Safety Communications > Battery Performance Alert and Cybersecurity Firmware Updates for Certain Abbott (formerly St. Jude Medical) Implantable Cardiac Devices: FDA Safety Communication

As a heart patient myself, I’m intrigued by the cyber-security aspects of these implantable devices. I think we’re going to see a lot in this area in the short-term.

~TJK

“Cybersecurity

Many medical devices—including Abbott’s ICD and CRT-D devices—contain configurable embedded computer systems that can be vulnerable to cybersecurity intrusions and exploits. As medical devices become increasingly interconnected via the Internet, hospital networks, other medical devices, and smartphones, there is an increased risk of exploitation of cybersecurity vulnerabilities, some of which could affect how a medical device operates.”

Source: Safety Communications > Battery Performance Alert and Cybersecurity Firmware Updates for Certain Abbott (formerly St. Jude Medical) Implantable Cardiac Devices: FDA Safety Communication

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Alexa, Fitbit and Apple Watch are your digital snitches – CNET

Alexa is always listening…..

~TJK

 

Source: Alexa, Fitbit and Apple Watch are your digital snitches – CNET

WEARABLE TECH

Your Alexa and Fitbit can testify against you in court

In today’s digital world, Big Brother may be on your wrist, in your room — or inside your heart.

BY 

  • MARGUERITE REARDON

Week of Mar 25th 2018 | FDA Sent These Warning Letters to Pharma Companies | FDAZILLA BLOG

Image result for fdaNew warning letters out! These are largely GMP-specific. Like no other agency, FDA is reknowned for updating regulations via warning letter (rather than the onerous process of getting an actual new or updated regulation approved)….so it is good to always keep an eye on these to be clear on “FDA’s current thinking”. YMMV. In any case, check out the full information at the link below!
~TJK

Source: Week of Mar 25th 2018 | FDA Sent These Warning Letters to Pharma Companies | FDAZILLA BLOG

FDA posted 8 warning letters this week, including:

 

reMarkable Tablet

Hi REMARKABLE eWriting Tablet Thingie people,

ReMarkable, £579

I’m very impressed with the concept and initial execution (you’ve shipped a viable product….Bravo!). That being said, there is a lot of promise here (untapped promise). Things like OCR, indexing, interfaces to external apps, an embedded web browser (even if only text), etc. etc. etc. There are so many ways you could go with this.

 

Is there a road map as to where you *actually are going* (or attempting to go). Not just exploring your options, but going with intent. I know that you don’t promise anything that you’re not sure of, but give us an idea. Is there a document online outlining this?
 
Before I drop $500+ on a tablet of this sort that only does some of what I’d need to ditch my paper notebooks, I’ll want to know what to a bit about the plan. Will earlyadopters be rewarded or will they be left holding a pricey beta device once the more polished/functional version comes out in 6 months or a year? Thanks and keep up the good work.
 
~TJK