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FDA Medical Device Approval Process Under Review Due to Recalls With Numbers of Implanted Devices

On medical devices we are back to the sometimes controversial Fast track 510 (k) approval method to where the device can be similar to another device on the market and is intended for low and moderate risk situations. Implants to me are not low...

Published Tue, Feb 02 2011 12:41 AM by The Medical Quack

Filed under: Medically Related, Technology, Pharma/FDA News, My Commentaries, Surgery, Medical Devices, FDA, clinical trials, software, Recalls, Implants, Patients, access, regulatory process, approvals

Varian Medical Systems Receives FDA Clearance for its Proton Therapy System

Last year at this time, Varian was not a real popular name due to the over exposure of radiation associated with their units and with the FDA approval I might guess that software certification was probably even more stringent at the FDA before approval...

Published Mon, Jan 01 2011 8:48 PM by The Medical Quack

Filed under: Medically Related, Technology, Education, Cancer, FDA, Heatlh IT, software, Heatlhcare, Safety, Algorithms, New York, Treatment plans, Varian System, accountability, radation treatment

FDA Scientist Complaints Are Not Allowed–2nd Time Rejection To Be Heard

There are some very good points here and the recent radiation news is the perfect example. In their complains, scientists complained they were coerced and pushed to giving approval to many areas. Software is coming into play more and more...

Published Sun, Nov 11 2010 2:42 AM by The Medical Quack

Filed under: Medically Related, Pharma/FDA News, healthcare, Medical Devices, FDA, software, radiation, scientists, harrassment

Group of House of Representatives Sends Letter to FDA Wanting More Transparency and Detail on Medical Devices–They Better Hire That “Algo Man” So They Can Comprehend

This is pretty much a no brainer in concept as many of the new devices and what is being approved revolves around software, thus they might think about understanding the basic concepts of what software (algorithms) does. Actually this could be a...

Published Wed, Oct 10 2010 9:32 PM by The Medical Quack

Filed under: Medically Related, Technology, Pharma/FDA News, Medical Devices, FDA, Congress, software, Transparency, Non participants, algoirthms, Algo man

Sanofi-Aventis Has a Glucose Reader and Software That Will Attach to an iPhone–Still Needs FDA Approval

The device is said to cost around $80.00 when available. The iBGStar attaches to the phone and does the data work. It has an option to be used while plugged into the phone too. As usual, there’s new technology and the hot stuff here according...

Published Mon, Sep 09 2010 5:21 PM by The Medical Quack

Filed under: Medically Related, Technology, Pharma/FDA News, healthcare, Mobility, FDA, Patient, Diabetes, Personal Health Records, Physicain, software, Glucose, iPhone, devices that report data, consumer, app, mHealth, iBGStar

CMS To Require Study For Off Label Use for Provenge to Evaluate Risk of Strokes as Well as On Label Use as Approved by FDA

The drug is just barely off and running and the treatment is not inexpensive by any means and according to this notice put out by the FDA, they want additional information at CMS on how stroke victims are affected that have received the drug so this appears...

Published Sun, Sep 09 2010 2:39 PM by The Medical Quack

Filed under: Medically Related, Technology, Pharma/FDA News, Biotech, FDA, Prostate Cancer, software, CMS, Algorithms, Dendreon, Provenge, off label, Intellivenge

SonoSite Catheter Guidance System Gets Approval from FDA

This is good news as we always can use more visuals when placing a catheter. The system uses an infrared technology combined with fiberoptics so having a visual to enable a visual on the screen. Below SonoSite is working with another partnership...

Published Fri, Aug 08 2010 2:56 PM by The Medical Quack

Filed under: Medically Related, Pharma/FDA News, EMR, healthcare, EHR, Medical Devices, Mobility, FDA, software, Medtronics, wireless, Ultrasound, Physio-Control, Sonosite, NanoMaxx

FDA Purchasing Additional Generic Drug Simulation Software for Scientists–Faster and More Efficient Than Physically Dissolving Tablets and Cleaning Up the Lab

The FDA is not alone in their thinking here either as earlier this year Bill Gates invested in drug simulation software too. According to the press release an additional 10 licenses were purchased. Bill Gates Invests In Software Company That...

Published Fri, Aug 08 2010 9:52 PM by The Medical Quack

Filed under: Medically Related, Pharma/FDA News, healthcare, microsoft, FDA, Generic Drugs, software, Bill Gates, Algorithms, Drug Development, healthcare reform, simulations, SimulationsPlus

Dendreon Corporation Selects Pilgrim Software As a Service Solution For Risk Management and Compliance Intelligence

Back in March I wrote about their own internal software that I believe was primarily put together for both clinical and tracking areas and now it looks like the definitive business intelligence area of reporting and compliance is added to the equation...

Published Tue, Aug 08 2010 6:14 PM by The Medical Quack

Filed under: Technology, Pharma/FDA News, Biotech, FDA, Prostate Cancer, software, Software as a Service, Algorithms, Dendreon, Provenge, Microsoft Tags, Bar Codes, Intellivenge, active cellular immunitherapy, Pilgrim

Dendreon Announces CMS Evaluation of Provenge for Late Stage Prostate Cancer Patients

Provenge costs a total of $93,000 for the full treatment of three infusions so this was no surprise that consideration would be needed before giving a blank check for all participants of Medicare with prostate cancer who would be in a position to require...

Published Thu, Jul 07 2010 3:23 AM by The Medical Quack

Filed under: Medically Related, Technology, Pharma/FDA News, Biotech, FDA, Prostate Cancer, software, CMS, Algorithms, Dendreon, Provenge, Microsoft Tags, Bar Codes, Intellivenge, active cellular immunitherapy

The Importance of Open Standards to Healthcare Medical Records Connectivity

As well all know the future of Health IT grows, open source is important and saves money; however a combination of both commercial and open source is what gets the job done. I like open source software myself and use quite a bit, but in some areas...

Published Wed, Jun 06 2010 12:55 PM by The Medical Quack

Filed under: Medically Related, Technology, Medical Records, Medical technology, Health IT, FDA, Open Source, software, Linux, Servers, HIE, open standards

Is a Non Technical FDA Recall System Like Another BP Oil Spill Waiting to Happen One Day

I don’t mean that the FDA has anything to do with oil, but by comparison if you look at how long, since 2004 since the FDA made the commitment to create a recall program that is easy and accessible for consumers, well we have waited about 6 years. ...

Published Fri, Jun 06 2010 3:37 PM by The Medical Quack

Filed under: Technology, Pharma/FDA News, Other Items of Interest, My Commentaries, drugs, healthcare, Medical Devices, FDA, software, Safety, Recalls, healthcare reform

FDA Approves Boston Scientific Genesys HTA™ System For Menorrhagia – Heavy and Prolonged Menstrual Periods

In women’s health, this could certainly be viewed as a plus and an alternative for an immediate hysterectomy with the procedure and device that can be done in a doctor’s office. If you are a female, you know that this is a very common condition...

Published Wed, May 05 2010 1:55 PM by The Medical Quack

Filed under: Medically Related, Technology, Pharma/FDA News, Medical Devices, FDA, software, Boston Scientific, menorrhagia, womens healthcare, endometrial ablation, menstrual bleeding

Venture Capital Concerned More About The FDA Decisions More Than Their Involvement in Healthcare Reform

I say in my opinion, this is pretty valid. The FDA like every other government structure is going through massive changes and updates, and one example is Social Security looking at emerging from old Cobol systems for another example. This...

Published Tue, May 05 2010 4:05 PM by The Medical Quack

Filed under: Medically Related, Technology, Pharma/FDA News, drugs, healthcare, Investors, Medical Devices, FDA, software, Algorithms, Venture Capital, healthcare reform, 501

Vasomedical Combined ECG Holter, Ambulatory Blood Pressure/Software Monitoring System Approved by the FDA

ECG or EKGs as sometimes called are getting quite sophisticated. Vasomedical has primarily been focused towards the cardiology area but with some of the new product lines and electronic monitoring, plan to bring this level to the primary care area...

Published Mon, Apr 04 2010 12:44 PM by The Medical Quack

Filed under: Medically Related, Technology, Pharma/FDA News, healthcare, Medical Devices, Health IT, Cardiology, FDA, ECG, software, wireless, infrared, pacemakers, devices that report data, Vasomedical

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