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Articles from 2008 In July


FDA Clears Test That IDs Types of Tumors

It compares the genetic material of a patientâEUR(TM)s tumor with genetic information on malignant tumor types stored in a database. It uses a microarray technology to analyze thousands of pieces of genetic material at one time. "With the help of microarray technology, [scientists] will be able to classify these types of cancers in a standardized non-reader dependent manner based on the patterns of gene activity in the tumor cells," said CDRH director Daniel Schultz. The test's software converts the scanned image data to gene expression measurements. The gene expression patterns are compared with known gene expression patterns in the database that correspond to different tumor types. And that knowledge can help clinicians determine the best course of treatment. The test is made by Pathwork Diagnostics. It uses a gene expression array made by Affymetrix Inc.

Abbott Gets DOJ Subpoena on Bile-Duct Stents

It is estimated that about 90% of the time, bile-duct stents are used off-label, and last year FDA held a meeting for bile-duct stent manufacturers to go over what they can and cannot promote to doctors. Abbott said that the government is seeking to determine whether the activities violated laws such as the Federal False Claims Act, the Food and Drug Cosmetic Act and the Anti-Kickback Statute in connection with Medicare or Medicaid reimbursement paid to third parties. UPDATE: Johnson & Johnson and Boston Scientific have also received subpoenas. UPDATE 2: Medtronic has received a subpoena as well.

Studies Doubt Oral Cancer Screening Test

However, some dentists that use screening tools like ViziLite say using the devices gives them the chance to take a second look in spotting lesions, which could still help detect cancer early.

Integra Spine Division in the Works

Theken Spine's product line includes plates, screws, and synthetic bone products, and Theken Disc is a research-stage company that develops spinal implants.

Zimmer Halts Sales of Artificial Hip Component

In April, a Los Angeles surgeon brought attention to the implant problems in a letter to his colleagues. Zimmer expects the sales suspension to slash $20 to $30 million from its sales estimates. The company is also stopping its U.S. premarketing trials of a resurfacing system.

New Device Trains Premature Babies to Feed

The system trains the baby's brain in a sense, enabling the baby to speed up the ability to eat without a feeding tube. KCBioMediX was founded to commercialize devices developed at the University of Kansas that assess the NNS of premature babies. It's possible that that target market for the device could be worth more than $1 billion.

Premier to Require Unique Device Identification

It announced in a release published on devicelink.com that it will require all medical device manufacturers it has contracts with to adhere to standards that essentially require unique device identification -- which usually consists of bar codes or RFID and can help in tracking devices in case of recalls, and preventing medical errors. Industry originally opposed unique device identification because of the difficulties in coming up with a single system that would work for all medical devices. FDA and industry have struggled to come up with one, and the process has taken a very long time, even though Congress finally mandated unique device identification in the FDA Amendments Act of 2007. Premier apparently had enough, and imposed its own standards. It hopes its action will force FDA to act. Premier has adopted the GS1 supply chain standards. This includes a Global Trade Identification Number, the Global Location Number, and the Global Data Synchronization Network. The first is a standardized number used to identify medical devices at various packaging levels. The second is a standardized number used to identify who has been in contact with a device. The third stores data from the first two, and allows users to access information about each device.

NIH to Address the Pediatric Device Gap

Last year's FDA Amendments Act provided financial incentives for companies developing pediatric devices, but also required them to track patients at their own expense, so it doesn't really do much to address the cost-of-development issue. Ethical issues also come in to play. Can you do a randomized clinical trial on children? On Wednesday, reports Reuters, the National Institutes of Health is sponsoring a meeting on pediatric devices, and an AdvaMed spokeswoman says industry will look to it for guidance.

Arthrocare to Restate Earnings

The new statements will reduce 2006 revenue by $4-7 million, 2007 revenue by $20-25 million, and 2008 revenue by $2-5 million. Now, the company's explanation makes it seem like there was no fraud at play, just a miscategorization. Here is how it categorizes the mistake: "The relationship between the company and DiscoCare, Inc. during the periods being restated was a sales agent relationship, rather than that of a traditional distributor; and the sales price of products sold to State of the Art Medical Products, Inc.("SOTA"), Boracchia & Associates and Clinical Technology, Inc. cannot be considered fixed or determinable upon shipment by ArthroCare during the periods being restated. The company will therefore account for sales by ArthroCare of products to each of these entities from the third quarter of 2006 to March 31, 2008, under a sell-through revenue recognition method that is appropriate for both of these situations, as opposed to a sell-in method. Under the sell-through method, revenue is not recognized until after the surgery is performed or a subsequent sale to another customer occurs. Sales to these companies for periods prior to the third quarter of 2006 will continue to be accounted for under the previous method of revenue recognition, either sell-in or sell-through, depending on the terms of the previous contract with each company." Some other things from the affected financial statements will also be recategorized, and the audit committee will oversee a review of the firm's internal controls -- a review that will involve outside investigators and may expand beyond that scope if necessary. Shares of Arthrocare, which makes a variety of surgical instruments that work by dissolving soft tissue, fell 21% in early trading, reports Reuters.

Cardinal Cited Over Sharps Container QSRs

Among the procedures lacking are written corrective and preventive action procedures, design change control procedures, complaint procedures, and medical device reporting procedures. Additionally, FDA's letter says a management representative has not been appointed to ensure that the quality system requirements are met, and management reviews do not ensure that the quality system satisfies the requirements of CFR part 820. The letter also cites the firm for failing to conduct quality audits and failing to have a procedure for acceptance and rejection of incoming product. --James G. Dickinson