FDA designates Medtronic recall as Class I
Medtronic (Minneapolis) said that the FDA classified as Class I its voluntary recall action initiated on February 11, 2009 of its BioGlide Ventricular Snap Shunt Catheter (Cat. #s 27782, 27708 and 27802) – the cerebral ventricular catheter component of a shunt for the treatment of hydrocephalus. FDA defines Class I recalls as, "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death." This recall action (applicable to units in the United States, Ireland and Australia) involved the retrieval of unused product and safety notification of implanted product of these three catalog numbers of Medtronic Cerebral Ventricular Catheters. Approximately 3,000 catheters have been distributed between 2002 and 2009. It is estimated that there are 300 unused catheters.
As of March 18, 2009, Medtronic completed contact with all users of these catheters. This was completed by visit from its field personnel delivering the recall notification and to retrieve unused products.
The recall involved the following models:
– Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782;
– Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27802;
– Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27708.
Tenet reports Florida medical centers merger
Tenet Healthcare (Dallas) said that Florida Medical Center (Ft. Lauderdale, Florida) will merge with North Shore Medical Center (Salem, Massachusetts). The merger will be effective on June 1. Both campuses will remain open and continue functioning as normal, with no expected reduction in services at either hospital.
"Merging Florida Medical Center and North Shore Medical Center enables us to capitalize on synergies to provide better, more efficient care to the communities we serve," said Marsha Powers, Tenet's regional senior VP for Florida. "We will be able to more effectively recruit specialized physicians, share service line expertise and consolidate back-office operations."
Gephardt to help MMR promote PHRs
MMR Information Systems (Los Angeles), which through its wholly-owned operating subsidiary, MyMedicalRecords provides consumer-controlled personal health records (PHR) and electronic safe deposit box storage solutions, said that Richard Gephardt, a member of MyMedicalRecords's board of advisors, will work with MMR to promote its mission of educating the public on the importance of starting a PHR now. Gephardt will also assist MMR in identifying opportunities to receive stimulus funds to subsidize the cost of getting an easy-to-use PHRs into millions of American households sooner than later.
Revolutions to move close to port of Charleston
Since the Revolutions Medical Corporation's (Mount Pleasant, South Carolina) recent FDA 510(k) clearance for its RevVac safety syringe, the company said it has decided to move to a new corporate sales headquarters in Charleston, South Carolina. The headquarters is expected to be complete in June and will be close to the port of Charleston and the shipping terminals, the company said. This will be the Revolutions Medical's main shipping hub for its safety syringe, the company noted.
Nasdaq extends rule suspension for VirtualScopics
VirtualScopics (Rochester, New York) reported that the Nasdaq Stock Market has further extended the temporary suspension of the $1 minimum bid price requirement until July 20. The company now has until Nov. 9 to regain compliance with the requirement. VirtualScopics said it has received stockholder approval to effectuate a reverse stock split, through May 9, in the event that the minimum bid price has not been achieved.
The company said it intends to request an extension from its stockholders to take advantage of the additional time allowed by Nasdaq to regain compliance. VirtualScopics provides imaging solutions designed to accelerate drug and medical device development.