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Industry Goes on Offense on FDA Medical Device Approvals

Will medical devices also have a longer and more focused process from the FDA in the future? This group and the follow up report that the FDA step up some of the process that are involved with approving medical devices, similar to the the same...

Published Fri, Sep 09 2008 11:28 AM by The Medical Quack

Filed under: Technology, Pharma/FDA News, healthcare, Medical Devices, FDA

Three hospitals turn to device instead of medication for anti-coagulation

The device is designed to serve as an alternative to the anticoagulants used to prevent thrombosis during surgery, so no drugs. The device looks to be a potentially safe alternative to medications to keep the blood thin, especially in view of recent...

Published Tue, Sep 09 2008 9:27 PM by The Medical Quack

Filed under: Medically Related, Technology, Medical Devices, FDA, anti-coagulant, Blood Thinner

Intel Health PHS 5000 - Home Health Monitor (one more)

Here is one more home health monitoring device. No word as to when this one might be available in the US. Intel just released another product September 1st for use in the US, as noted here. The devices keep getting smaller and each one...

Published Fri, Aug 08 2008 10:16 PM by The Medical Quack

Filed under: Medically Related, Pharma/FDA News, Other Items of Interest, healthcare, Intel, Medical Devices, Home Monitoring

Stanbio wins FDA approval on medical device to draw blood

It looks like the process of giving a blood sample is going to get a little easier for the patient and perhaps more efficient for the technician, and no air bubbles as well. Just from looking at the picture it appears this is an entirely new design...

Published Fri, Aug 08 2008 11:36 AM by The Medical Quack

Filed under: Technology, Pharma/FDA News, healthcare, Medical Devices, FDA, Blood

VC Funding for Biotech Companies Withering?

Is Biotech risky business? I think we can all agree due to the research and development and the unknown areas as far as predicting a winner can be close to a roll of the dice at times. The bar has risen a bit today to secure VC funds no doubt...

Published Thu, Aug 08 2008 11:09 PM by The Medical Quack

Filed under: Medically Related, Other Items of Interest, Genomics, Medical Devices, Biotech, Venture Capitalists

Intel launches first medical device

A couple months ago, the product was approved by the FDA and is now coming to market. According to the article hospitals and health organizations will be the first visits for marketing and sales, rather than a direct to consumer sale. Intel...

Published Thu, Aug 08 2008 12:32 PM by The Medical Quack

Filed under: Medically Related, Pharma/FDA News, healthcare, Intel, Medical Devices, FDA, Hospitals

Thermometers - I'll have one on my forehead please..

Take a look at the website , I had no idea that thermometers came in so many flavors. You can wear one, put one under your arm, and use on in your ear, which we have all pretty much seen that model used at our doctor's offices. I don't...

Published Wed, Aug 08 2008 11:36 AM by The Medical Quack

Filed under: Medically Related, Technology, healthcare, Medical Devices, Theremometers

FDA on the low end of the Endotec Ruling - Mobile Ankle devices are ok - Medical Devices

This is amazing that the battle has gone on over 25 years to restrict these devices from use in the US. The judge said they are"custom-made medical devices exempt from FDA regulation". This marks the first loss in the court...

Published Mon, Aug 08 2008 6:10 PM by The Medical Quack

Filed under: Medically Related, Pharma/FDA News, My Commentaries, Medical Devices, FDA, Endotec, Joint Replacment, Court, Ankle

India asking for more cooperation and help from FDA - Medical Devices

A group in India is looking for more help from the US FDA. This is probably good news in light of a few recent stories. One area of particular interest is the Medical device area, something all of us have an interest in as software is now...

Published Sun, Aug 08 2008 9:58 AM by The Medical Quack

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

Patient Who Needed Heart And Kidney Transplant Borrowed Time With Heart Assist Device

A medical device buys a man more time until transplant organs were available. His organs were causing heart failure and the transplant enabled his heart to continue working and now he's doing fine with both a heart and kidney transplant. ...

Published Wed, Aug 08 2008 11:09 AM by The Medical Quack

Filed under: Medically Related, Technology, Surgery, healthcare, Medical Devices, kidney, Transplant

Aetna "Take your Pill" Lottery...

How bad do the insurance companies want the patients to take their medications? Well enough to try a pilot program with an electronic umbilical cord to tie the patient to a device. It doesn't say exactly how the device will work...

Published Tue, Aug 08 2008 12:10 AM by The Medical Quack

Filed under: Medically Related, Insurance, Pharma/FDA News, Medical Devices, Pills, Prescriptions, Aetna

Gentag and MacroArray Develop Prostate Cancer Wireless Diagnostic Processes and Technology

According to this article, a patch would transmit the results direct to a cell phone, more telemedicine in the works? If the efforts are successful, this would allow more to be tested though the technology as the results could be relayed back to...

Published Fri, Jul 07 2008 12:40 PM by The Medical Quack

Filed under: Medically Related, Technology, Windows Mobile, healthcare, Medical Devices, Telemedicine, Prostate Cancer, PSA

PEAK Surgical Receives Clearance To Market PEAK(R) Surgery System For Use In General Surgery

This appears to be a replacement to the scalpel as known today. Less bleeding and better control are some of the benefits for surgeons. This gives the best of both worlds to the surgeon it appears. Other devices on the market also control...

Published Fri, Jul 07 2008 10:36 AM by The Medical Quack

Filed under: Medically Related, Technology, Pharma/FDA News, Hospital, Surgery, Medical Devices, FDA

FDA's June 2008 Clearances of 510(k)s

How fast is the FDA clearing medical devices? This page will show you a list of what was approved for the month of June. The list is quite long and lists medical devices from all areas of health care. BD Includes clearances...

Published Thu, Jul 07 2008 12:04 PM by The Medical Quack

Filed under: Medically Related, Pharma/FDA News, Medical Devices, FDA

FDA approves Pathway Medical's system for Plaque removal

With all the new breakthroughs in cardiology with the removal of plaque, soon this could be a worry of the past. The product won’t be on the market until later this year. The process of “roto-rootering” plaque is making some huge leaps and...

Published Tue, Jul 07 2008 10:57 AM by The Medical Quack

Filed under: Technology, Pharma/FDA News, Hospital, Medical Devices, Cardiology, FDA

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