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Testing Talk: ASTM F1717 spinal implant biaxial testing

March 15, 2010 by MassDevice

Testing Talk: ASTM F1717 spinal implant biaxial testing

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Spinal implants are tested according to several ASTM standards. ASTM F1717 is intended to provide a basis for the mechanical comparison among past, present and future spinal implant assemblies. Three static and one fatigue mechanical test of a spinal construct are governed by ASTM F1717. The three static tests are compression bending, tension bending and torsion. The fatigue test is a compression bending test.

MedGadget's MedTech Monday: Signaling pathways foreshadow novel vascular therapies

March 15, 2010 by MassDevice

Scientists at Yale University believe they have discovered the signaling mechanism at work during artery formation, opening up the possibility of growing replacement arteries; Rex Medical's thrombectomy system wins FDA nod; Cook's NavAlign IVC filter placement system gets femoral access option; and STJ's new Engage and Engage TR catheter introducers.

MedGadget's MedTech Monday: Signaling pathways foreshadow novel vascular therapi

Signaling pathways foreshadow novel vascular therapies: Scientists at Yale University believe they have discovered the signaling mechanism at work during artery formation, which may end up being used to control the growth of replacement arteries for people with coronary stenoses and other vascular ailments. Until now, scientists have focused on growth factors as tools to control vessel formation, but the new research provides a direct signaling mechanism that's already proving to be more effective.

Weekly Wireless Roundup: iPhone medical app denied 510(k)

March 15, 2010 by MassDevice

The iPhone medical app denied 510(k) clearance by the Food & Drug Administration; GE Healthcare offers up a Morsel; Johnson & Johnson vet takes WWHI helm; and Blue Cross, Blue Shield goes mobile in upstate N.Y.

Weekly Wireless Roundup: iPhone medical app denied 510(k)

iPhone medical app denied 510(k) MIMvista CTO Mark Cain on the torturous journey the company took along the Food & Drug Administration's regulatory pathway for the imaging app it designed for Apple's iPhone — only to be denied after a pair of 510(k) submissions.

FDA panel decision could boost Boston Scientific's CRM business

March 15, 2010 by MassDevice

A special Food & Drug Administration panel takes up Boston Scientific Corp.'s petition to expand indications for its CRT-Ds to larger pool of patients with heart failure, potentially providing a much-needed win for a company that's been down on its luck lately.

FDA panel decision could boost Boston Scientific

A Food & Drug Administration panel is set to decide whether Boston Scientific Corp. (NYSE:BSX) can sell its cardiac resynchronization therapy defibrillators to patients suffering from milder forms of heart failure, setting the stage for a big win for a company that's badly in need of positive news.

BSX goes before the the FDA's circulatory systems devices panel March 18 in College Park, Md., to press its case for the expanded indication. The panel will decide if the company provided enough evidence to convince regulators that the devices are effective in treating all types of heart failure.

Weekly Wireless Roundup: Express Scripts inks pilot deal for GlowCap

March 8, 2010 by MassDevice

St. Louis-based Express Scripts is set to launch a national pilot for Vitality’s GlowCap pill reminder device; Kaiser CMIO on mHealth opportunity; Aetna offers SMS, apps, mobile web services; and Epocrates CTO, CMO talk EHRs.

Weekly Wireless Roundup: Express Scripts inks pilot deal for GlowCap

Express Scripts inks pilot deal for GlowCap St. Louis-based pharmacy benefit manager Express Scripts is set to launch a national pilot for Vitality's GlowCap pill reminder device. Express Scripts plans to begin a small version of the pilot in about a month's time and will launch a larger trial focused on drugs related to cholesterol, diabetes, high blood pressure and heart failure during the summer months. Express Scripts notes that while the trial's purpose is to determine the efficacy of GlowCap's reminder service, the companies are also eager to learn more about how patients take medication and why they fail to take it at times.

MedGadget's MedTech Monday: Croc mummy tomography

March 8, 2010 by MassDevice

Researchers in California use CT scanners on a pair of mummified Egyptian crocodiles; Syncardia's Freedom mobile artificial heart driver wins CE Mark; Cook Medical's Hercules 3-stage esophageal balloon hits the market; and EEG used in absurd torture device.

MedGadget's MedTech Monday: Croc mummy tomography

Mummified crocs get tomographed: Conservators from Phoebe A. Hearst Museum at UC Berkeley teamed up with Stanford physicists and clinicians to CT scan two Egyptian crocodile mummies that reside at the museum. Stanford's SCOPE blog is reporting that the crocs were also put through a physics laboratory CT scanner that produces higher resolution images than clinical ones.

Weekly Wireless Roundup: Updates from HIMSS

March 1, 2010 by MassDevice

Updates on mobile news at this week's HIMSS conference in Atlanta; the current global mHeralth opportunity could be $50 billion; and a report from Continua that that that the FDA believes new laws for connected health device regulations are neither likely nor needed.

HIMSS Goes Mobile: Honeywell; Google; Nuance Google Health announced a number of deals at this weeks Healthcare IT conference in Atlanta.

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