Top Device Companies

Bayer, Duramed IUDs Subject Of Physician Import Scandal

Bayer and Duramed Pharmaceuticals interuterine devices are being obtained at a lower cost around the country as physicians buy imported versions from Canada for half the U.S. price. Bayer makes the Mirena hormonal IUD, which costs $700 in the United States, $320 in Canada. Duramed’s Paragard copper IUD, the only other IUD approved by the FDA, has a similar price differential because Canadian agencies bargain for discounts while U.S. agencies are barred by law from doing so. It also is against U.S. law to import devices that reached the market under the regulations of another country. (Click here for more)

“Rhode Island IUD Scandal Tip Of Iceberg” – Providence Journal (7/18/10)

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Bayer, GE, Avid Get Positive Feedback For Alzheimer’s Scans

Bayer, General Electric and Avid Radiopharmaceuticals, all makers of scanning devices for detecting Alzheimer’s disease, have received promising feedback about the efficacy of their machines. The three, which developed their scans independently, had to show their devices can reveal as much about the disease as an autopsy. Avid says it has done so in a study presented to an international conference. All of the new scanning devices rely on a radioactive dye that attaches to brain plaque, making it visible on PET scan. (Click here for more – a subscription may be required)

“New Scan May Spot Alzheimer’s” – New York Times (7/12/10)

Medical device manufacturers facing many challenges: from the rising clout of group purchasing organizations (GPOs) to payment bundling and physicians' growing allegiance with hospitals in product price negotiations. Get all the answers now in new Medtech Insight's new 24-page Special Report: Medical Device Landscape: How regulatory changes and cost control measures are reshaping the industry. Available for purchase now!

Bayer Alerts Rhode Island Officials To Unapproved Versions Of Its IUD

Bayer Healthcare Pharmaceuticals alerted the Rhode Island Health Department to hospitals using an unapproved version of intrauterine devices masquerading as Bayer’s own Mirena. The unapproved versions, sold at half the price Bayer charges, were purchased by OB-GYN Associates, a major provider of OB-GYN services in Rhode Island. The Health Department seized the firm’s IUDs in stock and began a probe into the source of the unapproved versions. (Click here for more)

“R.I. Health Department Investigates Use Of Unapproved IUDs” – Providence Journal (6/24/10)

Medical device manufacturers facing many challenges: from the rising clout of group purchasing organizations (GPOs) to payment bundling and physicians' growing allegiance with hospitals in product price negotiations. Get all the answers now in new Medtech Insight's new 24-page Special Report: Medical Device Landscape: How regulatory changes and cost control measures are reshaping the industry. Available for purchase now!

Bayer Sued Over Pregnancy Test Tied To Birth Defects 34 Years Ago

Bayer Schering Pharma’s pregnancy test in use for more than 30 years is the subject of a lawsuit filed in a German court. A Bavarian man said he was born 34 years ago with birth defects because his mother had used the company’s test, which was in the form of medication then. Bayer Schering denied a connection between its Duogynon test and the man’s birth defects, and said the suit was without merit. Bayer Schering was sued at the time over the tests, with claims that about 1,000 children were born with defects to mothers who used it, but an investigation was dropped in the 1980s, and the suits failed. (Click here for more)

“Bayer Hit By Lawsuit Over Pregnancy Test: Report” – AFP (6/5/10)

Medical device manufacturers facing many challenges: from the rising clout of group purchasing organizations (GPOs) to payment bundling and physicians' growing allegiance with hospitals in product price negotiations. Get all the answers now in new Medtech Insight's new 24-page Special Report: Medical Device Landscape: How regulatory changes and cost control measures are reshaping the industry. Available for purchase now!

Bayer, GE, Others Race To Make Brain Scan Agent To Detect Alzheimer’s

Bayer, General Electric and other makers of imaging devices are competing to develop agents to use in their equipment to enable brain scans to detect Alzheimer’s disease. No such compound has been developed to diagnose the disease, currently detectable only by studying brain tissue after death. Bayer, GE and the others are trying to develop molecules with radioactive markers that bind to amyloid plaques, using a distinguishable color to show up on brain scans. (Click here for more – a subscription may be required)

“New Tools To Detect Alzheimer’s” – Wall Street Journal (4/15/10)

Medical device manufacturers facing many challenges: from the rising clout of group purchasing organizations (GPOs) to payment bundling and physicians' growing allegiance with hospitals in product price negotiations. Get all the answers now in new Medtech Insight's new 24-page Special Report: Medical Device Landscape: How regulatory changes and cost control measures are reshaping the industry. Available for purchase now!

Bayer Counts On Alzheimer’s, Parkinson’s Diagnostics To Drive Sales

A Bayer executive says his company is counting on new diagnostics for Alzheimer’s and Parkinson’s diseases to bring the firm out of a sluggish growth period. Hans Maier, head of the diagnostic imaging unit, said Bayer’s neurology pipeline is very good, led by the two new disease diagnostics. He said the unit would match last year’s $2 billion in sales this year, but Alzheimer’s and Parkinson’s diagnostics are expected to drive a sales increase in 2010. (Click here for more)

“Bayer Sees Growth For Diagnostics In Nerve Diseases” – Forbes (Reuters) (12/2/09)

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Bayer, Covidien, GE MRI Agents Said To Risk Fatal Skin Disease

Bayer, Covidien and GE Healthcare have been advised by the FDA their MRI agents may be linked with an increased risk for nephrogenic systemic fibrosis, a potentially fatal skin disease. The products using the agents at issue are Bayer’s Magnevist, Covidien’s Optimark and GE’s Omniscan. Bracco Diagnostic’s Prohance and Multihance agents scored the lowest-risk as measured by the FDA. The agency said it planned to form a panel of outside experts to study the issue in December. (Click here for more)

“U.S. FDA Sees Varying Risk From MRI Agents” – Reuters (11/17/09)

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Bayer’s Mirena IUD Gets FDA Approval For Second Indication

Bayer AG received FDA clearance for its Mirena intrauterine device for handling heavy menstrual bleeding in IUD users. The device already had clearance as a contraceptive system, but the new indication allows it to be marketed just to treat the bleeding problem. Bayer said Mirena is the first device the FDA has cleared for treating heavy menstrual bleeding. (Click here for more)

“FDA Oks Bayer IUD For Heavy Menstrual Bleeding” – Reuters (10/1/09)

Medical Device Manufacturers’ Employee Training Programs Are Under FDA Scrutiny -- Click Here To Find Out Why...

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Bayer Gets FDA Approval For Diabetes Monitor That Plugs Into PC

Bayer AG unit Bayer Diabetes Care received FDA clearance for its monitor to check the blood glucose levels of diabetics and being plugged into a personal computer. Bayer’s Contour USB is designed to provide instant access to information key to patients for managing diabetes. The device is capable of storing up to 2,000 test results. (Click here for more)

“New Bayer Glucose Monitor Plugs Into Computers” – Pittsburgh Tribune-Review (9/21/09)

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Roche, Bayer Could Face Higher Standards For Blood-Glucose Monitors

Roche, Bayer and other makers of diabetes monitors may face added pressure to raise the standards for their products intended to help control glucose levels. At issue is the accuracy of the readings their monitors give, said in one government study of five monitors to vary by as much as 32 percent. Roche makes Accu-Check monitors for use by patients. A spokeswoman for the company noted that all blood-glucose monitors have a limitation or interference problem, such as with certain drugs the patient may be taking. A spokeswoman for Bayer, maker of Ascensia Breeze and Ascensia Breeze II, said to differ by an average of 62 points, said her company complies with government standards and would abide by changes. (Click here for more)

"Standards Might Rise On Monitors For Diabetics" – New York Times (7/18/09)

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