FDA warns on ERCP endoscope, CRE "superbug" link

The FDA warns ERCP endoscopes may allow for the transmission of certain drug-resistant "superbugs," even if the devices are properly cleaned.

The FDA is warning that ERCP endoscopes may allow for the transmission of certain drug-resistant "superbugs," even if the devices are properly cleaned.

The advisory was issued in the wake of news that contaminated endoscopes are suspected of causing a deadly outbreak of the superbug CRE, or carbapenem-resistant enterobacteriaceae (CRE), among patients at the UCLA Ronald Reagan Medical Center in Los Angeles.

Food & Drug Administration (FDA), Fujifilm Medical Systems U.S.A. Inc., Olympus, Pentax Medical

News Well, Patient Safety, Endoscopic / Arthroscopic

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Varicose vein treatment VenaSeal wins FDA approval

Federal regulators say they have approved the VenaSeal closure system to treat varicose veins

Covidien's VenaSeal closure system to treat varicose veins has been approved by the U.S. Food and Drug Administration, according to an agency press release.

Covidien, Food & Drug Administration (FDA)

News Well, Food & Drug Administration (FDA)

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Diabetes: CeQur touts study showing improvement in glycemic control

CeQur SA is touting preliminary results from study that evaluates long-term glycemic control produced by its wearable insulin delivery device.

CeQur SA, developer of a 3-day, wearable insulin delivery device, is touting promising preliminary results from a new study evaluating its glycemic control over three months.

The Horw, Switzerland-based company, said that early data from the trial shows its PaQ device consistently improved glycemic control in patients with type 2 diabetes. That conclusion comes from a single-arm treat-to-target 12-week pilot study involving eight people with the condition.

CeQur SA

News Well, Clinical Trials, Diabetes

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Report: Infraredx delays $56M IPO

Infraredx delays $56M IPO, according to a report from invesment advisory firm Renaissance Capital

InfraReDx Inc., Renaissance Capital

News Well, Initial Public Offering (IPO)

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TE Connectivity to Acquire AdvancedCath

SCHAFFHAUSEN, Switzerland – February 18, 2015 – TE Connectivity Ltd. (NYSE: TEL), a world leader in connectivity, announced today that it has entered into a definitive agreement to acquire AdvancedCath for $190 million USD in cash.

AdvancedCath is a leading source of advanced catheter systems, with estimated 2015 revenues of $60 million. The company combines best-in-class technologies with industry-leading expertise in lifesaving therapy areas.

The acquisition complements and significantly expands TE's connectivity and sensor position in the attractive, high-growth interventional space of the medical market. Further, it will allow TE to provide more complete integrated solutions to customers.

AdvancedCath

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SNN invests in Michelson's Series B | Medtech funding for the week of February 16, 2015

Here's a look at some of the top legal news stories for medical device companies this week: Smith & Nephew gets in on Michelson Diagnostics Series B round; Diabetes: Valeritas registers $90m IPO; HeartFlow raises $36m for non-invasive FFR system; Bellerophon prices $60m IPO low, issues more shares; Rainbow Medical raises $25m for China ops

Smith & Nephew gets in on Michelson Diagnostics Series B round

February 16, 2015 by Brad Perriello

Bellerophon Therapeutics, HeartFlow, Michelson Diagnostics, Rainbow Medical, Smith & Nephew, Valeritas Inc.

News Well, Funding Roundup

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FDA approves 23andMe's genetic screening test for rare disorder

Google-backed 23andMe won U.S. approval to market direct-to-comsumer genetic test

(Reuters) - Google (NSDQ:GOOG)-backed 23andMe won

U.S. approval on Thursday to market the first direct-to-consumer

genetic test for a mutation that can cause children to inherit

Bloom syndrome, a rare disorder that leads to short height, an

increased risk of cancer and unusual facial features.

23andMe Inc., Google Inc.

News Well, Food & Drug Administration (FDA)

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