Posts by: Tim Odell

Fast Freezing Nematodes for Synaptic Research

Researchers from the University of Illinois at Chicago led by Janet Richmond, professor of biological sciences, have found a better way to observe what happens with synaptic proteins in nematode worms.

Several proteins that have been shown to be major players in synaptic transmission have now been studied using a flash-freeze physical-fixation technique that reveals new details of their location and function in neuromuscular synapses. The technique was used with tiny, one-millimeter-long nematode worms, a lab animal widely studied by neuroscientists.

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The Lung Flute Cleared by FDA for Sputum Induction

Need some lung mucus for diagnostic purposes, but don’t want to inflame your patient’s bronchial tubes? Lucky for you Medical Acoustics, LLC’s Lung Flute, which is far less irritating when it comes to extracting that precious precious mucus, has just been cleared by the FDA

This simple, hand-held, disposable device supplements the patient’s natural mucus clearing system by introducing low frequency sound waves into the lungs. The Lung Flute is a novel medical device which will play a significant roll in drug development for asthma, chronic bronchitis, community acquired pneumonia and lung cancer. Deep lung secretions can be obtained to determine drug efficacy and progression of treatment for pulmonary drugs. Currently, sputum induction using hypertonic saline is the standard method, a process that is expensive, time consuming, uncomfortable to the patient and often causes bronchial spasm and inflammation. As a result, sputum samples, using hypertonic saline, cannot be collected more frequently then every 48 hours. The Lung Flute addresses these challenges and will allow sputum samples to be collected every 20 minutes which is important when monitoring inflammatory markers during asthma attacks.

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Subjects and Researchers Open Up Unusual MRI Application

It’s Friday. Friday holds a special place in the heart of us Medgadgeteers. It’s our excuse to loosen the collar a little bit, and post some content that might not fly on Monday…
We’ll open with the title: “Magnetic resonance imaging of male and female genitals during coitus and female sexual arousal”. That’s right, folks, the old sex-in-the-MRI trick. (Actually, that’s not old, we just made it up). Given that…maybe you could take a closer look at the attached MRI image. Here’s a hint: you can see two spines.

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More on Abiomed’s Artificial Heart

Here’s an interesting additional point on the story of Abiomed’s AbioCor total artificial heart that has been approved with a humanitarian device exemption for use in a limited patient population with only a few months to live. This new population represents as many as 4000 patients in the US, as opposed to their last group of 14. From the WaPo article:

The device would be limited to people with severe congestive heart failure who are estimated to have about a month to live and do not qualify for heart transplants. Those patients must also be able to take anticoagulant drugs.

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FDA To Regulate Complex Diagnostic Tests

The FDA is looking to begin regulation of complex genetic marker tests, known as “multivariate index assays.” Currently these tests are generally the intellectual property of a certain lab, basically the lab’s whole business model. As such, the means by which a result is given are not publicly available, leaving the validity of the algorithm in question. Thus…

Now the F.D.A. is saying it will regulate at least one category of such tests: those that measure multiple genes, proteins or other pieces of clinical information taken from a patient and then use an algorithm or software program to analyze the data. The F.D.A. is calling these tests “multivariate index assays.”

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Old Bootleg Records on X-Ray Film

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New Device to Improve Vision for Patients with Tunnel Vision

Researchers led by Dr Eli Peli at the Schepens Eye Research Institute, (a Harvard Medical School affiliate) have produced a vision aid system that superimposes parts of their outer field of view onto the center of their vision. More from the press release…

Peli’s new visual aid – which he developed with the help of MicroOptical Corp. of Westwood, MA- allows the patients to see detailed visual information through the transparent display, while also viewing a superimposed minified outline version of a wider visual field. The tiny computer-video system provides updated outline information 30 times per second. When a patient becomes aware of a possible obstacle or important object in the superimposed outline image, he can move his head and eyes to look directly at the object through the display.

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US Marshals Seize Defective Infusion Pumps at Alaris Facility

On August 25, US Marshals seized a batch of defective infusion pumps in a Cardinal Health Care (the pump’s manufacturer) facility. Apparently, Alaris (part of Cardinal) had failed to follow FDA regulations in the wake of two warning letters issued back in 98 and 99, and continued to manufacture the pumps without fixing the flaw. According to the FDA…

The seized infusion pumps have a design defect called “key bounce” that may cause potential over-infusion of medications. This seizure was intended to ensure that infusion pumps located at Alaris’ manufacturing facility are not distributed unless the problem is corrected.

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“Study” Says FDA Advisors Typically Recommend Approval, Medgadget.com Disapproves of AP’s Choices in Science Coverage

So, without further adieu, we’ll give you the flavor of the study they’re talking about…

A new study finds that F-D-A advisers rarely say ‘no’ when deciding whether to recommend a drug or medical device for approval.

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