Posts Tagged fda

FDA’s Mobile Health Guidance Removes Risk For Investors

Wednesday, February 12th, 2014 | Permalink

Investors and their limited partners really don’t like risk, especially not the kind due to uncertainty. Now, for developers of mobile health applications and their investors, at least one risk has been taken off the table: regulatory uncertainty. On September 23, the FDA published the much-anticipated final guidance on mobile medical apps.

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FDA’s Mobile Health Guidance Removes Risk For Investors

TYRX Gains FDA Clearance For Resorbable Antibacterial Device Envelope

Wednesday, November 13th, 2013 | Permalink

TYRX Inc. has received FDA clearance for a fully-resorbable version of its antibacterial envelope, used to prevent surgical site infections in patients who receive implantable devices such as ICDs. The resorbable device has important advantages over the previous durable envelope and could substantially boost physician adoption of the company’s technology.

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TYRX Gains FDA Clearance For Resorbable Antibacterial Device Envelope

3D-printed PEKK stakes out implant position

Tuesday, April 2nd, 2013 | Permalink

Oxford Performance Materials (OPM), which has been developing polyetherketoneketone (PEKK) as a medical implant plastic, has received FDA 510(k) clearance for its OsteoFab Patient Specific Cranial Device (OPSCD). “OsteoFab” implants are made from PEKK with additive manufacturing technology. According to OPM, it is the first approval for an additively manufactured polymer implant. Tagging Options Domain:  All Sites Keywords:  medical plastics implants PEKK 3D printing read more

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3D-printed PEKK stakes out implant position

Shape memory polymers boost implant performance

Friday, March 22nd, 2013 | Permalink

Medshape (Atlanta, GA) reports commercialization of the first FDA-cleared medical device made with shape memory polymers. Tagging Options Domain:  All Sites Keywords:  shape memory polymers Medshape Solvay read more

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Shape memory polymers boost implant performance

FDA tightening watch of AEDs | theheart.org

Friday, March 22nd, 2013 | Permalink

In addition to AEDs, there are 26 other medical devices that came to market prior to 1976, and the FDA is in the process of deciding which of those devices will now require a PMA. In its review, the FDA decided that AEDs …

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FDA tightening watch of AEDs | theheart.org