News

FDA approves M2 Compact MRI (Aspect Imaging) for wrist Imaging

The FDA has cleared the M2 Compact MRI system, from Aspect Imaging, for diagnostic Imaging of the wrist. Unlike conventional high field MRI systems, the M2 Compact Wrist System does not require a shielded room, cryogens, or high capacity electrical power. The system features an innovative 1 Tesla, self-shielded, permanent magnet operating in a quiet manner. As a result, the ...

FDA approves FibroScan Elastography Imaging system(Echosens) for non-invasive liver disease diagnosis

The FibroScan device from Echosens has received 510(k) clearance from the FDA for use in non-invasive liver disease diagnosis. Based on a technology called Transient Elastography, FibroScan assesses liver shear wave speed and equivalent stiffness in a rapid, simple, non-invasive and totally painless way. Initially introduced in the European market in 2003, it has received market clearances in China, Canada, ...

FDA approves AdreView (GE HealthCare) for gamma scintigraphic assessment of Heart Failure

The FDA has on 22 March 2013, approved an extension to the indication of AdreView (Iobenguane I 123 Injection) from GE HealthCare for the scintigraphic assessment of Myocardial Sympathetic Innervation (cardiac nerve activity) to assist in the evaluation of patients with New York Heart Association (NYHA) Class II or Class III Heart Failure and Left Ventricular Ejection Fraction (LVEF) ...

FDA approves Dotarem (Guerbet SA) for MRI Imaging

The FDA has on 20 March 2013 approved Dotarem (gadoterate meglumine) from Guerbet SA, for use in Magnetic Resonance Imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.

Dotarem is the only macrocyclic and ionic gadolinium-based contrast agent (GBCA) for the intravenous use with magnetic resonance imaging (MRI) in the brain (intracranial), spine ...

FDA approves Lymphoseek (Navidea Biopharma) for intraoperative Lymphatic Mapping

The FDA has approved on 13 March 2013, Lymphoseek (technetium Tc 99m tilmanocept) Injection, from Navidea Biopharmaceuticals , a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with Breast Cancer or Melanoma who are undergoing surgery to remove tumor-draining lymph nodes.

Lymphoseek is an imaging drug that helps locate lymph nodes; it is not ...

IQWiG finds no clear benefit of using PET/CT for patients with Bone or Soft Tissue Tumours

The German Institute for Quality and Efficiency in Health Care (IQWiG) has found no robust conclusions as to the benefits of using PET alone or in combination with CT for patients with Bone and Soft Tissue Tumours. IQWiG searched the international literature for studies that had examined the consequences of a diagnostic intervention using PET or PET/CT on health aspects ...

FDA gives 510(k) approval for the MicroDose SI SPECT imaging system (Philips)

The FDA has given 510(k) clearance for the MicroDose SI system, from Philips, which is a full-field digital mammography (FFDM) system with the capability to enable future Single-Shot Spectral Imaging applications. The MicroDose SI uses digital photon-counting technology, which enables clinicians to conduct exams using low radiation dose without compromising image quality. The technology allows clinicians to see more than ...

FDA committee recommends approval of Dotarem (Guerbet SA) as MRI contrast agent

The Medical Imaging Drugs Advisory Committee to the FDA has voted unanimously to recommend approval of the New Drug Application (NDA) for Dotarem (gadoterate meglumine), from Guerbet SA, for adults, and for pediatric use for children two years of age and older in MRI Imaging. The Committee voted 10 to 6 (with one member abstaining) not to recommend at this ...

FDA approves Verity Extremity Scanner (Planmed) for X Ray Imaging

The FDA has issued 510(k) approval for the Planmed Verity Extremity Scanner. Planmed's Verity system is intended to be used for X Ray computed tomography of anatomies within upper and lower extremities. It utilizes CBCT (Cone Beam Computed Tomography) technology to provide high resolution volumetric 3D images of the extremities at a particularly low dose. Unlike any other 3D imaging ...

FDA approves Edge Radiosurgery Suite (Varian Medical Systems) for Radiation Therapy

The FDA has given 510(k) clearance for Varian Medical System's Edge Radiosurgery Suite, a new dedicated system for performing advanced Radiation Therapy using new real-time tumor tracking and motion management technologies. The system includes an integrated six degrees of freedom couch that provides the accuracy, precision, and flexibility needed to position patients. It also allows expanded use of fluoroscopy and ...

European Commission approves Amyvid (li Lilly) for Alzheimers disease investigations

Eli Lilly and Company and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly, announced that Amyvid (Florbetapir F 18 Injection) has received marketing authorization from the European Commission as a diagnostic radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of beta-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's ...

3-D X-ray mammography using Hologics Inc system improves diagnosis of Breast Cancer

A new study found that the addition of three dimensional (3D) mammography (breast tomosynthesis) screening technology, from Hologic inc, to a 2D breast screening exam significantly increased Breast Cancer detection while reducing the number of false positives. The researchers using Hologic's 3D mammography technology in combination with a 2D mammogram found a significant increase in cancer detection rates, particularly for ...

NICE recommends Exogen (Bioventus) for treatment of long bone fractures

NICE has issued guidance on the use of Exogen, an ultrasound bone healing system from Smith & Nephew/Bioventus LLC, that benefits patients and the NHS when used for treating long bone fractures (bone fractures that have failed to heal after nine months). But NICE added that the case for adopting the device routinely for long bone fractures with delayed ...

Navidea Biopharma files Lymphoseek at EMA for Intraoperative Lymphatic Mapping

Navidea Biopharmaceuticals, Inc. a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, has announced that it has submitted a Marketing Authorization Application for its investigational radiopharmaceutical Lymphoseek (technetium Tc 99m tilmanocept) injection, a novel intraoperative lymphatic mapping agent, to the European Medicines Agency. Lymphoseek is used in intraoperative lymphatic mapping , a surgical oncology procedure used primarily in patients with ...

EU award CE mark approval to ExAblate Neuro System (InsighTec) for treatment of neurological disorders in the brain

The EU has awarded the ExAblate Neuro System, from InsighTec, the European CE mark for the treatment of neurological disorders in the brain including essential tremor, Parkinson's disease and neuropathic pain. InSightec recently received its second ExAblate FDA approval for the treatment of painful bone metastases in patients who are unable or unwilling to undergo radiation. This is in addition ...

FDA give 510(k) approval for NeuViz 64 CT Imaging System (Neusoft Medical)

The NeuViz 64 multi-slice CT scanner (Neusoft Medical) has received FDA 510(k) clearance. The NeuViz 64 design delivers low-dose scanning, high patient throughput, and performs advanced Cardiac Imaging along with a wide variety of clinically-relevant post processing and diagnostic techniques. Neusoft Medical is based in Shenyang, China. In 2004, Neusoft Medical Systems signed a joint venture with Philips (Netherlands) to ...

FDA approves 3D X- Ray for Breast Cancer

The FDA has approved the Selenia Dimensions System,from Hologic Inc., the first X-ray mammography device that provides three-dimensional (3-D) images of the breast for breast cancer screening and diagnosis. A mammogram is a safe, low-dose X-ray of the breast that is the best tool for early detection of breast cancer. However, with the limitations of conventional two-dimensional (2-D) imaging, about ...

FDA approve ExAblate (InsighTec) to treat Pain from Bone Metastases

The FDA has approved ExAblate MRI-guided focused ultrasound, from InsighTec, as a therapy to treat Pain from bone metastases in patients who do not respond or cannot undergo radiation treatment for their pain. The ExAblate system integrates magnetic resonance imaging and high intensity focused ultrasound. FDA approval was based on the results of an international, multi-center, randomized clinical study comparing ...

CHMP recommends Amyvid (Eli Lilly) for Alzheimers investigations

The Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Amyvid (florbetapir 18F) from Eli Lilly, as a diagnostic agent in patients who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive decline. Amyvid is a radiopharmaceutical agent used in positron emission tomography (PET) imaging in the brains of adults. It can ...

FDA approves somo-v Automated Breast Ultra Sound System for dense breast imaging

The FDA on 18 September 2012 approved the somo-v Automated Breast Ultrasound System (ABUS) from U-Systems Inc., which is the first ultrasound device for use in combination with a standard mammography in women with dense breast tissue who have a negative mammogram and no symptoms of breast cancer.

Dense breasts have a high amount of connective and glandular tissue ...

RepliGen withdraws application at EMA for SecreFlo an agent for Pancreatic Imaging

EMA has been advised by RepliGen of its decision to withdraw its application for SecreFlo (synthetic secretin human) as an agent for magnetic resonance imaging to improve the detection of pancreatic duct abnormalities in patients with pancreatitis....

F-18 PET helps predict disease-free survival for Breast Cancer patients

A new study shows that disease-free survival for invasive ductal Breast Cancer (IDC) patients may be easier to predict with the help of F-18-fludeoxyglucose positron emission tomography (PET)/computed tomography (CT) scans. Data show that high maximum standard uptake value (SUVmax) of F-18-FDG in the lymph nodes prior to treatment could be an independent indicator of disease recurrence. Researchers followed 65 ...

Aquilion CT scanner (Toshiba) accurately assess coronary blockages

The Toshiba Aquilion 320-detector computed tomography (CT) scanner can accurately sort out which people with chest pain need or don't need an invasive procedure such as cardiac angioplasty or bypass surgery to restore blood flow to the heart, according to an international study. The CORE 320 study is the first prospective, multicenter study to examine the diagnostic accuracy of high ...

Ecopipam (Psyadon Pharmaceuticals) success in Phase II study for Tourette Syndrome

Psyadon Pharmaceuticals, Inc. announced that its Phase II study of ecopipam in patients with Tourette Syndrome was stopped early when a planned interim analysis revealed a statistically significant reduction in the severity of the patients' tic symptoms. This decision was supported by both the independent Drug Safety and Monitoring Committee overseeing the study and by the external Research Committee established ...

FDA approve Magnatom Spectra 3T MRI imaging system (Siemens)

The FDA has approved the Magnetom Spectra 3 Tesla MRI system, from Siemens. The new system employs Tim (Total imaging matrix) 4G technology – Siemens' latest coil generation that provides improved imaging accuracy and flexibility. The array structure allows for high spatial and temporal resolution, which, along with a high-signal-to-noise ratio, enables Tim 4G to deliver improved image quality. The ...

FDA issues Complete Response Letter for RG 1068 (Repligen) for Pancreatic MRI Imaging

Repligen Corporation has announced that it has received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for RG1068 (synthetic human secretin). RG1068 was evaluated in a Phase III study to improve detection of pancreatic duct abnormalities in combination with MRI in patients with known or suspected pancreatitis. The CRL indicates that the FDA has ...

Stereotactic ablative radiotherapy effective in elderly patients with NSCLC

A new study shows that stereotactic ablative radiotherapy (SABR) with devices such as the CyberKnife VSI System, from Accuray, has become an option of treatment for many elderly patients with stage I Non-Small Cell Lung Cancer who would otherwise be left untreated. Standard techniques including surgery and conventional radiotherapy, are considered too risky and might compromise their quality of life. ...

FDA approves the Somatom Perspective (Siemens) CT Scanner

The FDA has cleared the Somatom Perspective, a 128-slice computed tomography (CT) scanner, from Siemens. It is designed especially for community hospitals, critical access hospitals and outpatient centers, offering the ability to extend the range of available examinations at reduced radiation dose at lower costs. The device uses Fully Assisting Scanner Technologies to help simplify and automate time-consuming, complex procedures, ...

Cardinal Health to distribute Amyvid diagnostic imaging agent for Alzheimer's Disease

Cardinal Health will manufacture and distribute Amyvid (florbetapir F18) the new diagnostic imaging agent from Eli Lilly and Company that aids in the evaluation of adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease and other causes of cognitive decline. The commercial launch of Amyvid is scheduled for June 1, 2012....

MRI-Guided Radiation Therapy System (ViewRay) for Cancer treatment receives FDA 510(k) approval

The MRI-Guided Radiation Therapy System, from ViewRay, has received US FDA 510(k) premarket notification clearance. The system features a combination of radiotherapy delivery and simultaneous magnetic resonance imaging (MRI) for the treatment of cancer and is designed to capture soft-tissue images continuously during treatment, so that clinicians are able to see where the actual radiation dose is being delivered and ...

FDA approves ProUroScan (ProUroCare Medical) for elasticity imaging of the prostate

The FDA has given 510(k) approval for the ProUroScan prostate mechanical imaging (PMI) system, from ProUroCare Medical. ProUroScan is an advanced medical elasticity imaging system that uses an array of ultrasonic sensors mounted on a rectal probe, a central processing unit and software and image construction algorithms to provide a real time color image of abnormalities in the prostate. It ...

ACUSON SC 2000 ultrasound system (Siemens) is launched

A new study shows that automated breast volume sonography (ABVS), or 3D ultrasound, significant improves detection of Breast Cancer compared to hand-held ultrasound. This study on 212 patients revealed that 3D Ultrasound agreed with the hand-held ultrasound system in spotting 15 suspicious lesions, but also uncovered 12 additional suspicious lesions and excluded 3 suspicious lesions. A five-year retrospective study on ...

Cyberknife VSI system (Accuray) used in Stereotactic Radiosurgery

The Cyberknife VSI system, from Accuray Inc., has been utilised in a new treatment method, stereotactic body radiotherapy (SBRT), which offers a more effective way to treat gynecologic cancers, shortening radiation treatment time from five weeks to three days. Unlike traditional radiation therapy, SBRT uses focused radiation beams and targets well-defined tumors. In order to focus in on the region, ...

Florbetaben Imaging Tracer is sold by Bayer to Piramel Imaging SA

Bayer HealthCare has sold its molecular imaging business including world rights of florbetaben to Piramal Imaging SA a subsidiary of Indian company Piramal Health Care. Florbetaben is currently in development for the detection of beta-amyloid plaques in the brain, which are one of two pathological hallmarks of Alzheimer's Disease,...

18F Flutemetamol (GE HealthCare) success in Phase III PET scan for Beta Amyloid

GE Healthcare has announced the preliminary results of two Phase III studies of its investigational PET amyloid imaging agent, [(18)F]flutemetamol, where both studies met their primary endpoints. One study, in terminally ill patients who agreed to undergo brain autopsy, showed strong concordance between flutemetamol PET images and Alzheimer's disease-associated beta amyloid brain pathology. The other study, in young healthy volunteers ...

FDA approves Amyvid (Eli Lilly) for beta-amyloid detection

The FDA has approved Amyvid (florbetapir F18)from Eli Lilly and its subsidiary Avid Radiopharmaceuticals. Amyvid is a radioactive diagnostic agent indicated for brain imaging of beta-amyloid plaques in patients with cognitive impairment who are being evaluated for Alzheimer's Disease and other causes of cognitive decline. Amyvid binds to amyloid plaques, a hallmark characteristic of Alzheimer's Disease and is detected using ...

RenalGuard (PLC Medical Systems) trial in Contrast Induced Nephropathy

Results from a new clinical trial of RenalGuard from PLC Medical Systems conducted in Italy -- the first to follow longer-term outcomes -- were presented at the annual conference of the American College of Cardiology (ACC.12), March 24 - 27, 2012, Chicago, Illinois. These results showed that RenalGuard is superior to two alternative methods at reducing rates of mortality, in-hospital ...

SIR-Spheres Microspheres (Sirtex) improves survival for patients with inoperable Liver Tumours

A multi-centre study performed to date using radioembolisation report a significantly prolonged survival benefit following SIR-Spheres microspheres in patients with treatment-refractory Liver tumours from Colorectal and other Cancers. Among the 251 patients with Colorectal Liver metastases, median survival in the 220 patients treated with SIR-Spheres microspheres was 11.6 months, compared to only 6.6 months for the 31 patients who received ...

FDA approves Progesterone Receptor 1E2 Image Analysis System (Ventana Medical Systems) for Breast Cancer

The FDA has given 510(k) approval for the Ventana Companion Algorithm Progesterone Receptor (PR) (1E2) image analysis application used with the Ventana iScan Coreo Au scanner running VIRTUOSO software, from Ventana Medical Systems, for use in diagnosing Breast Cancer. The PR (1E2) image analysis algorithm assists pathologists in the detection and semi-quantitative measurement of PR expression in formalin-fixed, paraffin-embedded normal ...

Lorqess is filed at EU by Arena Pharma for weight loss

Arena Pharma has filed at the EU its selective serotonin 2C receptor agonist, Lorqess (lorcaserin)for use in weight loss and maintenance of weight loss in patients who are obese (BMI>30) or who are overweight (BMI>27) and have at least one weight-related comorbid condition. The rights in the USA are held by Eisai and outside the EU the rights are held ...

Koning Breast CT System secures CE Mark Approval

Koning Corporation have announced that they have obtained CE mark approval for their Koning Breast CT (KBCT) system. KBCT is the first commercially available, fully-integrated, dedicated breast CT scanner designed specifically to image the entire breast with high spatial and contrast resolution at a radiation dose similar to or less than diagnostic mammography. The system acquires a set of images ...

Cyberknife (Accuray Inc) relieves pain of Trigeminal Neuralgia facial nerve condition

Cyberknife, the Intensity Modulated RadioTherapy system from Accuray Inc, can relieve the stabbing pain of the facial nerve condition Trigeminal Neuralgia. Researchers treated 17 patients with Trigeminal Neuralgia with Cyberknife radiosurgery between 2007 and 2009. The patients, who were aged between 36 and 90, had had their symptoms for between one and 11 years and had not responded to the ...

Brachytherapy associated with twofold increased risk for Mastectomy

Compared with women treated with whole-breast irradiation, those treated with brachytherapy experienced a twofold increased risk for losing their breasts, according to results at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium. The study evaluated the Medicare claims of all U.S. female beneficiaries (n=130,535) aged older than 66 years diagnosed with incident-invasive Breast Cancer between 2000 and 2007. Patients were ...

FDA approves Ingenuity PET/MRI (Philips) combined scanning system

Philips has received FDA clearance for the Ingenuity TF PET/MR, a whole body positron emission tomography/magnetic resonance (PET/MR) imaging system. It can perform both standalone MR and hybrid PET/MR studies. To facilitate this, the scanner gantries are lined up with each other, and during hybrid scans, the patient rotates between each modality for scanning. Combining PET and MRI helps to ...

FDA approves MelaFind (Mela Sciences) for spotting Skin Lesions and Melanoma

The US FDA has approved the pre-market approval (PMA) application for the MelaFind Lesion Imaging System, from Mela Sciences. The MelaFind system provides doctors with information about pigmented Skin Lesions to help them decide which Lesions to biopsy in order to detect Melanoma as early as possible. Detection of early Melanoma and conducting prompt treatment is essential to improving patient ...

C-11 choline PET/CT offers benefits for Prostate Cancer patients

Three studies highlight the role that C-11 choline positron emission tomography/computerized tomography (PET/CT) scans can play in cancer staging and as a potential therapeutic tool for patients with recurrent Prostate Cancer. The first of the three, released during a meeting of the American Urological Association, reveals that C-11 choline PET/CT scans can play a role as a staging tool instead ...

Z.One elastography imaging helps determine treatment for Crohn's Disease

A new study shows that the Z.One ultrasound elasticity imaging (elastography) system, from Zonare, can be used to tell whether a patient with Crohn's disease has intestinal fibrosis, which requires surgery, or inflammation, which can be treated with medicine. It suggests that elastography allows doctors to make the distinction between inflammation and fibrosis non-invasively, allowing patients to receive more appropriate ...

COX-2 targeted PET imaging agent offers view of Inflammation

Novel imaging agents derived from inhibitors of the enzyme cyclooxygenase-2 (COX-2), could make it possible to "see" inflammation due to Osteoarthritis or tumors in their earliest stages. COX-2 is an attractive target for molecular imaging. It's not found in most normal tissues, and then it is "turned on" in inflammatory lesions where it can be made detectable with positron emission ...

FDA approves Mobilett Mira mobile X-ray unit

The FDA announced that the Mobilett Mira, a portable digital X-ray system from Siemens, has received 510(k) approval. The Mira’s wireless capability makes examination of patients with limited mobility, such as those in intensive care, far easier and the machines unique rotating swivel arm helps increase ease of use. With its wireless connection, it is the first mobile X-ray system ...

Hologic presents its MammoSite ML for Radiation Therapy

Hologic featured its next-generation MammoSite ML (multi-lumen) radiation therapy system at the American Society of Radiation Oncology (ASTRO) meeting. By employing the MammoSite system, the radiation oncologist can deliver targeted radiation therapy directly to the area where cancer is most likely to recur, allowing a full course of radiation to be delivered in just five days. Additionally, targeted therapy of ...

Lower Contrast Agent Dose Feasible In 320 Row CT Angiography

An analysis of 180 computerised tomography angiography studies done using a 320-detector row CT scanner reveals that a contrast media protocol based on 60 milliliters of Isovue (iopamidol injection), from Bracco, provided sufficient enhancement in more than 96% of coronary segments. With many studies using a higher iodine load comparable or equal to 80 milliliters of Isovue, the ability to ...

MR-guided Focused Ultrasound promising for treatment of Essential Tremor

Preliminary results of a Phase I trial of InsighTec's ExAblate System indicate that MR-guided Focused Ultrasound has the potential to safely and effectively control Essential Tremor (ET). The results, presented at the 2011 Congress of Neurological Surgeons, reveal that the study’s first 10 patients showed a 78 percent improvement in contralateral tremor scores in the hand, as assessed with the ...

FDA supplies approval letter for MelaFind Melanoma imaging system

The FDA has issued an approval letter for the MelaFind Lesion Imaging System Pre-Market Approval application. MelaFind, from MELA Sciences, is a non-invasive multi-spectral computer imaging system intended for use on clinically atypical pigmented skin lesions with one or more characteristics consistent with Melanoma. The studies used to support the PMA application was a 1,383 patient US trial and the ...

SWIFT MRI assists detection of Oral Cancer

Research suggests that a magnetic resonance imaging (MRI) technique called SWIFT (sweep imaging with Fourier transform), developed by Agilent Technologies, appears to provide an enhanced three-dimensional assessment that may aid in detecting the spread of Oral Cancer in the jawbone. Detecting bone invasion prior to surgery is often difficult using currently available imaging techniques, but SWIFT offers delineated assessment of ...