OMEDtech has recently launched it’s first video on our YouTube channel. This video gives a brief overview of how OMEDtech meets the needs of the medical device community. Please take a moment to check out OMEDtech’s first video and subscribe to our channel so that you don’t miss any of our upcoming video presentations.
The FDA has released a draft guidance covering live case presentations during investigational device exemption (IDE) clinical trials. This draft guidance provides insight as to what should be provided in an IDE application regarding a live case presentation. A live case presentation is “the treatment of a human subject under the auspices of an approved or conditionally approved IDE, conducted and … Read More
The Medical Device Excise Tax (MDET) is on its way to a possible repeal. The medical device tax is a 2.3% excise tax on every sale of a medical device in the United States. The US Senate and the House have approved a new federal budget which includes a repeal of the MDET. The language in the new budget is … Read More
Automation of the Design Control process can help product development teams navigate mandatory FDA regulations for medical device design controls. By making this process easier and more efficient, innovative medical devices can get to market quicker thereby having a greater impact of people’s lives. Tietronix Software has developed a Medical Device Accelerator (MDA), a web based system that includes design … Read More
The senate passed new legislation, June 26, that reauthorizes the latest version of the user fee bill. The bill introduces performance goals for the FDA. The bill nearly doubles the fees paid by medical device manufacturers. Medical device Manufacturers are required to pay fees for certain services that include 510(k) and PMA submissions and establishment registration. The bill seems to … Read More
Novocure, a solid tumor treatment company, has seen promising results in a phase III trial with it’s NovoTTF therapy. NovoTTF therapy is indicated for chemotherapy free treatment of recurrent glioblastoma multiforme (GBM) brain tumors. The results of the trial were comparable to active chemotherapy in extending overall survival, with minimal side effects and far better quality of life. Read the … Read More
When you’re frustrated with the regulatory process of getting a new medical device to market. This article is a great reminder of why it’s worth the effort. Watch what happens when children, who have received a cochlear implant, react to hearing for the first time.
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