Hitachi wins FDA nod for proton beam therapy real time image gating system

Hitachi (NYSE:HIT) said this week it won FDA 510(k) clearance for its Real Time Image Gating System designed for use with its proton beam therapy systems. Real Time Image Gating Proton Beam Therapy is designed to track and irradiate tumors in motion, using a 2mm diameter gold marker close to the tumor to establish its location as a reference via computed tomography. A dual-axis, orthogonal X-ray system is then used with pattern recognition software to identify the spatial location of the marker, and irradiation during treatment is performed only when the gold marker moves to within millimeters of the planned irradiation location. Development of the technology was sponsored in part by a grant from the Funding Program for World-Leading Innovative R&D on Science and Technology in 2010, sponsored by the Japanese Government. The grant was awarded to a joint project between Hitachi and Hokkaido University. Hitachi won clearance for the RGPT technology from Japan’s Pharmaceuticals Medical Device Administration in 2014. “Hokkaido University has been developing motion tracking technology in the field of X-ray therapy. By combining this technology with Spot Scanning technology, the accurate irradiation of tumors, including those attached to large organs in motion which are difficult to irradiate with X-rays, will be possible and will lead to greater adaptation. I am very pleased that this innovation for highly precise irradiation will become broadly available around the wor...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Food & Drug Administration (FDA) Oncology Regulatory/Compliance Hitachi Source Type: news

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ConclusionsIn approximately 90% of patients, bony fusion is accomplished one year after ACDF. As there is no generally accepted definition of bony fusion, different measuring techniques cannot be compared to a gold standard and it is impossible to determine the most accurate method. Variations in study design hamper conclusions on optimising the rate of bony fusion by choice of material and/or additives. Insufficient attention is paid to correlation between bony fusion and clinical outcome.Graphical abstractThese slides can be retrieved from electronic supplementary material.
Source: European Spine Journal - Category: Orthopaedics Source Type: research
AbstractThe management of distal radius fractures needs to be adapted to the increasingly complex traumas in patients with greater functional requirements. The goal remains to restore normal anatomy in order to preserve function. A pre-operative assessment using x-rays and thin-slice CT scans with three-dimensional reconstructions enables the best possible understanding of the fracture prior to surgery and planning of the pre-operative strategy. Arthroscopy is a technique that allows visualisation of the bone fragments and their displacement, as well as their reduction. It is the only tool that allows diagnostic and progno...
Source: European Journal of Orthopaedic Surgery and Traumatology - Category: Orthopaedics Source Type: research
Uncertainty abounds when managing digital health regulatory uncertainty regarding the FDA and other international regulatory bodies. For this discussion we'll divide uncertainty into two categories, uncertainty due to a lack of knowledge about the potential regulations on the part of manufacturers and uncertainty about just what various regulatory agencies are doing - or going to do - about new and innovative products that meet the definition of a medical device. What is a Medical Device? Let's start with the first category; there is an astounding amount of misinformation and just plain wrong-headedness on the part of many...
Source: Medical Connectivity Consulting - Category: Information Technology Authors: Tags: Regulatory Bibliography Standards & Regulatory Source Type: blogs
Computed tomography (CT) data used for patient radiotherapy planning can nowadays be used to create 3D-printed boluses. Nevertheless, this methodology requires a second CT scan and planning process when immobi...
Source: Radiation Oncology - Category: Cancer & Oncology Authors: Tags: Research Source Type: research
Conclusions: The results demonstrated that PLC injuries are frequently misdiagnosed. Correlations between certain radiological parameters associated with PLC injuries can be useful indicators of the presence of such injuries requiring surgery. PMID: 30326695 [PubMed - as supplied by publisher]
Source: Asian Spine Journal - Category: Orthopaedics Tags: Asian Spine J Source Type: research
Computed tomography, or CT scanning, is one of the most powerful diagnostic tools to emerge during my medical career. Just look at the detail in the brain images above, taken at 90-degree angles through the brain. And I was there at the beginning. I remember well when I was a medical student taking neurology, and the first CT scanner arrived at the Mayo Clinic. By today’s standards, it was incredibly crude. It displayed a tiny image on a cathode ray tube that was then photographed with a Polaroid camera. Preservative lacquer was then smeared on the photograph and it was pasted into the patient’s chart with glue...
Source: Kevin, M.D. - Medical Weblog - Category: General Medicine Authors: Tags: Conditions Neurology Pediatrics Radiology Source Type: blogs
If self-care steps for back pain such as gentle activity, local heat, or massage don’t ease discomfort within a few weeks to a month, or if you struggle with chronic low back pain, a physiatrist can help you navigate the dizzying number of treatment options. These range from conservative therapies (such as medicines, physical therapy, and chiropractic care) to more invasive options (such as spine injections and spinal surgery). What is a physiatrist? Physiatrists are medical doctors who specialize in physical medicine and rehabilitation. We focus on holistic, nonsurgical care aimed at improving function for people wh...
Source: Harvard Health Blog - Category: Consumer Health News Authors: Tags: Back Pain Bones and joints Health Pain Management Source Type: blogs
ConclusionsCFR-PEEK plates provide a viable alternative to conventional titanium plates in PHFs, ensuring similar clinical outcomes and a lower rate of tuberosity resorption, but they involve higher stress shielding under the plate.
Source: Musculoskeletal Surgery - Category: Orthopaedics Source Type: research
Publication date: Available online 20 September 2018Source: Journal of Cranio-Maxillofacial SurgeryAuthor(s): Yi Sun, Lei Tian, Heinz-Theo Luebbers, Constantinus PolitisAbstractBilateral sagittal split ramus osteotomy (BSSO) surgery is used to correct various dento-skeletal deformities. Clinical outcomes are critically dependent on accurate and proper positioning of skeletal units created by BSSO. Monitoring skeletal changes postoperatively is a major part of follow-up. Between January 2015 and December 2015, 24 patients underwent BSSO surgery without any other segmental osteotomy (mean age, 29.9 ± 14.2 [range, 17&n...
Source: Journal of Cranio Maxillofacial Surgery - Category: ENT & OMF Source Type: research
Five years ago, Dawnia, who lives in Texas, was diagnosed with stage II kidney cancer at age 50. During a routine visit at her gynecologist ’s office, the nurse practitioner was alarmed when she learned that Dawnia’s mother was recently diagnosed with kidney cancer. The nurse urged her to get an ultrasound which showed a 9×9 tumor. Dawnia credits her nurse practitioner’s suggestion of getting an ultrasound with saving her life. S he has remained cancer-free following her nephrectomy. No chemotherapy or radiation was required. Dawnia had chest x-rays and abdominal CT scans every three to six months f...
Source: Kidney Cancer Association - Category: Urology & Nephrology Source Type: news
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