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 December 2018
in this issue
     I set out this month to focus on a few interesting technology developments and to wish you and yours a swell holiday season. Well, I did manage to accomplish those goals, but I also got severely sidetracked by the "breaking news" about potential regulatory upset at the US FDA and about recent critique of medical device reviews generally.

     I've tried to get it all in before my self-imposed deadline. Read on ...
Regards,
Joe

Is a Regulatory Upset in the Works?

Well, I'm not yet certain because a great deal of news broke in late November on the regulatory front re medical devices. (BTW, how is "breaking news" different from "news"?) I find it premature to reach any personal judgments about what changes are likely and when, but here's some relevant background. (Maybe I'll share some personal conclusions in a month or two.) 

I have diligently collected numerous recent articles on the subject for self-education and to share a summary of those articles with you. Here it is:

There's a lot to absorb here and undoubtedly even more fact and opinion to come. But I will venture out on a limb to say: Some regulatory changes are coming; best to be ready to respond appropriately, especially if you have a new device in the works.
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Potential Upsets of a Different Kind
    
Here are a few technology upsets (my favorite kind) that caught my attention recently:

A startup called Openwater is developing a portable, presumably inexpensive imaging technology combining infrared and ultrasonic imaging which is seen as potentially useful in a patient's home. The company is led by Mary Lou Jepsen, PhD, a veteran executive of Facebook and Google. The approach, if successful, could unfavorably impact the large MRI services market.

An algorithm named CheXNeXt (quite clever, actually) is being developed at Stanford University to diagnose multiple conditions by "reading" chest x-rays. Performance versus radiologists is impressive to date -- equivalent performance in detecting pathologies in 10 of 14 diseases -- at much greater speeds. The technology, a form of AI, could serve to augment or screen for classical radiology.

Amazon unveils a machine-learning service for medical records. The company continues its march into medical markets by unveiling a new service, called Amazon Comprehend Medical, to mine and decode unstructured medical records using machine learning. Since this emerging service will operate as part of Amazon Web Services, one wonders about patient data security and privacy.

Some very early work at Duke University is focused on a different approach to the old e-nose idea. The target application is replacing drug- and bomb-sniffing dogs with portable devices. The new technological "hook" is a prototype made from biological odor receptors (not chemical compounds) actually grown from the genes of mice that respond to targeted cocaine or explosive odors. 
 
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Finally -- and Most Importantly

Please enjoy this holiday season with your family and friends. Put business and politics aside, at least for a while.   
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ContactInfoJoseph J. Kalinowski, Principal
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