blog
04.06.2010
blog, FDA Approved
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Alair Bronchial Thermoplasty System
PMA Applicant: Asthmatx, Inc.
Address: 888 Ross Drive, Suite 100 Sunnyvale, CA 94089
Approval Date: April 27, 2010
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080032a.pdf
What is it?
The Alair Bronchial Thermoplasty System is composed of a catheter with an electrode that delivers radiofrequency energy (a form of electromagnetic energy) directly to the airways of the lungs. A controller unit generates and controls the energy. read more
04.06.2010
blog, FDA Approved
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Esteem®
PMA Applicant: Envoy Medical Corporation
Address: 5000 Township Parkway, St. Paul, MN 55110
Approval Date: March 17, 2010
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf9/P090018a.pdf
What is it?
The Esteem® is the first totally implantable hearing system used to treat moderate to severe hearing loss caused by a defective inner ear function. The Esteem® system includes three implantable components (Sound Processor, Sensor, and Driver), and external testing and programming instruments. read more
03.05.2010
blog
The pace of new technology in surgery is astounding. Just yesterday learning open surgery skills took many years to perfect. Now with minimally invasive surgery, there is a new skill set to learn and to master. Tomorrow is here today, “Robotic Surgery” is even a more advanced skill set that will allow for greater dexterity and skill for the surgeon. Patients benefit tremendously because with these advances, the ability for improved precision in surgery and better results is a significant benefit.
I remember training at Stanford in gynecologic surgery, it was a great enigma. Sitting at the end of the operating table, holding a retractor as a resident. I was the “third or fourth” surgical assist. I could not really see anything, there were so many bodies huddled around the operating table. I would begin to fall asleep because I had been up all night long on-call. I thought, this is no way to learn. I can’t see anything. But since those days of sleepless nights and frustration, I came out a pretty great surgeon. Learning minimally invasive techniques that have spared many patients from excess pain and disability. Truly remarkable surgery, allowing patients to go home that day or the next.
I am in favor of the rapid progress of these new surgical technologies, and I am very excited that surgeons all over the world are sharing videos and techniques. MDV1 is an agency for innovating physicians and surgeons consulting the BioDevice Space. If you have any questions, please contact us phone: 408-309-8457
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