September 20th, 2011 by Felasfa Wodajo, M.D. in News
Tags: Bakul Patel, CDDS, Clinical Decision Support Software, Draft Guidance, FDA, Featured, Federal Trade Commission, FTC, IBG Glucometer, iMedicalApps, MDDS, Medical Device, Medical Device Data Systems, mHealth, Mobile Medical Apps, Regulation, Smartphone, software, Tablet, Workshop
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The publication in July of the FDA Draft Guidance on mobile medical apps was a major milestone in the evolution of mobile medicine. The blazingly rapid growth in interest among physicians, medical software publishers and device manufacturers has made it clear that the mHealth revolution will be a major turning point, not just in health information technology, but likely in many aspects of physician-patient interactions.
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Last week (Sep 12-13), the FDA is held an important public workshop near its Washington DC headquarters to help it answer some key questions raised within the Draft Guidance and gather feedback from important stakeholders in mobile health. We are proud that iMedicalApps was invited to participate as one of the panelists.
We want to hear from you iMedicalApps readers – what do you want the FDA to consider in regulating mobile medical apps ?
Please add your voice in the comment section below and we will assemble them for submission to the official FDA docket on the Draft Guidance. Hurry because the deadline is just a few weeks away.
The FDA needs input from clinicians and others interested in mobile medicine and has identified two topics in particular as needing further specification:
- How to assess the risks inherent to clinical decision support software and
- How to classify mobile software that works in concert with a medical device.
*This blog post was originally published at iMedicalApps*
September 19th, 2011 by Toni Brayer, M.D. in News
Tags: auto-immune disorder, Blood Test, Diagnosis, Dry Eyes, Dry Mouth, Fatigue, Joint Pain, Rheumatology, Serena Williams, Sjogrens Syndrome, Tennis, Venus Williams, White Blood Cells
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I was lucky enough to see Venus Williams play her first professional tennis match when she was a teenager. It was obvious she was something special and her coach-father said “If you think she’s good, wait until you see her little sister.” (Serena Williams).
Venus and her sister, Serena have dominated women’s tennis over the past decade but she is currently sidelined with a diagnosis of Sjogrens Syndrome. (pronounced Show-grins). It is a chronic auto-immune disorder where white blood cells (immune function cells) target the body’s moisture-producing glands. Symptoms include dry eyes, dry mouth, extreme fatigue and joint pain. Sometimes it co-exists with other auto-immune diseases like thyroid disease or rheumatoid arthritis.
Symptoms can wax and wane and getting the right diagnosis can take time. I can imagine Venus going to her doctor and complaining of fatigue and dry mouth. Considering her athletic schedule, she was probably told to get some rest and fluids. The diagnostic key should have been Read more »
*This blog post was originally published at EverythingHealth*
September 16th, 2011 by Medgadget in News
Tags: Cook Medical, EchoTip Technology, Follicle Collection, In Vitro Fertilization, Local Anesthesia, Needle, OB/GYN, Otrieva Tapered Ovum Aspiration Needle, Outpatient Procedure, Ovum Collection, Press Release, Reproductive Medicine
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Cook Medical has announced the launch of its new Otrieva Tapered Ovum Aspiration Needle for ovum collection in women pursuing in vitro fertilization. The company claims its new needle’s reduced diameter will result in reduced pain and bleeding during the procedure compared to existing solutions, while still providing precise collection.
The Otrieva also makes use of Cook’s EchoTip technology to further enhance safety by improving the needle’s ultrasound visibility.
From the press release:
The Otrieva needle, developed exclusively by Cook, has Read more »
*This blog post was originally published at Medgadget*
September 15th, 2011 by Davis Liu, M.D. in News, Opinion
Tags: Back to the Future, Computers, Danielle Ofri, Doctor Patient Relationship, Electronic Medical Records, EMR, Meaningful Dialogue, New York Times, NYT, Personalized Medicine
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One of my favorite movies is Back to the Future starring Michael J. Fox. I must admit after reading this New York Times piece, titled “When Computers Come Between Doctors and Patients” I have to wonder.
Am I fortunate to be coming from the future? Because I completely disagree with Dr. Danielle Ofri, again.
I’ve had the privilege and opportunity to work in a medical group which has deployed the world’s largest civilian electronic medical record and have been using it since the spring of 2006. I don’t see the issue quite as much as Dr. Ofri did. It is possible that she examined patients in her office with a desk rather than an examination room.
If placed and mounted correctly in the exam room, the computer actually is an asset and can improve the doctor patient relationship. It is part of the office visit. The flat screen monitor can be rotated to begin a meaningful dialogue between the patient and me. Read more »
*This blog post was originally published at Saving Money and Surviving the Healthcare Crisis*
September 15th, 2011 by AndrewSchorr in News, Opinion
Tags: Artificial Hip Joints, Clinical Trials, FDA, Food and Drug Administration, Lifesaving devices, Medical Devices, Metal-on-metal hip joints, Pharma Research, Pharmaceutical Companies, Review Process, Stents, Stroke Prevention
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I speak to people in the pharmaceutical industry much more than folks who develop medical devices. I know how pharma researchers spend years and hundreds of millions of dollars trying to develop a useful, safe new drug that the FDA will approve for marketing. Certainly there are big payoffs, but the road is filled with potholes and trapdoors and the analysis by the FDA is rigorous.
But for years we’ve been hearing that it is much less rigorous when it comes to medical devices. Artificial hip joints and stents to open blocked arteries fall into this category. And recently, the less stringent review process has been highlighted in the news. Metal-on-metal hip joints are being removed from patients who had them implanted. They thought Read more »
*This blog post was originally published at Andrew's Blog*
The publication in July of the FDA Draft Guidance on mobile medical apps was a major milestone in the evolution of mobile medicine. The blazingly rapid growth in interest among physicians, medical software publishers and device manufacturers has made it clear that the mHealth revolution will be a major turning point, not just in health information technology, but likely in many aspects of physician-patient interactions.
