All I can say here is that this goes back to a earlier post: The 2 New Hot Words in Healthcare: Algorithms and Whistleblowers In this case we have a bit of both, algorithms created by the scientists, but a requested change by the clinical side of the table? Sounds a bit like the algorithms run...
Posted to
The Medical Quack .... by Barbara Duck
on 11-19-2008
Filed under: Medically Related, Technology, drugs, healthcare, Medical Devices, Prescriptions, FDA, Medications, Whistle Blower, Data, Data Base, Algorithms
A short while back I had said algorithms were one of the two hottest terms today in healthcare and this product is no exception as algorithms using thousands of patient data records are used to define brain dysfunction. The software contains a database of brainwave recordings, which serves as the basis...
As the article states, an individual can use the product without a clinician being present and it appears that a supply of disposable patches are included. Through ultrasound waves, the pain in the area under the patch is relieved. It has shown relief with acute and chronic pain as well as...
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 news stories on this topic. BD Medical...
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 also has a pretty large interest in biotech related...
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 room for the FDA on a suit they brought to task. ...
Posted to
The Medical Quack .... by Barbara Duck
on 08-18-2008
Filed under: Medically Related, Pharma/FDA News, My Commentaries, Medical Devices, FDA, Endotec, Joint Replacment, Court, Ankle
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 playing a very large role in how the devices work...