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Medical Device

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BUSINESS
February 27, 2016 | By Chris Mondics, Staff Writer
For much of his congressional career, U.S. Rep. Mike Fitzpatrick focused on policy issues from national security, to taxes, to health care. Medical device safety wasn't high on the list. But that changed in 2014 when Fitzpatrick had a chance meeting with cardiac surgeon Hooman Noorchashm and his wife, Amy Reed, an anesthesiologist, during a Christmas parade in Yardley. Noorchashm and Reed approached Fitzpatrick and in an hour-long talk in the chilly rain told him the disturbing story of how a widely used device called a power morcellator had spread an aggressive uterine cancer through Reed's abdomen during a hysterectomy.
NEWS
August 4, 1989 | By Kenneth J. Cooper, Inquirer Washington Bureau
Makers of various medical devices violated federal law by not reporting seven deaths and more than 100 serious injuries associated with their products in recent years, a consumer group alleged yesterday. The Public Citizen Health Research Group, founded by Ralph Nader, also criticized the Food and Drug Administration for failing to prosecute any companies for violating the reporting law, which took effect in late 1984. FDA documents obtained by the group indicated that 35 companies did not report seven deaths, 109 serious injuries and 265 malfunctions related to their products between December 1985 and June 1988.
BUSINESS
April 5, 2012 | By David Sell, Inquirer Staff Writer
The emerging market for generic medical devices is the backdrop for a legal fight between Synthes Inc., and several former employees who created a company to sell similar products for less money. Headquartered in Switzerland but with facilities in Chester County, Synthes is a global leader in selling plates, rods, screws, and power tools to fix broken bones, which is why Johnson & Johnson has agreed to pay $21.3 billion for Synthes. Yearly global medical-device sales amount to about $300 billion and, with aging populations in developed nations, the market isn't going away.
ENTERTAINMENT
September 5, 2015 | By Marie McCullough, Inquirer Staff Writer
The U.S. Government Accountability Office has agreed to investigate why an electric device used in gynecological surgery was marketed for two decades before safety warnings were issued by the Food and Drug Administration. The GAO, which investigates how the government spends tax dollars, sent a confirmatory letter to U.S. Rep Mike Fitzpatrick (R, Pa). He and 11 other members of Congress requested the probe last month. "GAO accepts your request as work that is within the scope of its authority," said the Sept.
BUSINESS
November 8, 2008 | By Miriam Hill INQUIRER STAFF WRITER
Revolutionary medical advances will force dramatic changes in the ways that drugs are tested and approved and will require pharmaceutical companies to overhaul their businesses, the outgoing head of the U.S. Food and Drug Administration said yesterday. In a talk to business students at St. Joseph's University, South Philadelphia native Andrew von Eschenbach compared developments in medicine to advances that resulted from scientific discoveries about the atom and its nucleus in the first half of the 20th century.
NEWS
October 28, 2015 | By Tom Avril, Inquirer Staff Writer
A medical device used for decades has emerged as a worrisome source of infections, apparently sickening eight patients at a central Pennsylvania hospital - four of whom died. The device is a heater-cooler unit, widely used during heart bypass surgery to control a patient's blood temperature. The infections at WellSpan York Hospital and elsewhere are attributed to bacteria in water that circulates within the devices. European researchers and the U.S. Food and Drug Administration both say patients can be exposed to bacteria that are aerosolized through the device's exhaust vent.
BUSINESS
September 6, 2012
Intact Vascular Inc., a Wayne medical device start-up, raised $15.5 million from Quaker Partners, of Center City; H.I.G. BioVentures, of Miami; and several angel investors. Founded in 2008, Intact Vascular will use the financing to complete a 138-patient clinical study being conducted in Europe of a stapling device to be used during leg surgery to improve blood flow in arteries, said Carol Burns, its chief executive officer. The privately held company also named Dennis Wahr, the former CEO of Minneapolis-based medical device maker Lutonix Inc., as its chairman.
NEWS
June 21, 2011
Cozen O'Connor, a 575-lawyer firm based in Center City, said today it will expand its New York office with 19 lawyers from Cohen Pontani Lieberman & Pavane L.L.P., a high profile intellectual property law firm based in New York, effective July 1. The Cohen Pontani firm represents domestic and foreign clients in the biotechnology, pharmaceuticals, medical device, automotive and telecommunications industries, among others, in patent prosecutions, licensing...
NEWS
May 16, 2011
Neuronetics Inc., a privately held medical device company in Malvern, has raised $30 million in a Series E investment round for its NeuroStar TMS Therapy System. The noninvasive treatment for major depression using MRI-strength magnetic field pulses was cleared by the Federal Drug Administration in 2008. Leading the latest fund-raising were life-science investors Polaris Venture Partners and Pfizer Venture Investments Inc. Polaris Venture principal Kevin Bitterman will join Neuronetics' board of directors; Pfizer Venture executive director Elaine Jones will serve as observer to the board.
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ARTICLES BY DATE
NEWS
April 17, 2016 | By Chad Terhune, KAISER HEALTH NEWS
The number of potentially deadly infections from contaminated medical scopes is far higher than what federal officials previously estimated, a new congressional investigation shows. As many as 350 patients at 41 medical facilities in the U.S. and worldwide were infected or exposed to tainted gastrointestinal scopes from Jan. 1, 2010, to Oct. 31, 2015, according to the Food and Drug Administration. A separate Senate investigation released in January found 250 scope-related infections at 25 hospitals and clinics in the U.S. and Europe.
BUSINESS
February 27, 2016 | By Chris Mondics, Staff Writer
For much of his congressional career, U.S. Rep. Mike Fitzpatrick focused on policy issues from national security, to taxes, to health care. Medical device safety wasn't high on the list. But that changed in 2014 when Fitzpatrick had a chance meeting with cardiac surgeon Hooman Noorchashm and his wife, Amy Reed, an anesthesiologist, during a Christmas parade in Yardley. Noorchashm and Reed approached Fitzpatrick and in an hour-long talk in the chilly rain told him the disturbing story of how a widely used device called a power morcellator had spread an aggressive uterine cancer through Reed's abdomen during a hysterectomy.
BUSINESS
January 21, 2016 | By Joseph N. Distefano, Staff Writer
Johnson & Johnson plans to cut about 3,000 employees, or 1 in 20, from its global medical-device workforce in hopes of saving up to $1 billion in yearly costs. The drug and medical-supply company will use that money to invest in "new growth opportunities," J&J said Tuesday. In a statement to employees, J&J said the cuts would "accelerate its pace of innovation. " The company expects a pretax restructuring charge of up to $2.4 billion by 2018, including $600 million later this year.
BUSINESS
November 15, 2015 | By Tom Avril, Inquirer Staff Writer
The U.S. Food and Drug Administration ordered a Bucks County manufacturer Friday to recall all 2,800 of its automated washing machines that are used to clean and disinfect endoscopes in hospitals and outpatient clinics. The FDA said its action against Custom Ultrasonics, of Ivyland, was prompted by continued violations of federal law and of a consent degree that the company entered into in 2007. Citing reports of serious bacterial infections at hospitals that use the company's machines, formally called reprocessors, the agency said in a news release that technicians should use alternate cleaning methods such as manual disinfection.
NEWS
November 6, 2015 | By Marie McCullough, Inquirer Staff Writer
A renowned Boston medical center was ordered by a judge Tuesday to stop imposing extraordinary security measures on a Bucks County cancer patient and her husband, who have been sharply critical of Brigham and Women's Hospital. The Massachusetts judge agreed with the couple, Amy Reed and Hooman Noorchashm, that the security was intended to intimidate them, and violated their right to free speech as well as the hospital's own policies. Hospital officials declined to comment. Reed, 42, an anesthesiologist at the University of Pennsylvania, and Noorchashm, 43, a cardiac surgeon at Thomas Jefferson University Hospital, have led a highly effective national campaign to ban a gynecological surgical device that Brigham doctors used to perform her hysterectomy two years ago. The tissue-slicing device, an electric morcellator, spread her hidden uterine cancer - a danger that they have since publicized.
NEWS
October 28, 2015 | By Tom Avril, Inquirer Staff Writer
A medical device used for decades has emerged as a worrisome source of infections, apparently sickening eight patients at a central Pennsylvania hospital - four of whom died. The device is a heater-cooler unit, widely used during heart bypass surgery to control a patient's blood temperature. The infections at WellSpan York Hospital and elsewhere are attributed to bacteria in water that circulates within the devices. European researchers and the U.S. Food and Drug Administration both say patients can be exposed to bacteria that are aerosolized through the device's exhaust vent.
NEWS
September 7, 2015 | By Marie McCullough, Inquirer Staff Writer
The U.S. Government Accountability Office has agreed to investigate why an electric device used in gynecological surgery was marketed for two decades before safety warnings were issued by the Food and Drug Administration. The GAO, which investigates how the government spends tax dollars, sent a confirmatory letter to U.S. Rep. Mike Fitzpatrick (R., Pa.). He and 11 other members of Congress requested the probe last month. The tissue-slicing device, called a power morcellator, enables hysterectomies to be done through small abdominal incisions, but it can also spread and worsen undetected uterine cancer.
NEWS
September 7, 2015 | By Tom Avril, Inquirer Staff Writer
Four years ago, Wendy Schnaars had a medical device implanted in her head so she could receive cancer treatment. Today the South Philadelphia resident is healthy. The device is still in her head, and has done something else for her she never could have imagined: Got her a ticket for the ride of a lifetime. She flew last month on the NASA plane that simulates the weightlessness of being in space. Scientists had searched the nation for people, like Schnaars, who have an implant that would let them measure pressure inside the brain.
NEWS
May 29, 2015 | By Marie McCullough, Inquirer Staff Writer
After a surgical device spread an aggressive but undetected uterine cancer inside anesthesiologist Amy Reed in late 2013, she and her husband launched a campaign to ban electric morcellators. Now, the Federal Bureau of Investigation has gotten involved, according to Reed's husband, Philadelphia heart surgeon Hooman Noorchashm, and Sarah Robinson, a California woman whose cancer was also worsened by the device. Both said Wednesday that they have been interviewed by FBI agents, and believe the FBI is looking into whether manufacturers failed to report deaths and serious injuries to the Food and Drug Administration, as required by federal law. "I had been trying to get the FBI's attention for a very long time," said Noorchashm, a heart surgeon at Thomas Jefferson University Hospital.
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