Revenue in the men’s health division barely budged, growing 0.8 percent to $89 million, partly because of slowing growth of erectile restoration (penile prosthesis) products. The company “was seeing some economic impact on [these] procedures, as men who have in some cases lived with the problem for years elected to delay treatment due to either copays or the lengthy recovery period,” wrote Brooks West, an analyst with Craig-Hallum in Minneapolis. Read the rest of this entry »

The Supreme Court decision “left consumers without any ability to get compensation for injuries caused by certain defective medical devices,” said Rep. Henry Waxman, D- Calif., in a statement to the Star Tribune. “The Supreme Court assumed that FDA approval ensures medical devices are safe, but the many recent stories of patients harmed by faulty devices have proven that assumption false.”
Waxman and Rep. Frank Pallone Jr., D-N.J., plan to introduce Read the rest of this entry »

Miami, FL – Millions of men and women suffer from thread veins, manifest by unsightly little clusters of red, blue or purplish veins that spiderweb the cheeks, thighs, calves, ankles and knees. In fact, for Western populations like the US, it’s been estimated that 25-30% of women and 10-20% of men suffer from this unsightly condition. But now there’s a thread of hope. Adding to its full suite of medical technologies, Techno-Derm, LLC, announced Read the rest of this entry »

.  According to
, Rep. Henry Waxman (D-Calif) and Rep. Frank Pallone (D-New Jersey) plan to soon reintroduce a bill to restore consumers’ rights, and similar action is expected in the Senate.
Last February, the Supreme Court ruled in a case called Riegel vs. Medtronic  that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require
(FDA) approval of medical devices preempt product liability lawsuits in state Read the rest of this entry »

said Wednesday it received clearance from the Food and Drug Administration for its Pathiam System with iScan for assessment of HER2/neu immunohistochemistry tests.
Cupertino-based BioImagene said the scanner and associated software are used to detect and provide a quantitative measurement of HER2/neu, a protein that is measured in breast cancer patients in order to determine if they are candidates for treatment with the breast cancer drug Herceptin.
Read the rest of this entry »

A year ago today, the
that federal law bars lawsuits “challenging the safety or effectiveness of a medical device,” as long as the device is marketed in a form approved by the FDA.
The ruling, in a case called
, relied heavily on a federal law that regulates medical devices; now, some key congressional players are looking to change the law, this morning’s
reports.
Democrats Henry Waxman and Frank Pallone plan to introduce Read the rest of this entry »

Maverick suffered second- and third-degree burns in the fire on Jan. 22, 2008, the day after he was born. Witnesses said flames erupted inside a plastic oxygen dome, which had been placed over the baby’s head to help him breathe. His bassinet had been placed beneath the warming device in the nursery.
Two nurses, who were standing beside him, put out the fire immediately, hospital officials said. Maverick was soon transferred to Hennepin County Medical Read the rest of this entry »

Diana Gore is 44 years old and minutes away from surgery to remove the cancer in her breast. The mother of three daughters from Clinton, N.C., is trying to control a flood of emotions.
“Fear. Will this be it?” she says in the pre-op room. “Will it be gone when we’re finished here, or will we come back later on and say, ‘Oh, you know, there’s a little more left there, we’ve got to go back,’” Gore says.
Inside the operating room, Gore’s surgeon, Read the rest of this entry »

The Food and Drug Administration has been justly pilloried for grievous flaws in its regulation of foods and drugs. Now Congressional investigators, and some of the agency’s own scientists, are charging that the F.D.A. has failed to adequately regulate medical devices.
The Government Accountability Office recently reported that the F.D.A. has failed — for decades — to subject some of the riskiest devices to a rigorous review mandated Read the rest of this entry »

’s request for approval to market its device for treating heart failure.
New Brighton-based Acorn has struggled in recent years to win the government’s OK for the CorCap product. In 2006, a
(FDA) dispute-resolution panel voted against approving Acorn’s device. But in May of last year, the FDA reached an agreement with Acorn that allowed the firm to conduct a new clinical trial, which has yet to wrap up.
The consumer group, Read the rest of this entry »