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Articles from 2007 In November

CT Scans May Be Linked to Cancer

But because they emit much more radiation than an X-ray, and because their use has grown swiftly in recent years, physicians need to think before they order CT scans, say the report's authors, who are from Columbia University Medical Center. ''Part of the issue is that physicians often view CT studies in the same light as other radiologic procedures, even though radiation doses are typically much higher,'' they said. This will require a shift in thinking. Doctors will have to ask themselves two questions when considering ordering a CT scan. First, is it medically necessary? Second, would a CT scan show something that couldn't be detected by a less-radioactive technology like ultrasound? As for the companies that make CT scanners, they probably shouldn't worry too much about the business implications -- as they tend to make X-ray, ultrasound and other imaging systems too. UPDATE: The Medical Imaging and Technology Alliance released a statement citing that the benefits of CT scanning far outweigh the cancer-related risks. It also highlighted a report on reduced radiation doses.

New Electrosurgical System Could Save Costs

The software is updated through secure electronic communications via RS-232 ports. Updates can also be done over the Internet at the hospital. Previously, these sorts of systems had to be sent out in order to receive software updates. The new way has the potential for significant cost savings.

Outlook for Abbott DES Approval Is Good

If the panel agrees with the staff, chances for approval become very high. The report said that over two years, patients with Xience were half as likely to die, suffer a heart attack, or need repeat surgery than patients with Boston Scientific's Taxus. It also advocated longer studies after approval to ensure the device does not cause blood clots over time. This is no surprise; post-approval studies of Class III devices are almost de rigeur by this point. UPDATE: On Thursday night Nov. 29, the advisory panel did indeed recommend Xience for approval.

Smith & Nephew Recalls Knee Implants

A company notice says the products should not pose any toxicity or biocompatibility dangers. This is the second recall for the firm this year; 185 hip implants were recalled in August.

Paternity Test Now Available OTC

It is not as simple as paying the suggested retail price of $29.99 and then doing the necessary swabs, though. To have the samples analyzed by a laboratory costs an additional $119. And if you want to use the test for legal purposes, a chain of custody for the samples must be set up, and that costs an extra $200. The United States is a free market, even for some aspects of healthcare these days. The solution is not to try to restrict access to these tests, but to make sure that they are based on sound science and that consumers know what the results mean.

The House That the Smallpox Vaccine Built

A predecessor company had been the primary manufacturer of a special kind of needles used for the smallpox vaccine, until the disease was virtually wiped out in the 1970s. But after 9/11, bioterrorism concerns came to the forefront, and the U.S. government decided it needed safeguards against a potential smallpox outbreak. Indeed, it decided that it needed to stockpile one needle for every American citizen. So it went to PMP, and despite its small size, the firm figured out a way to manufacture and package 400 million smallpox needles over the course of a year. The revenues from that project enabled the firm to build its new facility and compete against larger competitors. And, says George Weaver, vice president of marketing, it continues to excel at figuring out how to develop manufacturing processes for projects that seem difficult. For example, a client that designed an ear thermometer which had a disposable part couldn't figure out how to make the disposable. PMP designed a manufacturing process for it from scratch, said Weaver. Much is written about the ingenuity of medical device companies, but what's often overlooked is that many times their supplier companies need similar ingenuity to succeed.

Smith & Nephew Endoscopy Sells Vascular Business

Boston Scientific, ECRI Settle Dispute

Terms of the settlement were not disclosed. The controversy over medical device pricing will not go away, though. Sen. Chuck Grassley wants to introduce a bill that would require device companies to disclose prices on a quarterly basis. The secrecy over device pricing is arousing suspicion because of the rising costs of healthcare. While making device pricing more transparent would not solve the bulk of the problem, it wouldn't hurt, either. It just needs to be done in a way that doesn't encourage hospitals to opt for price over quality.

Lack of Recognition is Part of the Problem

In fact, the company has exceeded its own expectations in global sales this year and now leads the worldwide market in endovascular aortic repair. By the end of the third quarter, Cook surpassed Gore and captured 40% of the U.S. market (Gore had 35% and Medtronic held 23%). In Europe, Cook took the top spot in AAA stent grafts at 42%. The company is working on several projects for its Zenith Endograft product family for 2008. We can expect to see several clinical trials, PMA submissions, and even product launches in the coming year as Cook tries to keep a tight grip on the market.

FDA Announces Advisory Panel Reform

Transforming FDA LogoFDA announced it is taking steps to improve how its advisory panels are conducted, in accordance with recommendations from the Institute of Medicine. One guidance document lays out how conflicts of interest will be disclosed from now on. All panelists must now publicly disclose any interests for which FDA has granted them a waiver. Another guidance recommends that panels adopt simultaneous voting, announce voting results immediately, and record how each member voted in the public record. Operating procedures for the panels have also been formalized. And the agency's advisory panel Web site has been reworked to make it more understandable to the public. Also of interest, the agency posted a report from a consultant that outlines how difficult it is to find experts who are totally free from conflicts, and proves that panelists who have received conflict waivers are usually more qualified than panelists without them. This is a long-overdue response to the mainstream media belief that all conflicts are by definition wrong. Let us hope it gets the coverage it deserves.