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Report: New MRI technique improves brain scan accuracy
A new MRI technique could allow physicians to more accurately examine brain scans, according to an MIT News report. Researchers at MIT, working with physicians at Massachusetts General Hospital and other institutions, have developed a way to boost the quality of the brain scans so that they can be used for large-scale studies on the effects of stroke and treatment responses, according to the report. The scans could help researchers discover how genetic factors influence stroke survival, as well as serving as a new approach to understanding disorders such as Alzheimers, MIT News reported. The new scanning approach involves ...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Imaging Neurological Source Type: news

How to grow your medical device business through its life cycle
While every medical device business founder daydreams of pre-revenue exits and unicorn valuations, it is imperative to plan for the long and unpredictable haul. Richard F. Mattern, Bass, Berry & Sims PLC [Image from Unsplash]Despite the starting point being nearly universal (founder sees a clinical need, a promising market opportunity and a path to regulatory approval or clearance), a business’ opportunities, challenges and capital can vary significantly. Your corporate focus and related legal needs can shift through your medical device company’s life cycle as it grows. Surviving the burn (early stage) Whil...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News bassberrysims startups Source Type: news

Sommetrics wins Health Canada nod for non-invasive sleep apnea device
San Diego-based Sommetrics said yesterday it won Health Canada approval for its AerSleep system designed to apply negative external pressure to maintain an open airway during sleep. The company said that the AerSleep system was cleared as a prescription device for individuals diagnosed with obstructive sleep apnea. The system features a soft collar and integrated silent vacuum pump to allow sleeping in multiple positions, and has no hoses or masks, is cordless, portable and non-invasive, the company said. “Obtaining Health Canada’s approval for aerSleep is a major milestone for us. It’s a validation ...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance Respiratory Sommetrics Source Type: news

Median Technologies inks dev deal with Medidata for cloud-based imaging tech
Median Technologies (EPA:ALMDT) and Medidata said today they inked a collaborative deal looking to leverage their capabilities to streamline the growth and use of medical imaging in cancer clinical trials. Through the deal, Median Technologies will use Medidata’s Clinical Cloud to accelerate oncology medicine development, the companies said. Median will also use Medidata’s Medical Imaging system to transition its existing legacy imaging study management systems to a single digital environment, the companies said. “Our collaboration with Medidata will not only ease the management of images during clin...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Clinical Trials Imaging Median Technologies Medidata Solutions Source Type: news

S & S Plastics teams with StarMed on endoscopy bottle top
S&S Plastics has partnered with StarMed to develop a new endoscopy bottle top designed to reduce cross-contamination during gastroenterological investigations, according to a Medical Plastics News report. The device, designed by StarMed, is intended to keep endoscopes lenses clean and ensure a proper diagnosis and reduce procedure times. Read the whole story at our sister site, Medical Design & Outsourcing The post S&S Plastics teams with StarMed on endoscopy bottle top appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Endoscopic / Arthroscopic S&Splastics starmed Source Type: news

Insulin management software wins FDA nod
Insulin Algorithms said today that its decision-support software, designed to help clinicians manage insulin for patients with diabetes, won FDA clearance. The company’s software allows clinicians to analyze a patient’s blood sugar measurements regularly and develop an optimized plan for the patient’s insulin regimen. The software was developed with algorithms that are clinically proven to lower blood sugar, according to the company. Get the full story at our sister site, Drug Delivery Business News. The post Insulin management software wins FDA nod appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Food & Drug Administration (FDA) Regulatory/Compliance Software / IT insulinalgorithms Source Type: news

Survey: Boston Scientific ’s Mahoney is 3rd-most-liked CEO
Boston Scientific‘s (NYSE:BSX) Mike Mahoney has taken 3rd in a Glassdoor employee’s choice list of highest rated CEOs, falling just behind the Clorox Company’s Benno Dorer and World Wide Tech’s Jim Kavanaugh. While no other medtech execs made top spots, Mahoney was joined by SpaceX and Tesla head Elon Musk at 8 and Facebook founder Mark Zuckerberg at 10. The next medtech exec on the list is Johnson & Johnson‘s (NYSE:JNJ) Alex Gorsky at number 30, according to the report. Mahoney joined the company in 2012 and took over as CEO in 2013, and has been at the head of a significant turnaround ef...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Boston Scientific Johnson & Johnson Source Type: news

ClearFlow wins FDA 510(k) for FlowGlide
ClearFlow said today it won FDA 510(k) clearance for its FlowGlide active clearance technology system designed to prevent or reduce clot occlusions during chest drains. The Anaheim, Calif.-based company said that the device is designed to prevent retained blood syndrome, which can be detrimental to outcomes after cardiothoracic surgery and may require late interventions. “ClearFlow is committed to rapid technological innovation and this new generation of devices will offer features and benefits never before seen in ClearFlow products. It will also be available in shapes and sizes that previously were not availab...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Blood Management Food & Drug Administration (FDA) Regulatory/Compliance Surgical ClearFlow (formerly Clear Catheter Systems) Source Type: news

German court denies compensation claim for faulty breast implants
The federal supreme court in Germany rejected a woman’s claim for compensation from certification agency TÜV Rheinland, which approved faulty breast implants produced by Poly Implant Prothèse until it closed in 2010. PIP sold implants for almost 20 years until investigators found out it was posing a low-grade industrial silicone as a pricier medical product. The counterfeit substance was used in implants that were given to 300,000 women and thousands of them ruptured. The plaintiff, who was appealing to the supreme court after a lower court denied her complaint, had implants fitted in 2008 and subseq...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Legal News Wall Street Beat Women's Health Poly Implant Prothèse Source Type: news

MassDevice.com +5 | The top 5 medtech stories for June 22, 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. pSivida seeks European regulatory nod for Durasert pSivida is looking to market its Durasert 3-year treatment for posterior segment uveitis in the European Union. Today, the Watertown, Mass.-based company submitted a marketing ...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Exactech wins Japanese nod for shoulder, knee, hip replacement systems
Exactech (NSDQ:EXAC) said today that won Japanese approval for its shoulder, knee and hip replacement systems and that the devices had been recently used in their 1st procedures in the region. The Gainesville, Fla.-based company said it won regulatory approval to introduce additional products from its 3 segments to the Japanese market, including its Optetrak Logic CR knee system, Novation crown cup acetabular component, Alteon tapered wedge stem and Equinoxe reverse shoulder systems. The 1st procedures with all of the devices were performed between April 6 and June 5, the company said. “Exactech has maintained d...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Orthopedics Regulatory/Compliance Exactech Inc. Source Type: news

Aethlon looks fast-track FDA nod for Hemopurifier blood filter through EAP
Aethlon Medical (NSDQ:AEMD) said today it is submitting an expedited access pathway application to the FDA seeking a breakthrough technology designation for its hemopurifier. Aethlon’s Hemopurifier device is a single-use, disposable cartridge designed to target and filter out viruses or tumor-secreted exosomes. Blood flows through the cartridge into nearly 3,000 hollow fibers with pores 250 nanometers in diameter. A pressure deferential in the 1st third of the fiber pushes particles below 250 nanometers through the pores into a space between the fibers and the cartridge. The San Diego, Calif.-based com...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Regulatory/Compliance Aethlon Medical Inc. Source Type: news

Indivior touts late-stage trial for monthly buprenorphine depot
Indivior (LON:INDV) touted data today from its pivotal Phase III trial for RBP-6000, a once-monthly injectable buprenorphine depot for the treatment of adults with opioid use disorder. The 24-week study met its primary and key secondary endpoints for both dosage regimens, according to the company. Get the full story at our sister site, Drug Delivery Business News. The post Indivior touts late-stage trial for monthly buprenorphine depot appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Pain Management Pharmaceuticals Source Type: news

Two Supreme Court decisions take a whack at patent holders
Landmark U.S. Supreme Court decisions signal an effort to shoot down patent trolls, but one expert says small business could get caught in the crosshairs. U.S. Supreme Court Building [Image by Daderot – Own work, Public Domain]Recent Supreme Court decisions dealing with patents have some experts concerned that, rather than clarifying the rules and combating patent trolls, the rulings will instead weaken the rights of patent holders. 1. Powdered drinks case rewrites the patent venue rules In TC Heartland v. Kraft Foods Group Brands, a venue case, the Supremes limited the ability of patent holders to sue in other state...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Heather Thompson Tags: Business/Financial News Legal News Patent Infringement davismalmdagostine patent trolls patents U.S. Supreme Court Source Type: news

Philips picks up EEG dev Electrical Geodesics for $37m
Royal Philips (NYSE:PHG) said today it has agreed to acquire Electrical Geodesics for $36.7 million (GBP£ 29 million). Amsterdam-based Philips said that EGI’s portfolio of EEG hardware, software and acquisition sensors would work to complement its existing imaging tech and advanced informatics portfolio for neurological applications. In the sale, Philips is offering $133.50 (GBP £105.40) for each EGI share, constituting a 36% premium to its June 21 closing value, the company said. The transaction is subject to customary closing conditions and stockholder approval, with a slated completion date i...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Imaging Mergers & Acquisitions royal-philips Source Type: news

Insulet asks court to force docs from Unilife in bankruptcy sale
A Delaware judge this week ordered formal submissions from both Unilife (NSDQ:UNIS) and Insulet (NSDQ:PODD) as the companies fought over Unilife’s Chapter 11 bankruptcy sale, with Insulet claiming Unilife is selectively refusing to supply appropriate information and restricting it’s ability to participate. Insulet claims that Unilife has not provided it with enough data to make an informed bid on the assets, and has specifically targeted the company in its refusals, even after it signed a non disclosure agreement in May. Read the whole story on our sister site, Drug Delivery Business News. The post In...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Legal News Insulet Unilife Corp. Source Type: news

Mylan shareholders vote against executive pay package, but re-elect board
At the company’s annual meeting, Mylan (NSDQ:MYL) shareholders re-elected the drugmaker’s board despite a campaign spearheaded by major investors to do otherwise. The campaign hoped to encourage shareholders to vote down most of the board’s directors in response to Mylan’s drug pricing practices for its EpiPen device. The influential proxy advisory firm, ISS, also urged shareholders last week to vote against the directors. Get the full story at our sister site, Drug Delivery Business News. The post Mylan shareholders vote against executive pay package, but re-elect board appeared first on MassD...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Wall Street Beat Mylan Sanofi-Aventis Source Type: news

Senate hews to House blueprint with new Trumpcare bill
A new U.S. Senate version of the Trumpcare bill largely hews to the structure of the healthcare reform bill that passed the House last month, reportedly handing a huge tax cut to the rich by slashing the government’s contribution to the Medicaid program for the poor. The Senate bill would create a new tax credit for health insurance purchases and would allow states to drop Obamacare benefits such as maternity care, emergency services and mental health treatment, the New York Times reported. Although the Senate version would offer more financial help for the poor than its House counterpart, like that measure it w...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Healthcare Reform Capitol Hill Source Type: news

FDA committee supports Nordisk ’ s cardiovascular risk claim for Victoza label
Novo Nordisk (NYSE:NVO) shares ticked up 1% earlier this week after an advisory committee for the FDA voted to recommend that the company’s cardiovascular risk reduction claim be added to its Victoza (liraglutide) label. The discussions among committee members involved data from the 9,300-patient Leader trial, which involved people with Type II diabetes at high risk of major cardiovascular events. Get the full story at our sister site, Drug Delivery Business News. The post FDA committee supports Nordisk’s cardiovascular risk claim for Victoza label appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Diabetes Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Wall Street Beat Novo Nordisk Source Type: news

Swiss Kuros Biosciences wins CE Mark for NeuroSeal dural sealant
Swiss tissue repair and regenerative med focused Kuros Biosciences said today it won CE Mark approval in the European for its Neuroseal novel dural sealant. The Neuroseal sealant is designed as an adjunct to suturing and is used to seal the dura after cranial surgery and reduce the risk of cerebrospinal fluid leakage, the company said. Kuros added that the sealant was designed to be easy to prepare, use and handle to reduce adverse effect risks. Kuros Biosciences said that the approval is the 2nd for the company following the approval of its MagnetOs Granules, a novel synthetic bone graft substitute designed to regenerate ...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance Surgical kurosbiosciences Source Type: news

Imagion Biosystems raises $9m with Aussie IPO
Imagion Biosystems (ASX:IBX) said today that it raised $9.1 million (A$12 million) in an initial public offering on the Australian stock exchange for its MagSense cancer-tagging nanoparticles. The 15.1¢-per-share (A20¢) flotation of 60 million shares is earmarked for 1st-in-human trials, expected during the 2nd half of 2018, the Albuquerque-based company said. The MagSense nanoparticles have a 25nm iron oxide core and a specialized polymer coating and are designed to work with tumor-targeting biomarkers to attach themselves to cancer cells. Because they behave differently when bound to a cell antibody than w...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Diagnostics Funding Roundup Initial Public Offering (IPO) Oncology Wall Street Beat imagionbiosystems Source Type: news

pSivida seeks European regulatory nod for Durasert
pSivida (NSDQ:PSDV) is looking to market its Durasert 3-year treatment for posterior segment uveitis in the European Union. Today, the Watertown, Mass.-based company submitted a marketing authorization application to the European Medicines Agency. Earlier this month, pSivida reported that its 2nd Phase III trial, which followed patients for 3 years, met its primary endpoint of prevention of recurrence of posterior uveitis at 6 months. Get the full story at our sister site, Drug Delivery Business News. The post pSivida seeks European regulatory nod for Durasert appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Implants Optical/Ophthalmic Pharmaceuticals Regulatory/Compliance Wall Street Beat pSivida Corp. Source Type: news

Device monitoring is more than SDV
Many believe good monitoring should heavily focus on Source Data Verification (SDV), which stripped down to its simplest meaning equates to “X=X” and “Y=Y”.  And maybe some of you reading this are thinking “Isn’t that exactly what monitoring is?”  While data integrity is absolutely essential, it is only the beginning of what comprehensive monitoring encompasses.   The key to describing the critical role of a device monitor lies with 21 CFR  812.46, which states: Sponsor should secure compliance through monitoring of investigations If an investigator is not comp...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news

Bard shareholder looks to scuttle $24B merger with BD
A shareholder of C.R. Bard (NYSE:BCR) sued yesterday to stop a $24 billion merger with Becton Dickinson (NYSE:BDX), arguing that the price tag is too low and that the sale process was flawed and seeking class-action status for the suit. Plaintiff Richard Maser filed the lawsuit in the U.S. District Court for New Jersey, seeking to block the deal until the companies disclose more facts about their negotiations. Maser alleged that the agreement’s “no solicitation” clause “prohibits the company or the individual defendants from taking any affirmative action to obtain a better deal for Bard shareho...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Legal News Mergers & Acquisitions Wall Street Beat bectondickinson C.R. Bard Source Type: news

TriReme Medical touts Chocolate Heart drug-coated balloon data
QT Vascular subsidiary TriReme Medical touted angiographic data today from a 24-month follow-up of patients treated with its Chocolate Heart drug-coated balloon. The Chocolate Heart device is a paclitaxel-coated version of the company’s Chocolate coronary balloon that is commercially available in the U.S. The combo therapy was designed to reduce the incidence of repeat procedures and minimize the need for a stent, according to TriReme. Get the full story at our sister site, Drug Delivery Business News. The post TriReme Medical touts Chocolate Heart drug-coated balloon data appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Drug-Device Combinations Pharmaceuticals QT Vascular TriReme Medical Inc. Source Type: news

FDA Science: Working at the speed of emerging technologies
FDA Acting Chief Scientist Luciana Borio By Luciana Borio, M.D. Let’s face it, we’ve all gotten used to nearly instant access to almost anything. Today, with a tap of an app, we order a car ride, a book, or pizza for dinner. Need to navigate past traffic in downtown city streets? No problem. There’s an app for that, too. Some may wonder: Why hasn’t rapid medical product development partaken of this need for speed that has reshaped other sectors of our economy? Well, in many ways, it has. Innovation is happening extraordinarily fast in the biomedical sciences and at FDA. As FDA’s Acting Chief S...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog FDA Voice Source Type: news

5 secrets of contract manufacturing longevity
Whether it’s a few decades or the better part of a century, there are important factors that enable a contract manufacturer to last for a long time – business traits that OEM customers should value. We asked top executives from long-lasting medical device industry suppliers to share their secrets.  [Image from Unsplash]Mike Ondercin started Cleveland-based Criterion as a tool-and-dye company in 1953. Today Criterion is a precision manufacturing facility owned by Ondercin’s granddaughter Tanya DiSalvo – who bought out the former owner, her dad. The company doubled its employee roster over t...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Contract Manufacturing criterion donatelle infusmedical MTD Micro Molding sil-pro Source Type: news

Sigilon Therapeutics launches with encapsulated cell therapy tech
Backed with $23.5 million from Flagship Pioneering, Sigilon Therapeutics launched today with a plan to leverage its biocompatible Afibromer technology with engineered cells to treat hematologic, enzyme deficiency and endocrine disorders. Sigilon’s Afibromer platform represents a new class of implantable biomaterials that don’t trigger fibrosis, the company said. Encapsulated cell therapies have failed in the past in part because the body is designed to respond to and isolate foreign material. But capsules made from a biocompatible material, like Afibromers, could potentially help cell therapies survive the huma...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Funding Roundup Implants Research & Development sigilontherapeutics Source Type: news

Cochlear shares jump on FDA nod for Nucleus 7 sound processor
Hearing implant maker Cochlear Ltd. (ASX:COH) has seen shares rise nearly 4% after the company won FDA approval for its Nucleus 7 sound processor, according to a Motley Fool Australia report. The newly cleared N7 processor is superior to its prior N6 version, and is compatible with Apple’s iOS, while its telecoil is optimized for loops, according to the report. Shares rose as much as 3.9% yesterday in response to the news.  So far this year, the company has seen its shares rise 26%. The company has not yet commented on the approval officially. Last August, Cochlear said it won FDA premarket approv...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Otolaryngology Ear, Nose & Throat Regulatory/Compliance Cochlear Ltd. Source Type: news

Another extended-release ADHD drug wins FDA nod
Days after Neos Therapeutics (NSDQ:NEOS) nabbed U.S. regulatory approval for its controlled-release formulation of methylphenidate, Shire (NSDQ:SHPG) said it won a nod from the FDA for its long-acting ADHD drug. The drug, Mydayis, is made up of the same active ingredient in Shire’s ADHD treatment Adderall XR – amphetamine – but it is designed to last up to 16 hours. Adderall XR is formulated to control symptoms in patients for up to 12 hours. Get the full story at our sister site, Drug Delivery Business News. The post Another extended-release ADHD drug wins FDA nod appeared first on MassDev...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Food & Drug Administration (FDA) Neurological Pharmaceuticals Regulatory/Compliance Wall Street Beat neostherapeutics Shire Plc. Source Type: news

Impedimed wins CE Mark for Sozo monitoring system
Australian medtech developer ImpediMed said today it won CE Mark approval in the European Union for its Sozo bioimpedance spectroscopy platform. The Sozo system is designed to non-invasively measure and monitor fluid status and body composition using the company’s L-Dex lateral lymphedema assessment system. With the clearance, the Sozo platform is indicated for use as a bioimpedance spectroscopy platform for use in hospitals, clinics and in patient’s homes under a clinician’s direction, the company said. “Obtaining CE Mark for multiple indications for the Sozo platform is a pivotal regulat...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Diagnostics Regulatory/Compliance ImpediMed Source Type: news

Cleveland Clinic spinout Infuseon inks deal with OncoSynergy
Infuseon Therapeutics inked a deal this week with OncoSynergy to evaluate a glioblastoma therapeutic with the Cleveland Clinic spinout’s novel delivery device. The alliance hopes to demonstrate proof-of-concept that OncoSynergy’s candidate can be successfully delivered directly to a patient’s brain using the device in a Phase I glioblastoma trial. Get the full story at our sister site, Drug Delivery Business News. The post Cleveland Clinic spinout Infuseon inks deal with OncoSynergy appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Neurological Oncology Pharmaceuticals Research & Development infuseontherapeutics oncosynergy Source Type: news

Additive Ortho wins FDA nod for 3D printed bunion correction system
Early-stage orthopedics company Additive Orthopaedics said today it won FDA 510(k) clearance for its 3D printed, minimally-invasive, intramedullary bunion correction system. The Little Silver, N.J.-based company said the clearance was its 4th which leveraged additive manufacturing and 6th complete product line, including its 3D printed core products, biologics and custom equipment. “This new 3D printed implant allows us to have features in plates that we cannot get with standard manufacturing processes. Namely, it allows an area of the plate to provide additional fixation and strength over time enabling bone t...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Orthopedics Regulatory/Compliance Additive Orthopaedics Source Type: news

Chronic disease management wearable dev Spry Health raises $5.5m
Spry Health said this week it raised $5.5 million in a Series A round of financing to support the commercialization of its Loop wearable chronic disease management platform. Funds in the round were led by Grove Ventures and joined by the newly invested Stanford-StartX Fund and previous investors OVO Fund and Think+. “This round of funding will allow us to reach thousands of more patients with our technology. Our past and current deployments with hundreds of patients allowed us to create an invaluable second by second dataset of health. In the last three years, we developed an extensive set of Machine Learning and Exp...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Patient Monitoring spryhealth Source Type: news

MassDevice.com +5 | The top 5 medtech stories for June 21, 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. CBO scores Senate’s FDA user fees bill The Congressional Budget Office last week scored a U.S. Senate bill to re-up the user fee agreement between the medical device and pharmaceutical industries, saying it would add $740...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

LivaNova wins expanded MR indication for VNS Therapy device
LivaNova (NSDQ:LIVN) said today it won FDA approval for expanded MRI labeling for its Vagus Nerve Stimulation Therapy device, touting it as the only epilepsy device cleared by the FDA for MRI scans. With the approval, patients with the minimally invasive VNS system are cleared to visit any MRI center in the US, with access to more than 90% of routine scans for patients with epilepsy, the London-based company said. “The FDA’s approval to expand our MRI labeling changes the landscape for device-based epilepsy therapies. This further differentiates our technology from other epilepsy treatment options and adds...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Neuromodulation/Neurostimulation Regulatory/Compliance Source Type: news

Resuscitation device dev 410 Medical adds $2.1m to Series A
410 Medical said today it added an additional $2.1 million to its Series A financing, bringing the total up to $5.3 million to support its LifeFlow resuscitation device. The Durham, N.C.-based company’s LifeFlow is rapid infuser designed to deliver 1 liter of crystalloid fluid through a 20-gauge IV catheter in 5 minutes, for front-line treatment of patients needing urgent fluid delivery. Included amongst investors for the additional $2.1 million was Triangle Venture Alliance, a newly formed alliance group amongst angel investor networks at Duke University, NC State university, NC Central Universit...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News 410 Medical Innovations Source Type: news

Staar Surgical settles shareholder class action suit for $7m
Staar Surgical (NSDQ:STAA) has reached a $7 million settlement deal to end an investor suit claiming that the company concealed problems at its California plant which resulted in an FDA warning letter, according to court documents posted this week. The company reached the settlement with the certified class of investors after 3 years of litigation, according to court documents from the US District Court of the Central District of California. In the class-certified case, lead plaintiff Edward Todd claimed that Staar, president & CEO Barry Caldwell, ex-CFO Deborah Andrews and current CFO Stephen Brown “made fa...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Legal News STAAR Surgical Co Source Type: news

Medtronic wins reprieve in ‘ free services ’ false claims suit
A federal judge in Pennsylvania this week dismissed with leave to amend False Claims Act allegations suggesting Medtronic (NYSE:MDT) offered free services and support to customers to entice them to buy its medical devices on grounds that the suit did not clearly identify how the support services crossed the line and acted as kickbacks. The claims allege that Medtronic “paid healthcare providers illegal kickbacks in the form of free services and staff to induce providers to choose the defendant’s products over those of its competitors,” according to court documents. Medtronic filed to dismiss the amen...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Legal News Medtronic Source Type: news

Novartis trial results could spell trouble for Regeneron
Head-to-head late-stage clinical trials published on Tuesday showed that a Novartis (NYSE:NVS) drug to treat patients with neovascular age-related macular degeneration doesn’t need to be injected as frequently as a rival drug from competitor Regeneron (NSDQ:REGN). Analysts reportedly said the data gives Novartis’ treatment, RTH258, a competitive edge compared to its rival therapies. Get the full story at our sister site, Drug Delivery Business News. The post Novartis trial results could spell trouble for Regeneron appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Optical/Ophthalmic Pharmaceuticals Wall Street Beat Allergan Inc. Novartis Regeneron Roche Source Type: news

Zimmer Biomet cleaned house after FDA inspection at Warsaw plant
Zimmer Biomet (NYSE:ZBH) told the FDA that it cleaned house after the federal safety watchdog’s inspection last year turned up numerous violations at a plant in Warsaw, Ind., replacing 5 operations and quality executives as it sought to bring the facility back into compliance. The FDA inspected the North Campus location in Warsaw just before Thanksgiving last year and documented numerous violations in a Form 483. The company replied Dec. 21, 2016, with a lengthy account detailing its actions in remediating the problem, noting that company-wide audits put in place after the $14 billion merger of Zimmer and Biomet...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Orthopedics Regulatory/Compliance zimmerbiomet Source Type: news

Glaukos touts iStent study with topical travoprost
Glaukos (NYSE:GKOS) touted data today from a 53-patient glaucoma study showing that its iStent device combined with topical travoprost reduced mean intraocular pressure by 35% after 18 months of follow-up. The company’s flagship device is designed to lessen IOP by restoring the natural outflow of aqueous humor through the conventional pathway in a patient’s eye. Get the full story at our sister site, Drug Delivery Business News. The post Glaukos touts iStent study with topical travoprost appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Optical/Ophthalmic Pharmaceuticals Stents Wall Street Beat Glaukos Source Type: news

Digital health devices: FDA ’ s plan for innovation
Dr. Scott Gottlieb, FDA commissioner It is incumbent upon FDA to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers, and adopt regulatory approaches to enable the efficient development of these technologies. By taking an efficient, risk-based approach to our regulation, FDA can promote health through the creation of more new and beneficial medical technologies. We can also help reduce the development costs for these innovations by making sure that our own policies and tools are modern and efficient, giving entrepreneurs more opportunities to dev...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Food & Drug Administration (FDA) mHealth (Mobile Health) News Well FDA Voice Source Type: news

J & J, Medtronic push back against TGA priority review proposal
Johnson & Johnson (NYSE:JNJ) and Medtronic (NYSE:MDT) are pushing back against the Australian Therapeutic Goods Administration’s proposed priority review pathway for medical devices, citing faults in the proposal that they claim will keep them from using it, according to a RAPS report. The major medtech players said they had doubts whether the pathway, designed to hasten approval, would actually cut time to get medical devices to patients in the region. The companies also voiced concerns that the pathway could negatively impact new and breakthrough devices, according to the report. “We have concer...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance johnsonjohnson Medtronic Source Type: news

CBO scores Senate ’ s FDA user fees bill
The Congressional Budget Office last week scored a U.S. Senate bill to re-up the user fee agreement between the medical device and pharmaceutical industries, saying it would add $740 million to the budget and a negligible amount to the deficit over 2017 to 2022. The “FDA Reauthorization Act of 2017” would see medical device companies put up a collective $1 billion in user fees, which pharma firms putting up another $8 billion for drug reviews, the budget office estimated. That money, the fees companies pay to have the federal safety watchdog review their products, would offset most of the increase in ...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Capitol Hill User fees Source Type: news

Rubius snags $120m for red blood cell therapeutics
Rubius Therapeutics, a biotech engineering red blood cells as drug carriers, said today that it raised $120 million in an oversubscribed private financing round. The Cambridge, Mass.-based company plans to use its newly-acquired funds to support its Red-Cell Therapeutics portfolio and prepare for human clinical trials in 2018. Get the full story at our sister site, Drug Delivery Business News. The post Rubius snags $120m for red blood cell therapeutics appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Biotech Clinical Trials Funding Roundup Oncology Pharmaceuticals Research & Development rubiustherapeutics Source Type: news

Fostering medical innovation: A plan for digital health devices
By: Scott Gottlieb, M.D. It is incumbent upon FDA to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers, and adopt regulatory approaches to enable the efficient development of these technologies. By taking an efficient, risk-based approach to our regulation, FDA can promote health through the creation of more new and beneficial medical technologies. We can also help reduce the development costs for these innovations by making sure that our own policies and tools are modern and efficient, giving entrepreneurs more opportunities to develop product...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog FDA Voice Source Type: news

Emulate wins $2m NIH grant to study brain-on-a-chip in space
Organ-on-a-chip developer Emulate said today it won a research grant to use its human Brain-Chip system to develop a research platform to be sent to the International Space Station. The company’s Brain-Chip consists of neuronal and vascular endothelial cells in a micro-engineered environment, and experiments will be conducted under healthy and inflamed states to assess how space travel affects neuronal function. “We are honored to be selected for this research at the International Space Station which sets forth courageous goals to pioneer discoveries in space and to improve human health here on Earth. As we mak...
Source: Mass Device - June 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Neurological Emulate Inc Source Type: news

Pamplona Capital to acquire Parexel in $5B deal
Parexel said today that it would go private after Pamplona Capital agreed to buy the pharmaceutical research services company in a deal valued at $5 billion. Pamplona is slated to pay $88.10 per share for Parexel, which is a 5% premium to the stock’s close on Monday. Get the full story at our sister site, Medical Design & Outsourcing. The post Pamplona Capital to acquire Parexel in $5B deal appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 20, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Mergers & Acquisitions Pharmaceuticals Research & Development Wall Street Beat Parexel International Source Type: news

IsoRay touts another ‘ 100% ’ study
IsoRay (NYSE:ISR) today released data from a study of its Cesium-131 brachytherapy for treating patients with large brain metastases, touting a 100% freedom from local progression. Results from the study were published in the International Journal of Radiation Oncology, Biology, Physics, the Richland, Wash.-based company said. In the study, researchers assessed the impact of low-dose rate Cesium-131 brachytherapy on local control and radionecrosis in 42 patients treated for a total of 46 large brain metastases. Patients in the trial underwent surgical resection with intra-operative palcement of standard Cesium-131 see...
Source: Mass Device - June 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Oncology IsoRay Source Type: news