The Jailhouse

[Mr Wowza]

SUGO Reverse Merger more DD:


Old SUGO nothing to do with CareVision Clobal Inc, it's now new company!!

January 26, 2015 press release says: Effective with the close of the merger, Mr. Fred Pucillo, Jr. who served as the interim CEO and a director of the predecessor company American Mineral Group has retired.


Jack Zhang, founder and CEO of Vitall will now assume the role of President and CEO of the CaerVision Global, Inc. In addition to numerous other business ventures, Jack has provided consulting services in the area of strategic media technology to several companies including Arbitron Inc., a $300 million media rating company. Mr. Zhang received his Master's degree in Electro-Mechanical Engineering from Villanova University and has completed MBA studies at the University of Maryland.

Vitall CEO now controls whole Carevision operation!!!


CaerVision is legend and very big company!!!


Carevision was nominated twice in 2013, 2014 Governor's Impact Award

Celebrating Pennsylvania Companies
Gov. Tom Corbett, the PA Department of Community & Economic Development (DCED) and Team PA are pleased to announce an awards program designed to celebrate the companies and individuals who are investing in Pennsylvania and creating jobs. For event sponsorship opportunities, contact Nate Tile at the Central Penn Business Journal at 717-236-4300 or [e-mail].

http://teampa.com/2013/02/gov-impact-awards/

Vital Smart Watch is ready to sell!!

It doesn't need FDA approval!!

Unregulated Software

In its explanation surrounding the agency's proposed classification of Medical Device Data Systems published in 2008, FDA explains:

It is FDA's long-standing practice to not regulate those manual office functions that are simply automated for the ease of the user (e.g., office automation)?... For example, the report writing functions of a computer system that allow for the manual (typewriter like) input of data by practitioners would not be?... [regulated] because these systems are not directly connected to a medical device. In addition, software that merely performs library functions, such as storing, indexing, and retrieving information not specific to an individual patient, is not considered to be a medical device. Examples include medical texts or the Physician's Desk Reference on CD-ROM that are indexed and cross-referenced for ease of use.

FDA goes on to say it won't regulate "software that allows a doctor to enter or store a patient's health history in a computer file." On its face, that description of unregulated software is somewhat narrowly written. That is not surprising since FDA always takes an expansive view of its jurisdiction, and is not likely to concede much ground in that regard.

Beyond that passage, I would add that there are two key features for most unregulated software.

The data are entered manually; they are not inputted directly from any machine that touches the patient or a patient specimen. That's important to avoid becoming an accessory to a medical device.

Depending on how inputted, the output amounts simply to providing the stored data back to the patient or professional. The system does not automatically guide the diagnosis, nor does it guide any other instrument. In other words the software does not contain any algorithms that provide clinical-like functions that go beyond what FDA often refers to as library functions. It merely displays the data for the user to read and interpret.

Many mobile device apps do indeed fit this category of unregulated software. But it is important to remember to conduct an honest evaluation of the intended use of your product. The evaluation should focus on the clinical intended use of the product and less on the technical characteristics of your software or your system. In FDA's eyes, your software product does not have to provide a complete cure, mitigation, treatment, or prevention of disease to meet the legal definition of a device. If your software is intended to provide any part of cure, mitigation, treatment, or prevention of disease, FDA will probably consider it a device. Understanding the limits on the unregulated category is probably best explained, though, by looking at the other two categories.

http://www.ebglaw.com/publications/how-to-get-fda-to-clear-a-mobile-health-app-as-appeared-in-mobihealthnews/