Fujifilm has unveiled an upgraded version of its FCR Go portable digital X-ray system. The FCR Go2 now has a more powerful X-ray source and a larger workstation more comparable in size to stationary units. Along with the same user-friendly features that led to the success of the FCR Go and provided high image quality and efficiency gains, Fujifilm’s FCR Go 2 is now equipped with a higher output X-ray generator to better accommodate imaging of dense areas. Abdomen and spine exams, for example, which are frequently performed with portable systems, as well as X-rays of bariatric patients, will now result in even sharper images. The new system features a full size, 15 inch image display and upgraded functionality at the onboard workstation. By having more of the same features available at the portable station that are accessible at the main radiology workstations, technologists and radiologists can preview a full size image at the patient bedside, using a familiar platform. Additionally, the FCR Go 2 features a smaller, lighter weight chassis design, coupled with an improved driving system that will provide greater ease of maneuverability during transport in tight corridors and imaging environments. Press release: Portable Digital Imaging System with upgraded capabilities: FCR Go 2…

Researchers at the Fraunhofer Institute for Production Technology IPT in Aachen have developed a laser-based suturing device purposed for minimally invasive surgery. The idea is based on the laser welding process that is commonly used for plastics. Here the suture material is one of the two pieces to be welded together, the other one is the sleeve, which is located in the tip of the device. The process, as described in the press release: First, the surgeons access the abdominal cavity through a small tube – the experts call it a trocar. After they pierce the tissue with a needle, they pull the end of the suture material out with the surgical forceps, through the trocar, and clip it into the sleeve. A defined tension can be set for the suture by pushing the sleeve through the trocar and simultaneously tensioning the suture. Once the desired tension has been achieved, the suture material is welded to the sleeve by laser. The laser is located at the end of the suturing instrument, the laser beam is sent via the light conducting fiber through the instrument. The superfluous suturing material is cut off behind the sleeve. And, as a last step, the surgeons pull the suturing instrument out through the trocar. After the lasering, the sleeve remains in the abdominal cavity. Schütte remarked: “Currently, the sleeve consists of polypropylene, in the future we would like to manufacture it from resorbing materials.“ The suturing is done with a previously set, predefined tension and should be faster than traditional suturing. So far testing has happened in the laboratory, where suture tensions of zero to five newtons and a lasering time of 0.1 seconds were reached. Preclinical studies are planned to start later this year. Press release: Minimally invasive surgeries: Laser Suturing……

Allergan (Irvine, CA) received FDA approval to expand the labeled use of their Lap-Band device to "adults with obesity who have failed more conservative weight reduction alternatives, such as diet and exercise and pharmacotherapy, and have a Body Mass Index (BMI) of 30-40 and at least one obesity related comorbid condition." The approval to expand the use of the LAP-BAND® Adjustable Gastric Banding System is based on a review of full 12-month data and available 24-month data from a prospective, single-arm, non-randomized, multi-center five year-study and the more than 17-year safety and effectiveness record of the LAP-BAND® System. Following approval, the patients in the trial will continue to be followed for a total of five years. In addition, there will be an analysis of the outcomes of patients with BMI of 30 to 40 recorded in the Bariatric Outcomes Longitudinal DatabaseSM (BOLDSM). Established in 2007 by the Surgical Review Corporation, BOLD is now the world’s largest and most comprehensive repository of clinical bariatric surgery patient information. The database currently contains more than 300,000 patients and 12,000 new patients are added monthly. The BOLD analysis will consist of examining the explant rates, adverse events, weight loss, and changes in the status of obesity related comorbid conditions observed in LAP-BAND® System patients over the course of 10 years. Product page: LAP-BAND… Press release: FDA Approves Expanded Use of LAP-BAND® Adjustable Gastric Banding System for Obese Adults… Flashback: Lap Band Surgery Less Likely to Leave Patients Headed Towards Diabetes…

Cyberonics out of Houston, Texas received FDA clearance for its AspireHC implantable vagus nerve stimulation (VNS) therapy device. The unit is cleared for patients with refractory epilepsy and treatment-resistant depression and improves on previous devices by having a longer lasting battery and improved electronics. From the press release: The AspireHC generator (development name NXT HC) represents the fifth generation of VNS Therapy® technology. This product incorporates greater functionality for the benefit of patients and their physicians, including longer battery life, improved electronics and simplified features for programming. The AspireHC generator is expected to be in limited commercial release in the United States in the Company’s current quarter ending April 29, 2011. The company has applied for the CE Mark. Press release: Cyberonics Announces FDA Approval of Aspire High Capacity Generator for VNS Therapy… Cyberonics VNS therapy info page……

Cellphones have come a long way with the rise of the smartphone. What used to be simply a means of making phone calls remotely, now is the way by which we can send emails, text messages, photos, and…acquire fetal images! You can thank Redmond, Washington-based Mobisante for that last one, because it has announced that its MobiUS ultrasound imaging system has received FDA approval to be marketed in the United States. MobiUS is the world’s first smartphone-based commercial ultrasound system. It consists of an ultrasound probe and a Toshiba Windows Mobile-powered smartphone with Mobisante’s software on it. Since the system is based on smartphones, it is extremely portable and very affordable compared to traditional ultrasound systems. In addition, it can utilize the cellular network and Wi-Fi capabilities of the smartphone to send images remotely. Mobisante hopes to get their portable ultrasound systems into remote villages and rural hospitals where resources are limited, population density is lower, and medical assistance is not as easily accessible. Although if things continue to progress well for Mobisante and portable ultrasound technology as a whole, we may soon find expectant moms uploading fetal pictures of their bundle of joy to their Facebook newsfeeds. Thanks to Tom Cruise, only if they live outside of California, of course. Press release: World’s first smartphone-based ultrasound imaging system cleared by the FDA… (.pdf) Company page: Mobisante … Flashbacks: The Signos, Self Contained Handheld Ultrasound Gains FDA Approval; Mobile Clinical Imaging On a Smart Phone (hat tip: Engadget)…

A few years ago we wrote about the punnily named ResQPOD, pictured on top, an impedance-threshold device that prevents air from re-entering the lungs to assist with cardiac filling. The Lancet has just published a study comparing standard CPR to CPR using ResQPod combined with another assist device called the ResQPump (side below), both from Advanced Circulatory Systems, Inc (Roseville, MN). From the abstract: Findings 2470 provisionally enrolled patients were randomly allocated to treatment groups. 813 (68%) of 1201 patients assigned to the standard CPR group (controls) and 840 (66%) of 1269 assigned to intervention CPR received designated CPR and were included in the final analyses. 47 (6%) of 813 controls survived to hospital discharge with favourable neurological function compared with 75 (9%) of 840 patients in the intervention group (odds ratio 1·58, 95% CI 1·07—2·36; p=0·019]. 74 (9%) of 840 patients survived to 1 year in the intervention group compared with 48 (6%) of 813 controls (p=0·03), with equivalent cognitive skills, disability ratings, and emotional-psychological statuses in both groups. The overall major adverse event rate did not differ between groups, but more patients had pulmonary oedema in the intervention group (94 [11%] of 840) than did controls (62 [7%] of 813; p=0·015). Interpretation On the basis of our findings showing increased effectiveness and generalisability of the study intervention, active compression-decompression CPR with augmentation of negative intrathoracic pressure should be considered as an alternative to standard CPR to increase long-term survival after cardiac arrest. Full abstract in Lancet: Standard cardiopulmonary resuscitation versus active compression-decompression cardiopulmonary resuscitation with augmentation of negative intrathoracic pressure for out-of-hospital cardiac arrest: a randomised trial Good summary from Milwaukee Journal Sentinel: New CPR devices save lives, Medical College study finds… Study info and product pages: THE RESQ TRIAL……

Philips has unveiled its new DigitalDiagnost – ER Wireless, and is now making available the Juno DRF X-ray system in the U.S. DigitalDiagnost – ER Wireless is an X-ray system specifically meant for use in emergency rooms, recovery, and trauma applications. The Juno DRF is a digital radiography and fluoroscopy system in one package The two-in-one system is capable of all common radiographic procedures, gastro-intestinal studies, tomography and vascular studies. Its unique Source Image Distance (SID) of 180 cm (71”) and the high table weight capacity of up to 284 kg (626 lbs), without any restrictions for movements, allows for diverse exams and patient types. An optional stitching function and vascular imaging package also expand the system’s capability. The Juno DRF has been for sale in Western Europe since January 2010. By eliminating hardware and peripheral equipment that typically hinders access to the patient, the DigitalDiagnost – ER Wireless radiography configuration eases access to critical patients in emergency rooms (ER), trauma units and recovery bays. The rugged wireless portable detector with built-in handle and cable-free design enables simple maneuvering for even the most difficult anatomical views, allowing the system to be seamlessly integrated into the ER. The wireless portable detector also helps minimize the risk of interference with life-saving equipment. Press release: Philips introduces X-ray systems designed to advance patient care Product pages: Juno DRF; DigitalDiagnost……

Siemens has installed the world’s first combination MRI/PET machine at the hospital of Munich Technical University. The obvious benefit of obtaining both structural (3T MRI) and functional (PET) images at the same time cannot be overstated, and oncologists, surgeons, and other clinicians should be getting excited. The new system, dubbed Biograph mMR, is yet to receive regulatory approval and will be undergoing clinical testing in the meantime. While MR provides exquisite morphological and functional details in human tissue, PET goes further to investigate the human body at the level of cellular activity and metabolism. The innovative system has the potential to be a particularly valuable tool for identifying neurological, oncological and cardiac conditions of disease and in supporting the planning of appropriate therapies. Since MRI does not emit ionizing radiation, Biograph mMR may provide an added benefit with lower-dose imaging. The Biograph mMR also opens new opportunities for research, such as the development of new biomarkers or new therapeutic approaches. Initial research suggests that with this system, Molecular MR can scan the entire body in as little as 30 minutes for the combined exams, compared to one hour or more for sequential MR and PET examinations. Siemens video presenting the Biograph mMR… Press release: A world’s first in imaging – integrated whole-body molecular MR system available for clinical use testing…

Doctors at McGill University Health Centre, Canada, have recently performed the world’s first all-robotic surgery. The locally developed McSleepy put the patient on anesthesia, while surgeons used the well-known DaVinci robot to perform a prostatectomy. It was the first time these two robotic systems were combined. From the press release: “Providing anesthesia for robotic prostatectomy can be challenging because of the specific patient positioning and the high degree of muscle relaxation necessary to maintain perfect conditions for the surgical team,” added Dr. Hemmerling. “Automated anesthesia delivery via McSleepy guarantees the same high quality of care every time it is used, independent from the subjective level of expertise. It can be configured exactly to the specific needs of different surgeries, such as robotic surgery.” “Obviously, there is still some work needed to perfect the all robotic approach – from technical aspects to space requirements for the robots,” added Dr. Hemmerling. “Whereas robots have been used in surgery for quite some time, anesthesia has finally caught up. Robots will not replace doctors but help them to perform to the highest standards.” This first test was successful and now the team plans to expand their tests to more and larger types of surgery. Press release: McSleepy meets DaVinci……

Here’s an interesting simple technology that might come handy to anesthesiologists and others who tend to do lots of central lines. Making sure that you are not in a carotid (or subclavian or femoral arteries, etc) is not always as simple as many think. Sure, you can do a blood color comparison. You can also connect a vertical column, and see how far the blood will rise. But why to do these maneuvers, if you can have something at the end of a finder needle that does not add steps to your procedure? Meet Mirador Biomedical of Seattle, Washington that has just received FDA’s 510(k) clearance for its Compass Vascular Access pressure measurement device, as well as a similarly designed Compass Lumbar Puncture pressure monitor. From the Compass Vascular Access product page: Focus on the Procedural Site View your hands, the patient and the pressure without additional cabling, operators or connections Integrate Seamlessly with Needles and Syringes Easily incorporated into the Seldinger technique for inserting catheters Eliminate “Blind” Guidewire Insertion The port allows insertion of the guidewire while monitoring the pressure From Compass Lumbar Puncture product page: Indication of CSF Entrance: Entrance into the target space is indicated by a pressure increase. Seamless Integration with LP Needles: The CompassTM LP connects to standard Lumbar puncture needles. Immediate and Continuous Measurement of Opening Pressure: View the pressure continuously without additional cabling, operators or connections. Press release: Mirador Biomedical, developing the innovative Compass™ family of disposable medical devices, announced FDA 510(k) clearance of its two leading products… (.pdf) Product page: Compass pressure measurement devices……