Medtronic Activa Neurostimulators Approved in Europe for Full Body MRI Scans

Activa-PCMedtronic won European regulatory approval for its Activa line of deep brain stimulators (DBS) to be safe for use in full body MRI scans, given certain conditions. Previously, the company had approval for only head scans under MRI for patients wearing their DBS devices. The new announcement allows both future as well as existing patients to receive MRI scans of any part of the body, as long as specific precautions are taken by the radiology techs.

These are the only DBS systems to receive a full-body MR-conditional approval from the European authorities, allowing patients with Parkinson’s disease, essential tremor, refractory epilepsy, and dystonia to continue receiving medical care that requires MR scans. The implants have to be appropriately programmed before undergoing a scan, keeping them working so as to allow the acquisition of sharp images unaffected by the jerky motions associated with neuromotor disease.

Product page: Activa neurostimulators…

Source: Medtronic…

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Mobidiag Presents Two New Diagnostic Platforms at ECCMID 2015

Novodiag™ and Amplidiag™ Easy platforms to serve both low- and high-throughput customer needs with emphasis on accessibility and affordability

Espoo, Finland – April 22, 2015 – Mobidiag Ltd, a Finnish molecular diagnostics company specializing in the development of innovative diagnostics solutions for infectious diseases, today announced the first public presentation of two new diagnostic platforms – Novodiag and Amplidiag Easy – at ECCMID 2015 in Copenhagen on April 25-28.

The entirely new Novodiag platform is a fully integrated and automated system, enabling accessible and affordable molecular testing. The platform enables fast, very easy to use and highly multiplexed on-demand molecular testing for any throughput needs. It combines advanced features, ease of use, and affordability unmatched by currently available products, and requires no dedicated molecular testing expertise. The Novodiag platform will be readied for a full commercial launch in mid-2016 to serve various testing needs in the infectious diseases space, as well as in other potential markets which are unserved by current molecular platforms.

“Although molecular diagnostics has been around for a long time, the market has not seen solutions which leverage its full potential,” says Tuomas Tenkanen, CEO of Mobidiag.“Until now, major limitations have been complexity of use, the ability to detect only a very limited amount of pathogens, or simply too high a price. We aim to solve these issues with our Novodiag system by combining high multiplexing capacity with a simplified, easy-to-use design. The system and its benefits will be accessible to a broader group of diagnostic laboratories, both centralized and decentralized. Due to its simplified design, it represents industry-leading value, setting a new benchmark for affordability and functionality.”

Mobidiag is also launching its new Amplidiag Easy system for automating high-throughput gastrointestinal testing with Amplidiag test kits, including the recently CE-marked Amplidiag Bacterial GE and Amplidiag C. difficile+027. The system performs batch nucleic acid extraction and PCR plate setup from stool samples with unmatched speed and performance. Combined with Amplidiag test kits and Amplidiag Analyzer software for automatic result analysis, the platform provides ease of use and uncompromised reliability in high-throughput molecular testing.

“We value the feedback of our customers, and it is clear that in many high-throughput laboratories, automated systems are not only appreciated for reducing the burden of tight resources, but the only way of working,” Mr. Tenkanen continues. “That’s why we created Amplidiag Easy specifically to meet this need, combining automation with speed and reliability. For example, the system can process a batch of 48 C. difficile samples in one hour, from a liquid stool sample transfer vial ending up in a ready set-up PCR plate to be transferred to a qPCR instrument. In an optimized workflow, the results are available for a large batch of samples in two hours from sample to result. The best thing is that the high speed does not compromise performance at all.”

About Mobidiag

Established in 2000, Mobidiag develops novel technologies for improving the diagnostics of infectious diseases and has served the European clinical diagnostics market with its multiplex Prove-it™ product family since 2008. In 2013, Mobidiag successfully completed a three-way merger with Genewave and Amplidiag, solidifying its position in the field of molecular diagnostics. Mobidiag’s new Amplidiag™ product line encompasses innovative multiplex diagnostic tests for gastrointestinal infections. The products use well-established qPCR technology, ensuring optimal performance, suitability for high-volume screening use and cost-effectiveness in mid-sized to large laboratory settings. Mobidiag’s new Novodiag™ platform will set a new benchmark to automated, integrated molecular diagnostics. Mobidiag is headquartered in Espoo, Finland, with a subsidiary in Paris, France.

 

Contact:
Mobidiag Oy/Ltd.
Tuomas Tenkanen, CEO
+350 50 553 4980
tuomas.tenkanen@mobidiag.com

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IdentRx Promises to Prevent Nearly All Medication Errors

PerceptiMed-identrxMedication errors continue to plague the clinical community and even rare cases of mistakes can make a big splash in the news. And for a good reason: we all expect to be treated than harmed when receiving medical care. A new device is currently in the third round of pilot testing, including at major retail pharmacies and Purdue University, that may help avoid prescription errors altogether. The IdentRx system from PerceptiMed, a Mountain View, California firm, optically analyzes every single pill that will be given to a patient to make sure it precisely matches each prescription.

It is the only device that visually inspects each pill, recognizing the manufacturer imprints on them all. The system confirms that the pills themselves, and not only the container bottles, match the issued prescriptions, hopefully preventing errors just before the pills are handed to the patients.

Product page: IdentRx…

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Again With the Claim tPA is “Safe” in Mild Strokes

In yet another exercise in asking the wrong questions, these authors put forth a rather great deal of effort to regurgitate a vast quantity of mostly meaningless data.

Neurologists, generally those well-supported by Genentech and Boehringer Ingelheim (as in this article), are keen to expand the use of tPA beyond the license criteria.  One of the easiest targets is the giant cohort of stroke patients excluded from treatment for low NIHSS.  In some respects, it seems reasonable to discard an ordinal cut-off in a measure of stroke severity having a non-linear relationship with disability.  But, when media coverage describes an expansion of tPA to mild stroke patients as “saving hundreds of millions of dollars” or “having no downside”, even the hypothetical best intentions have clearly gone awry.

This is a retrospective review of the Get With the Guidelines-Stroke registry, a voluntary, prospective quality improvement project used by hospitals in the U.S.  Between 2010 and 2012, 7,621 patients were treated with IV tPA for AIS having an NIHSS of 5 or less, with 5,910 having data for analysis.  Ranging from 192 patients with an NIHSS to 0 to 1,800 having NIHSS of 5, treatment complications were fairly consistent: 1.3% died, 1.8% suffered sICH, 0.2% suffered serious systemic hemorrhage, and 1.8% suffered other serious complications (e.g., angioedema).

So, of course, for a treatment with no demonstrated efficacy in this population, the authors conclude a number-needed-to-harm somewhere between 30 and 50 “provide[s] reassurance about the safety of IV rtPA in patients with low NIHSS scores”.

Interestingly, this data is essentially an update of the authors’ prior work, published using the 2003 to 2009 GTWG-Stroke registry data.  That publication provided a helpful data supplement comparing outcomes of tPA-treated patients with non-tPA-treated patients with NIHSS 5 or less.  Within the limitations of such a comparison, tPA treatment was associated with significantly increased odds of death, decreased discharges to home, and decreased ambulation at discharge.  The authors have in no way muddled this article with such negativity, nor did they perform any sort of gross comparison between the ambulatory and independence outcomes in the present study with the prior, non-treated population – as they are essentially identical.

But, when you're fed free money from your sponsors, including free airfare to Chicago, why report or suggest anything that might disrupt the narrative?

“Outcomes in Mild Acute Ischemic Stroke Treated With Intravenous Thrombolysis: A Retrospective Analysis of the Get With the Guidelines–Stroke Registry”
http://www.ncbi.nlm.nih.gov/pubmed/25642650

Rectal Acetaminophen dosing is higher than you think

Though 15mg/kg for acetaminophen are firmly ingrained in your brain, remember that initial and subsequent dosing for the rectal suppository is higher.

Rectal Acetaminophen

Per Birmingham et al in 2001 the “loading” dose of rectal acetaminophen is 40 mg/kg followed by 20 mg/kg doses every 6 h. The risk of significantly high levels or drug accumulation was not seen over a subsequent 24 hour period.