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FDA gives Mauna Kea the green light for its optical biopsy miniprobe
With 510(k) clearance, French device maker Mauna Kea plans to begin immediate U.S. distribution of its AQ-Flex 19 miniprobe.Mauna Kea Technologies (ENT:MKEA) landed FDA clearance for its AQ-Flex 19...
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Haemonetics plans to cut 320 jobs, move manufacturing to Mexico, Asia
Haemonetics said it plans to cut 320 jobs as its shifts its manufacturing base to Mexico and Asia and posts lower profits for its fiscal 4th quarter and full year 2013.Haemonetics (NYSE:HAE) said it...
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Zimmer to buy Knee Creations
Medical device company Zimmer Holdings said it plans to acquire Knee Creations and its subchondroplasty knee pain treatment for an undisclosed amount.Zimmer (NYSE:ZMH) said it agreed to pay an...
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Boston Scientific leads $9.7M Series B round for Channel Medsystems
Medical device giant Boston Scientific leads a $9.7 million funding round for San Francisco-based cryoablation delivery technology maker Channel Medsystems.Massachusetts-based medical device industry...
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FDA gives Covidien recall highest-risk label
Medical device company Covidien got the FDA's highest-risk classification for its recall of ventilator batteries.The FDA this week put its highest-risk label on medical device maker Covidien's...
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Delcath plunges after FDA panel recommends against liver cancer treatment...
An FDA advisory panel unanimously recommends against approval for Delcath's liver cancer treatment, citing a too-high mortality rate, slashing nearly half the value from the company's stock.Shares of...
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Allergan rebounds after Q1 numbers send shares down 13%
Shares of medical aesthetics giant Allergan initially drop 13% on its Q1 results and a lowered earnings forecast, with shares rebounding toward the end of the week.Allergan (NYSE:AGN) took a ride on...
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InVivo expects to raise $10.4M from early warrants call
Spinal devices maker InVivo Therapeutics expects to raise $10.4 million from a call for early exercise of warrants issued in 2010.Massachusetts-based spinal devices maker InVivo Therapeutics (OTC:NVIV)...
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Over-stenting trial settles ahead of cardiologist Midei's testimony
A civil trial against Dr. Mark Midei, the cardiologist stripped of his Maryland license to practice medicine for alleged "over-stenting," settles a day before Midei's scheduled testimony.The civil...
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Thoratec shares drop 10% on a harsh 1st quarter report
Wall Street sends Thoratec shares down 10% after the company posts a 7% drop in revenue and a 29% slide in profits during its 1st quarter of 2013.Medical device company Thoratec (NSDQ:THOR) took a...
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CardioFocus raises $11M in debt round | Wall Street Beat
CardioFocus raises $11 million for its HeartLight endoscopic ablation system in a round of debt financing from Oxford Finance and Silicon Valley Bank.CardioFocus added $11 million to its coffers in a...
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MassDevice.com +7 | The top 7 med-tech stories for the week of April 29, 2013
If you read nothing else this weekend, make sure you're still in the know with MassDevice +7.Say hello to MassDevice +7, a bite-sized view of the top seven med-tech stories of the week. This latest...
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Masimo gains on Q1 numbers, affirmed guidance
Shares of medical device company Masimo gain on solid 1st-quarter sales and earnings and affirmed sales guidance for the rest of 2013.Masimo (NSDQ:MASI) shares are up following the Irvine, Calif.-based...
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Docs defend Medtronic in brain implant recall, analysts say it's no "big deal"
Despite the FDA's warning and high-risk classification, doctors defending Medtronic's deep-brain stimulation device recall say the issue discovered isn't life-threatening for patients.Minnesota medical...
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MassDevice.com +3 | The top 3 med-tech stories for May 6, 2013
If you read nothing else today, make sure you're still in the know with MassDevice +3.Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of...
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The strange case of the diabetes market
It wasn't so long ago when diabetes was 1 of the hot sectors of med-tech. Times have changed.By Stephen SimpsonNews Well, MassDevice.com Earnings Roundup, 2013, Diabetes, Q1, Wall Street Beatread more
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Boston Scientific wraps up 1st human trial for IntellaTip ablation catheter
Boston Scientific completes a 10-patient feasibility trial for the IntellaTip MiFi XP ablation catheter for treating cardiac arrhythmia.Boston Scientific (NYSE:BSX) said it completed a 10-patient,...
View ArticleJ&J's Ethicon Endo-Surgery wins FDA approval for Sedasys computer-assisted...
Johnson & Johnson's Ethicon Endo-Surgery division finally wins pre-market approval from the FDA for its Sedasys computer-assisted anesthesia device.Johnson & Johnson's (NYSE:JNJ) Ethicon...
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China issues regs for niche pathway for "innovative" medical devices |...
Chinese healthcare regulators issue guidance on a new approval process for "innovative medical devices" that represent the 1st of their kind in the country.MASSDEVICE ON CALL — Chinese healthcare...
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FDA's collaboration with Chinese partners gets stronger each year
FDA's official blog brought to you from FDA's senior leadership and staff stationed at home and abroad - sharing news, background, announcements and other information about the work done at the FDA on...
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