All Articles in: USA

U.S. First-In-Man Laparoscopic Cholecystectomy with Fortimedix Surgical’s Lowest Profile Single-Port Surgery SolutionOctober 10, 2016

FMX314 is the world’s first single-port surgery solution that is compatible with a standard 15mm trocar for MIS abdominal laparoscopic surgery.

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Smartinhaler™ Company Sets Stall Out in U.S.March 24, 2016

Adherium establishes North American operation and appoints Senior Vice President of Business Development to lead market expansion

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New Drug Delivery Device Company, Medallion Therapeutics Emerges from Alfred Mann FoundationMarch 6, 2014

An implantable drug delivery pump forms the basis of a new company, Medallion Therapeutics, Inc., which has sprung from the Alfred Mann Foundation (AMF) for Scientific Research.

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HIMSS Congress Sees Launch of SmartLinx™ Medical Device Information SystemFebruary 24, 2014

Medical device integration solutions company Capsule Tech, Inc., is using the HIMSS event in Florida this week to announce the introduction of its SmartLinx™ Medical Device Information System.

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Metal-on-Metal Hip Ends Up Costing Biomet $56 MillionFebruary 4, 2014

Biomet, Inc. has reached a settlement amounting to $56 million in Multi-District Litigation (MDL) 2391 relating to its M2A Magnum Hip Implant Products.

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Legalists Point to Surgical Robot Training and Technical FailingsNovember 27, 2013

Law firm Bernstein Liebhard LLP has issued a press release that brings us up to date, pointing in particular to a piece of research that suggests 30% of robotic surgery complications using Intuitive’s da Vinci system, as reported on the FDA’s MAUDE database, were either a result of operator error or technical failure of the robotic system itself.

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Ethicon Reality Checks into Collaboration with Megadyne®November 22, 2013

Ethicon Endo-Surgery, Inc. and Megadyne®, Inc have both issued press releases, confirming that they have entered into a collaboration agreement. The deal will see customers offered a contracting solution that incorporates the two companies’ combined product offerings, increasing choice and access to a broad energy portfolio.

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Johnson & Johnson Considering $3 Billion Settlement of DePuy Hip Implant LawsuitsNovember 1, 2013

Johnson & Johnson is considering a settlement with injured hip implant patients that could total more than $3 billion. Sources close to the matter have told Bloomberg that the company is weighing their options in settling thousands of cases involving DePuy hip implants that have been linked to early failure rates and a host of serious complications.

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Could “Pacemaker Tax” Provide the Wriggle Room to End Obamacare Deadlock?October 1, 2013

It looks like the US medtech sales tax could be the straw that breaks the camel’s back, as concessions need to be made to get the budget approved. Whether a repeal would be enough to cajole republicans into accepting Obamacare is doubtful, but it just might be.

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MIS Rib Fracture Fixation with US Launch of Depuy Synthes CMF MatrixRIB™ SystemSeptember 12, 2013

DePuy Synthes CMF has announced the U.S. launch of new instrumentation that enables less invasive surgical fixation and stabilization of rib fractures. The MatrixRIB™ System offers precontoured, low-profile titanium plates, locking screws and intramedullary splints.

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Medlatest’s Weekly Editorial Online NowMarch 15, 2013

In the western world’s chase for technological advancement and the less savoury side of human nature it occasionally brings to the surface, perhaps we should reflect on the life of the Iraqi girl with one leg and no prospects. Just to even things up a bit.

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Metal-on-Metal Vultures CirclingMarch 12, 2013

Law firm, Legal Bay has issued this release following the jury’s massive award to Loren Kransky, plaintiff against J&J DePuy. It’s predicting many many more such cases.

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Alcon On FDA’s “Very” Naughty Step For Improperly Marketing Its LaserFebruary 25, 2013

This envelope must have been an unpleasant one to open. Following an inspection of Alcon Inc.’s Aliso Viejo site in California, the agency wrote a stinging warning letter to the company citing a number of serious shortfalls in its activities.

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12%, 37% or 49%? What Exactly Is DePuy’s All-Metal Hip Failure Rate At 5 YearsJanuary 24, 2013

Bloomberg has reported on the pre-trial testimony of Paul Voorhorst, a DePuy biostatistician, as a preamble to proceedings in the case of Loren Kransky vs J&J (DePuy), for which the jury sits tomorrow (Friday 25th January). In it, previously unseen documents suggest that the company’s own estimates of failure rate for some of its metal-on-metal hip prostheses are now as high as 37%, significantly higher than the 12 or 13% cited in the original recall notices.

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St.Jude’s To-do List: Secure Durata Coating Supply, Tick. Next Job, Address FDA Warning LetterJanuary 15, 2013

St.Jude’s shareholders are a resilient lot. It’s been bad stuff on top of bad stuff for ages, but now that Durata seems to be weathering the storm and the coating supply deal is secured, there’s just the simple matter of dealing with a stern warning letter from the FDA over its practices.

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Class I Recall For Ethicon’s SurgiFlo Due To Potential for Packaging BreachDecember 17, 2012

Ethicon, a division of J&J, has identified an issue in the packaging process for its SurgiFlo haemostatic matrix. It seems certain products, manufactured between September 16 2011 and July 27 2012 are susceptible to a potential breach of the double Tyvek pouch of the packaging.

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