FDAnews Device Daily Bulletin

Companies preparing to comply with the Jan. 1, 2013, imposition of the medical device excise tax face significant stumbling blocks because the Internal Revenue Service (IRS) has yet to issue a final regulation on how the tax will be applied and is not expected to do so before the November elections, according to a panel of tax experts at the AdvaMed 2012 conference here.

Riverside, Calif.-based Pacific Consolidated Industries received a nine-count Form 483 after inspectors from the Irvine, Calif., CDRH office found deviations in the company’s complaint and adverse event handling activities. The report followed a Jan. 31 – Feb. 13 inspection of the portable and mobile air separation equipment maker.

Leaders of the medical device industry expressed confidence last week that the votes are there in the U.S. Senate for a full repeal of the medical device tax, slated to go into effect in January 2013.

A Capital Region medical devicemaker is acquiring a privately held company that makes technology that clears blood vessels blocked by clots.

To overcome the ongoing difficulties and challenges in the spinal business, leading medical device player Medtronic is currently focusing on portfolio expansion.

Natick medical devicemaker Boston Scientific said it has agreed to buy Rhythmia Medical, a Burlington developer of software used in medical procedures.

Sanofi launched the country’s first indigenously manufactured reusable insulin pen, specially tailored for diabetics in India.

A nanotech material containing an extract from liquorice can be used to sterilize and protect medical devices and implants which include biological components, and protects these functional bio-components during the sterilization process.