SAMSUNG SEEKS TO EXPAND IN MEDICAL EQUIPMENT FIELD
Samsung Electronics Co., whose empire ranges from memory chips to televisions, is in talks to buy makers of MRI scanners and X-ray machines to challenge General Electric Co. and Siemens AG in medical equipment.
Samsung is in contact with some companies, Senior Vice President Jo Jae Moon, who leads a team of medical-equipment developers, said in an interview in Seoul on July 15, without elaborating on the potential targets. The company has said it plans to spend 1.2 trillion won ($1.1billion) in the medical- equipment business by 2020.
Any purchases would build on Chairman Lee Kun Hee’s plans to build the medical-equipment operations into one that generates 10 trillion won in annual sales. Lee is counting on demand for health-care gear to spur sales of scanners as the proportion of elderly residents in markets from the U.S. to Europe and Japan climb to records each year.
Samsung fell 2.3 percent to 813,000 won at the 3:00 p.m. close of trading in Seoul, while the benchmark Kospi index lost 0.7 percent.
Value Added Technologies Co., which supplies parts for X-ray machines, jumped 8.3 percent to 10,500 won, the biggest daily gain since Feb.
24. Medical-gear maker Vieworks Co. surged 15 percent to 16,250 won, the most since April, 2009.
No. 1 Target
The maker of Galaxy phones and tablet computers, with a plan to invest
23.3 trillion won in new businesses by 2020, made its biggest acquisitions in the health-care industry last year when it bought a controlling 43.5 percent stake in diagnostic ultrasound devices maker Medison Co., as well as 100 percent of Prosonic from Consus Asset Management Co. for 331.3 billion won. Samsung increased its stake in Medison to 65.8 percent in April.
They have a lot of companies on their list, and they have been contacting most of them. Samsung prefers to acquire small companies overseas with niche technology. They stated they will continue to meet them and negotiate, adding that they have a target to be the No. 1 across ultrasound devices, X-rays and MRIs.
Samsung is making a push into an industry led by General Electric, which had $16.9 billion of revenue from health care last year, a growth of 5.6 percent.
Siemens had 12.3 billion euros ($17.4 billion) in revenue from medical solutions, a 3.4 percent increase.
Aging Population
Royal Philips Electronics NV grew its medical systems business 10 percent to 8.6 billion euros. By comparison, 24.3 percent of Samsung’s revenue last year was from semiconductors and 26.6 percent from telecommunications equipment. The company’s total revenue is expected to grow 7.9 percent to 167 trillion won this year.
Samsung is expanding into health care as its overall revenue grows at the slowest pace in five years and as populations worldwide get older.
The number of people aged 65 and above will account for 8.3 percent of the world’s population by 2014, compared with 7.9 percent this year. Japan may be the oldest society, with the portion of elderly projected to account for 25 percent of the population in three years.
Medison
Besides takeovers, Samsung will also invest to boost hiring as well as research and development at its own medical-equipment business, where the number of staff grew from less than 10 people in 2009 to more than 200 now, Jo said.
Medison aims to increase sales by more than fivefold to $1.6 billion by 2020 from last year, he said. The company had a 5 percent share in the global market for diagnostic ultrasound devices last year and targets to increase that to 24 percent within a decade, Jo said.
The company may roll out its first products with the new Medison brand in the second half. Closely-held Medison, which currently has more than 1,000 employees globally with 12 overseas branches, may set up a research base in Seattle. The company will also seek more patents.
Medison was set up in 1985 and went bankrupt in 2002 because of excessive expansion. The company was taken over by Consus in 2006.
Showing posts with label Medical Scanners. Show all posts
Showing posts with label Medical Scanners. Show all posts
29 September 2010
Feds Reopen Probe into Medical Scanner Approvals
Associated Press
Federal inspectors have reopened an investigation into complaints by Food and Drug Administration scientists who say they were pressured by their managers to approve high-tech medical scanners that could pose harm to patients.
The lead inspector overseeing the matter told The Associated Press on Tuesday that the inquiry into the allegations, which were dismissed in February, is being revisited to look at manager misconduct.
"The original intent of the investigation was to look at criminal matters and our agents did that," said Gerald Roy, deputy inspector general for investigations in the Department of Health and Human Services. "But I point toward broader issues that really compelled me to take a second look at this and reopen it from an administrative perspective."
The HHS office of inspector general, which oversees the FDA, closed the case in February after finding there was "no violation of law."
But the whistleblowers have repeatedly stressed that their grievances involve mismanagement and violations of regulations - which don't fall under criminal law.
Nine FDA medical device reviewers alleged in 2008 that agency management overruled their opinions without supporting evidence and tried to intimidate them when they went public with their concerns.
At issue are CT scanners, MRI machines and other medical devices that use radiation to detect or treat diseases. Many of the devices allow lifelike pictures of the human anatomy, but carry a higher risk from radiation than older scans such as X-rays.
In recent years, hundreds of radiation overdoses have been reported with imaging devices used by hospitals across the country. The whistleblowers say these problems underscore the concerns they raised about such devices.
The new probe comes after prodding from lawmakers and nonprofit watchdog groups, including the Project for Government Oversight. In a letter to the inspector general Tuesday, the group calls the previous investigation a "sham."
"If these allegations are true, the FDA is failing in its primary mission of keeping people safe," said Danielle Brian, the group's executive director.
An agency spokeswoman said she could not immediately provide comment Tuesday.
Since the FDA whistleblowers went public with their concerns - in letters to Congress and the Obama administration in 2008 and 2009 - at least two scientists have been let go and another has quit after alleged intimidation.
Interviews with the staffers and internal e-mails obtained by The Associated Press provide new details of alleged mismanagement in the FDA's device division.
Central to the scientists' complaints is an FDA pathway to approval that allows speedy clearance if a device appears comparable to others already on the market.
Former FDA reviewer Dr. Gamal Akabani repeatedly recommended against clearing radiation-emitting devices used to treat cancer under the accelerated system, saying the devices needed to undergo actual testing to prove their safety and effectiveness. Between 2007 and 2008, Akabani said he was frequently pressured by supervisors to change his opinion, he said in an interview with The Associated Press.
In the final incident, Akabani's manager asked about the health of his wife, who has cancer, and his son, who was born severely handicapped. According to Akabani, the manager suggested his job - and health insurance for his family - would be safe as long as he cooperated with his supervisors.
"It shook me to the core because I realized that he was coercing me," said Akabani, who resigned from the FDA and currently teaches nuclear physics at Texas A&M University.
Akabani and other whistleblowers say a key problem at the agency is that managers - who have often spent decades in government - have far less expertise and up-to-date training than the medical reviewers they oversee. Akabani was recruited to the FDA after a decade in the radiology department at Duke University Medical Center.
The whistleblowers also point out that FDA managers are evaluated, in part, on their ability to get speedy reviews of devices, causing them to pressure and sometimes overrule scientists who slow down the process.
In another case of alleged retaliation, an Oxford-trained medical specialist's contract was not renewed after he repeatedly opposed approving a CT scanner for routine colon cancer screening. Dr. Julian Nicholas said that he objected to exposing otherwise healthy patients to the cancer risks of radiation. He says he was ridiculed by agency managers for "raising the bugaboo of radiation."
"They conspired against me because I refused to change my expert medical opinion to conform with their desired regulatory outcome," Nicholas wrote in an e-mail to FDA Commissioner Margaret Hamburg after his termination late last year.
Both Akabani and Nicholas say they were never contacted by the office of inspector general, which they say makes the inspectors' original report flawed and incomplete.
The inspector general's office issued a memo to FDA leadership in February when it concluded there had been no criminal violations.
The whistleblowers complain that FDA officials have used the four-page memo to try to dissuade members of Congress from looking into their allegations.
Robert Smith, a former radiology division reviewer who left the agency in July, said FDA leadership assured the whistleblowers that the investigation would be comprehensive.
"It was the FDA's responsibility to make sure the investigation they requested was properly conducted and reported," Smith said, "And it was the responsibility of the inspector general to conduct a legitimate investigation - which they know they did not."
The lead inspector overseeing the matter told The Associated Press on Tuesday that the inquiry into the allegations, which were dismissed in February, is being revisited to look at manager misconduct.
"The original intent of the investigation was to look at criminal matters and our agents did that," said Gerald Roy, deputy inspector general for investigations in the Department of Health and Human Services. "But I point toward broader issues that really compelled me to take a second look at this and reopen it from an administrative perspective."
The HHS office of inspector general, which oversees the FDA, closed the case in February after finding there was "no violation of law."
But the whistleblowers have repeatedly stressed that their grievances involve mismanagement and violations of regulations - which don't fall under criminal law.
Nine FDA medical device reviewers alleged in 2008 that agency management overruled their opinions without supporting evidence and tried to intimidate them when they went public with their concerns.
At issue are CT scanners, MRI machines and other medical devices that use radiation to detect or treat diseases. Many of the devices allow lifelike pictures of the human anatomy, but carry a higher risk from radiation than older scans such as X-rays.
In recent years, hundreds of radiation overdoses have been reported with imaging devices used by hospitals across the country. The whistleblowers say these problems underscore the concerns they raised about such devices.
The new probe comes after prodding from lawmakers and nonprofit watchdog groups, including the Project for Government Oversight. In a letter to the inspector general Tuesday, the group calls the previous investigation a "sham."
"If these allegations are true, the FDA is failing in its primary mission of keeping people safe," said Danielle Brian, the group's executive director.
An agency spokeswoman said she could not immediately provide comment Tuesday.
Since the FDA whistleblowers went public with their concerns - in letters to Congress and the Obama administration in 2008 and 2009 - at least two scientists have been let go and another has quit after alleged intimidation.
Interviews with the staffers and internal e-mails obtained by The Associated Press provide new details of alleged mismanagement in the FDA's device division.
Central to the scientists' complaints is an FDA pathway to approval that allows speedy clearance if a device appears comparable to others already on the market.
Former FDA reviewer Dr. Gamal Akabani repeatedly recommended against clearing radiation-emitting devices used to treat cancer under the accelerated system, saying the devices needed to undergo actual testing to prove their safety and effectiveness. Between 2007 and 2008, Akabani said he was frequently pressured by supervisors to change his opinion, he said in an interview with The Associated Press.
In the final incident, Akabani's manager asked about the health of his wife, who has cancer, and his son, who was born severely handicapped. According to Akabani, the manager suggested his job - and health insurance for his family - would be safe as long as he cooperated with his supervisors.
"It shook me to the core because I realized that he was coercing me," said Akabani, who resigned from the FDA and currently teaches nuclear physics at Texas A&M University.
Akabani and other whistleblowers say a key problem at the agency is that managers - who have often spent decades in government - have far less expertise and up-to-date training than the medical reviewers they oversee. Akabani was recruited to the FDA after a decade in the radiology department at Duke University Medical Center.
The whistleblowers also point out that FDA managers are evaluated, in part, on their ability to get speedy reviews of devices, causing them to pressure and sometimes overrule scientists who slow down the process.
In another case of alleged retaliation, an Oxford-trained medical specialist's contract was not renewed after he repeatedly opposed approving a CT scanner for routine colon cancer screening. Dr. Julian Nicholas said that he objected to exposing otherwise healthy patients to the cancer risks of radiation. He says he was ridiculed by agency managers for "raising the bugaboo of radiation."
"They conspired against me because I refused to change my expert medical opinion to conform with their desired regulatory outcome," Nicholas wrote in an e-mail to FDA Commissioner Margaret Hamburg after his termination late last year.
Both Akabani and Nicholas say they were never contacted by the office of inspector general, which they say makes the inspectors' original report flawed and incomplete.
The inspector general's office issued a memo to FDA leadership in February when it concluded there had been no criminal violations.
The whistleblowers complain that FDA officials have used the four-page memo to try to dissuade members of Congress from looking into their allegations.
Robert Smith, a former radiology division reviewer who left the agency in July, said FDA leadership assured the whistleblowers that the investigation would be comprehensive.
"It was the FDA's responsibility to make sure the investigation they requested was properly conducted and reported," Smith said, "And it was the responsibility of the inspector general to conduct a legitimate investigation - which they know they did not."
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