Blogs

Testing Talk: ASTM F1717 spinal implant biaxial testing

MassDevice — Mon, 15 Mar 2010 21:33:38 +0000

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

MassDevice — Mon, 15 Mar 2010 21:02:31 +0000

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.

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)

MassDevice — Mon, 15 Mar 2010 20:46:23 +0000

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.

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

MassDevice — Mon, 15 Mar 2010 19:28:29 +0000

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.

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.

What to expect when you’re expecting

Tod Brubaker — Fri, 12 Mar 2010 19:53:00 +0000

The process of naming — whether it's a new baby, a new product or a new company — can be fraught with conflict. Here are five simple suggestions to follow when brainstorming a new name.

Any parent can tell you the first rule of naming: Don’t blab your names to the whole world. It’s one of those lessons you learn the hard way. For example, when my wife was pregnant with our first child, I made the mistake of floating one of our top contenders past my father-in-law. “Ava?” he scoffed. “Ava Gardner was such a tramp.” Good thing we also loved the name Lucy.

Chance-takers are accident-makers

Tim Mohn — Thu, 11 Mar 2010 20:34:30 +0000

Improving medical device safety from pre-review to post-market.

It pays to remember an old adage: "Better to be safe than sorry." Indeed, many medical device manufacturers are re-evaluating their quality systems as a result of the Food & Drug Administration's recent review of pre-market notifications and a FY 2011 budget request for additional funds to address product safety. Device makers should heed this advice and take the necessary steps to pro-actively — rather than reactively — address compliance issues.

Weekly Wireless Roundup: Express Scripts inks pilot deal for GlowCap

MassDevice — Mon, 08 Mar 2010 17:25:30 +0000

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.

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

MassDevice — Mon, 08 Mar 2010 16:10:42 +0000

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.

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.

Congress is incapable of a positive contribution to health care reimbursement

Edward Berger — Fri, 05 Mar 2010 21:58:50 +0000

Congress has demonstrated that it is incapable of designing policies to reform healthcare reimbursement and it doesn't have the political courage to set standards and allow the incentives created by those standards to force change.

Three health care reimbursement developments of interest in the last few days:

Technically speaking, you don't always have to be technical

Angel Micarelli — Fri, 05 Mar 2010 21:11:12 +0000

Sometimes less is more when gauging the right level of technical jargon to use in clients' marketing campaigns.