PolarityTE responds to short-seller report
PolarityTE yesterday responded to a scathing report from Citron Research which accused the company of fraud, saying that the report was used by short sellers to drop the company’s share value. The Salt Lake City, Utah.-based company said that the publication is “well-known to be used as a tool by notorious short sellers” and that they are “designed to negatively impact PolarityTE’s share price for the benefit of short sellers and other colluding agents.” The company goes on to say that the report contains false and misleading assertions contrary to the company and its physician partners&...
Source: Mass Device - October 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat polarityte Source Type: news

Report: IBM Watson Health head DiSanzo steps down
International Business Machine‘s (NYSE:IBM) Watson Health GM Deborah DiSanzo is stepping away from her position heading the division to join the strategy team for IBM Cognitive Solutions, according to a STAT News report. Cognitive Solutions and IBM Research senior VP John Kelly will step in to take the reins of the healthcare-focused division, according to the report. Circumstances around the departure are “unclear,” STAT News reports, adding that Watson Health has been seeking to recover from “a series of stumbles.” DiSanzo joined the company in 2015, having previously headed Philips Healthca...
Source: Mass Device - October 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Software / IT IBM IBM Watson Health Source Type: news

Stryker extends deadline on $1.4B K2M buy as shareholders sue
Stryker (NYSE:SYK) yesterday filed to extend the anti-trust deadline on its $1.4 billion acquisition of K2M (NSDQ:KTWO) to give the U.S. Federal Trade Commission more time to examine the deal, as shareholders filed suit to block the merger, K2M said today. The new FTC filing pushes the anti-monopoly waiting period out to Nov. 16, the Leesburg, Va.-based spinal implant maker said. And although a shareholder vote on the buyout is slated for Nov. 7, K2M revealed a pair of investor lawsuits filed in the U.S. District Court for Delaware seeking to challenge the deal. The lawsuits argue that the company and its ma...
Source: Mass Device - October 19, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured Mergers & Acquisitions Orthopedics Spinal Wall Street Beat Anti-Trust Federal Trade Commission (FTC) K2M Stryker Source Type: news

FDA approves Abbott ’ s HeartMate 3 as a destination therapy
Abbott (NYSE:ABT) said today it won FDA approval for its HeartMate 3 left ventricular assist device, now approved as a destination therapy for patients with advanced heart failure. With the approval, the Chicago-based company said that the device can now be used in patients not eligible for a transplant as a life-long implant. “We partner with physicians to holistically develop therapies that benefit patients and achieve better outcomes. The unique design of the HeartMate 3 LVAD—with its Full MagLev technology—takes an established innovation and improves upon it in meaningful ways to help people with...
Source: Mass Device - October 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Abbott Source Type: news

NuVasive taps Medtronic surgical innovation prez Barry as new CEO | Personnel Moves – October 19, 2018
NuVasive (NSDQ:NUVA) said today it named Medtronic (NYSE:MDT) surgical innovations prez J. Barry as its new CEO, replacing Gregory Lucier, effective November 5. Barry will also join the company’s board of directors, where Lucier will continue to serve as board chair and aid in transition efforts, the San Diego-based company said. NuVasive also said that it promoted current strategy, tech and corp dev exec VP Matt Link to president. Link has worked with NuVasive since 2006, holding numerous roles in the company primarily around building the US commercial organization. In his role with Medtronic, Ba...
Source: Mass Device - October 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Bigfoot Biomedical Cardinal Health Clearside Biomedical fundamentalvr IRRAS Nuvasive Personnel Moves Simplify Medical Source Type: news

Valeritas launches wearable insulin delivery device in Italy
Valeritas (NSDQ:VLRX) said today that its wearable insulin delivery device has launched in Italy. The Bridgewater, N.J.-based company inked an exclusive distribution deal with Movi SpA to bring its V-Go device to the more than 2 million people in Italy with Type 2 diabetes. Get the full story at our sister site, Drug Delivery Business News. The post Valeritas launches wearable insulin delivery device in Italy appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 19, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Pharmaceuticals Wall Street Beat Valeritas Source Type: news

FDA deals warning letter to Ocular over eye sealant
Ocular Therapeutix (NSDQ:OCUL) said today that it received a warning letter from the FDA over its ReSure hydrogel ocular wound sealant. The warning letter, dated Oct. 17, relates to Ocular’s compliance with data collection and reporting obligations in a post-approval device exposure registry study, according to the company. The registry study was a condition for approval of the premarket approval application for Ocular’s ReSure product. Get the full story at our sister site, Drug Delivery Business News. The post FDA deals warning letter to Ocular over eye sealant appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 19, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Featured Food & Drug Administration (FDA) Optical/Ophthalmic Regulatory/Compliance Wall Street Beat Wound Care oculartherapeutix Source Type: news

Intuitive Surgical jumps on Q3 beats, increased procedures outlook
Shares of Intuitive Surgical (NSDQ:ISRG) got a pre-market bump today after the robot-assisted surgery pioneer posted third-quarter results that beat the consensus forecast, despite lower profits, and upped its outlook on procedure growth for the year. Sunnyvale, Calif.-based Intuitive posted profits of $292.5 million, or $2.45 per share, on sales of $920.9 million for the three months ended Sept. 30. That amounts to a -2.0% profit decline on top-line growth of 14.0% compared with Q3 2017. Adjusted to exclude one-time items, earnings per share were $2.83, 17¢ ahead of the consensus on Wall Street, where analysts w...
Source: Mass Device - October 19, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured MassDevice Earnings Roundup Robotics Wall Street Beat Intuitive Surgical Source Type: news

FDA launches pilot to expand special 510(k) market pathway
By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration has initiated a new pilot program for expanded eligibility in the agency’s Special 510(k) pathway, potentially easing market compliance requirements for more manufacturers whose devices have undergone modifications. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees. The post FDA launches pilot to expand special 510(k) market pathway appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 19, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news

NxStage touts home hemodialysis study data
NxStage Medical (NSDQ:NXTM) today released data from a study comparing home hemodialysis to traditional treatment in a skilled nursing facility, touting a lower risk of death and cardiovascular hospitalization for those treated more often with home hemodialysis. Full results from the trial are slated to be presented at the American Society of Nephrology Kidney Week 2018 Annual Meeting next week, the Lawrence, Mass.-based company said. Investigators analyzed data collected from 3,619 patients treated in skilled nursing facilities between 2011 and 2015, and found that patients treated more frequently at home experienced...
Source: Mass Device - October 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials NxStage Medical Inc. Source Type: news

Synoste raises $6m for skeletal deformation tech
Medtech firm Synoste has raised $5.8 million (EU €5.1 million) to support its patented skeletal deformation correction tech. Funding came from Lifeline Ventures and AO Invest, the Finnish company said, and raises the total the company has raised to approximately $11.5 million (EU €10 million) so far. “Synoste is exactly the type of company that interests AO Invest; they have created not just a product but a platform that will enable various intelligent solutions from traditional intramedullary nails to flat plates that can be used in the treatment of extremely painful and psychologically debilitating condit...
Source: Mass Device - October 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Orthopedics Synoste Source Type: news

FDA clears Viseon ’ s Voyant MIS spinal surgery tech
Early stage, spinal-focused medical device maker Viseon said today it won FDA 510(k) clearance for its minimally-invasive Voyant system intended for accessing, visualizing and illuminating spinal procedures. The Voyant system is composed of a sterile single-use, disposable retractor device featuring integrated visualization technology and a reusable controller for manipulation of the surgical site image. The system is designed to display images on existing operating room display monitors, and the sterile device component allows for the adjustment of interoperative depth of focus, the Irvine, Calif.-based company said. &ldq...
Source: Mass Device - October 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Spinal Surgical Viseonspine Source Type: news

U Penn trial regrows dental pulp from baby tooth stem cells
Data from recent clinical trial out of the University of Pennsylvania suggest that the use of stem cells from a patient’s baby teeth could be used to help regrow dental pulp tissue. Results from the trial, which was conducted in China, were published in the journal Science Translational Medicine. In the trial, 40 children were selected who had injured a permanent incisor but still had baby teeth, with 30 assigned to the experimental treatment and 10 to the controlled treatment with the standard of care, apexification. The stem cells, officially known as human deciduous pulp stem cells (hDPSC), are extracted from heal...
Source: Mass Device - October 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Dental Regenerative Medicine University of Pennsylvania Source Type: news

TransEnterix CEO Pope makes Time ’ s 50 Most Influential People in Healthcare
TransEnterix (NYSE:TRXC) said today that its president and CEO Todd Pope has been named to Time Magazine’s Most Influential People in Health Care for 2018, highlighted for their work bringing the Senhance robotic surgical platform to the market. Pope was an inaugural selection for the list, which Time Magazine said it assembled to highlight “physicians, scientists, and business and political leaders whose work is transforming health care right now.” Time lauded Pope and TransEnterix for offering “budget-friendly features” for the Senhance system which they said “helps hospitals...
Source: Mass Device - October 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Robotics Surgical TransEnterix Source Type: news

Abbott alleges ex-marketing exec lifted its neuromod marketing playbook
Abbott (NYSE:ABT) this week accused a former marketing executive of purloining the marketing playbook for its neuromodulation business on his way out the door to a marketing job at competitor Nevro Corp. (NYSE:NVRO). In a lawsuit filed in the U.S. District Court for Northern Illinois, Abbott alleged that former neuromodulation global marketing product manager Blayne Fleck was instrumental in crafting the Chicago-area company’s marketing and global expansion plans. On Oct. 3, just a week after the plan was finalized, according to the Oct. 15 complaint, Fleck tendered his resignation and said he’d accepted a job ...
Source: Mass Device - October 18, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured Legal News Neuromodulation/Neurostimulation Abbott Nevro Corp. Personnel Moves Source Type: news

Cardiac Dimensions wins German reimbursement for Carillon mitral repair device
Cardiac Dimensions said today that it won reimbursement from Germany’s Institute for the Hospital Remuneration System (InEK) for its Carillon mitral contour system intended to treat patients with functional mitral regurgitation. The Kirkland, Wash.-based company’s percutaneous Carillon device is designed to use a distal anchor and proximal anchor, connected by a shaping ribbon, to re-form the mitral annulus by bending the coronary sinus. The system has had CE Mark approval in the European Union since 2011. “With this reimbursement in place and following the positive late-breaking clinical data f...
Source: Mass Device - October 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Cardiac Dimensions Source Type: news

Getinge ’ s Atrium Medical deals biosurg biz to SeCQure Surgical parent
Getinge (PINK:GETI B) subsidiary Atrium Medical said today that it agreed to deal its biosurgery business to the parent company of SeCQure Surgical for an undisclosed amount. Göteborg, Sweden-based Getinge acquired the biosurgery unit, which makes soft tissue reinforcement devices, in the $680 million deal for Atrium back in 2011. Today Getinge said it agreed to sell the business, which at $14.2 million in 2017 sales (SEK 128 million) is a relatively small segment, to SeCQure parent HJ Capital 1. The deal for the biosurg business, Getinge’s only general surgery offering, covers all ...
Source: Mass Device - October 18, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured Mergers & Acquisitions Surgical Wall Street Beat Atrium Medical Corp. Getinge SeCQure Surgical Source Type: news

Novocure wins CMS review of Optune glioblastoma Tx
NovoCure (NSDQ:NVCR) said today that the durable medical equipment Medicare Administrative Contractors accepted a new local coverage determination reconsideration request for the treatment of newly diagnosed glioblastoma with its Optune system. The St. Helier, Jersey-based company said it plans to “take steps to publish a final LCD for newly diagnosed GBM,” and per the Centers for Medicare and Medicaid Services and Medicare policy, both DEM MAC’s will issue a single joint policy for all DME regions. The DME MACs plan to assemble a Contractor Advisory Committee prior to publishing the proposed LCD for...
Source: Mass Device - October 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Optical/Ophthalmic Regulatory/Compliance NovoCure Source Type: news

Report: Nevada ’ s Heller pushed unapproved TMS treatment on VA
Nevada Senator Dean Heller (R-NV) encouraged doctors at a Reno-based Veterans Affairs medical center to use an off-label transcranial magnetic stimulation technology marketed by a company with connections to his office, according to a new ProPublica report. The company, called CereCare, markets a technology it says uses electrical scans of the brain and heart to detect an “intrinsic brainwave frequency” to identify areas of the brain “in need of restoration,” according the the report. The areas are then targeted with stimulation from a TMS system. The meeting was arranged because two partners at Cer...
Source: Mass Device - October 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Neurological cerecare Source Type: news

Dexcom wins CMS nod for latest glucose monitor
Dexcom (NSDQ:DXCM) said today that its G6 continuous glucose monitoring system will be covered for Medicare beneficiaries. The company’s product won coverage as a therapeutic CGM system, making it available to beneficiaries who closely manage their insulin dosing. Get the full story at our sister site, Drug Delivery Business News. The post Dexcom wins CMS nod for latest glucose monitor appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 18, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Featured Patient Monitoring Weight loss Dexcom Source Type: news

Evolent Health prices $150m convertible debt offering
Evolent Health (NYSE:EVH) yesterday priced an upcoming $150 million convertible debt offering. The Arlington, Va.-based company said it plans to offer 1.5% convertible senior notes due 2025 in the offering, with a 30-day option to initial purchasers to acquire an additional $22.5 million aggregate principal amount of notes. Interest on the notes is payable semiannually in arrears on April 15 and October 15 of each year beginning next April 15 at a rate equal to 1.5% per annum, according to an sec filing. The notes are convertible into cash, shares of the company’s Class A common stock or a combination of the two...
Source: Mass Device - October 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Wall Street Beat Evolent Health Source Type: news

Abbott CEO on Libre: ‘We’re just getting started’
Abbott (NYSE:ABT) posted its third quarter financial results yesterday, meeting its own forecast and the consensus set by analysts on Wall Street. The healthcare giant also narrowed its earnings outlook for the rest of the year. Abbott noted particularly high gains in revenue for its medical device division – sales were up 8.4% to $2.82 billion, in part driven by double-digit growth for its diabetes business. Get the full story at our sister site, Drug Delivery Business News. The post Abbott CEO on Libre: ‘We’re just getting started’ appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 18, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Featured MassDevice Earnings Roundup Patient Monitoring Wall Street Beat Abbott Source Type: news

Fresenius plunges on missed prelims, guidance cut
Fresenius (NYSE:FMS) shares closed down some $17% yesterday after it cut its outlook for the rest of the year on lower-than-expected third-quarter results. The German dialysis giant released preliminary figures for the three months ended Sept. 30, saying it expects to report profits of €285 million on sales of €4.06 billion. Analysts were looking for sales of €4.12 billion. Fresenius cut its forecast for 2018, saying it now expects to log adjusted net income growth of 2% to 3%, down from 7% to 9% previously. Sales growth is now pegged at 2% to 3%, compared with 5% to 7% previously, &ldquo...
Source: Mass Device - October 18, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Dialysis Featured Mergers & Acquisitions Wall Street Beat Fresenius Source Type: news

What “ no-deal ” Brexit means for medical devices
By Ronald Boumans, Emergo Group The UK will leave the European Union on March 29, 2019 – Brexit day. On that day the EU will lose an important Member State, and the UK will no longer have direct access to the 27 remaining Member States. Therefore both the EU and the UK want to work out a good relationship for the period after Brexit. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees. The post What “no-deal” Brexit means for medical devices appeared first on M...
Source: Mass Device - October 18, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news

Medtech issues again take center stage in Minn. Congressional races
The medical device industry is yet again positioned to play a major role in Minnesota congressional races. Incumbent Rep. Erik Paulsen (R-Minn.), who has been a longtime supporter of the medtech industry and led numerous attempts to repeal the medical device tax, is facing a tough re-election campaign. Paulsen is facing off against 48-year-old liquor heir Dean Philips (D), and is considered unlikely to keep his seat, which would be the first time since 1961 that Minnesota’s 3rd District was represented by a Democrat. In his last race, against former state Sen. Terri Bonoff (D), Paulsen won with a nearly 14-point lead...
Source: Mass Device - October 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Source Type: news

These 10 medtech companies care a lot about research
[Image from unsplash.com]These 10 medical device companies spent the largest portion of their budgets on research and development. Here’s a look at what they produced. Each year, Medical Design & Outsourcing compiles a list of the top 100 medical device companies across the globe and ranks the companies based on annual revenue for the most recent fiscal year. We also take into account research and development spending because it can provide an indication of where innovation is taking place in the industry. Read on to discover the 10 medtech companies spending the largest portion of their budgets on R&D, as we...
Source: Mass Device - October 17, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiovascular Featured Imaging Implants Oncology Orthopedics Patient Monitoring Regenerative Medicine Research & Development Abiomed Accuray Inc. AtriCure Inc. Big 100 BioMerieux Inc. cochlear conformis Dexcom Edwards Li Source Type: news

FDA, DHS ink cooperative medtech cybersecurity agreement
The FDA said yesterday that it is partnering with the U.S. Department of Homeland Security seeking to jointly improve cybersecurity in medical devices. The two agencies inked a memorandum of agreement looking to implement a new framework that will improve coordination and cooperation between the two bodies, according to the release. Through the agreement, both agencies will look to share information and coordinate on potential or confirmed medical device cybersecurity vulnerabilities and threats in hopes that the they will be better equipped to handle such threats to patient safety in a timely manner, according to the rele...
Source: Mass Device - October 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Featured Food & Drug Administration (FDA) Cybersecurity Dept. of Homeland Security Source Type: news

Anthem, Novo Nordisk team up for real-world diabetes drug study
Anthem’s outcomes research unit, HealthCore, and Novo Nordisk (NYSE:NVO) have joined forces to study Novo Nordisk’s semaglutide GLP-1 receptor agonist in people with Type 2 diabetes. The real-world trial is designed to compare the long-term effectiveness of the drug, also known as Ozempic, against 40 other medications among 2,250 adults with Type 2 diabetes. Get the full story at our sister site, Drug Delivery Business News. The post Anthem, Novo Nordisk team up for real-world diabetes drug study appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 17, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Diabetes Pharmaceuticals Wall Street Beat Anthem Inc. Novo Nordisk Source Type: news

BARDA adds $26m to Stratatech ’ s StrataGraft development deal
Mallinckrodt‘s (NYSE: MNK) Stratatech has won an additional $26 million in Project BioShield funding from the the U.S. Biomedical Advanced Research and Development Authority to support pediatric studies of its StrataGraft engineered skin tissue. The funding will support continued development of the StrataGraft as a potential medical countermeasure for large-scale burn incidents, U.K.-based Mallinckrodt said. BARDA previously supplied funding to Stratatech during its Phase 3 trial of the Stratagraft in adults, which explored the safety and efficacy of the device in promoting autologous skin regeneration...
Source: Mass Device - October 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Regenerative Medicine Wound Care Mallinckrodt Stratatech Corp. Source Type: news

DeviceTalks Boston: 5 medtech startups you need to know
From an individually tailored intra-corneal implant to an improved heart pump for open-heart surgery to new exoskeleton technology, there was a variety of medtech to check out during MassMEDIC’s recent Medtech Showcase. The 20th annual showcase, held last week at DeviceTalks Boston, provided a chance for a batch of 20 companies from around the world to tout their technologies to potential investors. Brian Johnson, MassMEDIC’s president (and co-founder and former publisher of Medical Design & Outsourcing) describes it as a “beacon for the local medtech startup community, providing a launchpad for dozen...
Source: Mass Device - October 17, 2018 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News Featured Implants Research & Development Surgical ablehumanmotion DeviceTalks Boston exoskeletons magoptics MassMEDIC neurescence qura startups ventriflo Source Type: news

Gauss Surgical raises $20m in Series C
Gauss Surgical said today it raised $20 million in a Series C round of financing to support its Triton surgical blood loss monitoring platform. The Los Altos, Calif.-based company’s Triton device and software are designed to help reduce unnecessary transfusions by scanning surgical sponges and blood bearing canisters while image-processing algorithms estimate the amount of blood contained in them. The system has received FDA de novo approval and CE Mark approval in the European Union, Gauss Surgical said. The round was joined by Northwell Health, SoftBank Ventures Korea, the LS Polaris Innovation Fund and seven other...
Source: Mass Device - October 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Software / IT Surgical Wall Street Beat Gauss Surgical Source Type: news

New eye health companies gain funders ’ focus
Photo by Victor Freitas on Unsplash Startups pioneering less-invasive technologies to treat common eye diseases are changing the outlook for both patients and the industry. A new study by CB Insights revealed that investors have been pouring money into smaller companies in 2017 and 2018, with some FDA approvals to begin marketing their technologies and treatments. These firms are eyeing conditions common among those age 40+, including refractive errors (e.g. near- or farsightedness), cataracts, and retinal diseases like diabetic retinopathy and macular degeneration. Get the full story on our sister site, Medical Design &am...
Source: Mass Device - October 17, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Featured Funding Roundup Optical/Ophthalmic Vision AcuFocus Inc. azura CB Insights google Ivantis lensgen rxsight tearfilminnovations Source Type: news

Where medtech is putting its money this November
Photo by Louis Velasquez on Unsplash Republicans reaped nearly $3.3 million in federal political contributions from the medtech industry in the 2017-18 election cycle, compared with $1.85 million for Democrats, according to data collected by the Center for Responsive Politics, a nonprofit campaign finance watchdog group. Medtech has “historically been a little more Republican than the average industry,” said Andrew Mayersohn, committees researcher at the center, which runs the opensecrets.org website. Indeed, Republicans pulled in more than $4.6 million in contributions in the 2015-16 electi...
Source: Mass Device - October 17, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Featured News Well AdvaMed Boston Scientific centerforresponsivepolitics Masimo MassMEDIC Medical Alley Medical Device Manufacturers Association Medtronic starkey Source Type: news

How to ensure compliance before your medical device trial begins
By Sandra Maddock, IMARC The only way to gain the FDA approval you need to bring your medical device to market is to ensure compliance at every stage in the clinical trial lifecycle. That starts long before you sign up your first subject. The planning stage is crucial because it sets expectations for how your team will work together to collect data, monitor results and protect your trial’s subjects. In this post, the first in a three-part series, we’ll cover five important steps you can take to ensure compliance before you start your medical device trial. Have a regulatory strategy A regulatory strategy a...
Source: Mass Device - October 17, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news

Si-Bone prices upsized $108m IPO
Si-Bone yesterday priced its initial public offering, which launched today, lifting the total it hopes to bring in from a previous maximum of $103.5 million up to $108 million. In the offering, the Santa Clara, Calif.-based company said it will offer 7.2 million shares at $15 per share. Si-Bone had previously said it expected to offer 6.9 million shares at between $13 and $15 per share, which would have brought in between $89.7 million and $103.5 million. The company said that it listed on the Nasdaq Global Market under the ticker symbol “SIBN,” and that the IPO was set to begin today, according to a press...
Source: Mass Device - October 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Initial Public Offering (IPO) Wall Street Beat Si-Bone Source Type: news

Nanobiotix reels in $18.5m tranche from European Investment Bank
Nanobiotix (PAR:NANO.PA) received €16 million ($18.5 million) in the first tranche of a previously-announced non-dilutive loan from the European Investment Bank. The five-year funding deal is designed to support the company’s development of nanoparticle-based cancer therapies. Get the full story at our sister site, Drug Delivery Business News. The post Nanobiotix reels in $18.5m tranche from European Investment Bank appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 17, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Funding Roundup Oncology Pharmaceuticals Wall Street Beat nanobiotix Source Type: news

Boston Scientific closes $600m Augmenix buyout
Boston Scientific (NYSE:BSX) said yesterday that it closed the $600 million acquisition of Augmenix and its SpaceOar device. The deal for Bedford, Mass.-based Augmenix, announced in September, called for $500 million in up-front cash and another $100 million pegged to sales-based milestones. “This close marks the third completed acquisition in 2018 for the company’s urology & pelvic health portfolio, further building upon our substantial momentum in this category,” medsurg president Dave Pierce said in prepared remarks. “The addition of the SpaceOAR hydrogel System, which has been used in o...
Source: Mass Device - October 17, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured Mergers & Acquisitions Urology Wall Street Beat augmenix Boston Scientific Source Type: news

Phillips-Medisize inks deal to develop connected health platform for drugs
Phillips-Medisize said this week that it teamed up with healthcare software tech company InterSystems to develop a data-sharing and analytics platform designed for connected drug-delivery devices and mobile medical apps. The third-generation of Phillips-Medisize’s connected health platform, combined with InterSystems’ HealthShare platform, will allow pharma companies to connect medication and diagnostic data across their drugs and therapeutic areas on a single system. Get the full story at our sister site, Drug Delivery Business News. The post Phillips-Medisize inks deal to develop connected health platfor...
Source: Mass Device - October 17, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Drug-Device Combinations mHealth (Mobile Health) Pharmaceuticals Phillips-Medisize Source Type: news

Abbott slips on narrowed earnings guidance
Abbott shares slipped in pre-market trading today after the company narrowed its earnings outlook for the rest of the year, after just meeting both its own forecast and the consensus Wall Street outlook. The Chicago-area healthcare giant’s profits for the three months ended Sept. 30 were off -6.6% at $563 million, or 32¢ per share, despite sales growth of 12.1% to $7.66 billion compared with Q3 2017. Adjusted to exclude one-time items, earnings per share were 75¢, dead even with the top end of Abbott’s guidance and the average on The Street, where analysts were looking for sales of $7.65 billion. &ldq...
Source: Mass Device - October 17, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured MassDevice Earnings Roundup Wall Street Beat Abbott Source Type: news

Valeritas aims for $50m in stock offering
Valeritas (NSDQ:VLRX) said this week that it plans to offer 37,593,984 shares of its common stock, hoping to raise $50 million in gross proceeds. The medical technology company also announced its preliminary financial results this week for the third quarter of 2018. Get the full story at our sister site, Drug Delivery Business News. The post Valeritas aims for $50m in stock offering appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 17, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Funding Roundup Pharmaceuticals Wall Street Beat Valeritas Source Type: news

India regulators update medical device and IVD oversight programs
By Stewart Eisenhart, Emergo Group Indian regulators have recently announced several updates regarding their medical device and IVD oversight programs. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees. The post India regulators update medical device and IVD oversight programs appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 17, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news

Smith & Nephew launches portable negative pressure wound therapy system
  [Image from Smith & Nephew]Smith & Nephew announced today that it has launched its Pico 7Y single-use negative pressure wound therapy system (sNPWT) in Europe. The system features AirLock technology and includes an integrated Y extension that allows for two dressings to be used from one pump to allow for two wounds to be treated at the same time. Get the full story on our sister site, Medical Design & Outsourcing. The post Smith & Nephew launches portable negative pressure wound therapy system appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 16, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Wound Care Smith & Nephew Source Type: news

FDA approves five-year hormonal contraceptive
Allergan (NYSE:AGN) and the nonprofit women’s health pharma company Medicines360 said today that the FDA approved an application to extend the duration of use for Liletta for the prevention of pregnancy for up to five years. Medicines360 first won approval for the levonorgestrel-releasing intrauterine device in February of 2015. The system’s latest FDA approval is based on a review of additional efficacy and safety data from an ongoing Phase III trial. The Access IUS trial, which includes 1,751 women across the U.S., found that Liletta is more than 99% effective in preventing pregnancy for up to ...
Source: Mass Device - October 16, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat Allergan Medicines360 Source Type: news

ReWalk Robotics dips on Q3 prelims, registers $15m offering
ReWalk Robotics (NSDQ:RWLK) shares took a hit today after the rehabilitation exoskeleton maker posted preliminary third-quarter sales that missed the mark on Wall Street, even as the company revealed plans for a $15 million public offering. The Yokneam, Israel-based company also registered a $14.8 million offering of stock and other securities. ReWalk said it expects to report sales of roughly $1.6 million for the three months ended Sept. 30, well shy of the $2.2 million expectation on The Street and off -5.9% compared with Q3 2017. That sent RWLK shares down -1.1% to 80.73¢ apiece today in mid-day trading. In a ...
Source: Mass Device - October 16, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup MassDevice Earnings Roundup Wall Street Beat Rehabilitation Equipment ReWalk Robotics Source Type: news

Teleflex, Arcis enter agreement for cancer diagnostics
Cancer-detection company Arcis Biotechnology said today it has signed an agreement allowing Teleflex (NYSE:TFX) to use Arcis’ advanced nucleic acid sample preparation chemistry in the development of a novel technology. Daresbury, England-based Arcis’ diagnostics use a two-step nucleic acid extraction and preservation technology. The company said it has an extensive patent portfolio covering DNA and RNA extraction and preservation for downstream processing by qPCR, RT-qPCR and sequencing in under three minutes. The platform may be used for point-of-care, microfluidics or field-based testing, and supports both co...
Source: Mass Device - October 16, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Business/Financial News Diagnostics Featured Oncology arcisbiotechnology Teleflex Source Type: news

CryoLife gains on Q3 prelim beat
CryoLife Inc. (NYSE:CRY) shares ticked up today after it announced preliminary third-quarter sales numbers that beat the consensus forecast on Wall Street. Kennesaw, Ga.-based CryoLife said it expects to post sales of roughly $64.6 million, 4.5% ahead of The Street’s forecast for a $61.8 million top line. “Our third-quarter revenue results were driven by continuing strength in Jotec, which increased 32% on a non-GAAP basis, On-X, which increased 36% year-over-year, and tissue processing, which grew 15%,” president & CEO Pat Mackin said in prepared remarks. CryoLife said it plans to issue its full thir...
Source: Mass Device - October 16, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular MassDevice Earnings Roundup Wall Street Beat CryoLife Source Type: news

Appeals court overturns Stryker win in retaliatory filing case
A federal appeals court yesterday overturned a lower court’s decision to toss a retaliatory filing case against Stryker (NYSE:SYK) after finding conflicts within the company’s testimony. Plaintiff Kelley Donley sued the orthopedics giant in June 2015 after Stryker fired her, allegedly for taking compromising pictures of an important vendor – but also shortly after she lodged a sexual harassment complaint that led to a manager’s ouster, according to court documents. The U.S. District Court for Northern Illinois dismissed the case in January 2017 after finding that Donley failed to link her filing and...
Source: Mass Device - October 16, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Legal News personnel-moves Stryker Source Type: news

Neovasc touts Tiara TMVR success rate in study
A small study of the Neovasc (NSDQ:NVCN) Tiara transcatheter mitral valve replacement (TMVR) in high-risk patients revealed a 100% procedural success rate and immediate elimination of mitral regurgitation. Published in Circulation: Cardiovascular Interventions, the study also showed no death, myocardial infarction, stroke, major bleeding, or access site complications at 30 days. The twelve patients in the study had had a previous aortic valve replacement. Such patients have been excluded from most TMVR trials because of the potential risks of left ventricular outflow tract obstruction or interaction between the T...
Source: Mass Device - October 16, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiac Implants Cardiovascular Featured Replacement Heart Valves Research & Development Mayo Clinic neovasc Neovasc Inc. Source Type: news

3 ways HHS can help medtech innovators
The U.S. Department of Health and Human Services (HHS) is doing everything from sharing more data to cultivating entrepreneurial talent and engaging in partnerships in order to support medical device innovators, the department’s CTO Ed Simcox told than 100 industry insiders in the Twin Cities today. A major goal at HHS is to build an innovation-focused culture, what Simcox described as an internal means to an end. “And the end is to improve health outcomes and reduce costs,” said Simcox, who spoke a “Healthcare Startup Day Minnesota” event that the University of Minnesota and Medical Alle...
Source: Mass Device - October 16, 2018 Category: Medical Devices Authors: Chris Newmarker Tags: Medicare Regulatory/Compliance Dept. of Health & Human Services (HHS) Medical Alley Medical Alley Assn. Minnesota Reimbursement University of Minnesota Source Type: news

BD ’ s Bard updates on higher restenosis rate for LifeStream covered iliac stent
In this study, a PSVR of more than 2.4 suggests greater than 50% restenosis. At the time of the analysis, 155 subjects passed their nine-month visit and were evaluated for the primary and secondary endpoints. Restenosis through nine months following the procedure was among the factors measured in the study’s primary endpoint composite. Patients will be followed through 36 months. Bard won pre-market approval from the FDA for the LifeStream covered iliac stent for treating peripheral artery disease in June 2017. The PMA covers the treatment of atherosclerotic lesions in common and external iliac arteries wit...
Source: Mass Device - October 16, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Featured Stents Vascular BD Clearstream Technologies crbard Source Type: news