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Bracco Imaging acquires SurgVision
Bracco Imaging said today it acquired real-time fluorescence image guided surgery start-up SurgVision for an undisclosed amount. Netherlands-based SurgVision is developing a real-time fluorescence image guided surgery platform which combines targeted imaging agent and a tumor visualization device designed for use during oncology surgical procedures, Bracco said. “With the acquisition of SurgVision, one of the most advanced companies in a very promising field, we intend to address a relevant, unmet medical need for oncology patients who have to undergo tumor removal surgery. SurgVision platform expands our imaging sol...
Source: Mass Device - October 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Imaging Mergers & Acquisitions Bracco Diagnostics surgvision Source Type: news

EnteroMedics raises $61 million
EnteroMedics (NSDQ:ETRM) has raised $61 million in a new round of equity financing, according to an SEC filing posted this week. Money in the round comes from 13 anonymous investors, with the 1st sale noted on October 2, according to the filing. Funds raised represent the value of common stock issued or convertible from Series C convertible preferred stock, the liquidation of new preferred stock at $2.75 per share as well as $5 million in cash, according to the filing. The fundraising comes shortly after St. Paul, Minn.-based Enteromedics agreed to pay approximately $38 million to acquire ReShape Medical. The deal cal...
Source: Mass Device - October 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News EnteroMedics Inc. Source Type: news

Intuitive Surgical buys $6m NC facility in close proximity to TransEnterix
Intuitive Surgical (NSDQ:ISRG) paid $6 million to acquire a 60,000-square-foot building in Durham, N.C. just a few miles down the road from rival surgical robot maker TransEnterix (NYSE:TRXC), according to a Triangle Business Journal report. The new acquisition joins a smaller facility Intuitive has in the region at N.C. State University’s Centennial Campus, according to the report. Read the whole story on our sister site, The Robot Report The post Intuitive Surgical buys $6m NC facility in close proximity to TransEnterix appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News intuitivesurgical Source Type: news

DarioHealth wins CE Mark for glucose meter that connects to iPhone 7, 8 devices
DarioHealth (NSDQ:DRIO) said today that it won CE Mark approval for the version of its Dario blood glucose monitoring system that fits with the Lightning connector on Apple’s iPhone 7 and iPhone 8 smart phones. With this regulatory win, DarioHealth’s smart glucose meter can be used with a 3.5 mm headphone jack or Lightning connector, the company said. Shares in the company jumped more than 13% today, trading at $2.05 apiece in early morning activity. Get the full story at our sister site, Drug Delivery Business News. The post DarioHealth wins CE Mark for glucose meter that connects to iPhone 7, 8 devices a...
Source: Mass Device - October 18, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Regulatory/Compliance Wall Street Beat DarioHealth Corp Source Type: news

Abbott ticks up as Q3 tops Wall Street ’ s forecast
Share prices ticked up today in pre-market trading for Abbott (NYSE:ABT) after the healthcare giant posted sales and profits that beat the consensus forecast on Wall Street. Chicago-area Abbott reported profits of $1.16 billion, or 34¢ per share, on sales of $6.83 billion for the three months ended Sept. 30, for a bottom-line gain of 31.1% on sales growth of 28.8% compared with Q3 2016. Adjusted to exclude one-time items, earnings per share were 66¢, a penny ahead of The Street, where analysts were looking for sales of $6.72 billion. “We’re very pleased with our performance and the steady cadence of i...
Source: Mass Device - October 18, 2017 Category: Medical Devices Authors: Brad Perriello Tags: MassDevice Earnings Roundup Wall Street Beat Abbott Source Type: news

OptiScan ’s glucose monitoring system for the ICU wins 510(k) clearance
OptiScan Biomedical said today that its OptiScanner 5000 glucose monitoring system won 510(k) clearance. The device is the first of its kind, providing physicians with trending and tracking information to manage their patients’ blood glucose levels in surgical intensive care units. Get the full story at our sister site, Drug Delivery Business News. The post OptiScan’s glucose monitoring system for the ICU wins 510(k) clearance appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 18, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: 510(k) Diabetes Food & Drug Administration (FDA) Hospital Care Regulatory/Compliance OptiScan Source Type: news

Tampering allegations in Johnson & Johnson hip case prompt judge to trigger probe
A federal judge in Texas this week took the unusual step of asking federal prosecutors and the FBI to probe possible witness tampering by lawyers for Johnson & Johnson (NYSE:JNJ) in a bellwether trial over metal-on-metal hip implants made by J&J subsidiary DePuy Orthopaedics. Mark Lanier, lead attorney for the plaintiffs in one of six cases being tried in the U.S. District Court for Northern Texas bellwether before Judge Ed Kinkeade, raised the tampering issue during an Oct. 16 hearing based on a conversation between a DePuy sales rep and a surgeon who’s a witness in the case. Dr. David Stein filed an affidav...
Source: Mass Device - October 18, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Legal News Metal-on-Metal Product Liability depuysynthes johnsonandjohnson Source Type: news

Attune Medical, formerly Advanced Cooling Therapy, raises $10m in Series C
Attune Medical, formerly known as Advanced Cooling Therapy, said today it closed a $10 million Series C financing round to support its Enso esophageal temperature management system alongside revenue growth in North America and market expansion worldwide. The Chicago-based company touts the EnsoETM as the only patient temperature management system approved for use in the esophageal environment for whole-body temperature modulation including warming and cooling. The triple lumen system is designed to be inserted into the esophagus, with 2 lumens attached to existing temperature modulation equipment while a 3rd lumen simultan...
Source: Mass Device - October 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News attunemedical Source Type: news

Amgen, Boston Children ’ s Hospital partner to find genes linked to pain disorders
Amgen (NSDQ:AMGN) announced today that it inked a one-year collaboration with Boston Children’s Hospital to study patients with pain syndromes in an effort to identify potential genetic targets. The collaboration will combine Amgen’s work in genetic target identification and the division of pain medicine at Boston Children’s Hospital. Get the full story at our sister site, Drug Delivery Business News. The post Amgen, Boston Children’s Hospital partner to find genes linked to pain disorders appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 17, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Neurological Pharmaceuticals Research & Development Wall Street Beat Amgen Boston Children's Hospital Source Type: news

Viveve wins Mexican clearance for Viveve system
Viveve (NSDQ:VIVE) said today it won approval from Mexico’s regulatory authority, COFEPRIS, to market its Viveve system in Mexico with indications for treating vaginal introitus, after vaginal childbirth and to improve sexual function. The Englewood, Colo.-based company’s Viveve System is designed as a non-surgical treatment for post-partum laxity of the vaginal introitus. The new regulatory clearance brings the total number of countries where the device is cleared up to 50, Viveve said. “We are very pleased to receive regulatory approval in Mexico for our clinically-proven device that deli...
Source: Mass Device - October 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Regulatory/Compliance Women's Health Viveve Medical Source Type: news

Arthrex to build $74m plant, add 1,000 jobs to SC over 5 years
Arthrex is planning to build a $74 million manufacturing plant and add 1,000 jobs over 5 years in South Carolina, according to a Naples Daily News report. The plan was announced Monday and had been kept secret as the company worked out incentives with Anderson County, where the facility will be built, according to the report. The 200,000 square foot plant will manufacture surgical devices and is slated to begin construction during the 1st quarter of next year with a hopeful completion date in early 2019, the Naples News reported. “This investment is part of Arthrex’s global expansion plan to support the gr...
Source: Mass Device - October 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Arthrex Inc. Source Type: news

MassDevice.com +5 | The top 5 medtech stories for October 17, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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. Get this in your inbox everyday by subscribing to our newsletters.   5. Less than half of healthcare professionals think medtech brands meet needs Roughly two-fifths of healthcare professionals say medical device brands aren’t meeting expectations, and failure to offer flexible contract optio...
Source: Mass Device - October 17, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

How etectRx ’ s “ smart pill ” aims to improve patient compliance trends
When Harry Travis first met Neil Euliano and learned about his medication adherence technology, the pharmaceutical industry was beginning to usher in the age of pricey drugs with Hepatitis C therapies that hit the market at prices like $500 or $1,000 dollars a pill. “It just so happened at the time, really expensive medications were front and center in everybody’s mind in the world of pharmacy,” Travis told Drug Delivery Business News. “No one had ever experienced a $1,000 pill. That was a first through the industry. We were all in sticker shock.” Travis would know – he’s a ph...
Source: Mass Device - October 17, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Patient Monitoring Pharmaceuticals Baxter Cardinal Health etectrx Gilead Sciences Source Type: news

TransEnterix CEO Pope, riding high on FDA nod, eyes the laparoscopic surgery market
Share prices for TransEnterix (NYSE:TRXC) have more than doubled since the robot-assisted surgery company won an important clearance from the FDA last week and CEO Todd Pope is optimistic about his companies chances against the undisputed market leader, Intuitive Surgical (NSDQ:ISRG). Morrisville, N.C.-based TransEnterix, which acquired Senhance for $100 million in September 2015, finalized its clearance bid last month after applying in April; the federal safety watchdog granted 510(k) clearance last week, pushing TRXC shares up 92.5% to a $2.81 close yesterday; the stock had ga...
Source: Mass Device - October 17, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Robotics Wall Street Beat TransEnterix Source Type: news

FDA OKs trial for MiMedx AmnioFix knee treatment, prelims
MiMedx (NSDQ:MDXG) saw shares rise today after announcing 3rd quarter revenue that beat consensus on The Street alongside FDA approval to proceed with the Investigational New Drug phase 2B study of its AmnioFix injectable product. The Marietta, Ga.-based company said it expects to post sales of $84.6 million for its 3rd quarter, well ahead of both its guidance of between $70 and $80 million and Wall Street consensus of $80.1 million. Revenue for MiMedx grew 31% compared to sales from the 3rd quarter of the previous year, according to an SEC filing. “Our third quarter revenue performance was very strong, and we a...
Source: Mass Device - October 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Clinical Trials MiMedx Group Inc. Source Type: news

Anika ’ s Monovisc therapy gets green light in Australia
Anika Therapeutics (NSDQ:ANIK) said yesterday that regulatory authorities in Australia approved the company’s single injection viscosupplement, Monovisc, for the treatment of pain associated with osteoarthritis of the synovial joints. This latest regulatory win means that Monovisc is commercially available in more than twenty countries, including the U.S. and Canada. The Bedford, Mass.-based company said it plans to move into additional international markets next year with its therapy for hip and knee pain. Get the full story at our sister site, Drug Delivery Business News. The post Anika’s Monovisc therap...
Source: Mass Device - October 17, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Orthopedics Pain Management Pharmaceuticals Regulatory/Compliance Wall Street Beat Anika Therapeutics Inc. Source Type: news

VA head Shulkin under consideration for HHS head
Current US Secretary of Veterans Affairs David Shulkin is slated for an interview as a candidate to lead the Dept. of Health and Human Services, replacing recently resigned HHS Secretary Tom Price, according to a Wall Street Journal report. VA Secretary Shulkin, a holdover from the Obama administration, is being considered among several candidates to replace Price who resigned late last month, according to the report. The HHS is currently being led by deputy secretary Eric Hargan, a former Greenberg Traurig attorney out of the Chicago office who was assigned to the role last week. Price resigned last month amid a...
Source: Mass Device - October 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Wall Street Beat Capitol Hill U.S. Department of Health and Human Services Source Type: news

Adventist Health System to use Glytec ’ s diabetes management system at 39 acute care facilities
Glytec has partnered with Adventist Health System to bring its eGlycemic diabetes management system to 39 of the health system’s acute care facilities. Glytec’s cloud-based eGMS will become a part of the standard of care for patients who need insulin therapy, in both the critical care units and on the medical-surgical floor, the companies said. Get the full story at our sister site, Drug Delivery Business News. The post Adventist Health System to use Glytec’s diabetes management system at 39 acute care facilities appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 17, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Hospital Care Pharmaceuticals Glytec Source Type: news

Second Sight wins go-ahead for German Argus II study in better-sighted RP patients
This study has the potential to change the management of patients with RP and, if successful, greatly expand the patient population who can benefit from this treatment, and for whom the Argus II could be a solution,” Dr. Walter of Germany’s Universitätsklinikum Aachen said in a prepared statement. In July, Second Sight said its Argus II retinal prosthesis system won expanded reimbursement coverage from the Centers for Medicare and Medicaid Services in 11 additional states and the District of Columbia. See the best minds in medtech live at DeviceTalks West, Dec. 11–12 in Orange County, Calif. The post...
Source: Mass Device - October 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Optical/Ophthalmic Regulatory/Compliance Second Sight Source Type: news

Researchers combine a smart phone, insulin pump and CGM in diabetes study
In a study published this week in Diabetes Care, researchers combined an insulin pump, a continuous glucose monitoring receiver and a smart phone with cloud-based algorithms to automatically monitor and adjust a patient’s glucose levels. The team pointed towards a number of systems that are designed to function as an artificial pancreas, but still require that users input their carbohydrate estimates when they need insulin after meals. Get the full story at our sister site, Drug Delivery Business News. The post Researchers combine a smart phone, insulin pump and CGM in diabetes study appeared first on MassDevice...
Source: Mass Device - October 17, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Diabetes Drug-Device Combinations Pharmaceuticals Harvard University Source Type: news

J & J ’ s DePuy fields 341 hip cases in the England
Johnson & Johnson (NYSE:JNJ) subsidiary DePuy saw its 1st day in court in the UK this week as it faces 341 claims that it sold “defective” Pinnacle hip implants that caused metal particles to be released into patients bodies, according to a Bloomberg report. The metal-on-metal hip case is one of the largest product liability group actions to reach the UK’s courts, according to the plaintiff’s law firm Leigh Day. A number of other cases against other manufacturers of “metal-on-metal” hip implants have been delayed pending the results of the J&J case, according to the rep...
Source: Mass Device - October 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Legal News Orthopedics johnsonandjohnson Source Type: news

ReWalk shares slide on Q3 prelim release
ReWalk Robotics (NSDQ:RWLK) today saw shares dip slightly after releasing preliminary financial results for its 3rd quarter despite posting revenues ahead of consensus on Wall Street. The Israel-based company said it expects to post sales of $1.7 million for the 3 months ended Sept. 30, up 21.4% from the $1.4 million the company posted for the same period during the prior fiscal year. Read the whole story at our sister site, The Robot Report The post ReWalk shares slide on Q3 prelim release appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Robotics ReWalk Robotics Source Type: news

Mylan: Allergan ’ s legal move with tribe reveals “ duplicitousness ” towards patent system
Allergan (NYSE:AGN) was dealt a major blow yesterday after a Texas judge ruled that claims to a number of patents for its dry eye drug, Restasis, were invalid due to obviousness. The ruling opens the door for generic versions of the drug that accounted for nearly 10% of Allergan’s revenue last year. The decision came in a suit involving generic drugmakers like Mylan (NSDQ:MYL), which celebrated the ruling as a push back against Allergan’s recent move to transfer its Restasis patents to a Native American tribe. Get the full story at our sister site, Drug Delivery Business News. The post Mylan: All...
Source: Mass Device - October 17, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Legal News Patent Infringement Pharmaceuticals Wall Street Beat Allergan Inc. Mylan Source Type: news

Johnson & Johnson ’ s Q3 results top estimates despite profit slide
Although third-quarter profits for Johnson & Johnson (NYSE:JNJ) were off nearly -13%, the healthcare giant still managed to top the consensus estimate for sales and earnings per share on a top-line gain of more than 10%. New Brunswick, N.J.-based J&J posted profits of $3.76 billion, or $1.37 per share, on sales of $19.65 billion for the three months ended Sept. 30, for a bottom-line slide of -11.9% on sales growth of 10.3%. Adjusted to exclude one-time items, earnings per share were $1.90, a full dime ahead of the consensus on Wall Street, where analysts were looking for sales of $19.28 billion. That sent JNJ share...
Source: Mass Device - October 17, 2017 Category: Medical Devices Authors: Brad Perriello Tags: MassDevice Earnings Roundup Wall Street Beat johnsonandjohnson Source Type: news

ResMed claims wins, updates on continuing patent war with Fisher & Paykel
ResMed (NYSE:RMD) this month updated on a number of global patent infringement suits in the UK, Australia and New Zealand as it continues to battle with Fisher & Paykel Healthcare (NZE:FPH). The San Diego, Calif.-based company said that it has decided to proceed with the defense of 1 of 3 UK ResMed patents that were challenged by Fisher & Paykel while agreeing to revoke the other 2 patents. ResMed said that the revoked patent will “have no commercial impact on sales of ResMed’s products” and that it’s not binding on the European Patent Office or the German Courts. In Australia, Res...
Source: Mass Device - October 16, 2017 Category: Medical Devices Authors: Fink Densford Tags: Legal News Patent Infringement Respiratory Fisher & Paykel Healthcare ResMed Inc. Source Type: news

Texas judge rules Allergan ’s Restasis patents invalid
U.S. judge William Bryson ruled that patents covering Allergan‘s (NYSE:AGN) Restasis medicine are invalid on the grounds of obviousness, driving the company’s shares down more than -6% in afternoon trading today. The decision, made in a Texas federal court, is part of an ongoing case between Allergan and generic drugmakers like Mylan (NSDQ:MYL) and Teva Pharmaceuticals (NYSE:TEVA). Get the full story at our sister site, Drug Delivery Business News. The post Texas judge rules Allergan’s Restasis patents invalid appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 16, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Legal News Optical/Ophthalmic Patent Infringement Pharmaceuticals Wall Street Beat Allergan Inc. Mylan Teva Pharmaceuticals Source Type: news

J & J ’ s DePuy launches Maxframe limb correction system
Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes said late last week that it launched the Maxframe multi-axial limb correction system designed to gradually correct bone or soft tissue deformities in the arm, leg, foot or ankle. DePuy said the Maxframe system includes 3D planning software intended to create accurate patient treatment plans and reduce the number of X-rays required and the procedural complexity of treatments. The newly launched limb fixation system also includes the company’s Assure-Strut technology designed to emit an audible click after patient adjustment of the device as the strut ...
Source: Mass Device - October 16, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Orthopedics depuysynthes johnsonandjohnson Source Type: news

OptiNose IPO pulls in $120m
OptiNose (NSDQ:OPTN) raised $120 million with its initial public offering last week, adding $20 million to the target is set earlier this month. Yardley, Penn.-based OptiNose floated 7.5 million shares at $16 apiece in the offering, above the range it set Oct. 3 for 6.3 million shares at $15 to $17 apiece. Get the full story at our sister site, Drug Delivery Business News. The post OptiNose IPO pulls in $120m appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 16, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Drug-Device Combinations Funding Roundup Initial Public Offering (IPO) Otolaryngology Ear, Nose & Throat Wall Street Beat OptiNose Source Type: news

Medizone wins CE Mark for AsepticSure
Medizone International (OTC:MZEI) said today that it won CE Mark approval in the European Union for its AsepticSure disinfection system. The AsepticSure system is designed to be turned on from outside the room to be disinfected, enabling the machine to safely fill the room with a disinfecting gas formula. The device later clears the atmosphere in the room and restores it to within EPA standards. The Kalamazoo, Mich.-based company is pursuing a de novo clearance from the FDA in the U.S. for AsepticSure. “The receipt of CE Mark approval is a significant and important step in the commercial development of AsepticSure in...
Source: Mass Device - October 16, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Hospital Care Regulatory/Compliance Sterilization / Calibration Medizone Source Type: news

Abbott launches Proclaim DRG neurostim
Abbott (NYSE:ABT) said today it launched its Proclaim dorsal root ganglion neurostimulator system designed to treat pain in patients with complex regional pain syndrome of the lower limbs. The company’s Proclaim DRG system is designed to be used via Bluetooth with an Apple (NSDQ:AAPL) iPod touch as a system controller and is magnetic resonance-conditional and recharge free, all upgrades from previous versions of the device, the Abbott Park, Ill.-based company said. Abbott said it originally launched the DRG therapy system in 2016 and data from the Accurate study of it showed the system delivers “...
Source: Mass Device - October 16, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Neuromodulation/Neurostimulation Pain Management Abbott Source Type: news

Stryker wins FDA nod for cementless Mako total knee system
Stryker (NYSE:SYK) said today it won FDA 510(k) clearance for its cementless Mako total knee system with Triathlon Tritanium. The Kalamazoo, Mich.-based company touted the Triathlon Titanium as combining kinematics from its Triathlon knee with highly porous biologic fixation technology. The system features the company’s Tritanium tibial baseplate and metal-backed patella components as well, the company said. Stryker said that cementless procedures are increasing in popularity, and the newly cleared platform expands the robotics offerings for orthopedic surgeons seeking an alternative to bone cement. “...
Source: Mass Device - October 16, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Orthopedics Regulatory/Compliance Stryker Source Type: news

NanOlogy takes nanoparticle tech into Phase II trials
In the last two weeks, NanOlogy has launched trials evaluating its cancer-fighting paclitaxel nanoparticle suspension in patients with prostate cancer and in patients with ovarian cancer. The Texas-based company’s nanoparticle tech is based on a production process that cuts the size of chemotherapy crystals by up to 400 times, creating stable nanoparticles with increased surface area and unique geometry, NanOlogy explained. The particles do not require coating agents for stability and are suspended prior to use. Get the full story at our sister site, Drug Delivery Business News. The post NanOlogy takes nano...
Source: Mass Device - October 16, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Oncology Pharmaceuticals nanology Source Type: news

Medtronic inks telehealth deal with American Well
Medtronic (NYSE:MDT) said today its Medtronic Care Management Services inked a strategic partnership deal with American Well to bring telehealth services to complex, chronic and co-morbid patients. Under the deal, Medtronic will allow access to American Well’s telemedicine services on its MCMS video-enabled platforms to enable remote patient monitoring and consultations with a goal of providing improved patient access. “We are thrilled to partner with American Well to provide an innovative, patient-centric solution to our customers. Providing care to complex, chronic, co-morbid populations requires access ...
Source: Mass Device - October 16, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Patient Monitoring American Well Medtronic Source Type: news

4 questions to ask about electronic informed consent
What is electronic informed consent? Informed Consent is a voluntary agreement to participate in research.  Clinical research professionals know that the informed consent process is more than just a signature on a form; it is a process of information exchange that may include:  providing subject recruitment materials, verbal instructions, question/answer sessions, time for the patient to read the form individually or with family members, and measures of subject understanding.  This is all in addition to actually signing the informed consent document.   Traditionally, paper-based consent has been the met...
Source: Mass Device - October 16, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news

BrainStorm enrolls first ALS patient in late-stage NurOwn trial
Brainstorm Cell Therapeutics (NSDQ:BCLI) said today that the first patients have been enrolled in its Phase III trial evaluating NurOwn as a treatment for amyotrophic lateral sclerosis, or ALS, at Massachusetts General Hospital and UC Irvine Medical Center. The trial, which is slated to enroll 200 patients, is designed to include the pre-specified patient subgroups who saw superior outcomes in the NurOwn Phase II ALS trial. BrainStorm said it expects top-line data from the trial in 2019. Get the full story at our sister site, Drug Delivery Business News. The post BrainStorm enrolls first ALS patient in late-stage NurO...
Source: Mass Device - October 16, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Neurological Stem Cells Wall Street Beat BrainStorm Cell Therapeutics Inc. Source Type: news

ReWalk Robotics aims for 2018 release for Restore softsuit robotic exoskeleton
ReWalk Robotics (NSDQ:RWLK) said today it completed all internal processes related to its Restore robotic rehabilitation softsuit exoskeleton and is ready to initiate clinical trials of the device in 2018, with hopes for a commercial launch in the same year. The Restore softsuit is designed to transmit power to key joints in the legs with cable technologies, powered by software and mechanics similar to those used in its ReWalk exoskeleton system for patients with spinal cord injuries. The cables are connect to fabric-based designs that attach to the leg and foot, and make it a ‘soft suit’, the Israel-...
Source: Mass Device - October 16, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Research & Development Robotics ReWalk Robotics Source Type: news

Insulet shareholder sues over OmniPod Eros
Insulet (NSDQ:PODD) shareholder Frank Carnazza filed a derivative suit against the Billerica, Mass-based company last week in a Massachusetts federal court, alleging that Insulet misrepresented the success of its OmniPod Eros roll-out in 2013, which eventually caused the shares in the company to plummet. Carnazza named a number of former and current executives in the suit, including ex-CEO Duane DeSisto and chairman & chief executive Patrick Sullivan. Get the full story at our sister site, Drug Delivery Business News. The post Insulet shareholder sues over OmniPod Eros appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 16, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Food & Drug Administration (FDA) Legal News Pharmaceuticals Wall Street Beat Insulet Source Type: news

TransEnterix wins FDA nod for Senhance robot-assisted surgery platform
TransEnterix (NYSE:TRXC) said last week that it won 510(k) clearance from the FDA for its Senhance robot-assisted surgery platform. TransEnterix, which acquired Senhance for $100 million in September 2015, finalized its clerarance bid last month after applying in April. Get the full story from our sister site, The Robot Report. The post TransEnterix wins FDA nod for Senhance robot-assisted surgery platform appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 16, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Robotics Wall Street Beat TransEnterix Source Type: news

Reva Medical launches Fantom in Switzerland with first implant of bioresorbable scaffold
Reva Medical (ASX:RVA) has expanded its commercial operations into Switzerland, the company said today, with the first implant of its Fantom bioresorbable scaffold. The scaffold is made from Reva’s tyrosine-derived, radiopaque polymer, rendering Fantom visible under fluoroscopy – a characteristic that is unique to Reva’s product. Get the full story at our sister site, Drug Delivery Business News. The post Reva Medical launches Fantom in Switzerland with first implant of bioresorbable scaffold appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 16, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Vascular Wall Street Beat Reva Medical Inc. Source Type: news

FDA expands indication for NuVasive ’ s TLX spine implant
NuVasive Inc. (NSDQ:NUVA) said today the it won expanded 510(k) clearance from the FDA for its TLX implant used in spinal fusion surgery. San Diego-based NuVasive said the new clearance covers an new, expandable 20° cage and new indications for use covering allogeneic bone grafts and more spine levels. “With the additional clearance for our latest TLX system, we now provide the leading tools for [transforaminal lumbar interbody fusion] procedures with our MAS TLIF solution, validating our commitment to improving spine solutions,” strategy, technology & corporate development EVP Matt Link said in pr...
Source: Mass Device - October 16, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Orthopedics Regulatory/Compliance Spinal Nuvasive Source Type: news

Stryker wins $3m tax break for Utah facility expansion
Stryker (NYSE:SYK) has won a $3.4 million tax-rebate incentive from the state of Utah to expand its neurotechnology training and manufacturing center in Salt Lake City, according to a Salt Lake Tribune report. Kalamazoo, Mich.-based Stryker aims to add 540 people and spend $100 million over the next 10 years as part of the expansion, according to the report. As part of the tax break deal, workers hired by Stryker will be required to be paid 100% of the average wage in Salt Lake County, resulting in new wages of $192 million and $17 million in state tax revenue, the SL Tribune reports. “World-class companies like...
Source: Mass Device - October 13, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Stryker Source Type: news

Philips wins FDA 510(k) for small parts ultrasound transducer
Royal Philips (NYSE:PHG) said today it won FDA 510(k) clearance for its eL18-4 ultrasound transducer designed for ‘small parts’ assessments to detect abnormalities in small organs close to the skin. The Amsterdam-based company said the device is part of its Ultimate Small Parts Solution which also features the company’s MicroFlow Imaging, Elastography and Precision Biopsy technology. The eL18-4 transducer is also designed to assess musculoskeletal injuries. “The superb image quality derived from Philips’ breakthrough, ultra-broadband frequency transducer along with full solution Elastogra...
Source: Mass Device - October 13, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Imaging Regulatory/Compliance royalphilips Source Type: news

Manus Medical wins $10m DoD contract
Surgical supplies company Manus Medical has won a $9.9 million contract with the US Department of Defense to supply it with medical equipment, according to a DoD release. Through the contract, Manus Medical will supply the Dept. of Defense with medical equipment for 5 years, including supplies to the Army, Navy, Air Force, Marine Corps and federal civilian agencies. The contract with the DoD was a competitive acquisition, with a total of 57 responses received, according to the release. The contract will last through the DoD’s fiscal year 2018 through 2023. See the best minds in medtech live at DeviceTalks West, Dec. ...
Source: Mass Device - October 13, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News manusmedical Source Type: news

CDC: Overdose-related deaths in 2016 surpassed death count from peak of AIDS crisis
More than 63,000 people died from a drug overdose last year – that’s more than the number of deaths caused by AIDS in 1995, according to data from the Centers for Disease Control and Prevention. Between 2015 and 2016, the number of people who died from a drug overdose involving illicitly-manufactured fentanyl, a synthetic opioid, more than doubled. Available data shows that heroin contaminated with fentanyl has largely driven the recent increases in opioid-related overdose deaths, Dr. Deborah Dowell from the CDC wrote in an article published this week in JAMA. Get the full story at our sister site, Dr...
Source: Mass Device - October 13, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Healthcare Reform Hospital Care Pharmaceuticals Centers for Disease Control & Prevention (CDC) Source Type: news

FDA ’ s Shuren bullish on improved patient inclusion in trials at 1st PEAC meeting
The FDA is looking to step up its patient engagement efforts, FDA Center for Devices and Radiological Health Director Jeffrey Shuren said during the 1st meeting of the federal watchdog’s Patient Engagement Advisory Committee. Shuren said that with MDUFA IV, the agency is now better equipped to move forward with patient engagement efforts, according to a Regulatory Affairs Professionals Society report. “We’re now, for the first time, getting resources to build out a patient engagement group at CDRH. Prior to that, believe it or not, there were never dollars that had been allocated to us specifically for th...
Source: Mass Device - October 13, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

FDA advisory committee backs Aerie ’s Rhopressa eye drug
An FDA advisory committee voted today in favor of Aerie Pharmaceuticals‘ (NSDQ:AERI) Rhopressa product candidate. The dermatologic and ophthalmic drugs advisory committee voted unanimously that clinical trials support the efficacy of Aerie’s netarsudil ophthalmic solution for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Nine members of the committee voted to say that the product’s efficacy outweighs its safety risks, while one member voted against that claim. Get the full story at our sister site, Drug Delivery Business News. The post FDA advisor...
Source: Mass Device - October 13, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Optical/Ophthalmic Pharmaceuticals Regulatory/Compliance Wall Street Beat Aerie Pharmaceuticals Source Type: news

7 medtech stories we missed this week: Oct. 13, 2017
[Image from unsplash.com]From Orthocell’s distribution deal to CorNeat unveiling its artificial cornea, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. OrthoCell inks Australian distro deal Orthocell announced in an Oct. 10 press release that it has signed a distribution deal with Surgical Specialities. The deal will make Surgical Specialities the exclusive distributor in Australia and New Zealand for Orthocell’s cell therapies for tendon regeneration and cartilage regeneration. Surgical Specialties is set to take over distribution responsibilities of the Orth...
Source: Mass Device - October 13, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Business/Financial News Clinical Trials Cosmetic/Aesthetic Food & Drug Administration (FDA) Implants Patient Monitoring Regulatory/Compliance Research & Development Alcon Bonesupport CorNeat Faxitron Masimo MedTech Ort Source Type: news

MassDevice.com +5 | The top 5 medtech stories for October 13, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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. Get this in your inbox everyday by subscribing to our newsletters.   5. 10 tips for selecting and managing a medtech development partner There many things to consider when searching for and interacting with a product development firm – and the stakes are high! Most early-stage medical device ...
Source: Mass Device - October 13, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Propeller Health launches API to provide local asthma conditions to orgs, patients
Earlier this week, Propeller Health released an application programming interface to give local asthma conditions to anyone within the U.S. who is interested in using that data. The Air by Propeller API is a free service that uses a machine-learning model based on millions of days of anonymous asthma symptom data and environmental data. The model uses that information to predict potential effects on people’s breathing. Get the full story at our sister site, Drug Delivery Business News. The post Propeller Health launches API to provide local asthma conditions to orgs, patients appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 13, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Big Data Health Information Technology Pharmaceuticals Respiratory Propeller Health Source Type: news

CHF Solutions pulls trigger on 1-for-20 reverse stock split
CHF Solutions (NSDQ: CHFS) said yesterday it enacted a 1-for-20 reverse split of its common stock, putting 1 share in the hands of each shareholder for every 20 they previously owned. The move was approved at a special meeting of stockholders on Tuesday, the Eden Prairie, Minn.-based company said, with trading beginning on a split adjusted basis today. With the split, the total number of authorized shares of CHF Solutions, formerly known as Sunshine Heart, will remain at 100 million, though the number of outstanding shares was reduced from approximately 12.5 million to approximately 626,000, according to a press ...
Source: Mass Device - October 13, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News CHF Solutions Inc. Source Type: news