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Articles from 2007 In June

Tyco Splits, Spins off Healthcare Company

The Boston Globe is also reporting that Covidien is making a clear effort to distinguish itself from the tarnished Tyco name via billboards and other advertisements. The company markets a range of healthcare products under brand names including Autosuture, Kendall Healthcare, and Syneture.

A Registry for Gifts to Doctors?

The New York Times article about this is almost entirely about the drug industry, but it refers to "legislation that would create a national registry of gifts and payments to doctors by the makers of drugs and medical devices." Yet the uproar doesn't seem to be about medical devices; that was the only mention of them in the whole piece. The device industry's trade associations need to weigh in on this quickly.

Advisory Panel Green Lights Heart Device

Similar technologies are available that use radiofrequency energy instead of cold. The panel recommended that the company create a patient registry and conduct follow-up studies. The agency usually, but not always, follows the advice of its panels.

First Rapid Test for Malaria Gets FDA Clearance

While malaria is not common in this country, it is common in other parts of the world, and Americans who travel abroad may be susceptible to it.

Roche Offers $3 Billion for Diagnostics Firm

The Guidant deal may also have encouraged device CEOs to overspend, if they think their target is a particularly good fit. That may be the case with Roche Diagnostics, which according to Bloomberg News, has offered $3 billion to buy another diagnostics company, Ventana Medical Systems Inc. (Tuscon, AZ). That works out to $75 a share, which is a whopping 45% higher than Ventana's closing share price yesterday. Why would Roche pay that much of a premium? Because Ventana makes screening tests that can determine which patients are a fit for which drugs. Roche has been one of the firms at the forefront of the leap into personalized medicine, and Ventana's technology is something that can bring it closer to that goal. Also key is that one of Ventana's tests determines who will respond to a breast cancer drug made by Genentech -- whose majority shareholder is Roche. Indeed, today Ventana's share price has risen even higher than the $75 Roche offered, indicating investors think the company can get an even better deal.

Shelhigh Settles with FDA

Supreme Court Will Hear Case Against Medtronic

(This applies to PMA products; suits have been allowed to proceed against 510(k) and pre-1976 products, which are less rigorously reviewed.) The case involves a patient who had a Medtronic catheter burst inside of him during an angioplasty, and then required bypass surgery. Medtronic says the doctor was using the catheter off-label.

New MA Nonprofit to Focus on Pediatric Devices

The institute is based in Cambridge, MA and its first three hospital partners are based in California, Kansas, and Ohio. Up until now, the options for pediatric-use devices were not great. Either a device company could run expensive pediatric studies, or it could do nothing but sit back and watch hospital personnel improvise ways to use their products on children. Creating a systematic way to retrofit devices for children might be a reasonable middle ground. Also, the Institute for Pediatric Innovation and similar nonprofits stand to benefit from language in the version of the FDA Revitalization Act passed by a House subcommittee on Friday. Congress would give such organizations $6 million per year for the next five years. It would also extend to the device industry something in place for the drug industry: patent extensions in exchange for performing pediatric studies. And it would allow device companies to price such devices high enough to make a profit, provided volume was 4,000 per year or less.

Healthcare Plan Affordable While Fostering Innovation

It will also offer financial incentives for those providers and plans that give efficient care, especially related to chronic diseases. "Our plan shows you can finance expanded coverage without rationing care or stifling innovation," said AdvaMed President and CEO Stephen Ubl in a statement. AdvaMed estimates that the plan will save $226 billion in national spending and $105 in federal spending as a result of better treatment and disease prevention, medical innovation, and more use of health IT.

AdvaMed to Unveil Health Care Reform Plan

Most importantly to industry, the plan also includes "mechanisms to promote health quality, effiiciency, and innovation to help improve patient oucomes and control costs." In other words, a cost-control plan to serve as an alternative to gainsharing.