dijous, 30 d’abril del 2015

'Disappearables': As sensors shrink, will wearables become obsolete?

Rapidly advancing sensor technology may wind up making wearable device obsolete.

'Disappearables': As sensors shrink, will wearables become obsolete?

(Reuters) — Forget "wearables," or even "hearables." The next big thing in mobile devices: "Disappearables."

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MassDevice.com +3 | The top 3 medtech stories for April 30, 2015

Plus 3

Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com's coverage highlights our 3 biggest and most influential stories from the day's news to make sure you're up to date on the headlines that continue to shape the medical device industry.

 

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Skin in the game: Can risk sharing energize medtech?

Everyone wants advances in medical technology, but getting paid for innovation is tough even with the most convincing story about improving care and saving costs. Hospitals are understandably skeptical; can these magical benefits be realized in our institution, or will we just get stuck with the bill? Better to keep doing what we do now, right? As advisors to companies attempting to create and grow markets for new medical technologies, usually without killer data or labeling out the gate, S2N is keenly aware of the current economic realities in healthcare. But we also believe there is measurable value in many med tech innovations. So how do innovators persuade customers, particularly early ones, to take that leap of faith to gain a foothold, or even a toehold, in the market?

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The silk scaffold: A promising road to hollow organ reconstruction

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.

The silk scaffold: A promising road to hollow organ reconstruction

By Maureen McCarthy

Silk production and global interest in the lustrous fiber date back to prehistoric times. Today, the natural protein is solidifying itself as a biomaterials alternative in the world of regenerative medicine.

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Study: Low-battery defib revisions costly

A Boston Scientific-sponsored study finds that replacing implantable cardiac devices due to battery expirations adds extra costs and complications.

Study: Low-battery defib revisions costly

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US FDA identifies more than 20 PMA devices eligible for reclassification to Class II

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 US Food and Drug Administration's Center for Devices and Radiological Health (CDRH) has identified 21 medical device product codes as candidates for reclassification from Class III to Class II as part of a broad review of pre- and post-market data collection processes.

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Medtronic: Strong data from real-world Endurant AAA stent graft registry

A new analysis of more than 1,200 patients treated with Medtronic's Endurant AAA stent graft showed 'strong results' in short- and standard-neck abdominal aortic aneurysms.

Medtronic: Strong data from real-world Endurant AAA stent graft registry

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Surprise CE Mark for Stentys Xposition S stent

Stentys says CE Mark approval in the European Union for its Xposition S stent came ahead of schedule.

Surprise CE Mark for Stentys Xposition S stent

Stentys this week said it won a CE Mark ahead of schedule for its latest self-apposing coronary stent, a product that will be used with delivery system technology it acquired last June.

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Smith & Nephew 'working hard' on acquisitions trail, CEO says

Smith & Nephew CEO Olivier Bohuon says the company is 'working hard' on the acquisitions trail, looking to expand its emerging markets footprint and evaluating early-stage bolt-ons.

Smith & Nephew 'working hard' on acquisitions trail, CEO says

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Boston Scientific gets into value-based healthcare

Boston Scientific gets into the value-based healthcare business, inking deals with MedAxiom and TogetherMD to help build out its Advantics offering.

Boston Scientific gets into value-based healthcare

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FDA approves MRI-safe SCS device from St. Jude Medical

The FDA approves St. Jude Medical's Protégé MRI spinal cord stimulation device for head and extremity MRI scans.

FDA approves MRI-safe SCS device from St. Jude Medical

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Renal denervation: Medtronic launches afib trial

Medtronic says it's launching a clinical trial evaluating renal denervation and cardiac ablation in treating atrial fibrillation.

Renal denervation: Medtronic launches afib trial

Medtronic (NYSE:MDT) today said it's launching a study of a new, combination treatment for atrial fibrillation using renal denervation and cardiac ablation.

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Zimmer cuts outlook on strong dollar, Biomet synergies

Zimmer Holdings, which is set to close its $13 billion merger with Biomet next month, cuts its 2015 earnings outlook on the continued strengthening of the U.S. dollar and better-than-forecast synergies from the union.

Zimmer cuts outlook on strong dollar

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In brief: European regulators make radio and wireless revisions, update website

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

Although major news regarding new European medical device regulations remains forthcoming, European Commissioners have recently rolled out a new directive for devices using wireless components and reorganized their website so that manufacturers can more easily research laws and regulations beyond the Medical Device Directives that may also require compliance.

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dimecres, 29 d’abril del 2015

Wright Medical delays Augment timeline

Wright Medical says it now expects its Augment bone graft to win FDA approval in the 2nd half of the year, not next month as previously forecast.

Wright Medical delays Augment timeline

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MassDevice.com +3 | The top 3 medtech stories for April 29, 2015

Plus 3

Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com's coverage highlights our 3 biggest and most influential stories from the day's news to make sure you're up to date on the headlines that continue to shape the medical device industry.

 

read more



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Alliqua prices $30m offering

Alliqua Biomedical prices a $30 million offering for its hydrogel wound care products.

Alliqua prices $30m offering

Alliqua Biomedical (NSDQ:ALQA) today said it priced a public stock offering worth $30 million for its hydrogel wound care technology.

The Langhorne, Pa.-based company said it plan to offer nearly 6.9 million shares at $4.55 apiece.

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WHO: Few countries ready for 'superbug' fight

Few countries are prepared to deal with so-called 'superbugs,' or antibiotic-resistant infections that put even basic healthcare at risk.

WHO: Few countries ready for 'superbug' fight

(Reuters) — Only 34 countries have national plans to fight the global threat of antibiotic resistance, meaning few are prepared to tackle the "superbug" infections that put even basic healthcare at risk, the World Health Organization said today.

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Lombard Medical takes out $26m loan for Aorfix stent graft

Lombard Medical takes out a $26 million term loan from Oxford Finance to back the global rollout of its Aorfix stent graft for treating abdominal aortic aneurysms.

Lombard Medical takes out $26m loan for Aorfix stent graft

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NuVasive settles Justice Dept. probe for $14m

NuVasive says it agreed to pay nearly $14 million to settle a U.S. Justice Dept. probe into possible Medicare fraud.

NuVasive settles Justice Dept. probe for $14m

NuVasive Inc. (NSDQ:NUVA) today said it agreed to pay $13.8 million to settle a U.S. Justice Dept. probe into possible healthcare fraud.

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Study finds biomarkers linked to NFL players' brain injuries

Researchers at the Boston University School of Medicine & Exosome Sciences say they've spotted blood biomarkers linked to a neurodegenerative brain condition in patients who suffer repeated brain trauma.

Study finds biomarkers linked to NFL players' brain injuries

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Stryker inks $3m settlement in Howmedica reimbursement suit

Stryker pays $3 million to settle a class-action lawsuit filed by a former sales rep who alleged that its Howmedica subsidiary failed to reimburse employees for business expenses.

Stryker inks $3m settlement in Howmedica reimbursement suit

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Boston Scientific's Mahoney is bullish on Watchman

Boston Scientific CEO Mike Mahoney is bullish on the company's Watchman anti-stroke device, saying he wants to double the number of hospitals offering the treatment beginning in the 3rd quarter.

Boston Scientific's Mahoney is bullish on Watchman

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A biomarker for Rett syndrome: Measuring hand movements

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 Alice McCarthy

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dimarts, 28 d’abril del 2015

Boston Scientific inks DBS deal with Brainlab

Boston Scientific inks a deal to distribute Brainlab's deep-brain stimulation surgical planning software along with its own Vercise DBS system in select countries.

Boston Scientific inks DBS deal with Brainlab

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FTC: We might force M&A divestitures in outside markets

The U.S. Federal Trade Commission says it may force companies to sell off assets outside the market it's seeking to keep competitive.

FTC: We might force M&A divestitures beyond the market

The U.S. Federal Trade Commission last week said it may force companies to divest assets outside of the market the anti-monopoly bureau its trying to regulate.

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MassDevice.com +3 | The top 3 medtech stories for April 28, 2015

Plus 3

Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com's coverage highlights our 3 biggest and most influential stories from the day's news to make sure you're up to date on the headlines that continue to shape the medical device industry.

 

read more



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Majestic: Boston Scientific reveals 9-month Eluvia data for PAD

Boston Scientific reveals 9-month data from the Majestic trial of its Eluvia stent for treating peripheral artery disease.

Majestic: Boston Scientific reveals 9-month Eluvia data for PAD

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Boston Scientific inks $119m pelvic mesh deal

Boston Scientific agrees for the 1st time to a $119 million settlement of product liability lawsuits brought over its pelvic mesh offerings.

Boston Scientific inks $119m pelvic mesh deal

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Globus: Witness for J&J's Synthes faked credentials

Globus Medical wants a federal judge to toss its $16 million loss to Johnson & Johnson's Synthes division because a key expert witness faked his credentials.

Globus: Witness for J&J's Synthes faked credentials

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UDI is here: Seven things you need to know

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

Now that US medical device regulators have begun implementing their Unique Device Identification (UDI) system, many device manufacturers are questioning how best to comply with the new requirements in the most efficient manner possible. At Emergo, we've identified seven key (and common) issues firms should consider as they undertake their UDI compliance projects.

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Philips Healthcare's Q1 operating profits plunge

Profits for Royal Philips' healthcare business plunge more than 84% during the 1st quarter.

Philips Healthcare's Q1 operating profits plunge

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FDA panel on aneurysm devices | Regulatory news for the week of April 27, 2015

Here's a look at some of the top regulatory stories for medical device companies this week: FDA panel issues aneurysm device recommendations; Burr introduces fast-track FDA bill; Medtronic wins EU approval for MRI-safe Activa DBS devices; FDA approves Siemens 3D breast tomo device; Maquet's TigerPaw II recall is Class I

FDA panel issues aneurysm device recommendations

April 21, 2015 by Brad Perriello

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Haemonetics ends its fiscal year in Q4 red

Haemonetics ends its 2015 fiscal year in the red, posting a loss for the 4th quarter on uncertainty in Russia, currency fluctuations and restructuring costs.

Haemonetics ends year in the red

Haemonetics (NYSE:HAE) finished out its 2015 fiscal 4th quarter in the red, hammered by a U.S. market shift that affected its blood center business, uncertainty in Russia, currency fluctuations and restructuring.

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FDA closes out CryoLife warning letter, PerClot trial launches

CryoLife says the FDA closed out a 2013 warning letter sent over problems at a Georgia plant and announces the launch of a clinical trial for its PerClot surgical hemostasis powder.

FDA closes out CryoLife warning letter, PerClot trial launches

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ACC issues 'urgent' message, but to whom?

Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicago's Pritzker School of Medicine.

By Westby G. Fisher, MD, FACC

Westby Fisher

The American College of Cardiology (ACC) leadership, troubled by the "complex situation" presented by the changes in re-certification by the American Board of Internal Medicine (ABIM), issued an "urgent message" yesterday on their blog.

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FLASH: Boston Scientific swings to Q1 loss on legal charges

Boston Scientific swings to 1st-quarter red ink on a $193 million legal tab.

FLASH: Boston Scientific swings to Q1 loss on legal charges

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Intarcia adds $225m for Type II diabetes trial

Intarcia adds $225 million to its coffers to fund a clinical trial and commercialization of its drug-device combination to treat Type II diabetes.

Intarcia adds $225m for Type II diabetes trial

Intarcia Therapeutics yesterday took its total raise to more than $1 billion with a $225 million funding round it plans to use to run clinical trials and commercialize its the drug-device combination treatment it's developing for Type II diabetes.

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dilluns, 27 d’abril del 2015

Medtronic agrees to FDA deal over SynchroMed, neuromodulation system

Medtronic says it agreed to the terms of a consent decree with the FDA over its SynchroMed drug-infusion pump and its neuromodulation quality system.

Medtronic inks deal with FDA over SynchroMed, neuromodulation system

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Key Strategies to Staying in Control of Your Study Financial Forecast

Halloran logo

By Dyana Boutwell

I know, clinical financial forecasting is everyone's favorite topic. Don't hold back your excitement in wanting to think all about your budget management responsibilities. Now is it because you are struggling to keep on top of your study budget? Is your forecast up, down, up again, and you are seeing fire come from the eyes of your Finance rep? I've been there. I've seen the fire. And I'd like to take this opportunity to give you some key pointers to throwing the bucket of water so all is peas and carrots at the monthly Finance meeting.

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MassDevice.com +3 | The top 3 medtech stories for April 27, 2015

Plus 3

Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com's coverage highlights our 3 biggest and most influential stories from the day's news to make sure you're up to date on the headlines that continue to shape the medical device industry.

 

read more



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Maquet's TigerPaw II recall is Class I

The FDA issues a Class I recall of Maquet's TigerPaw left atrial appendage closure device.

FDA recalls Maquet's TigerPaw II device

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Inside the Lancet Commission on Global Surgery: A conversation with John G. Meara

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.


John G. Meara, MD, plastic surgeon-in-chief at Boston Children’s Hospital, co-chaired the Lancet Commission on Global Surgery, which released its findings today.

By Jenny Fernandez and Ray Hainer

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Contego Medical raises $6m for embolic filter tech

Contego Medical raises nearly $6 million in a Series B round it plans to use to expand its roster and develop its embolic protection balloon and stent-delivery systems.

Contego Medical raises $6m for embolic filter

Contego Medical said it pulled in $5.6 million in a Series B round to advance its embolic protection technology for angioplasty balloon and stent-delivery catheters.

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Medtronic launches Endurant Evo stent graft trial

Medtronic launches a clinical trial of its Endurant Evo stent graft for treating abdominal aortic aneurysms.

Medtronic launches Endurant Evo stent graft trial

Medtronic (NYSE:MDT) today said it launched a clinical trial of its Endurant Evo stent graft for treating abdominal aortic aneurysms.

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Medtech approvals: FDA releases February 2015 PMAs

The U.S. Food & Drug Administration releases a list of pre-market approvals granted in February 2015.

FDA logo

Summary of PMA Originals & Supplements Approved

Originals: 2
Supplements: 62
Summary of PMA Originals Under Review

Total Under Review: 62
Total Active: 29
Total On Hold: 33
Summary of PMA Supplements Under Review

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Appeals court MDT win in InFuse case | Medtech legal news for the week of April 27, 2015

Here's a look at some of the top legal news stories for medical device companies this week: Appeals court upholds preemption ruling in Medtronic InFuse lawsuit; Appeals court declines Medtronic's review bid in NuVasive spat; Cochlear Ltd. wins reprieve in $131m patent loss to Advanced Bionics; Arthrex loses another appeal bid in $35m loss to KFx; Supremes deny BD bid for appeal in Retractable Technologies case

Appeals court upholds preemption ruling in Medtronic InFuse lawsuit

April 22, 2015 by Brad Perriello

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Guided Therapeutics eyes China with $775k share sale

Guided Therapeutics raises $775,000 from Chinese investors to pursue distribution in the People's Republic for its LuViva cervical scanner.

Guided Therapeutics eyes China with $775k share sale

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Invuity registers for $69M IPO

Advanced surgical lighting maker Invuity registers for an initial public offering worth $69 million.

Invuity registers for $69M IPO

Invuity this month filed registration papers for an initial public offering that could bring in as much as $69 million for the advanced surgical lighting maker.

San Francisco-based Invuity said it plans to list on the NASDAQ exchange under the "IVTY" symbol.

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Punitive damages claims stand in Boston Scientific pelvic mesh case

Claims for punitive damages can stand in 1 of the 15,000 product liability lawsuits filed over Boston Scientific's pelvic mesh devices, a federal judge rules.

Punitive damages claims stand in Boston Scientific pelvic mesh case

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Tendyne mitral valve study launches in U.S.

Minnesota's Tendyne Holdings says its transcatheter mitral valve implant was successfully implanted in its 1st U.S. patient.

Tendyne mitral valve study launches in U.S.

Tendyne Holdings this month said its transcatheter mitral valve implant was implanted in the 1st U.S. patient as part of a global feasibility study.

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