MDV1 – Medical Device/Data Innovation & Investment

FDA Medical Device Regs Updated

Medtronic, Stryker, J&J Face New U.S. Rules for Medical Device Approvals
By David Olmos and Sophia Yan – Aug 3, 2010 9:01 PM PT

Medical device makers Medtronic Inc., Johnson & Johnson and Stryker Corp. face new safety rules under a revamped program laid out by U.S. regulators that may help speed approval of products from condoms to CT scanners.

The Food and Drug Administration released the proposed new requirements for the so-called 510(k) program that covers products similar to previously approved devices, or about 90 percent of products cleared for sale.

Medical device companies say the 510(k) process is rife with delays and inconsistent requirements, while consumer advocates say patients are at risk because of inadequate safety rules. The new proposals address both issues, giving device makers a more predictable process while insisting they provide more safety data, said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. read more

Parma hospital part of settlement in heart device kickback scheme

By Peter Krouse, The Plain Dealer June 04, 2010, 11:39AM

PARMA, Ohio — Parma Community General Hospital must pay part of a $3.9 million settlement that resolves civil allegations that St. Jude Medical Inc. paid illegal kickbacks to two hospitals to secure heart-device business, the U.S. Justice Department announced Friday.

The kickbacks represented improper rebates paid to Parma Community General and Norton Healthcare of Louisville, Ky., according to the Justice Department.

St. Jude, based in St. Paul, Minn., will pay $3.725 million under the settlement, Parma Community General will pay $40,000 and Norton Healthcare will pay $133,000

The investigation was initiated by a whistleblower named Jerry Hudson who worked for St. Jude. He received $640,050 as part of the settlement, the Justice Department stated. read more

New Technology for Fibroid Ablation.

News from the Wall Street Journal on a novel new minimally invasive device  that treats fibroids in women.

Of all the pains and indignities the female body suffers, some of the most common are uterine fibroids—benign tissue growths in the womb. It’s estimated that as many as 70% of women develop them at some point. Most are asymptomatic and women never know they’re there. But in about one-third of cases—even more among African-American women—the fibroids become large enough to cause pain in the back, abdomen and pelvis, bloating and very heavy menstrual bleeding. Some grow to be as large as a grapefruit and can interfere with other organs.

The standard treatment is a hysterectomy, which permanently removes the uterus along with the fibroids. More than 200,000 hysterectomies are performed in the U.S. each year for fibroids; it’s the second most common surgical procedure for women, after Cesarean sections. read more