Top Stories
Storm brews over VA security breach
As you are likely well aware, the personal information of 26.5 million U.S. veterans, and some 2.2 million active-duty personnel in May was taken from Veterans Affairs after a laptop containing the information was stolen from the home of a data analyst working for the government organization. The employee had taken the computer home to do work, and it contained information such as names, Social Security numbers, birthdates, some phone number and addresses, and even some diagnostic codes for conditions. The theft puts Veterans at high risk for potential identify theft.
The news has obviously caused uproar in many sectors, and the VA did not do itself any favors by reportedly stalling in passing information regarding the theft to the FBI for several weeks. Plus, cleaning up the mess and helping veterans protect their identities will likely cost taxpayers big, with estimated possible costs running from $100 million to $500 million.
Heads within the VA have rolled as well. The agency’s Deputy Assistant Secretary Michael McLendon resigned his position in response to the growing controversy over his apparent delay in informing top VA officials or the FBI. Also, the data analyst who took the computer home was also let go. Also, Dennis Duffy the acting head of the division for which the data analyst worked has been placed on administrative leave.
Fuji gains ‘approvable letter’ for CR mammography
FUJIFILM Medical Systems USA is “one step closer” to getting its computed radiography mammography (FCRm) system to market in the U.S., having recently received an approvable letter from the FDA for what the company calls “the world’s leading full-field digital mammography system.” Fuji said the letter indicates that the FDA has completed its review of Fuji’s Pre-Market Approval (PMA) application and that it is approvable. Once approved, the Fuji unit would be the first CR mammography system available for sale in the U.S.
Fuji’s CR mammography system does not require replacing an existing mammography acquisition unit. Additionally, the FCRm reader will provide multi-purpose capability for both mammography and general radiography exams, delivering significant cost savings for sites that perform both exams.
GE looks to double compact ultrasound business
In a push that the company hopes will double its compact ultrasound business, GE Healthcare has introduced four new clinically specialized ultrasound systems for use in real-time imaging at the point-of-care. The new Compact Series has the power and imaging capabilities of a high-performance, 400-pound system in a laptop-size design, the company said.
The Compact Series builds upon GE’s Vivid i, a high-performance cardiovascular ultrasound system in a compact design. The series also includes the new Voluson i and LOGIQ i systems. Voluson i is designed for obstetrics and gynecology applications, while the LOGIQ i will serve the general imaging needs of radiology. GE’s “e” products focus on expanding ultrasound’s reach to new clinical areas. The new LOGIQ e is designed to support real-time clinical decisions in emergency and surgical settings, while the Vivid e is a dedicated cardiac ultrasound imaging system for the physician office in a practical, easy to use design.
Health IT use grows in hospitals, helps boost care
Health IT has the potential to offer considerable quality of care improvements such as improving clinical informatics, diagnosis, treatment, patient safety and decreasing inefficiencies, according to a new study from Mathematica commissioned by the Centers for Medicare & Medicaid Services (CMS).
Regarding quality:
Global wireless health IT to boom by 2010
Spending on mobile IT including hardware, software, and support services within healthcare is set to rise globally to $2.7 billion by 2010, according to Juniper Research.
Juniper sees the potential for wireless throughout healthcare elevating across the globe from $289 million last year to $1.51 billion by 2010. Also, wireless technology usage will likely reach 85 percent of primary healthcare professionals in North America, and 95 percent in some European sectors.
FDA aims to speed medical devices to market
The U.S. Food and Drug Administration (FDA) has launched its Medical Device Innovation Initiative to improve early interaction between the FDA and vendors to get devices approved more quickly. A new process will be instituted that, among other things, promotes scientific innovation, modernizes the review of innovative devices and improves clinical trials.
As part of this initiative, FDA has issued new guidelines to outline the use of adaptive clinical trial designs with hopes to create shorter, cheaper trials. The guidelines provide FDA’s recommendations on the use of Bayesian statistical methods in the design and analysis of medical device clinical trials. The use of Bayesian statistics offer the industry the option of using prior, legally available information about safety and/or effectiveness in a mathematically acceptable way to design more efficient, scientifically viable trials.
New Studies
Obese women at greater risk of breast cancer
Women who gain weight in adulthood face a higher lifetime risk of all types of breast cancer, according to a study in the July issue of the journal CANCER from the American Cancer Society. The risk is true even if the women do not take hormone replacement therapy after menopause.
The most extremely obese women were up to three times more likely to have regional or distant metastases than women with less weight gain. Women who gained over 60 pounds have nearly two times the likelihood of developing ductal type tumors and are more than 1.5 times more likely to have lobular type cancers. The risk for metastatic disease increased for all women who gained weight, with the risk greater than three-fold for women who gained over 60 pounds.
10-year interval for colonoscopy tests is optimal
A new study suggests that individuals who have gotten negative colonoscopy results have a decreased chance of developing the disease for up to 10 years following the exam, according to the results of a study published in the Journal of the American Medical Association. Cure rates for colorectal cancer — including the colon — are high when the disease is detected and treated early. This new study supports the recommendation to patients undergoing screening colonoscopy that a 10-year interval between screenings is optimal.
Ultrasound departments extend capabilities
Diagnostic ultrasound utilization in U.S. hospitals has risen significantly since 1998 at the nearly 5,000 general ultrasound or radiology departments that exist in the U.S., according to the IMV Medical Information Division.
“In 2005, an estimated 31.2 million patient exams were conduced in 4,720 general ultrasound or radiology departments in U.S. hospitals,” said Lorna Young, senior director, Market Research. “Diagnostic ultrasound utilization has grown steadily. For hospitals with 200+ beds, patient exams grew 41 percent from 13.1 million in 1998 to 18.5 million in 2005, for an annual growth rate of 5 percent per year.”
More information: www.imvlimited.com/mid
Patent News
UltraSPECT patents Single Photon Emission Imaging
UltraSPECT LTD has been granted a patent for “Efficient Single Photon Emission Imaging” (U.S. Patent no. 7,026,623). According to the patent, shorter scanning time and clinically diagnostic images may be obtained by resolution recovery reconstruction methods such as the UltraSPECT patented Wide Beam Reconstruction (WBR) technology. Scan time of cardiac perfusion and bone SPECT studies range between 15 and 30 minutes in a conventional dual-head gamma camera. Shortening the scan time is a desirable feature for very busy nuclear medicine clinics.
CardiArc receives patent for heart imaging system
CardiArc Inc. announced it has received additional Notices of Allowance from the U.S. Patent and Trademark Office for its ultra-compact CardiArc heart imaging system. The system was cleared for marketing by the FDA back in January.
Several of the most recent patent allowances are for a new technology called FOVea, which can be used with nearly any planar or SPECT nuclear medicine system to dramatically expand its field-of-view with only minimal modifications. Additionally, the company is considering application of the FOVea technology beyond the CardiArc heart system.
Kodak rolls out new DR image sensors
Eastman Kodak Co. has announced two new CCD sensors for digital radiography, as well as for applications in the scientific imaging markets.
The new KAF-16803 model offers a 20 percent increase in sensitivity, one-third less noise, and increased DQE.
New MRI breast biopsy device from Ethicon
Ethicon Endo-Surgery has released its new Mammotome MR, an MRI-guided breast biopsy device to help doctors accurately diagnose women who are at high risk for breast cancer and have lesions that cannot be accurately detected with mammography or ultrasound.
Elekta adds to Gamma Knife line
Elekta has introduced its Leksell Gamma Knife Perfexion, which can further refine and expand procedures in the brain, cervical spine and head and neck regions during stereotactic radiosurgery.
As you are likely well aware, the personal information of 26.5 million U.S. veterans, and some 2.2 million active-duty personnel in May was taken from Veterans Affairs after a laptop containing the information was stolen from the home of a data analyst working for the government organization. The employee had taken the computer home to do work, and it contained information such as names, Social Security numbers, birthdates, some phone number and addresses, and even some diagnostic codes for conditions. The theft puts Veterans at high risk for potential identify theft.
The news has obviously caused uproar in many sectors, and the VA did not do itself any favors by reportedly stalling in passing information regarding the theft to the FBI for several weeks. Plus, cleaning up the mess and helping veterans protect their identities will likely cost taxpayers big, with estimated possible costs running from $100 million to $500 million.
Heads within the VA have rolled as well. The agency’s Deputy Assistant Secretary Michael McLendon resigned his position in response to the growing controversy over his apparent delay in informing top VA officials or the FBI. Also, the data analyst who took the computer home was also let go. Also, Dennis Duffy the acting head of the division for which the data analyst worked has been placed on administrative leave.
Fuji gains ‘approvable letter’ for CR mammography
FUJIFILM Medical Systems USA is “one step closer” to getting its computed radiography mammography (FCRm) system to market in the U.S., having recently received an approvable letter from the FDA for what the company calls “the world’s leading full-field digital mammography system.” Fuji said the letter indicates that the FDA has completed its review of Fuji’s Pre-Market Approval (PMA) application and that it is approvable. Once approved, the Fuji unit would be the first CR mammography system available for sale in the U.S.
Fuji’s CR mammography system does not require replacing an existing mammography acquisition unit. Additionally, the FCRm reader will provide multi-purpose capability for both mammography and general radiography exams, delivering significant cost savings for sites that perform both exams.
GE looks to double compact ultrasound business
In a push that the company hopes will double its compact ultrasound business, GE Healthcare has introduced four new clinically specialized ultrasound systems for use in real-time imaging at the point-of-care. The new Compact Series has the power and imaging capabilities of a high-performance, 400-pound system in a laptop-size design, the company said.
The Compact Series builds upon GE’s Vivid i, a high-performance cardiovascular ultrasound system in a compact design. The series also includes the new Voluson i and LOGIQ i systems. Voluson i is designed for obstetrics and gynecology applications, while the LOGIQ i will serve the general imaging needs of radiology. GE’s “e” products focus on expanding ultrasound’s reach to new clinical areas. The new LOGIQ e is designed to support real-time clinical decisions in emergency and surgical settings, while the Vivid e is a dedicated cardiac ultrasound imaging system for the physician office in a practical, easy to use design.
Health IT use grows in hospitals, helps boost care
Health IT has the potential to offer considerable quality of care improvements such as improving clinical informatics, diagnosis, treatment, patient safety and decreasing inefficiencies, according to a new study from Mathematica commissioned by the Centers for Medicare & Medicaid Services (CMS).
Regarding quality:
- 71 percent of respondents viewed health IT as making care more timely
- 22 percent felt that technology reduced errors and boosted patient safety
- 10 percent felt there had been gains in communication.
- 88 percent use IT for electronic laboratory results
- 59 percent use electronic clinical notes systems
Global wireless health IT to boom by 2010
Spending on mobile IT including hardware, software, and support services within healthcare is set to rise globally to $2.7 billion by 2010, according to Juniper Research.
Juniper sees the potential for wireless throughout healthcare elevating across the globe from $289 million last year to $1.51 billion by 2010. Also, wireless technology usage will likely reach 85 percent of primary healthcare professionals in North America, and 95 percent in some European sectors.
FDA aims to speed medical devices to market
The U.S. Food and Drug Administration (FDA) has launched its Medical Device Innovation Initiative to improve early interaction between the FDA and vendors to get devices approved more quickly. A new process will be instituted that, among other things, promotes scientific innovation, modernizes the review of innovative devices and improves clinical trials.
As part of this initiative, FDA has issued new guidelines to outline the use of adaptive clinical trial designs with hopes to create shorter, cheaper trials. The guidelines provide FDA’s recommendations on the use of Bayesian statistical methods in the design and analysis of medical device clinical trials. The use of Bayesian statistics offer the industry the option of using prior, legally available information about safety and/or effectiveness in a mathematically acceptable way to design more efficient, scientifically viable trials.
New Studies
Obese women at greater risk of breast cancer
Women who gain weight in adulthood face a higher lifetime risk of all types of breast cancer, according to a study in the July issue of the journal CANCER from the American Cancer Society. The risk is true even if the women do not take hormone replacement therapy after menopause.
The most extremely obese women were up to three times more likely to have regional or distant metastases than women with less weight gain. Women who gained over 60 pounds have nearly two times the likelihood of developing ductal type tumors and are more than 1.5 times more likely to have lobular type cancers. The risk for metastatic disease increased for all women who gained weight, with the risk greater than three-fold for women who gained over 60 pounds.
10-year interval for colonoscopy tests is optimal
A new study suggests that individuals who have gotten negative colonoscopy results have a decreased chance of developing the disease for up to 10 years following the exam, according to the results of a study published in the Journal of the American Medical Association. Cure rates for colorectal cancer — including the colon — are high when the disease is detected and treated early. This new study supports the recommendation to patients undergoing screening colonoscopy that a 10-year interval between screenings is optimal.
Ultrasound departments extend capabilities
Diagnostic ultrasound utilization in U.S. hospitals has risen significantly since 1998 at the nearly 5,000 general ultrasound or radiology departments that exist in the U.S., according to the IMV Medical Information Division.
“In 2005, an estimated 31.2 million patient exams were conduced in 4,720 general ultrasound or radiology departments in U.S. hospitals,” said Lorna Young, senior director, Market Research. “Diagnostic ultrasound utilization has grown steadily. For hospitals with 200+ beds, patient exams grew 41 percent from 13.1 million in 1998 to 18.5 million in 2005, for an annual growth rate of 5 percent per year.”
More information: www.imvlimited.com/mid
Patent News
UltraSPECT patents Single Photon Emission Imaging
UltraSPECT LTD has been granted a patent for “Efficient Single Photon Emission Imaging” (U.S. Patent no. 7,026,623). According to the patent, shorter scanning time and clinically diagnostic images may be obtained by resolution recovery reconstruction methods such as the UltraSPECT patented Wide Beam Reconstruction (WBR) technology. Scan time of cardiac perfusion and bone SPECT studies range between 15 and 30 minutes in a conventional dual-head gamma camera. Shortening the scan time is a desirable feature for very busy nuclear medicine clinics.
CardiArc receives patent for heart imaging system
CardiArc Inc. announced it has received additional Notices of Allowance from the U.S. Patent and Trademark Office for its ultra-compact CardiArc heart imaging system. The system was cleared for marketing by the FDA back in January.
Several of the most recent patent allowances are for a new technology called FOVea, which can be used with nearly any planar or SPECT nuclear medicine system to dramatically expand its field-of-view with only minimal modifications. Additionally, the company is considering application of the FOVea technology beyond the CardiArc heart system.
Kodak rolls out new DR image sensors
Eastman Kodak Co. has announced two new CCD sensors for digital radiography, as well as for applications in the scientific imaging markets.
The new KAF-16803 model offers a 20 percent increase in sensitivity, one-third less noise, and increased DQE.
New MRI breast biopsy device from Ethicon
Ethicon Endo-Surgery has released its new Mammotome MR, an MRI-guided breast biopsy device to help doctors accurately diagnose women who are at high risk for breast cancer and have lesions that cannot be accurately detected with mammography or ultrasound.
Elekta adds to Gamma Knife line
Elekta has introduced its Leksell Gamma Knife Perfexion, which can further refine and expand procedures in the brain, cervical spine and head and neck regions during stereotactic radiosurgery.