dimecres, 31 de desembre del 2014

Quality assurance for genome editing




Vector is Children's Hospital Boston's blog about research and innovation in pediatric and adult medicine. We report and comment on medical innovations and advances – from bench to bedside – touching on scientific, business and policy issues. Our ranks include science writers, physicians, lab researchers, market analysts and others inside and outside the hospital.








When chromosomes break, the ends can join together in a number of ways, some of which can cause trouble. A new QA method could help researchers avoid making problematic breaks when using gene editing technologies like CRISPR.


By Tom Ulrich




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from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://www.massdevice.com/blogs/massdevice/quality-assurance-genome-editing

dimarts, 30 de desembre del 2014

Ex-MLB player DeCinces asks federal court to throw out case in Abbott-AMO insider trading flap




Ex-Orioles player Doug DeCinces said a Second Circuit decision offers reason to throw out insider trading charges against him involving ex-Advanced Medical Optics CEO James Mazzo.





Feds fight dismissal of charges in Abbott-AMO insider trading case

Doug DeCinces, the ex-professional baseball player for the Baltimore Orioles, embroiled in an insider trading case linked to the former CEO of Advanced Medical Optics, is using a newly decided appeals case in an attempt to get charges against him thrown out of court.




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Another important step in FDA's journey towards enhanced safety through full-scale "active surveillance"




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 behalf of the American public.






By Janet Woodcock, M.D.




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Report: BiOM may file for IPO in 2016




Personal bionics maker BiOM may take its case to the public markets, eyeing a potential initial public offering, according to a report in the Boston Business Journal.






Personal bionics maker BiOM may eventually take its case to the public markets, eyeing a potential initial public offering, according to a report in the Boston Business Journal.




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Elder-care challenges prompt tech execs to create startups, apps




A growing number of high-level Silicon Valley executives from the "sandwich generation" - those who are simultaneously caring for children and parents - have left their jobs to launch mobile and digital health startups








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Medical Device Tax: Rep. Charlie Dent puts repeal at top of GOPs priority list for 2015




Pennsylvania Republican Charlie Dent, who will serve as chairman of the House Ethics Committee in the next Congress, says GOP should focus on repealing the medical device tax immediately.





Rep. Charlie Dent's jobs bill would repeal medtech tax

Rep. Charlie Dent (R-Pa.) says repealing the 2.3% medical device excise tax should be 1 of the GOP's top priorities after it assumes control of both houses of Congress next month.




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Chinese regulators agree to accelerated market access for US medical devices




The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.





Emergo Group

By Stewart Eisenhart, Emergo Group


Chinese government officials have agreed to reduce registration timelines for US medical device manufacturers during bilateral trade talks in Chicago.




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dilluns, 29 de desembre del 2014

Entellus Medical registers for $69m IPO




Entellus Medical, maker of devices to treat clogged sinuses, released plans for a proposed IPO worth as much as $69 million.






Minnesota's Entellus Medical disclosed a proposed initial public offering shortly before Christmas, with plans to raise as much as $69 million.


No date for the offering has been set as of yet. Plans are to trade on the NASDAQ exchange under the symbol "ENTL," according to a regulatory filing.




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Seizure-detecting wristband could prevent sudden death from epilepsy




Vector is Children's Hospital Boston's blog about research and innovation in pediatric and adult medicine. We report and comment on medical innovations and advances – from bench to bedside – touching on scientific, business and policy issues. Our ranks include science writers, physicians, lab researchers, market analysts and others inside and outside the hospital.





By Nancy Fliesler







"My biggest fear is that if I am not there to help him, when I wake him up he will be dead from seizures."





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ITC issues final ruling in ResMed spat with BMC Medical




The International Trade Commission issues a mixed final decision in a patent infringement war over sleep apnea devices between ResMed and China's BMC Medical.








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Covidien inks deal to settle lawsuit over Medtronic merger




Covidien agrees to a deal that would settle a consolidated derivatives lawsuit filed by shareholders looking to block its $43 billion merger with Medtronic.








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India eases foreign ownership rules for medical device makers




India eases restrictions on foreign ownership of companies in its $7 billion medical device industry.






(Reuters) — India has made it easier for foreigners to fully own existing medical device makers in the country, in a bid to boost investment in the $7 billion sector.


The government said Dec. 24 that foreigners wanting to buy 100% of device makers no longer need to get prior approval.



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Judge won't stop Medtronic plan to cover $63m tax tab for execs, directors




A Minnesota federal judge declines to stop Medtronic's plan to cover a $63 million tax tab stemming from its Covidien buyout for its top executives and directors.








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dimarts, 23 de desembre del 2014

Prosthetic arm reads muscle impulses




A prosthetic arm developed in Argentina uses sensors to respond to nerve impulses.





A prosthetic arm developed in Argentina uses sensors to respond to nerve impulses.

REUTERS/Enrique Marcarian. Click image to enlarge





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Ekso raises $23m, needs 510(k)




Robotic exoskeleton maker Ekso Bionics pulls in nearly $23 million, but must pursue 510(k) clearance from the FDA for its main product.








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Year in review: CEOs chime in on 2014




MassDevice.com asks medical device CEOs about the key issues of 2014 and what's ahead for the New Year.






As 2014 draws to a close, MassDevice.com asked several medical device company CEOs for their takes on 2014 and what they're looking for in 2015.


We wanted to get their views on the major trends seen in medtech this year, including the red-hot M&A and IPO scenes, the medical device tax, the regulatory environment in the U.S., and more.




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FDA awards priority review status to Cohera Medical's surgical sealant Sylys | Regulatory news for the week of December 22, 2014




Here's a look at some of the top regulatory stories for medical device companies this week: Cohera's Sylys sealant wins quick review at FDA; Hypertension: CVRx wins FDA nod for Barostim neo legacy; Sorin wins FDA nod for Memo3d ReChord mitral annuloplasty ring; Bio2 Technologies wins FDA nod for bioactive bone scaffolds; FDA approves Cerus blood plasma purification device






Cohera's Sylys sealant wins quick review at FDA


December 18, 2014 by Val Kennedy




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BeneChill files for $14m IPO




BeneChill registers for an initial public offering worth $14 million for RhinoChill brain-cooling device.






The red-hot IPO market for medical device companies shows no signs of abating as the year comes to a close, with BeneChill yesterday tossing its hat in the ring for a nearly $14 million flotation.




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Abbott closes $250m Topera buyout




Abbott says it closed the $250 million buyout of Topera Medical and its cardiac arrhythmia mapping technology.






Abbott (NYSE:ABT) said yesterday that it closed its acquisition of Topera Medical, paying $250 million up front and placing another unspecified amount on the table in performance-based milestones.




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Infraredx files for $55m IPO




Intravascular imaging company Infraredx files for an initial public offering worth $55 million.






Infraredx yesterday registered for an initial public offering with the Securities & Exchange Commission, estimating the flotation's worth at $55 million.


Burlington, Mass.-based Infraredx makes an imaging system that combines intravascular ultrasound and near-infrared spectroscopy to provide images of the interior of coronary blood vessels.




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FDA approves Eos Imaging's 3D orthopedic software




The FDA approves Eos Imaging's hipEos 3D software for planning hip replacement surgeries.






Eos Imaging said the FDA approved its hipEos 3D software for planning hip replacement surgery.


Eos said the software uses patients' anatomical data to create a functional, weight-bearing 3D image that can help physicians determine what size implant to use and how it should be positioned.




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Study: Medtronic's In.Pact Admiral balloon beats standard angioplasty




Medtronic touts a new study showing that its In.Pact Admiral drug-eluting balloon performed better than a standard angioplasty balloon in the treatment of symptomatic peripheral artery disease of the upper leg.








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Seeding medical innovation: The Technology Development Fund




Vector is Children's Hospital Boston's blog about research and innovation in pediatric and adult medicine. We report and comment on medical innovations and advances – from bench to bedside – touching on scientific, business and policy issues. Our ranks include science writers, physicians, lab researchers, market analysts and others inside and outside the hospital.






By Monique Yoakim


Since 2009, Boston Children's Hospital has committed $6.2 million to support 58 hospital innovations ranging from therapeutics, diagnostics, medical devices and vaccines to regenerative medicine and healthcare IT projects. What a difference six years makes.




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dilluns, 22 de desembre del 2014

Zoll Medical to acquire Advanced Circulatory Systems




Zoll Medical agrees to acquire Advanced Circulatory Systems and its noninvasive circulatory support devices for an unspecified amount.






Zoll Medical is averaging an acquisition per month over the fall, announcing its 3rd deal in as many months, this time for Advanced Circulatory Systems and its non-invasive circulation assist devices.




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Iradimed gets MRI infusion pump back on the market




Iradimed's stock shoots up nearly 15% on news that it can return to market with MRI-friendly intravenous infusion pump systems, which were pulled after an FDA inspection.








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2014 in review: Changes at the top for medical device companies




There was a significant amount of turnover this year in the corner offices of medical device companies, including exits by some of medtech's biggest names.






There was a revolving door on medtech's corner office this year, with more than 35 CEOs leaving their positions through planned transitions, retirement or termination, according to a MassDevice.com analysis.




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NxStage Medical wins FDA nod for nocturnal home dialysis




NxStage Medical says it won 510(k) clearance from the FDA for nocturnal home hemodialysis treatments using its System One device.








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Diabetes: Asante Solutions registers for $45m IPO




Modular insulin pump maker Asante Solutions files for a $45 million initial public offering.






Asante Solutions registered for a $45 million initial public offering for its modular Snap insulin pump, which is designed to use pre-loaded insulin cartridges.




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divendres, 19 de desembre del 2014

Meridian Medical Technologies lands $130m Pentagon deal for nerve agent antidotes




The U.S. Defense Dept. agrees to pay Meridian Medical Technologies $130 million to develop auto-injectors that can deliver nerve agent antidotes.






Maryland's Meridian Medical Technologies is moving ahead with a whopping $129.5 million U.S. government contract to develop auto-injectors that can deliver nerve agent antidotes.




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Bio2 Technologies wins FDA nod for bioactive bone scaffolds




The FDA grants 510(k) clearance for Bio2 Technologies' CLM bioactive scaffold wedges.






Massachusetts startup Bio2 Technologies plans a limited rollout in 2015 of its high-tech bioactive bone scaffold wedges, following the FDA's recent 510(k) clearance of the product.




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Medicare drops national coverage decisions for some lobotomies, tinnitus masking, others




The Centers for Medicare & Medicaid Services will officially remove national coverage decisions for 7 procedures under a program initiated in November 2013, including stereotactic cingulotomy, tinnitus masking and more.






The Centers for Medicare & Medicaid Services are removing national coverage decisions for 7 medical procedures, including certain types of lobotomies and tinnitus masking devices, after a year-long review initiated in November 2013.




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Appeals court overturns triple damages in Stryker-Zimmer spat




Zimmer is off the hook for the triple damages it owed Stryker after a patent infringement loss last year.








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Report: FDA grounds plan to test unmanned inspection drones




The FDA reportedly grounds an internal feasibility study of using unmanned drones in facility inspections.






An FDA proposal to test unmanned drones in facility inspections was grounded before it could take flight, according to a report in Regulatory Focus.


An internal FDA memo obtained by the publication revealed that the agency was planning to "perform a test of drone technology" sometime this week.




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Pulmonx taps ex-Asthmatx CEO French for the corner office | Personnel Moves




Pulmonx taps former Asthmatx CEO Glen French to be its new chief executive.





Pulmonx taps ex-Asthmatx CEO French for the corner office | Personnel Moves

Pulmonx said yesterday that it named Glen French, the co-founder and CEO of Asthmatx who led it to an acquisition by BSX, to be its new president and chief executive.




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InSightec names Ferré for board, raises $59m for ExAblate fibroid device | Medtech funding for the week of December 15, 2014




Here's a look at some of the top legal news stories for medical device companies this week: InSightec raises $59m, taps ex-Mako CEO Ferré for board; Engineer looks to crowdfund heart valve; Aethlon sells $3.3m in securities to investment fund; Stealthy Cotera raises nearly $8m for knee implants






InSightec raises $59m, taps ex-Mako CEO Ferré for board


December 15, 2014 by Brad Perriello




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China to cut red tape on imports of medical devices, medicine




The U.S. says it hammered out a deal with China to speed American-made medical devices and drugs to the Chinese market.






(Reuters) — China agreed to allow U.S. medical devices and medicines into local markets more quickly and open up its anti-trust procedures, U.S. Commerce Secretary Penny Pritzker said yesterday after bilateral trade talks between the 2 nations.




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dijous, 18 de desembre del 2014

Cohera's Sylys sealant wins quick review at FDA




The FDA awards priority review status to Cohera Medical's surgical sealant Sylys because the product addresses a significant unmet medical need.






The FDA awarded priority review status to Cohera Medical's surgical sealant Sylys because the product addresses a significant unmet medical need.




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Sonoma Orthopedic raises $12 million for ankle implant




Sonoma Orthopedic Products raises $12 million from First Analysis for its 'flexible-to-rigid' ankle implants.






Sonoma Orthopedic Products added $12 million to its coffers, thanks to private equity shop First Analysis, saying it plans to use the proceeds to get its "flexible-to rigid" ankle implant on the U.S. market.




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AliveCor plans January debut on Amazon for 3rd-gen home heart monitor




AliveCor said it will start selling its 3rd-generation at-home heart monitor on Amazon.com in January, with help from Japanese medtech titan Omron Healthcare.






AliveCor is rolling out a 3rd-generation version of its at-home heart monitor, with plans to put the device on the market at Amazon.com next month.




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FDA OKs expedited enrollment for InVivo study




The FDA approves an expedited enrollment plan for a 5-patient pivotal study testing InVivo Therapeutics' neuro-spinal scaffold devices in the treatment of severe spinal cord injuries.








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Medtronic CEO Omar Ishrak on Covidien deal, value based healthcare at LSA2014


Medtronic CEO Omar Ishrak speaks with Lifescience Alley CEO Shaye Mandle at LSA2014.







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Stealthy Cotera raises nearly $8m for knee implants




Stealthy knee implant startup Cotera reports raising more than $7.8 million in an equity offering.






Stealthy Cotera, a developer of implantable devices to treat knee osteoarthritis, lifted the veil enough to report raising more than $7.8 million in an ongoing equity offering.




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Aethlon sells $3.3m in securities to investment fund




Aethlon Medical deals $3.3 million in securities to an unnamed healthcare-focused investment fund, according to a recent regulatory filing and the company.






Aethlon Medical (OTC:AEMD) said it dealt $3.3 million worth of securities an investment fund, as it pursues various approvals for its Hemopurifier blood filtration device.




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Integra launches regenerative burn treatment




Integra Lifesciences launches its latest skin-regeneration product for 3rd-degree burns and scar contractures that haven't responded to other therapies.





linx




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EU's top court opens door to some stem cell patents




Europe's top court today opened the door to stem cell patents in the European Union, ruling that an organism incapable of developing into a human is not an embryo and may be patented.






(Reuters) — Europe's top court today opened the door to certain stem cell patents in the European Union by ruling that an organism incapable of developing into a human being is not a human embryo and may be patented.




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2014: The year of the medtech IPO | Medtech Wall Street news for the week of December 15, 2014




Here's a look at some of the top Wall Street stories for medical device companies this week: Year in review: 2014 was the year of the medtech IPO; Symmetry Medical closes surgical spinout, OEM sale; Inogen affirms 2014 outlook, predicts 2015 growth of up to 25%









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FDA warns on 'keepsake' ultrasounds




The FDA warns consumers about the health risks of so-called "keepsake" fetal ultrasound imaging and over-the-counter fetal heartbeat monitors.






The FDA wants to dissuade expecting parents from using unregulated fetal ultrasound devices to create "keepsake" images or monitor their babies' heartbeats at home, warning that the devices pose serious risks in untrained hands.




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Biological 'programmers' crack new code in stem cells




Vector is Children's Hospital Boston's blog about research and innovation in pediatric and adult medicine. We report and comment on medical innovations and advances – from bench to bedside – touching on scientific, business and policy issues. Our ranks include science writers, physicians, lab researchers, market analysts and others inside and outside the hospital.








Researchers discovered many small nuances in pluripotency states of stem cells by subjecting the cells to various perturbations and then analyzing each individual cell to observe all the different reactions to developmental cues within a stem cell colony. (Credit: Wyss Institute at Harvard University)


By Kat J. McAlpine




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dimecres, 17 de desembre del 2014

Varian nabs German cancer screening software maker MeVis Medical




Varian Medical Systems says it agreed to pay $37 million to acquire German cancer screening software maker MeVis Medical Solutions.








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Indian authorities scrutinizing medical device pricing practices




The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.





Emergo Group

By Stewart Eisenhart, Emergo Group


The Indian government has begun requesting pricing data from medical device and pharmaceutical product manufacturers in order to more tightly monitor extreme, potentially illegal price variations.




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China halts anti-dumping probe into EU, Japan dialysis kit makers




China closes out an anti-dumoing probe into foreign dialysis kit makers including Fresenius, Nikkiso and Nipro.








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3D printing points to smarter cancer treatment




British researchers develop a new method using 3D printing to create personalized models of cancerous tissues.






(Reuters) — British scientists have developed a new use for 3D printing, putting it to work to create personalized replica models of cancerous parts of the body to allow doctors to target tumors more precisely.




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