InsuLine Medical of Petach-Tikvah, Israel has begun a clinical trial to test the safety and efficacy of its InsuPatch catheter in type 1 diabetics. The InsuPatch catheter is designed to increase local blood flow by the application of controlled thermal energy to local tissue. Preliminary data has shown that participants using the device demonstrated more rapid delivery and clearance of insulin, as well as higher peak concentrations than controls.
The trial will take place in the US and in Israel, and will involve 100 participants. InsuLine Medical expects the trial to be complete in the third quarter of 2011, and following a successful outcome, anticipates that the device may receive FDA approval by the end of 2011. The US trial will take place at the Mills Peninsula Health Center, California.
Posts by: Aaron Rulseh
InsuLine Medical Launches InsuPatch Trial in T1DM
Portable RF Breast Scanner Shows Tumors in Real-time
Professor Zhipeng Wu at the University of Manchester has developed a novel radiofrequency scanner to be used for real-time breast tumor detection. Unlike traditional mammography, which relies on the varying X-ray attenuation properties of tissues to produce image contrast, the portable scanner uses radiofrequency waves to perform complex permittivity mapping of tissue. Benign and malignant breast tumors have (complex) permittivity characteristics that differ from surrounding tissue, and although the scanner is not able to differentiate between benign and malignant structures, it could prove to be a sensitive and inexpensive screening tool. Such a device could potentially improve breast cancer detection in women under 50 and would be very welcome in the developing world.
Professor Zhipeng Wu describing the system:
Researchers Develop Portable X-ray Device
A team of researchers at Kyoto University, Japan have developed a portable X-ray device measuring only 3×5 cm. The device is powered by two D batteries and uses two tantalic-acid-lithium electrodes, which when subjected to electric current, affect electron emission from a gas within the device’s glass enclosure.
X-rays are routinely used in the elemental analysis of various samples, and the team, led by professor Jun Kawai, hopes that their device could be used with a portable X-ray detector to bring elemental analysis to the field.
Simbionix Gets FDA Nod for PROcedure Rehearsal Studio Software
Simbionix of Cleveland, OH has received 510(k) approval from the FDA for the PROcedure Rehearsal Studio Software. The software creates patient-specific 3D anatomical models for use in analyzing and planning surgical procedures. The 3D model created by the PROcedure Rehearsal Studio Software can also be exported to the Simbionix ANGIO Mentor Simulator practice environment, allowing the user to rehearse difficult procedures.
Press release: Simbionix Receives FDA Clearance to Take Medical Simulation Technology One Step Further into Clinical Settings…
Nano-CT Resolves Fine, Structural Detail of Bones
A letter published in the current issue of Nature describes the use of a ptychographic coherent approach in CT imaging to resolve nanoscale structures. The nano-CT approach, developed by Franz Pfeiffer of Technische Universität München and his team, uses not only X-ray beam intensity of a sample but also beam diffraction to provide additional nanoscale data. Diffraction patterns are then processed by a novel image reconstruction algorithm, generating high-resolution 3D-images. The technique allows the visualization of minute structures, such as osteocyte lacunae and the connecting canaliculi, and promises to advance research in a variety of fields.
More from Technische Universität München :
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Hologic’s Selenia Dimensions 3-D Receives Unanimous Recommendation from FDA Advisory Panel
Hologic, Inc. of Bedford, MA has received unanimous recommendation for approval from the Radiological Devices Panel of the FDA for the Selenia Dimensions (3-D) Digital Mammography Tomosynthesis System. The system, which we have covered previously, uses multiple low-energy X-ray shots to produce 3-D images of the breast. Viewing a three-dimensional structure in 3-D has obvious advantages, and data from the multicenter clinical study indicate that 3-D digital tomosynthesis has the potential to improve cancer detection and reduce recall rates.
Although a favorable vote is only advisory in nature, the FDA regularly follows the recommendations of these panels. Selenia Dimension systems are currently available in the USA in 2-D versions, and these systems may be upgraded to 3-D if FDA approved.
Brainovi is GPS for the Visually Impaired
Brainovi is a conceptual portable device designed to assist the visually impaired with navigation. The unit interprets voice commands from the user and relays navigational information via a touch display and bluetooth headset. The touch display uses a pin matrix surface to show roads and buildings in the immediate vicinity (surrounding ten meters) and provides the correct orientation with a built in compass. Complimentary voice directions are given to the user via a headset. Developed by Korean designers Seung-Hyun Yoon, Seol-Hee Son and Ji-Youn Kim, we feel this concept device has great promise.
(Via Yanko Design)
Solta’s Fraxel Re:store Dual Gets FDA Ok for Treatment of Actinic Keratosis
Solta Medical of Hayward, CA has received 510(k) from the FDA for its Fraxel re:store Dual laser system to be used in the treatment of actinic keratosis (AK). The system uses a novel Thulium fiber laser (1927 nm) that has a more superficial focus in addition to a deep penetrating Erbium fiber laser (1550 nm). The Fraxel re:store Dual was found to perform satisfactorily during a six month multi-center clinical study (of surprisingly only 21 subjects), with an 82.5% average reduction of AK lesions.
More from Solta Medical:
Motorola Launches New Handheld Computer for Healthcare Workers
Motorola has just announced a new handheld device specifically aimed at healthcare professionals – the MC75A0-HC Rugged Healthcare Enterprise Digital Assistant (EDA). The device is designed to withstand regular exposure to disinfectants, water and dust, and should survive a five foot drop on a concrete floor. There are a lot features geared towards clinicians, such as push-to-talk communication with other mobile devices, support for “virtually all point-of-care applications”, compatibility with Motorola-HC bar code scanners, and HIPAA compliance. The MC75A0-HC runs MS mobile 6.5 and is expected to cost around $2000.
Some more details from the press release:
