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FDA clears Nephros after 2015 warning letter
Nephros (OTC:NEPH) said last week it received a notice from the FDA closing out a warning letter the company received last May concerning issues with the manufacturing of a variety of its filtration...
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Ex-Insulet CEO DeSisto is new chief exec at MannKind | Personnel Moves
MannKind Corporation said last week it picked up ex-Insulet (NSDQ:PODD) CEO Duane DeSisto as its new prez and CEO, effective January 5, 2016. DeSisto will replace interim CEO Alfred Mann, who has held...
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HART CEO Green bows out | Personnel Moves
Harvard Apparatus Regenerative Technology (NSDQ:HART) said chairman, president & CEO David Green agreed to bow out but remain on the board as the company seeks a leader with experience in clinical...
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DexCom elevates COO Sayer, Gregg to chairman | Personnel Moves
Dexcom Inc. (NSDQ:DXCM) said it promoted COO Kevin Sayer to president & CEO this week, elevating former chief executive Terry Gregg to executive chairman after 7 years in the corner office. Sayer...
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Nephros expands European distribution deal
Nephros (OTC:NEPH) said it plans to extend and expand its deal with Italian distributor Bellco Srl, adding more countries to their existing deal. Mirandola-based Bellco is focused on providing...
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Nephros plummets 68% on filter recall
Nephros (OTC:NEPH) shares plummeted nearly 68% today after it issued a recall of 3 of its in-line ultrafilters after receiving reports of bacterial contamination that may have led to a patient’s...
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Report: CMS Innovation Center’s 1st chief on the way out
Dr. Richard Gilfillan, the 1st leader of the recently-created Center for Medicare & Medicaid Services Innovation Center, will hand over the reigns at the end of the month, and no replacement has...
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AtriCure prices $24M stock offering | Wall Street Beat
AtriCure (NSDQ:ATRC) priced a public offering of nearly 3.5 million shares of stock at $7.25 per share, saying it expects net proceeds of about $23.5 million. The West Chester, Ohio-based medical...
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FDA clears Ethicon’s 1st surgical set docs can assemble inside the body |...
Johnson & Johnson (NYSE:JNJ) Ethicon Endo-Surgery won FDA clearance for the 1st surgical instruments that can be assembled and disassembled inside the body during surgery. Ethicon’s Percutaneous...
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Amgen mourns death of founder George Rathmann | Personnel Moves
Amgen mourns death of George Rathmann, founding CEO Biotech giant Amgen‘s (NSDQ:AMGN) founding CEO George Rathmann died this week at the age of 84. In his final years, Rathmann was a dialysis patient...
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Abbott, St. Jude Medical re-up ‘cardiovascular alliance’| Wall Street Beat
Abbott (NYSE:ABT) and St. Jude Medical (NYSE:STJ) are renewing and expanding an alliance to co-market their cardiovascular products, including Abbott’s market-leading Xience coronary stent line. The...
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Bovie swings to 2011 black | Earnings Roundup
Bovie Medical swings to 2011 black Bovie Medical (NYSE:BVX) posted losses of $876,000, or 5¢ per share, on sales of $6.2 million during the 3 months ended Dec. 31, 2011. That compares with losses of...
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Ex-J&J CEO Weldon to walk with $143.5M in retirement | Personnel Moves
Outgoing Johnson & Johnson (NYSE:JNJ) CEO William Weldon will take home $143.5 million in retirement benefits when he walks in April. The veteran J&J employee racked up more than $95 million...
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GE Healthcare begins PMA process for 3D breast scanner | Regulatory Roundup
GE Healthcare (NYSE:GE) filed the first module of its pre-market approval application for the breast tomosynthesis option of its Senographe Essential system. The health care giant said the first...
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FDA approves first drug-eluting implant for chronic sinusitis | Regulatory...
Intersect ENT Inc. announced a landmark win for its flagship Propel drug-eluting implant for treatment of chronic sinusitis. The Palo Alto, Calif.-based company’s device claims to be the first of a...
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Nephros corporate strategy update highlights CEO search
Therapeutic filtration company Nephros Inc. (OTC:NEPH) unveiled a new corporate strategy this week, highlighting the search for a new chief executive to replace acting CEO Dr. Paul Mieyal. "Nephros’s...
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Penis stimulation device touts landmark FDA clearance for erectile...
Reflexonic LLC landed FDA clearance for the first hand-held, non-pharmaceutical device intended to help men with moderate erectile dysfunction, poor maintenance and rigidity or spinal cord injuries...
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Cambridge Heart’s Q1 sales slide on Cardiac Science buyout | Earnings Roundup
Cambridge Heart Inc. (OTC:CAMH) took a hit during the first quarter, as last year’s acquisition of partner Cardiac Science helped drive sales down 3.2 percent, even as it prepped an offering to raise...
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Derma Sciences sales jump 16 percent | Earnings roundup
MassDevice keeps a close eye on public medical device companies, tracking their quarterly sales and earnings reports. For the most recent filings, check out our Earnings Roundup, where we collect each...
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CardioDx drums up $57 million for genetic tests | Funding roundup
CardioDx Inc. raised $57.5 million from equity and options investments, according to its latest filing with the Securities & Exchange Commission. The Palo Alto, Calif.-based genomics firm is...
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