Medical Devices

CHICAGO - Wireless systems used by many hospitals to keep track of medical equipment can cause potentially deadly breakdowns in lifesaving devices such as breathing and dialysis machines, researchers reported yesterday in a study that warned hospitals to conduct safety tests. Some of the microchip-based "smart" systems are touted as improving patient safety, but a Dutch study of equipment - without the patients - suggests the systems could actually cause harm. A US patient safety specialist said the study "is of urgent significance" and said hospitals should respond immediately to the...

A $6.4 billion effort to speed US reviews of new drugs and medical devices is a step closer to law as the agreements Mylan Inc., Pfizer Inc., and other companies struck with regulators wind through Congress. The Senate is set to begin voting soon on more than $2 billion in new fees that drug and device companies will pay regulators through 2017 to review their products for safety and efficacy. The figure includes $1.56 billion from generic- drug companies such as Pennsylvania-based Mylan, which had been exempt from such review fees.

Pacemakers are smaller than they used to be, but not really that different from one that might have kept your grandfather alive decades ago. Ultrasound machines still look pretty much the same as they did when you or your children were born. Tests for strep throat still take days to come back from the lab. While computers, phones, and even watches have been transformed at breathtaking speed, improvements to medical devices have arrived slowly and incrementally. Now, a new center at MIT wants to bring the breakneck pace of consumer tech development to such devices, and cement the Boston region’s...

MANY CORPORATE GIANTS count on billion-dollar blockbuster products, from Coca-Cola to the iPad, to make money. Covidien PLC, on the other hand, has stitched together a bulging catalog of more than 50,000 obscure health products, ranging from surgical instruments to bandages, that together generate billions of dollars in sales a year. Solid sales and profit growth drove Covidien to number 16 on the Globe 100 - the highest for a medical device maker this year. In 2011, Covidien reported $11.7 billion in revenue, up 11 percent from the previous year.

The world's largest medical-device trade group will bring its annual conference to Boston next year, the first time the event will be held outside of Washington, D.C. AdvaMed 2012, a gathering of the American Medical Technology Association, could draw more than 2,500 people to the Boston Convention & Exhibition Center on Oct. 1-3, 2012, said Ray Briscuso, producer of the conference. If it meets that goal, it would be the largest conference ever for the association, known as AdvaMed.

WASHINGTON - Medical devices designed to help paralyzed patients move won US regulators' approval to use a block of radio spectrum for transmitting wireless signals to incapacitated limbs. The Federal Communications Commission adopted rules that give access needed by so-called advanced microstimulator devices that use implanted electrodes to stimulate muscles with the help of a wireless controller worn outside the body. The airwaves at stake are part of a block of spectrum used primarily by the federal government.

CHICAGO — More than 70,000 children and teens go to the emergency room each year for injuries and complications from medical devices, and contact lenses are the leading culprit, the first detailed national estimate suggests. About one-fourth of the problems were things like infections and eye abrasions in contact lens wearers. These are sometimes preventable and can result from wearing contact lenses too long without cleaning them. Other common problems found by researchers at the US Food and Drug Administration include puncture wounds from hypodermic needles breaking off...

WASHINGTON — Makers of X-ray machines, drug pumps, and other medical devices would have to submit more safety information to win federal approval under a proposal designed to tighten regulation of thousands of products reviewed each year. The Food and Drug Administration has released recommendations designed to improve oversight of the US device industry, including the government’s ability to recall products that prove unsafe or ineffective. The FDA’s report comes nearly a year after the FDA’s medical devices division endured a storm of criticism from public health...

Federal health regulators asked the country's leading medical experts two years ago to recommend ways to improve the government's system for approving most medical devices, ranging from pacemakers to X-ray scanners. On Friday the experts came back with a surprise answer: scrap it because it fails to protect patients. Even more surprising, FDA summarily dismissed the idea. The Institute of Medicine's panel said in a report that the U.S. government should abandon the 35-year-old system used to clear medical devices because it provides little assurance...

Zoll Medical Corp., a Chelmsford-based maker of medical devices, said that the Saudi Arabia Ministry of Health purchased six of its intravascular temperature management systems to treat pilgrims suffering from heat stroke during the annual Hajj pilgrimage to Mecca last November. In 2010, severe desert heat and "sun-related hazards" caused 140 pilgrims to die from heat stroke during the gathering, according to a Zoll press release. While the weather for this year's pilgrimage was cooler, 10 cases of heat stroke were reported, two of...

New Hampshire state economic officials say exports of the state's products totaled nearly $4.3 billion last year, down slightly from a year ago. This comes after a record year for the state in exports, amounting to nearly $4.4 billion, which was up more than 42 percent in 2009. Tina Kasim of the state's Office of International Commerce said the 1.69 percent dip in 2011 was anticipated, given challenging economic conditions overseas. Last year, the state's largest trading partner was Mexico, where over $943 million worth of goods was sent.

John Fox, chief executive of Parietal Systems Inc. in North Andover, had a tough engineering job and small budget. So he turned to Olin College in Needham, where a team of six engineering students built a robot that would allow Parietal to demonstrate its machine learning software. The cost to the company, which creates advanced data analytics for the Department of Defense, was $50,000, a fraction of what it would have cost for professional engineers to do the job. But the results were so good that Parietal this year engaged another team of five Olin students to enhance the...

The Food and Drug Administration is taking steps to reduce "alarm fatigue" in hospitals by intensifying its pre-market review of medical devices that sound alarms and could contribute to the desensitization of nurses - a problem that The Boston Globe reported last year was linked to hundreds of deaths. The agency is providing additional training on alarm standards and alarm safety to its reviewers, who are responsible for scrutinizing 4,000 applications a year from manufacturers seeking permission to sell their medical devices, including heart and oxygen monitors.

Japan's Asahi Kasei Corp. has agreed to buy Zoll Medical Corp., a Chelmsford company that makes Lifevest defibrillators and other medical devices, for about $2.2 billion in an effort to sharpen its focus in the health care business. Asahi Kasei is a major Japanese chemical manufacturer with a variety of businesses including health care. Under the deal announced Monday, Asahi is offering $93 per share for each Zoll share, a 24 percent premium over Zoll's closing price of $75.10 on March 9.

The health care products giant Johnson & Johnson continued to market an artificial hip in Europe and elsewhere overseas for a year after the Food and Drug Administration rejected its sale in the United States based on a review of company safety studies. During that same period, the company also continued to sell a related model in this country, which earlier went on the market using a regulatory loophole that did not require a similar safety review. It is not known how many people overseas received the replacement hip after the agency decided in 2009 not to approve it, nor the number...

Federal prosecutors dropped fraud charges yesterday against a fourth executive of the pharmaceutical company Stryker Biotech, effectively closing a high-profile felony case against representatives of the Hopkinton-based company. Mark Philip, the former president of Stryker, and three former sales managers were accused of committing fraud against surgeons by promoting medical devices beyond their approved use. But just as a trial for the managers began, prosecutors dropped all charges after apparently concluding that no fraud had occurred.

The Food and Drug Administration is taking steps to reduce "alarm fatigue" in hospitals by intensifying its pre-market review of medical devices that sound alarms and could contribute to the desensitization of nurses - a problem that The Boston Globe reported last year was linked to hundreds of deaths. The agency is providing additional training on alarm standards and alarm safety to its reviewers, who are responsible for scrutinizing 4,000 applications a year from manufacturers seeking permission to sell their medical devices, including heart and oxygen monitors.

WASHINGTON -- The Food and Drug Administration has agreed to work toward more predictable, transparent reviews of new medical implants in return for a 100 percent increase in user fees from manufacturers, under a preliminary agreement. The pact with the medical device industry is expected to provide $595 million in user fees to the FDA over five years, allowing the agency to hire 200 new scientists. That amount essentially doubles the $295 million industry paid over the last five years of the arrangement.

To say Steven Lloyd was good with his hands would be an understatement. He refurbished the run-down ranch house he and his wife, Jodi, bought when they were engaged, installing walls and plumbing, and built a wrap-around deck and stone walls along the property's edge. He repaired friends' cars and restored a 25-year-old Jeep for off-roading. But Lloyd was unexpectedly stricken by a massive brain hemorrhage in October, on the day before his 44th birthday. As he lay dying in the hospital, the New England Organ Bank called his wife at their New...