Posts by: Smit Shah

Researchers Develop Non-Invasive PET Imaging Options for Alzheimer’s Disease

by Smit Shah on Apr 23, 2012

It is estimated that Alzheimer’s disease will affect 100 million people by 2050, but currently doctors rely on family history and intellectual tests to diagnose patients. Using these current methods, about 20% of patients diagnosed with AD are false positives, and the only definitive way to identify AD is post-mortem analysis of beta-amyloid in the patient’s brain tissue.

Now, Siemens Healthcare has announced an imaging solution which can detect beta-amyloid plaques in the brains of living patients. The new technology utilizes Amyvid, Eli Lilly’s recently FDA approved radioactive agent, to make the plaques visible in PET scanning. Images are captured using Siemens’ Biograph mCT PET-CT, and the company’s 510(k)-pending syngo.PET Amyloid Plaque quantification software can help doctors determine actual amyloid levels. Siemens plans to begin providing Amyvid to imaging centers this June.

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New Blood Test Might Predict Heart Attack Risk

by Smit Shah on Mar 22, 2012

While the presence of certain cardiac biomarkers in blood can be used to determine whether a patient has already suffered a heart attack, there is currently no blood test to determine a patient’s imminent heart attack risk. Now, researchers from Scripps Translational Science Institute and the Scripps Research Institute believe they may have found such a test.

The team characterized the circulating endothelial cells (CECs) of heart attack patients, and found that the patients’ CECs were misshapen, had multiple nuclei, and were larger than CECs in a healthy control group. The researchers hope to validate their findings and develop a test to predict heart attacks within the next two years.

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Abbott’s FreeStyle InsuLinx System Set for US Launch

by Smit Shah on Mar 9, 2012

Abbott has announced FDA clearance of its FreeStyle InsuLinx Blood Glucose Monitoring System, which will be made available in the US later this year. The system, which was CE marked last year, incorporates an easier to use touchscreen interface which can be personalized with messages and a home screen photograph.

Additionally, Abbott claims the system’s USB connectivity via the accompanying FreeStyle Auto-Assist software will help diabetics better manage their blood sugar by providing reports and reminders.

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AccessClosure’s MynxGrip Vascular Closure Device Grips Artery Wall for a Better Seal

by Smit Shah on Feb 28, 2012

Mountain View, CA-based AccessClosure, Inc. has announced the launch of its new MynxGrip vascular closure device, which is based on the company’s popular Mynx platform.

Like the Mynx Cadence, MynxGrip uses polyethylene glycol (PEG) to provide an extravascular seal which dissolves completely within 30 days. It improves on the previous device’s seal with the incorporation of the “Grip Tip,” a new configuration of PEG which better conforms to the artery wall.

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Boston Scientific Introduces First 16-Contact Percutaneous SCS Lead

by Smit Shah on Dec 9, 2011

Boston Scientific has announced FDA approval of its new Infinion 16 Percutaneous Lead for use with the company’s Precision Plus Spinal Cord Stimulator (SCS) system.

The Precision Plus system is used to treat chronic pain by electrically stimulating the spinal cord, and Boston Scientific claims that by providing greater coverage of the spinal cord, the Infinion 16 lead will be able to better alleviate chronic pain.

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Tandem t:slim Insulin Pump Gets FDA Clearance

by Smit Shah on Nov 16, 2011

Tandem Diabetes Care out of San Diego, CA will soon be marketing in the U.S. its t:slim insulin pump thanks to a newly issued FDA approval.  The t:slim looks more like an iPhone 4 than a critical medical device, including a color touchscreen and USB connectivity for syncing with a computer and for recharging the internal battery.

This may not be a coincidence because the rep for Tandem, in an email to Medgadget, specifically mentioned Amy Tenderich’s open letter to Steve Jobs calling for Apple to design an insulin pump from four years ago. We think Amy should take at least a bit of credit for encouraging such a stunning design.

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Torax’s Medical Beads Adapted to Treat Fecal Incontinence

by Smit Shah on Nov 14, 2011

Torax Medical, Inc., maker of the LINX Anti-Reflux Treatment System, has announced CE Marking of its FENIX Continence Restoration System. Like LINX, the FENIX System consists of a band of magnetic beads, but instead of being implanted around the esophageal sphincter, it is implanted around the anal sphincter to treat fecal incontinence.

Magnetic attraction between the beads keeps the sphincter closed, but this attraction is broken to allow the band to expand during voluntary passage of fecal matter.

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Valkee Headset Treats Seasonal Depression by Shining Light on the Brain

by Smit Shah on Nov 10, 2011

As the days continue to grow shorter in the Northern Hemisphere, patients who suffer from seasonal affective disorder (SAD) will start to experience symptoms of depression. Finish company Valkee Ltd. has performed research which shows that the brain is sensitive to light, and claims that its bright light headset can help treat SAD. The CE Marked device looks like an mp3 player with earbuds, but instead of filling the patient’s head with the sounds of Lady Gaga or whatever they are playing nowadays, it pumps bright light to the brain through the ear canals.

In initial trials, 92% of patients reported that the Valkee headset reduced or completely eliminated symptoms of SAD.

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Abbott’s New Hepatitis B Test is More Sensitive, Can Detect Mutant Virus Strains

by Smit Shah on Nov 9, 2011

Abbott Labs has announced CE Marking of its new ARCHITECT HBsAg Qualitative II assay for diagnosis of hepatitis B. Like existing Hep B tests, the new assay detects hepatitis B surface antigen (HBsAg) to aid in diagnosis of acute or inactive chronic carrier phase of the infection.

Abbott claims that its new test can also detect HBsAg mutants and is more sensitive than existing tests, which allows for diagnosis of patients who have been infected with a mutant strain of the virus and those with particularly low HBsAg levels.

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