Three former executives of Spectranetics are accused of illegally importing unapproved medical devices in a 12-count criminal indictment announced this week. Also named in the indictment, which was announced by Colorado U.S. attorney John Walsh's office, was a representative of a Florida company contracted by Spectranetics. The four are listed below:

• George John Schulte, 62, former CEO
• Obinna Adhigije, also known as Larry Adighije, 50, former VP of business development
• Trung Pham, 37, former business development manager
• Hernan Ricaurte, 41, former contract rep

The charges include conspiracy, making false statements, receipt of illegal imports, sales of adulterated and misbranded medical devices, and other offenses. (Note that not every defendant is being charged with every crime.)

The concept may be a bit strange, which is why it's probably still experimental. Researchers from UFL's College of Medicine conducted a study that showed that surgical robots could be used to enable anesthesiologists to perform robot-assisted procedures from remote locations. Using the daVinci robot, experiments using an ultrasound phantom  simulated what an anesthesiologist would see. Note: human patients were not used as subjects in the study. Once the anesthesiologist placed the ultrasound probe, a catheter placement procedure was performed. Although the study showed that teleanesthesia is possible with existing equipment, Steven Shafer of Columbia University says that there aren't enough skilled regional anesthesiologists to meet the demand. The technology is also still too young, but Shafer says that if future studies demonstrate that the technology is practical, then one highly trained anesthesiologist could...

Companies have had varying responses to FDA's recent investigation of genetic tests. MD+DI columnnist Jim Dickinson adds:
 
San Diego-based Sequenom says it is disputing a recent FDA untitled letter seeking regulatory approval or clearance of the company’s genetic test. FDA’s letter is part of a recent crackdown on so-called laboratory-developed tests (LDTs) under which the agency asserts approval authority over devices that are more commercial in nature.

According to FDA’s letter in July, it had come to the agency's attention that Sequenom was marketing without approval or clearance its SEQureDx, “a prenatal genetic diagnostic technology, intended to enable the detection and analysis of circulating...

Senator Amy Klobuchar (D-MN) delivered the keynote address at a LifeScience Alley conference on Monday, Aug. 23 featuring leaders from Minnesota’s medical device and health care industries.
“Minnesota is a national leader in the healthcare community, setting the standard for high-quality, affordable patient care,”Klobuchar said. “The medical device industry will help us continue to build a healthcare system that is streamlined, innovative, and able to harness the power of technology.”
In her remarks, Klobuchar highlighted the importance of medical technology and innovation in the U.S. economy and outlined how healthcare reform will benefit Minnesotans. She also discussed Minnesota’s medical device industry and the new FDA report that addresses 510(k) approval process.
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