Archives: 2/2011

bqa3hqa FDA Approves Hologics Selenia Dimensions 3 D System
Bedford, MA based Hologic, Inc. has announced FDA approval of its Selenia Dimensions 3-D system for three dimensional breast imaging. 651nn2344 FDA Approves Hologics Selenia Dimensions 3 D SystemThe system was recommended for approval by the FDA’s Radiological Devices Panel this past September, and is now the first 3D breast imaging solution to be FDA approved. Hologic also announced that existing Dimensions 2-D systems can be upgraded to incorporate the new 3D functionality, which uses multiple X-ray views to produce a 3D representation of the patient’s breast.
From the press release:

Unlike prior-generation mammography systems which generate two-dimensional images, breast tomosynthesis produces three-dimensional images which are intended to reveal the inner architecture of the breast, free from the distortion typically caused by tissue shadowing or density. Tomosynthesis images are acquired with the breast held briefly in compression. The examination, which includes a 3-D tomosynthesis image in combination with a 2-D image, takes only seconds longer than a conventional 2-D digital mammogram at a total exam dose within current FDA guidelines. The 3-D scan results in a stack of thin high-resolution image slices intended to provide clear rendition of structures in the breast and their spatial relationship with the surrounding breast tissue. The images are displayed on a standard diagnostic workstation for review by the radiologist.

Press release: Hologic Receives FDA Approval for First 3-D Digital Mammography (Breast Tomosynthesis) System…
Flashbacks: Hologic 3D Mammography System to be Reviewed by FDA; Hologic’s Selenia Dimensions 3-D Receives Unanimous Recommendation from FDA Advisory Panel

yihu48iv Extracellular Electric Fields Affect Function of Brains NeuronsNeuroscientists have long considered extracellular electric fields in the brain to be too weak to affect the day to day functioning of the organ. A new study out of Caltech now shows that in reality these seemingly stray electric fields actually alter the functioning of neurons, giving scientists another puzzle to work out.

Extracellular electric fields exist throughout the living brain. Their distant echoes can be measured outside the skull as EEG waves. These fields are particularly strong and robustly repetitive in specific brain regions such as the hippocampus, which is involved in memory formation, and the neocortex, the area where long-term memories are held.
Previously, neurobiologists assumed that the fields were capable of affecting—and even controlling—neural activity only during severe pathological conditions such as epileptic seizures, which induce very strong fields. Few studies, however, had actually assessed the impact of far weaker—but very common—non-epileptic fields. "The reason is simple," Anastassiou [Costas Anastassiou, postdoc at Caltech] says. "It is very hard to conduct an in vivo experiment in the absence of extracellular fields," to observe what changes when the fields are not around.
To tease out those effects, Anastassiou and his colleagues focused on strong but slowly oscillating fields, called local field potentials (LFP), that arise from neural circuits composed of just a few rat brain cells. Measuring those fields and their effects required positioning a cluster of tiny electrodes within a volume equivalent to that of a single cell body—and at distances of less than 50 millionths of a meter from one another; this is approximately the width of a human hair.
An "unexpected and surprising finding was how already very weak extracellular fields can alter neural activity," he says. "For example, we observed that fields as weak as one volt per meter robustly alter the spiking activity [firing] of individual neurons, and increase the so-called ‘spike-field coherence’"—the synchronicity with which neurons fire. "Inside the mammalian brain, we know that extracellular fields may easily exceed two to three volts per meter. Our findings suggest that under such conditions, this effect becomes significant."
What does that mean for brain computation? At this point we can only speculate, Koch [Christof Koch, Professor of Cognitive and Behavioral Biology and professor of computation and neural systems at Caltech]says, "but such field effects increase the synchrony with which neurons become active together. This, by itself, enhances the ability of these neurons to influence their target and is probably an important communication and computation strategy used by the brain."

Abstract in Nature Neuroscience: Ephaptic coupling of cortical neurons
Link at Caltech: Neurobiologists Find that Weak Electrical Fields in the Brain Help Neurons Fire Together

dndrtyy Robot Therapy by Motorika is Effective in Improving Mobility for Stroke PatientsNew research presented at the American Stroke Association’s International Stroke Conference in Los Angeles shows that robot-assisted therapy is effective in improving arm and shoulder mobility in patients who are paralyzed as a result of a stroke.
According to the study, 60 patients with hemiplegia (paralysis on one side of the body) due to a stroke were given physical therapy. Half of the group received robot-assisted therapy using a Reo Therapy System by Motorika Ltd. (Caesarea, Israel), which repeatedly moves the forearm in various pre-programmed directions. The other half spent the same amount of time undergoing traditional rehabilitation.
According to the study:

Patients on robotic therapy showed marked improvement in two measures of upper extremity function: the Fugl-Meyer flexor synergy score, a 0 to 12 scale with higher numbers reflecting recovery of voluntary arm movement; and the Fugl-Meyer shoulder/elbow/forearm score, a 0 to 36 scale with higher numbers reflecting recovery of motor function in the shoulder, elbow and forearm.

The study suggested that the success of robot-assisted rehabilitation may be due to the fact that, unlike human physical therapists, robots can carry out repetitive exercises with exactly the right movement pattern every time.
Article from the AHA/ASA 2011 International Stroke Conference…
Interview with Dr. Kayoko Takahashi (lead author of study)…
Audio clips of comments from Dr. Pamela Duncan from the AHA…
Motorika homepage…

5oowcbnr Stryker MDM X3 Hip Replacement System Gets US Green LightStryker has received clearance from the FDA for its MDM X3 Modular Dual Mobility Mobile Bearing Hip System.

MDM X3 is a third-generation dual mobility device that allows surgeons to offer the benefits associated with Stryker’s dual mobility technology to a broader patient population, including those who may benefit from advanced fixation. Like Stryker Orthopaedics’ ADM X3, MDM X3 is designed to enhance stability and jump distance, which may increase range of motion in specific patients.
ADM X3 Mobile Bearing Hip System is Stryker’s flagship mobile bearing product and was developed to enhance joint stability. To address limitations in stability, conventional designs focus on the use of metal-on-metal large head technologies, which, based on recent studies, suggest added risk due to metal-on-metal articulation. Combining an evolution in design with the only anatomic dual mobility acetabular system and its patented X3 Advanced Bearing Technology, Stryker Orthopaedics’ Mobile Bearing Hip is designed to offer the benefits of a large diameter bearing without a metal-on-metal articulation.
The dual points of articulation in dual mobility constructs help accommodate multi-directional movement, which provides the potential for greater range of motion and reduced wear compared to competitive fixed implant designs, based on laboratory testing.

Press release: Stryker Receives FDA 510(k) Clearance to Market Modular Dual Mobility Acetabular (Hip) System…

Links: Stryker X3 Bearing Technology, Mobile Bearing Hip…

Art

The Science Gallery in Dublin, Ireland is hosting an art exhibit with works related to “living art.” One amusing “installation” is a work by Kathy High, a New York artist and Associate Professor of Video and New Media in the Department of Arts at Rensselaer Polytechnic Institute. Her project Blood Wars is a competition between people’s immune systems, played out under a microscope on a petri dish in front of the audience. Here’s the artist describing her work:


More from Wired UK
Blood Wars tournament page…
Link: VISCERAL: The Living Art Experiment…
(hat tip to reader David R)

COR analyzer COR Automatic Coronary CT Angiography Gets US Green Light
Rcadia Medical Imaging out of Haifa, Israel received FDA regulatory clearance for the COR Analyzer System. The software does automatic analysis of coronary CT angiography scans to identify potential stenotic lesions.
Features from the product page:
fsffs3 COR Automatic Coronary CT Angiography Gets US Green Light

  • Flags patients that are suspevted of having significant lesions in coronary arteries

  • Display 3D coronary tree & curved MPRs with marked lesions
  • Generates a report with summary of findings and curved MPR snapshots
  • Export results to PACS and workstation
  • Deliver the report by e-mail (cell phone)
  • Run on any 64 or higher CT scanner
  • Product page: COR Analyzer System…
    Press release: Rcadia COR Analyzer® System Receives Expanded FDA Clearance to Rule Out Coronary Artery Disease in Coronary Branch Vessels…
    Flashbacks: COR Analyzer for Automatic Identification of Coronary Stenoses; Rcadia COR Analyzer Wants Computer to Study Your Coronaries

    e4iggh6q Siemens Mobile Device Warns of Oncoming Asthma Attacks
    Engineers at Siemens have developed a mobile phone sized device that is capable of detecting nitric oxide (NO), an oncoming asthma attack marker, at parts per billion scale. Once the device makes it to the consumer market, asthma patients will be able to take preemptive action and raise their drug dosage levels when an attack looks impending.

    The new sensor can detect increases in NO one day before an acute asthma attack occurs. Over the past few years, medical researchers and health insurance companies have recognized that NO levels are an effective indication of an impending asthma attack. In the analysis of a patient’s breath, the system first converts nitrogen monoxide into nitrogen dioxide, after which the air flows across the actual sensor. Only the particles signaling the attack adhere to the sensor’s surface. This generates a voltage that is measured by a field-effect transistor. The intensity of the voltage is directly dependent on the amount of nitrogen monoxide in the patient’s breath. On the basis of this value, the patient can decide what dose of anti-inflammatory medication he or she should take.
    Another type of breath sensor under consideration would allow athletes to check whether they are exercising enough to burn fat. The detection principle is the same, except that the system measures the level of acetone. The latter is generated in the body when fat is burned and is also detectable in a person’s breath.

    Press release: Sensor Warns Patients in Advance of Asthma Attack…

    The National Geographic Channel is currently featuring the latest in organ generation technology in its Explorers series. Here’s a snippet from the full show:


    Check your local listings for timing…
    Link: Explorers: How to Build a Beating Heart…

    ipcjfy0k FDA Approves miraDry System for Long Term Treatment of Excessive Underarm Sweat, Makes Antiperspirant Obsolete?Remember the good old days when primary hyperhidrosis of the upper limbs was treated by sympathectomy via thoracotomy? As time goes by, we have new kids on the block, and they have zero respect for traditions. Miramar Labs from Sunnyvale, CA has announced 510(k) clearance of its miraDry System for treatment of excessive underarm sweat. The system utilizes microwave energy to cause thermal necrosis of sweat glands in the target area. Treatment with the miraDry system is noninvasive and requires two hour-long doctor’s office visits.
    vzf23sd FDA Approves miraDry System for Long Term Treatment of Excessive Underarm Sweat, Makes Antiperspirant Obsolete?From the product page:

    The miraDry treatment is a non-invasive, in-office procedure that is performed in three simple steps:
    1 – Placing temporary markings on the skin,
    2 – Administering local anesthesia, and
    3 – Treating using the miraDry system.
    The total patient appointment time is 60 minutes, with treatment itself taking approximately 40 minutes. A touch-up visit may be needed to treat any areas that may have been missed. Custom software guides you or your staff through the process, making it easy to conduct the procedure. Most patients begin to notice the effect of the treatment immediately following the procedure.

    Press release: miraDry by Miramar Labs Receives FDA 510(k) Clearance…
    Product page: The miraDry System…