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Sleep Apnea dev Invicta Medical raises $21m
Sleep apnea device developer Invicta Medical has raised approximately $21 million in a new round of equity financing, according to an SEC filing posted this week. The Palo Alto, Calif.-based company,...
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Hologic wins CE Mark for MyoSure Manual
Hologic (NSDQ:HOLX) said today it won CE Mark approval in the European Union for its MyoSure Manual device. The MyoSure Manual device features an integrated vacuum with no external suction required,...
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Gore launches FDA IDE Excluder conformable AAA endoprosthesis trial
W.L. Gore & Associates today announced the first implant of its Gore Excluder conformable abdominal aortic aneurysm endoprosthesis in the US as part of an FDA-approved investigational clinical...
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Medical device companies need to worry more about liability: Here’s why
Mike Drues has a piece of advice he likes to repeat to clients of his medical device regulatory consulting business: Don’t fear FDA; fear the product liability attorneys. “You should fear the product...
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Glaukos seeks FDA IDE nod for iStent infinite trial
Glaukos (NYSE:GKOS) said today it submitted an investigational device exemption application to the FDA as it looks to launch a study of its iStent infinite trabecular micro-bypass system. The San...
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FDA issues Class I recall for select J&J Sterilmed Agilis steerable...
The FDA yesterday issued a recall for Johnson & Johnson (NYSE:JNJ) subsidiary Sterilmed’s reprocessed Agilis steerable introducer sheaths over issues with possible air embolisms, labeling the...
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Tandem Diabetes Care launches manufacturing ops at new San Diego plant
Tandem Diabetes Care (NSDQ:TNDM) said today that its new San Diego, Calif.-based manufacturing facility is fully operational. The 50,000 square foot plant doubles the company’s previous manufacturing...
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InVivo to end Inspire trial despite meeting primary endpoint, plans new study
InVivo Therapeutics (NSDQ:NVIV) today released updated results from the Inspire study of its neuro-spinal scaffold but said that it would not be reopening enrollment, which it paused last July, and is...
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Why innovation isn’t the key for treating stroke
Stacy Pugh, VP and general manager of Medtronic’s neurovascular unit Technology and innovation are not the most important things we can do for stroke, according to Stacey Pugh, VP and general manager...
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Egalet teams up with Valeant division to promote pain-relief nasal spray
Egalet (NSDQ:EGLT) has partnered with a division of Valeant Pharmaceuticals (NYSE:VRX), OraPharma, to co-promote its pain-relief nasal spray to dentists and oral surgeons in the U.S. Sprix nasal spray...
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Abbott gains on Morgan Stanley upgrade, touts MR conditional FDA labeling
Abbott (NYSE:ABT) shares have risen approximately 1.3% after the company received an upgrade from a Morgan Stanley analyst and won updated MR-conditional labeling from the FDA for two of its cardiac...
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BD shares get boost from CNBC’s Jim Cramer
Becton Dickinson & Co. (NYSE:BDX) shares have risen nearly 3% since receiving a boost from CNBC Mad Money host Jim Cramer yesterday. Shares rose approximately 1.3% yesterday after Cramer supported...
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Value-based healthcare: Evolent closes $10m deal for New Mexico Health...
Evolent Health (NYSE:EVH) said yesterday it completed its acquisition of commercial business assets from New Mexico Health Connections for approximately $10.3 million in cash. Assets purchased in the...
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These lab-grown blood vessel replacements could benefit dialysis patients
[Image from University of Minnesota]University of Minnesota researchers have developed a blood vessel replacement made of biological materials in a lab. The lab-grown vessels have no living cells at...
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Infusion catheter developer Ablative Solutions raises $4m
Delaware-based Ablative Solutions has raised $4 million as part of a $10 million round, according to regulatory filings. The company is developing the Peregrine System, an infusion catheter that...
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Axonics touts first patients treated in sacral neuromod study
Axonics Modulation Technologies said today that the first 11 patients in its Artisan-SNM sacral neuromodulation study have been implanted with the company’s device designed to treat urinary and bowel...
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Corindus joins with Mayo Clinic in study of tele-robotic stenting
Corindus Vascular Robotics (OTC:CVRS) said today it is working with the Mayo Clinic to launch preclinical studies exploring the use of telestenting, a robotic treatment for percutaneous coronary...
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FDA wants Fresenius to hire a consultant to fix long-standing CGMP woes
The FDA issued a warning letter to one of Fresenius‘ (NYSE:FMS) drug manufacturing plants in India last week, citing concerns that the company has not adequately addressed a sterility problem noted...
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Medical Device Excise Tax set to return early this year
By Stewart Eisenhart, Emergo Group Despite multi-year efforts to fully repeal the Medical Device Excise Tax (MDET) on device sales in the US, the tax appears set to come back into force in early 2018....
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Report slams European Union’s high-risk medical device approvals rate
A health economics and outcomes research group has concluded that the assessment for high-risk medical devices in the European Union is of low quality and needs improvement. The report appears in the...
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