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Medigus wins nod to start Chinese trial for Muse transoral stapler
Medigus (TLV:MDGS) said today it won approval from the China Food and Drug Administration to initiate a clinical study of its Muse endoscopic device designed for trans oral fundoplication procedures to...
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NuVasive wins $9m tax break for Tennessee distro hub
The Economic Development and Growth Engine for Tennessee’s Memphis and Shelby County yesterday approved a $9 million, 11-year PILOT tax incentive for NuVasive Inc. (NSDQ:NUVA), which has distribution...
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InTouch Health releases expanded telehealth suite
InTouch Health said today it launched an expanded range of FDA Class II telehealth devices and software including dedicated tablets and software solutions to enable telehealth delivery. The Santa...
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Arch Therapeutics bumps up dates for FDA submission on AC5 hemostasis device
Arch Therapeutics (OTC:ARTH) today announced it accelerated the timeframe for FDA 510(k) clearance submission for its AC5 hemostasis device, moving from late 2017 to mid-2017. The Framingham,...
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GI Dynamics touts preliminary Endobarrier data in adolescent prediabetes...
GI Dynamics (ASX:GID) today released preliminary findings from the 1st clinical trial evaluating the use of its EndoBarrier treatment for obesity in adolescents, touting a 10% decrease in BMI with no...
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How surgical robots are creating super surgeons
Faster than a scalpel-wielding hand, able to snake to hard-to-reach surgical sites in a single bound—future surgeons will be super surgeons, all thanks to robotics. Alistair Fleming, VP Medical at...
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Chinese regulators modify IVD classification requirements
By Stewart Eisenhart, Emergo Group Regulators at the China Food and Drug Administration (CFDA) have issued a new order affecting how in vitro diagnostic (IVD) devices are classified according to risk...
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Senate bill aims to streamline FDA inspections process
A bill filed this week in the U.S. Senate seeks to streamline FDA inspections of medical device manufacturers by creating a more transparent, risk-based approach applied consistently across the federal...
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Japan approves Medtronic’s Micra leadless pacemaker
Medtronic (NYSE:MDT) said today that Japanese regulators approved its Micra leadless pacemaker, which it claims as the world’s smallest pacemaker. At 1/10th the size of a conventional pacemaker, or...
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Vascular Solutions shareholders approve $1B Teleflex takeover
The $1 billion takeover of Vascular Solutions (NSDQ:VASC) by Teleflex (NYSE:TFX) is slated to close today after Vascular Solutions shareholders yesterday approved the deal. The $56-per-share sale...
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Insulet touts Omnipod Horizon hybrid closed-loop system in patients with T1D
Insulet (NSDQ:PODD) touted data today from the 1st feasibility study of its Omnipod Horizon hybrid closed-loop system in patients with Type 1 diabetes. Data from the study showed that the Omnipod...
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How virtual and mixed reality are changing drug delivery and device design
Kai Worrell believes that virtual and mixed reality may change the way companies design medical devices, and he’s putting that idea into practice. “We think it’s going to transform the way we do...
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QuiO adds MedCrypt data security to Smartinjector pen
MedCrypt and QuiO said earlier this month that the companies are partnering to integrate MedCrypt’s data security software into QuiO’s Smartinjector devices. According to the agreement, MedCrypt will...
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Details emerge on plan to repeal, replace Obamacare
The evolving Republican plan to repeal and replace Obamacare would repeal cuts in payments to hospitals treating large numbers of uninsured patients, repeal the penalties for individuals and employers...
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CMS nominee Verma: Mylan’s EpiPen case ‘disturbing’
Seema Verma, the nominee to head the Centers for Medicare & Medicaid, said at her confirmation hearing that she would like to review the way pharmaceutical companies classify products as generic or...
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FDA: Zimmer Biomet recall of Comprehensive Reverse Shoulder System is Class I
The FDA this week released information on a Class 1 recall of Zimmer Biomet‘s (NYSE:ZBH) Comprehensive Reverse Shoulder System over issues with the devices fracturing. The Warsaw, Ind.-based company’s...
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Genetically engineered T-cells treat leukemia in babies
[Image courtesy of Caroline Davis2010, per Creative Commons 2.0 license]Researchers in London have successfully treated leukemia in two babies, in what they are touting as the world’s first treatment...
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J&J’s Ethicon to buy Torax Medical
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon agreed to buy Torax Medical and its Linx acid reflux treatment for an undisclosed amount. J&J, which got in on a $25 million funding round for...
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TiGenix, Takeda highlight data for cell therapy in patients with Chron’s disease
Takeda (TYO:4502) and TiGenix (EBR:TIG) today touted long-term data from its phase III Admire-CD trial evaluating its suspension of allogenic expanded adipose-derived stem cells, Cx601, in patients...
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7 medtech stories we missed: Feb. 17, 2017
[Image from unsplash.com]Several companies released diabetes study results this week, while companies like BioTime closed on their public offerings and Pixium implanted its first bionic eye. Here are 7...
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