Medical Device Link.

Although the legislation is in a state of flux, certain features persist throughout the various versions introduced since last summer. In this month's lead article, Jonathan R. Sick, a shareholder at the law firm of McAndrews, Held & Malloy (MHM; Chicago), presents a high-level introduction to these features, with a particular focus on how they are likely to affect the medical technology industry. [ More ]

HRS's Curtis: Seeking stakeholder input.

HRS is soliciting input from physicians, patients, regulatoryagencies, and the general public on the CRM device guidelines through May 30. The final recommendations are expected in October. Referring to the guidelines as "an important step toward strengthening patient and physician knowledge, confidence, and trust," HRS president Anne B. Curtis, MD, said, "We believe these suggested changes will ensure that patients continue to have access to these lifesaving treatments." [ More ]

Although medtech manufacturers generally support the purpose and objectives of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), a large majority takes issue with the way the program has been implemented and its impact to date—particularly with regard to the predictability and timeliness of device approvals. That is one of the core findings of a study commissioned by FDA and administered by The Lewin Group (Falls Church, VA), a national healthcare consulting firm. According to the report, many manufacturers say MDUFMA has not produced a good return on their investment. Many respondents view user fees as a "double tax" and are concerned that Congress is not funding the program adequately. [ More ]

A review of recently released financial data for the first three months of 2006 points to significant performance variability among leading public medtech manufacturers. Among the top 20 firms, the strongest performances were turned in by companies in the medical imaging and healthcare information systems sector. Imaging giants Siemens Medical Solutions (Malvern, PA), Philips Medical Systems (Andover, MA), and GE Healthcare (Chalfont St. Giles, UK) all posted double-digit revenue gains over the prior-year period. By contrast, three companies—Guidant (Indianapolis), now a division of Boston Scientific Corp. (Natick, MA); Kodak Health Group (Rochester, NY); and Beckman Coulter Inc. (Fullerton, CA)—all reported revenue declines. Revenues for Boston Scientific and Baxter International Inc. (Deerfield, IL) were essentially flat.

Orthopedic firms Stryker Corp. (Kalamazoo, MI), Zimmer Holdings Inc. (Warsaw, IN), and Smith & Nephew plc (London) all continued to report revenue gains. The top performer for the period was St. Jude Medical Inc. (St. Paul, MN), which saw its year-to-year quarterly revenues increase by 18%. [ More ]

Kodak's Perez: Investigating multiple options.

In a conference call with analysts, Kodak chairman and CEO Antonio M. Perez acknowledged that the sale of the health unit was an option, but he also cited the possibility that the company might pursue a partnership. "Our stated corporate goal is to be among the top three in each of the businesses in which we compete," Perez said. "While the Health Group is enjoying strong organic growth in elements of its digital portfolio, such as digital capture solutions and healthcare information solutions, we have been observing for some time consolidation in this industry. Given our valuable assets and the changing market landscape, we feel that now is the time to investigate strategic alternatives." [ More ]

"We are experiencing the regular ebb and flow of venture investing, and we are truly at our healthiest and most sound investment point since the mid 1990s," said Mark Heesen, president of the NVCA. "That said, we will need to see improvements in the initial public offering markets and better evidence of early-stage investing momentum in future quarters if we expect to sustain this reasonable pace."   [ More ]

At the time of their initial indictment in February 2003, Ross Caputo was president and CEO and Robert Riley was vice president of regulatory affairs for AbTox Inc. (Mundelein, IL). Both were found guilty of three counts of wire fraud, four counts of mail fraud, conspiracy to defraud FDA, and seven counts of selling an adulterated or misbranded human medical device. "These convictions are evidence of FDA's resolve to ensure the safety and efficacy of human medical devices," said Margaret Glavin, FDA's associate commissioner for regulatory affairs. "Our criminal investigators aggressively pursue those that endanger the public health by manufacturing and selling unsafe products." [ More ]

Siemens' Reinhardt: A groundbreaking combination.

"The potential is huge to drive groundbreaking innovations by combining DPC's in vitro diagnostics leadership with Siemens' leading position in medical imaging and healthcare information technology solutions," said Erich R. Reinhardt, president and CEO of Siemens Medical Solutions. "Together, both companies will be empowered to continue to revolutionize the prevention, diagnosis, treatment, and management of disease." [ More ]