Archive for FDA

“MicroSort” Genetics and IVF Institute’s answer for the age old question “Is it a Boy or a Girl?”

MicroSort is a system designed to separate X (female) and Y (male) sperm cells. It has the ability to identify and measure then separate them based on the measurable differences. This technology is based on the fact that the X chromosome is much larger than the Y chromosome. Using a modified flow cytometer instrument MicroSort is now able to provide 80% accuracy rates.

This idea was originally developed by Dr. Lawrence Johnson at the USDA (United States Department of Agriculture). His original clinical trials were produced using animals. The Genetics & IVF Institute began collaboration with Dr. Johnson to further develop this technology for use in humans.

The option to choose whether a pregnancy will render a boy or a girl seems quite frivolous, but there are directly X-linked diseases that can now be avoided. The opportunity for a family to ensure the sex of their child, maybe the only way they will ever have children. This based on the possibility of their child having a debilitating disease if it is born a certain sex. Another reason is family balancing this ensures a family (thus the population) has an adequately balanced female, male ratio.

Currently MicroSort is undergoing human clinical trials. To be considered for these trials the couple must be married, they must have an X-linked or X-limited chromosome or at least one other child and the sort must be for the opposite sex of that child, and both must be HIV and HepB negative. While the FDA has granted GIVF permission to allow enrollment of new participants, access does not represent FDA approval.

There is a great ethical debate with this topic, especially in light of such technology and the probability of its approval by the FDA and use in genetic labs. When understanding that some diseases only affect a certain sex child of some gene carrying parents, it seems logical. The question is when discussing family balancing where does the line get drawn and who draws it?

A “Trauma Pod” A Robot in a Robotic trauma room save Soldiers lives.

The robotic technology used to perform a totally unmanned surgical procedure is their major hurdle. A human surgeon will be the actual conductor from a remote location, utilizing a system of surgical manipulators through wireless connection. A level of automation is needed to assist the surgeon during all phases of any surgical procedures. There will also be a robotic scrub nurse available to lend assistance or care for other patients.

A supply robot system SDS (Supply Dispensing System) is included in the “Trauma Pod”. It will dispense medications and supplies, as well as dispose of used supplies in a medical waste container. General Dynamics Robotic Systems have come up with several plans for this idea, which include SCMS (Supply Chain Management System) to assist with issuing and restocking orders.

SRI has the reputation to create and produce this technological idea. In the late 1980’s it was their da Vinci prototype that was approved by the FDA for use in general laparoscopic surgery. The da Vinci project was originally funded by the Army with the idea of a robotic system for battlefield medical assistance. They expect a prototype to be in effect in the next year hopefully speeding up the application of this needed technology.

For more information you can go to the SRI website at:

http://www.sri.com