Medical Devices

Imagine having the fountain of youth as close at hand as the bathroom. We're not there yet — but there's a burgeoning number of at-home, high-tech beauty gadgets that claim to smooth wrinkles, whiten teeth and remove hair without the need to invest in pricey beauty treatments at the spa, dermatologist or plastic surgeon's office. Some of these gadgets are so high-tech the Food and Drug Administration considers them medical devices, so approach the world of cosmetic gadgetry with caution.

The chief drawback of a law as complex as the Affordable Care Act, the health insurance reform measure passed in 2010, is that it provides self-interested opponents a multitude of places to stick a wedge in and hammer away. But you'd be hard-pressed to find a campaign against the ACA as narrow-minded and dishonest as the one mounted by medical device manufacturers. This industry, which encompasses makers of everything from tongue depressors to MRI machines, has been grousing from the outset about an excise tax of 2.3% the act imposes on sales of its products.

The Food and Drug Administration warned the nation's dietary supplements industry Wednesday against spiking its products with steroids, prescription drugs and other prohibited substances. The warning was the latest salvo in a long-running battle between federal regulators and an industry that is held to far less rigorous health and safety standards than those imposed on makers of pharmaceuticals and medical devices ? thanks in part to powerful friends in Congress. Unlike drugs, dietary supplements don't have to be proven safe before being sold, and manufacturers can make general claims about health benefits.

Some talented humans can fold their tongues into a three-leaf clover, but some bats accomplish an even greater feat: Hair-like structures on their tongue tips stand to attention when they lap up nectar, allowing them to collect more. This "nectar mop," described in the Proceedings of the National Academy of Sciences, could become a useful model for future medical devices, researchers said. Scientists have seen many methods of nectar collection. Butterflies suck liquid with a straw-like proboscis, and hummingbirds have forked tongues that help them 'grab' droplets during feeding.

Reporting from El Cajon, Calif. -- Sharlotte Hydorn peddles a product touted for its deadly simplicity. Inside her butterfly-decorated boxes are clear plastic bags and medical-grade tubing. A customer places the bag over his head, connects the tubing from the bag to a helium tank, turns the valve and breathes. The so-called suicide kit asphyxiates a customer within minutes. Orders come from all over the world, from people young and old, depressed and terminally ill. "People commit suicide by jumping out of windows and buildings, and hanging themselves," said the 91-year-old former elementary school science teacher.

* Santa Clara-based Coherent Inc. shares fell 12% after the laser maker warned that fiscal third-quarter earnings would be hurt by charges and by a revenue shortfall caused by production delays. Stock of Coherent fell $2.63 to close at $19.38 in Nasdaq trading.

Some talented humans can fold their tongues into a three-leaf clover, but some bats accomplish an even greater feat: Hair-like structures on their tongue tips stand to attention when they lap up nectar, allowing them to collect more. This "nectar mop," described in the Proceedings of the National Academy of Sciences, could become a useful model for future medical devices, researchers said. Scientists have seen many methods of nectar collection. Butterflies suck liquid with a straw-like proboscis, and hummingbirds have forked tongues that help them 'grab' droplets during feeding.

Prosecutors probing insider trading in the medical devices industry are investigating a senior Goldman Sachs banker and a former employee of the notorious hedge fund Galleon Group. The investigation, according to a person briefed on the matter, is focused on the 2009 takeover of Advanced Medical Optics in Santa Ana. The U.S. attorney's office in Los Angeles has been scrutinizing the ties between Goldman managing partner Matthew Korenberg, who worked on the Advanced Medical Optics deal, and Paul Yook, a former portfolio manager at Galleon, the person said.

The patient was listed as unstable, in critical condition. On July 30, 2007, between 8 and 9 a.m., he was receiving insulin, anesthetic and blood pressure medication through a volumetric infusion pump when all three of the pump's channels failed. His blood pressure dropped. Pressure on his brain rose. The pump was replaced, but not in time. The patient was brain dead. The problem, according to a stark "adverse event report," was software, specifically an overflow in the memory buffer.

Katherine Ayers was 36 when she decided the pain in her hip had become too much to bear. A surgically implanted metal-on-metal hip joint soon made her pain-free. But a few years later, she was startled to receive a letter saying the artificial joint was being recalled. "In my mind, recalls were for dishwasher and cars, not body parts," she told a congressional hearing earlier this year. Ultimately, Ayers had to have a new implant. It was experiences such as Ayers' — and scores of others with even more serious consequences — that has led the Institute of Medicine, an arm of the National Academy of Sciences, to call on the government to design a new system for evaluating and approving many high-risk medical devices before they reach the market.

Closing arguments are set to begin Thursday in Los Angeles in a high-stakes trial where healthcare giant Johnson & Johnson is accused of negligence in designing and marketing a once-popular artificial hip. The case in Los Angeles County Superior Court pits the world's biggest maker of medical products against Loren Kransky, a 65-year-old former prison guard who claims he suffered metal poisoning and other health problems from the company's ASR...

Re "A better ending," Column, Dec. 19 Kudos to Steve Lopez and The Times for moving the "death with dignity" discussion front and center. Life is finite and none of us is going to get out of this alive. Healthcare professionals and loving families must have the compassion and moral fortitude to acknowledge the difference between prolonging life and prolonging death. The quality of our last days hangs in the balance. Lynn F. Kessler Sherman Oaks Just as the nation is taking a serious look at violence in our culture, your paper has a major article promoting another example of an attempt to solve our "problems" through violence.

MIT and Harvard scientists have figured out a way to harness a tiny electric current in the inner ear. The work, believed to be the first to pull electricity from the cochlea and use it to drive electronics, could make it possible some day to make self-powered implantable medical devices to diagnose and treat disorders of the ear or even the brain, the researchers wrote last week in the journal Nature Biotechnology. Anantha Chandrakasan of the MIT Microsystem Technology Laboratories in Cambridge, Mass., and Konstantina Stankovich of the Massachusetts Eye and Ear Infirmary in Bostonand colleagues took advantage of the ear's own way of powering hearing -- a battery-like feature known as the endocochlear potential, which is created because of differences in the number of potassium ions (charged atoms)

Talk about a boo-boo. Every year, Americans suffer more than 1.5 injuries from medical tape removal - and the ones who suffer most are babies in neonatal units, whose fragile skin is easily ripped when nurses and doctors remove medical devices affixed to the infants by super-sticky adhesive.  Some kids suffer permanent scarring. Senior citizens are frequently hurt by tape removal too. To try to help out these fragile-skinned patients, a team of researchers at Brigham and Women's Hospital in Boston, along with collaborators at MIT, have invented a new type of quick-release medical tape that may reduce skin injuries.  When ripped away from the body, with its three-layer design that inserts a laser-etched release liner between the tape backing and the sticky adhesive, it doesn't tear apart from the skin.

Prosecutors probing insider trading in the medical devices industry are investigating a senior Goldman Sachs banker and a former employee of the notorious hedge fund Galleon Group. The investigation, according to a person briefed on the matter, is focused on the 2009 takeover of Advanced Medical Optics in Santa Ana. The U.S. attorney's office in Los Angeles has been scrutinizing the ties between Goldman managing partner Matthew Korenberg, who worked on the Advanced Medical Optics deal, and Paul Yook, a former portfolio manager at Galleon, the person said.

Consumer Reports has criticized the safety testing that went into the Lap-Band weight-loss device, raising concerns about poor regulatory oversight of medical equipment implanted in U.S. patients. In a report issued Wednesday the consumer magazine also expressed concerns about risks related to surgical mesh, metal hips and certain cardiac devices. It highlighted how the federal government allows some products to be sold with little or no advance safety testing. Consumer Reports questioned the effectiveness of Allergan Inc.'s Lap-Band product and said government approval was based on a clinical study of only 299 patients.

Consumer Reports has criticized the safety testing that went into the Lap-Band weight-loss device, raising concerns about poor regulatory oversight of medical equipment implanted in U.S. patients. In a report issued Wednesday the consumer magazine also expressed concerns about risks related to surgical mesh, metal hips and certain cardiac devices. It highlighted how the federal government allows some products to be sold with little or no advance safety testing. Consumer Reports questioned the effectiveness of Allergan Inc.'s Lap-Band product and said government approval was based on a clinical study of only 299 patients.

Manufacturers of medical devices are sounding an alarm that some hospitals are harming patients by reusing "single-use" medical devices like biopsy needles and cardiac catheters. They cite incidents in which improperly "reprocessed" devices have infected patients with bacteria and harmed them during surgical procedures. The troubling accounts point to a solution sought by the manufacturers, calling on the Food and Drug Administration to flatly ban the reuse of all single-use devices.

Question: Price gains in my shares of Moog Inc. have slowed. What are the prospects? Answer: This global maker of precision control components and systems, for use with such things as aircraft, satellites and medical devices, has had a good year. Founded in 1951 as Moog Valve Co. with the inventions of William Moog, it continues to grow through new products and acquisitions. This year it acquired sensor-maker Crossbow Technology Inc. for $32 million and motion-technology company Animatics Corp.

The gig: Alfred E. Mann, 85, is an aerospace and biomedical entrepreneur who founded 17 companies over six decades and became a billionaire philanthropist. Niche man: Although he had no formal business training, Mann has demonstrated a knack for capitalizing on investment opportunities. His secret: Identify an unmet need and come up with a technology to fill it. The result has been a string of companies with names like Spectrolab, Heliotek, MiniMed and Advanced Bionics.