Sonitus Medical revs up Euro launch of behind-the-teeth hearing device

By Mark Hollmer   Sonitus Medical is rolling out its new behind-the-teeth hearing device in Europe and beefing up its executive team as the company expands. The San Mateo, CA ...

I-Flow recalls infusion pumps over deadly flaw

The FDA has flagged the recall with its most serious label By Damian Garde   I-Flow has recalled its ON-Q Pump with OnDemand Bolus Button, and the FDA says a malfunction in ...

DESyne BD Coronary Drug Eluting Stent from Elixir Medical Gets Green Light from EU

By GENE OSTROVSKY Elixir Medical out of Sunnyvale, California received European CE Mark clearance to offer its DESyne BD Novolimus Eluting Coronary Stent System to coronary artery ...

As Salmonella Outbreak Investigation Continues, Retailers Recall Mangoes from Mexico

More than 100 ill in Salmonella Braenderup outbreak BY HELENA BOTTEMILLER Nearly a dozen U.S. retailers have recalled Mexican mangoes for potential Salmonella contamination as federal ...

Boston Sci gets expanded CE mark for Watchman, awaits FDA nod

By Damian Garde   Boston Scientific ($BSX) got some good news for its beleaguered cardiac unit, snagging an expanded indication in Europe for its Watchman device. The tech is ...

New CEO tapped to run armed-antibody biotech Actinium

By John Carroll   Veteran biotech exec Jack Talley has stepped into the top job at Actinium Pharmaceuticals, a low-profile developer which has been pursuing a lengthy effort ...

CareFusion hit with another Class I recall over pump

By Damian Garde   CareFusion’s ($CFN) summer of regulatory discontent isn’t over yet, and the company is in the midst of its fourth Class I recall since June. This ...

EndoStim touts European win for “ideal therapy” for acid reflux

By MassDevice staff EndoStim B.V. lands CE Mark approval in the European Union for its LES Stimulation implant for patients with severe acid reflux disease. Netherlands-based device ...

FDA Warns About Pediatric Codeine-Related Deaths

By: ELIZABETH MECHCATIE, Family Practice News Digital Network   The Food and Drug Administration issued a warning on Aug. 15 about the risk of death in children who receive codeine ...

Australian court approves tobacco pack logo ban

By James Grubel (Reuters) – Australia called on the world to match its tough new anti-tobacco marketing laws that will ban logos on cigarette packs, after its highest court on ...

FDA Issues Update on Burch Farms Melons Recall

Listeria monocytogenes found on honeydew and in packing facility BY HELENA BOTTEMILLER The U.S. Food and Drug Administration is reminding consumers that the Burch Farms cantaloupe ...

Investors punish Given Imaging for FDA pathway, but analysts say ‘relax’

Given Imaging will not pursue FDA approval for PillCam Colon 2 for a general screening indication By Mark Hollmer   Investors were angry, to say the least, at Given Imaging ($GIVN) ...
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