by emma
13. October 2011 14:32
Canon has received FDA clearance for its CR-2 Plus Digital Non-Mydriatic Retinal camera for use in eye diagnostic imaging.
Tsuneo Imai, Senior Director and General Manager of the Medical Systems Division at Canon USA, said that the approval “brings Canon one step closer to improving eye exam efficiency and eventually leading to the early prevention and treatment of vision threatening diseases”.
The medical device features EOS camera technology using 18 megapixels with low-flash intensity, minimising pupil constriction while shortening the time required for taking multiple pictures.
The product’s use of Canon’s Retinal Imaging Control Software (RICS) allows images to be captured, processed and sent to be stored or printed.
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Tags: FDA, USA, US, Canon, eye camera, clearance, approval, CR 2 Plus Digital Non Mydriatic, retinal camera, imaging, diagnostic, diagnostic imaging, Tsuneo Imai, Senior Director, General Manager, Medical systems, Canon USA, eye exam, diseases, vision, medical device, medical technology, EOS camera, technology, megapixels, low flash intensity, pupil, multiple pictures, product, retinal imaging control software, RICS, images
Medtech News
by emma
28. September 2011 13:00
MedX Health’s skin imaging diagnostic systems, MoleMate and SIMSYS, have been granted FDA approval for sale in the US.
These non-invasive medical technologies use light to look beneath suspicious moles, creating accurate images to help physicians evaluate lesions, often eliminating the need for painful and expensive skin biopsies.
Steve Guillen, President and CEO of MedX Health, said: “The US market alone is estimated to be a $1 billion opportunity, and MoleMate and SIMSYS are the only FDA approved and patent protected siascopy products in this important health segment.”
MoleMate features a hand-held scanner designed for office use, providing images of the pigment, blood, and collagen below the mole or lesion.
SIMSYS allows image capture and storage as well as special features that can be used to compare moles. It will support ‘mole mapping’ in 2012, where the entire surface of the patient's skin is photographed to observe changes over time, so that suspicious moles can be monitored more closely.
Dr. R. H. Falcon, a dermatologist in New York, said: “I chose this technology because it gives me extra information about my patients’ suspicious moles and lesions through the additional views of the skin and helps me and the patients to come to a more informed decision about removal.”
Almost 13 million people in the US have a history of non-melanoma skin cancer, usually diagnosed as basal cell carcinoma or squamous cell carcinoma. The survival rate for patients whose melanoma is detected early is about 99%. This statistic falls to 15% for patients with advanced disease.
The MoleMate and SIMSYS medical technologies are already available in Australia, Europe and the UK.
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Tags: FDA, US, USA, approve, approval, non invasive, mole, lesion, scan, scanner, mole scanner, medical technologies, med tech, medtech, medical technology, suspicious moles, images, Steve Guillen, President, CEO, MedX Health, health, healthcare, market, US market, medtech market, med tech market, MoleMate, SIMSYS, Dr Falcon, technology, health technology, health technologies, health news, medical sales, health sales, Australia, Europe, UK, patients, patient care
Medtech News
by emma
27. September 2011 12:52
The FDA has approved Calgary Scientific’s medical imaging device, ResolutionMD Mobile, as a mobile diagnostic app for use in the US.
The new technology gives physicians remote access to patient images and reports stored within any healthcare facility, enabling clinical diagnosis of the patient from any location.
Dr James A. Brink, Professor and Chair of the Department of Diagnostic Radiology at Yale University School of Medicine, said: “The ability to view diagnostic quality images on mobile devices promises to speed healthcare delivery, particularly for urgent conditions or after hours.”
The mobile app promises complete security and advanced capabilities through minimal bandwidth, even on 3/4G wireless. The technology also ensures that patient image data cannot be lost or stolen, and no highly sensitive or confidential patient data is ever retained on the device.
Dr Byron Osing, CEO and Chair of Calgary Scientific, said: “Lost or stolen patient data is a critical issue in the medical IT sector, with regular announcements of significant HIPAA compliance fines being levied and legal settlements in the tens of millions of dollars.”
“The FDA clearance of the ResolutionMD solution is a key strategic step forward for the Medical IT sector in enabling a high performance and secure ‘mHealth’ paradigm, as well as ensuring that vast regions of the world that are currently dependent upon wireless connectivity can now leapfrog directly into the realm of advanced medical solutions," added Dr Osing.
Non-diagnostic versions of the app are already licensed under OEM agreements with global leaders in medical imaging and information technology.
The software has also been approved by Health Canada, has acquired the CE Mark for distribution in the EU, and is available on Apple iPhone and iPad devices.
Calgary Scientific is a provider of accessible, advanced visualisation solutions in medical imaging and web, mobility and collaboration enablement technologies, used to help industries achieve secure access with their existing technology.
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Tags: FDA, USA, US, patients, patient care, data, mobile app, app, application, mobile phone, iphone, ipad, Calgary Scientific, medical imaging device, medical devices, imaging, medical, medical technologies, medical technology, medtech, med tech, ResolutionMD Mobile, Resolution MD, diagnostic app, diagnostics, James Brink, radiology, Yale, medicine, physicians, doctors, remote access, patient images, healthcare, health, healthcare technology, health device, health news, images, mobile devices, security, mhealth, Byron Osing, 3G, 4G, wireless, wifi, internet, access, market, medical sales, Apple, Health Canada, CE Mark approval, approval, web, www, industry, sector, business, company, companies, medtech company, medtech companies
Medtech News
by emma
31. August 2011 21:11
A new imaging technique enables scientists to trace individual cancer cells as the growth of a tumour spreads through the brain.
Researchers at the Case Western Reserve University School of Medicine used cryo-imaging to look at a mouse model of glioblastoma multiforme, an aggressive cancer with no treatments to stop it spreading.
Susann M. Brady-Kalnay, Professor of Molecular Biology and Microbiology at the Case Western Reserve School of Medicine said: “We're able to see things we couldn't before, and we can use these images to understand how tumour cells invade and disperse”.
The cryoimaging system consisted of a fluorescence microscope, robotic imaging positioner, customized cryostat, PC-based control system, and visualization/analysis software. The technique alternates between sectioning and imaging, collecting colour brightfield and fluorescent blockface image volumes.
The scientists used a model that included four different cell lines of brain cancers at various stages of tumor development and dispersion. The cancer cells were modified with fluorescent markers and implanted in the model's brain.
Researchers found that two cell lines, a human brain cancer LN229, and a rodent cancer CNS-1, best resembled the actions of glioblastoma multiforme in human patients.
The ability to produce clear and detailed images will be invaluable when evaluating the potency of drugs and other therapies designed to block dispersal of glioblastoma multiforme cells.
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Tags: imaging, diagnostics, brain cancer, cell, tumour, researcher, Case Western Reserve, cancer cell, growth, glioblastoma multiforme, treatment, therapy, Susann Brady Kalnay, microbiology, cancer research, images, drugs, patients, medtech, medtechbusiness, medtech business, product news, innovation news
Medtech News