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Hill-Rom rises on Q3 prelims, needs new CFO

July 18, 2013 by Brad Perriello

Hill-Rom Holdings releases its preliminary 2nd-quarter results and says CFO Mark Guinan is leaving the medical device company.

Hill-Rom rises on Q3 prelims, needs new CFO

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Rusckowski out, DiSanzo in at Philips Healthcare

April 11, 2012 by MassDevice staff

Deborah DiSanzo is the new CEO of Philips Healthcare as Steve Rusckowski departs to take the corner office at Quest Diagnostics.

Philips Healthcare

Steve Rusckowski is leaving the corner office at Philips Healthcare (NYSE:PHG) to succeed Quest Diagnostics (NYSE:DGX) CEO Surya Mohapatra.

Conceptus names new CEO, lowers 2012 guidance | Personnel Moves

December 8, 2011 by MassDevice staff

Conceptus lowers its sales guidance for 2012 for the third time and names Keith Grossman its new president & CEO after the sudden resignation of Mark Sieczkarek.

Conceptus logo

In a sudden switch, Conceptus (NSDQ:CPTS) named Keith Grossman president & CEO upon the resignation of Mark Sieczkarek, whose departure was announced on the heels of lowered sales guidance for 2012.

Sieczkarek's resignation, after 7 years at the helm, was announced simultaneously with Grossman's appointment. Grossman will join the company's board of directors, from which Sieczkarek also resigned.

Med-tech industry to FDA: IOM's 510(k) report falls way short

September 21, 2011 by MassDevice staff

The Institute of Medicine's report on the FDA's 510(k) clearance process for medical devices is effectively meaningless, industry reps tell the watchdog agency.

MDUFMA

The Institute of Medicine's report on the FDA's 510(k) clearance process for medical devices falls so far out of the scope of the questions it was meant to answer that it's essentially meaningless, med-tech industry reps told the agency during negotiations over re-authorizing the Medical Device User Fee & Modernization Act.

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Kidney dialysis in a purse | MassDevice.com On Call

August 17, 2011 by MassDevice staff

Awak Technologies shrinks hemodialysis down to the size of a purse, hopes to submit for E.U. and U.S. regulatory review in 2013.

MassDevice On Call

MASSDEVICE ON CALL — Singapore's Awak Technologies Pte. has cut a dialysis machine down to the size of a purse with its portable, wearable artificial kidney.

The product is undergoing animal and lab tests in Singapore and the company hopes to submit data for European and U.S. regulatory review in 2013.

Several U.S. companies are simultaneously developing their own wearable hemodialysis machines, but none have yet hit the market, the Wall Street Journal reported.

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Medsquire sues Quest, HP, 12 others in HIT patent spat

May 31, 2011 by MassDevice staff

Medsquire LLC sues 14 companies, including Quest Diagnostics, Hewlett-Packard and Athenahealth, over a patent covering part of an electronic medical records software patent.

MassDevice.com Legal News

Medsquire LLC slapped 14 companies, including some of corporate America's biggest names, with a patent infringement lawsuit covering electronic medical records systems.

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FDA approves low testosterone gel from Abbott | Regulatory roundup

April 30, 2011 by MassDevice staff

Abbott Laboratories wins Food & Drug Administration approval for AndroGel, a testosterone gel to help correct for under-performing testicles.

Clearances roundup

Abbott Laboratories (NYSE:ABT) landed FDA approval for a new testosterone-boosting product.

The company's AndroGel 1.62% is treatment for male low testosterone levels, also know as hypogonadism, which affects nearly 14 million men in the United States, according to the company.

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