Tag Archive for: FDA

CEA’s 2014 Technology Trends To Watch

Consumer Digital Health Care: Featuring GrandCare Systems and VP Business Development, Laura Mitchell
By Rachel Horn

An excerpt from Remote Monitoring and Health Maintenance

Some remote monitoring products combine software and hardware to track and transmit multiple data points and virtually connect people with doctors and loved ones. The GrandCare System, for example, incorporates daily living monitoring with health data capture technologies, socialization tools, video chat capabilities, entertainment features and medication management tools. “We’re a platform that interacts with and engages with a ton of different technologies and different sensors,” explains Laura Mitchell, vice president for business development at GrandCare. The system is designed to be fully customizable and very easy to use. “The system is as intuitive as an ATM or a microwave. It’s very simple,” Mitchell says.

On FDA Approval for Medical Apps

GrandCare’s Laura Mitchell says it makes sense for the FDA to get involved with software in the same way they get involved with hardware, to make sure these services work properly. GrandCare is in the final stages of securing FDA approval for its aging-in-place system. “We had to prove that our software is actually accurately reading those devices,” Mitchell says. “Does it stop innovation? A little bit, definitely, but it’s also sort of a necessary evil because we’re dealing with someone’s health and wellness. It makes sure that we’re giving them the right information and sound advice.

Additional Articles included in CEA’s 5 Technology Trends To Watch include:

  • A Hundred Billion Nodes, By Shawn G. DuBravac, CFA
  • On the Road to Driverless Cars, By Jack Cutts
  • Robots Ahead, By Richard Kowalski
  • The Curators of New Video, By Mark Chisholm

Download the full report at http://content.ce.org/PDF/2014_5tech_web.pdf

Pre-CEDIA HIPAA Boot Camp in 90 minutes or less….

SIGN UP DEADLINE AUGUST 31st…There will be no extensions, so please make sure to sign up before the 31st!!!!

GrandCare Systems Presents:

pre-CEDIA 90 Min HIPAA BootCamp – Wed Sept 7th, 4-530p

Please join us before CEDIA at our 90 minute HIPAA Intensive!!!
GrandCare’s Security and Compliance Officer, Kristin Bayer, will be leading us in helping us to understand what exactly is HIPAA, why it’s important to you, how to become compliant and steps to get started.


Wednesday Sept 7, 2011 4p – 530p Eastern Time

Indianapolis – Crowne Plaza Hotel: Historic Union Station

$129 per person (GrandCare Dealer & AgeTek Member Discounts apply)

Why: According to new government regulations, all resellers/installers of tele-health devices (blood pressure, weight, pulseox, glucose, etc.) MUST be fully HIPAA Compliant….it is more than just the declaration. There are steps involved, policy/quality statements, etc. Kristin will tell us exactly what it takes!!!

MIXER/NETWORKING SESSION: Directly after, from 6-8p, you can join the GrandCare team and AgeTek Board members at the no-host pre-CEDIA MEET & GREET (location TBA).

To sign up, contact: info@grandcare.com or call us: 262-338-6147

Thanks and we’ll see you at CEDIA 2011!!!!!

Your friends at GrandCare Systems

GrandCare Presents HIPAA Compliance Training, Sept 7th Indianapolis

CEDIA HIPAA Training Seminar:
When: Wednesday Sept 7, 2011  8am – 5p
Where: Indianapolis – Hotel to be announced
GrandCare Presents: 8 HOURS OF HIPAA Compliance Training
Cost: $995 (includes 8 hours of training, training packet, refreshments, lunch and 2 drink tickets)
Discounts available to GrandCare Dealers& AgeTek Members
Refreshments & Lunch included in this day long session.


– WHO needs to become HIPAA Compliant?

– WHY Become HIPAA Compliant?

– WHAT it takes to become HIPAA Compliant?

Led by GrandCare’s HIPAA Compliance Officer, Kristin Bayer.

Coffee Hour/Networking 8 – 9am

9a – 5p Training

530p – 8p GrandCare Mixer

Attendees receive 2 drink coupons for the GC Mixer (immediately following)

SIGN-UP BEFORE July 4th 2011 and receive a 20% discount

Limited Seating! Contact 262-338-6147 or info@grandcare.com

If you don’t get HIPAA compliance training through us, PLEASE get HIPAA training somewhere!!! 🙂

FDA plans modest changes to medical device system

Associated Press (Link to Article)
WASHINGTON – The Food and Drug Administration is laying out plans to update the 35-year-old system used to approve most medical devices, which has been subject to increasing criticism by public safety advocates.
The agency announced a series of changes it plans to make this year, including streamlining the review process for some low-risk devices. But regulators said they will delay a decision on the most drastic proposals, which would give the government new power to police device makers.
Those proposals, widely supported by public safety advocates, included clarifying the FDA’s power to revoke approval for products that prove unsafe or ineffective. Another key proposal would have established a new subset of devices that would require more medical data to gain approval.
But those proposals, unveiled for comment last summer, received strong pushback from device companies, and the FDA said in its report “that implementing them may be problematic.”
The device industry’s chief trade group, AdvaMed, lobbied against the changes, saying they would make device reviews longer and more expensive, hurting innovation and endangering jobs. The group represents most of the largest device firms, including Medtronic Inc., Stryker Corp. and Johnson & Johnson.
AdvaMed’s president Stephen Ubl called Wednesday’s announcement “a good first step that will address some of the major problems with the program.”
But Dr. Diana Zuckerman of the National Research Center for Women and Families said the FDA’s plan suggests “industry lobbyists won, and the public lost.”
“Today’s FDA report gives the impression that FDA backed down on several safeguards as a result of unfavorable comments,” Zuckerman said in a statement. “FDA decisions should not be based on a popularity contest, especially since lobbyists rig the results”
The FDA said it would wait for the guidance of the Institute of Medicine before making a final decision on more sweeping changes. The group, which advises the federal government on medical issues, is expected to make its recommendations this summer.
The so-called 510(k) system for devices was created in 1976 to grant speedy approval to devices that are similar to products already on the market. It is popular among manufacturers because it is a faster, cheaper path to market than the review process for novel devices, which must undergo rigorous medical testing. Hip replacements and drug pumps are among the devices cleared under the system.
But FDA critics say that high-risk devices, such as heart pacemakers, are increasingly slipping through the 510(k) process without thorough testing and scrutiny.
About 4,000 devices are cleared every year under the 510(k) system, while about 50 devices are approved under the more stringent system.
Last October the FDA took the unprecedented step of acknowledging that a knee repair device cleared via 510(k) in 2008 should not have made it to market. The FDA’s two top device regulators who oversaw the device’s review have since left the agency.
Beginning in March the FDA said it will make 25 changes to the 510(k) process, including:
• establishing a database with photos and safety labeling for all devices
• clarifying when companies must submit clinical data for a 510(k) application
• establishing a council of experts within the agency to work on timely device approvals
Medical device executives praised the FDA for not significantly altering the system for approving their products.
“The fact that they are not going to take on more than they should right now, and deferring some of the tougher proposed changes to the appropriate guidance process, was a constructive outcome,” said Bill Hawkins, chief executive of Medtronic, the world’s largest medical device company.