovation to improve safety, detect safety risks…

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Recall is a Wakeup call: Abbott Announces Defib Cybersecurity Updates

  Today, Abbott announced the latest in what it has described as a planned series of cybersecurity updates for the company’s implantable cardioverter defibrillators (ICDs). The voluntary recall reportedly applies to 382,000 devices in the U.S. alone, 350,000 of which are currently implanted in patients. The FDA said in its simultaneous alert about the firmware…

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