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Ventripoint touts publication of VMS heart analysis system study
Ventripoint Diagnostics this week announced the publication of a study of its VMS heart analysis system, touting that the system’s functionality. The study, undertaken by the cardiology group at London’s Royal Free Hospital, was published in the journal Echocardiography. Results from the study indicate that the system was able to follow patients with enlarged right ventricles and accurately measure small but significant changes in volume and function, Ventripoint said. The company said that the system’s ability to monitor clinical outcomes after therapy has been initiated is important in determining if th...
Source: Mass Device - August 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials VentriPoint Diagnostics Source Type: news

Alpinion prohibited from selling E-CUBE 12R research ultrasound in arbitration with Verasonics
Ultrasound device developer Verasonics said today that as part of a binding arbitration decision in a trade secret dispute, Alpinion Medical Systems has been prohibited from marketing or selling its E-Cube 12R ultrasound system for 5 years. The decision, which also came with a final award of more than $5.6 million, was confirmed last week by the U.S. District Court for the Western District of Washington, Verasonics said. The arbitrator in the case found that Alpinion Medical Systems had breached both non-disclosure and lease agreements between itself and Verasonics, as well as misappropriating Verasonic’s trade ...
Source: Mass Device - August 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Legal News Ultrasound alpinionmedicalsystems verasonics Source Type: news

MassDevice.com +5 | The top 5 medtech stories for August 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. Silver and electricity can kill bacteria: Here’s how Swedish researchers have developed a way to use silver nanoparticles and electrical currents to prevent bacteria from growing on plastic surfaces – helping to pre...
Source: Mass Device - August 22, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Microinnovation: what paper towels have to teach us about medtech
[Image by managing editor Chris Newmarker]How can you double the efficiency of a paper towel? Turns out you don’t need to reformulate or make the paper thicker. Instead, you find a simple concept that offers users a new way to think about the product. That’s what happened when paper towel manufacturers began producing the half-sized sheet. Roger Smith thinks the medical industry is ripe for this type of innovation. Smith is chief technology officer for Florida Hospital’s Nicholson Center for Surgical Advancement. Listen to the full podcast on our sister site Medical Design & Outsourcing.  The pos...
Source: Mass Device - August 22, 2017 Category: Medical Devices Authors: Heather Thompson Tags: Research & Development Florida Hospital microinnovation Source Type: news

Fast BioMedical raises $8m to support blood volume, kidney function dx tech
Clinical-stage medtech firm Fast BioMedical said it has raised $8 million in mixed funding, with proceeds slated to support its blood volume and kidney function diagnostic technologies, as well as internal growth. The Carmel, Ind.-based company is developing a technology platform to measure blood volume and kidney function in timely, precise and convenient manner, according to the company’s website. The technology works by measuring concentrations of fluorescent in in vivo markers which are injected through a small bolus IV of VFI comprised of 2 different fluoresced molecular weight markers. The larger marker is reta...
Source: Mass Device - August 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Business/Financial News Diagnostics fastbiomedical Source Type: news

FDA approves Malin ’ s Hourglass peripheral embolization plug
Irish life sciences company Malin Corp said today it won FDA 510(k) clearance for its Hourglass peripheral embolization plug. The company said the Hourglass plug is designed to be deployed over-the-wire for peripheral embolization procedures, and can provide immediate occlusion with a single integrated device. “This is the 1st integrated, over-the-wire device designed for peripheral embolization procedures. The goal with over-the-wire design is to provide physicians with accurate, stent-like delivery of the device in the vessel,” Hourglass co-developer George Wallace, said in prepared remarks. “The Hourgl...
Source: Mass Device - August 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Regulatory/Compliance Vascular malincorp Source Type: news

Silver and electricity can kill bacteria: Here ’ s how
Group members discussing experimental results in the Richter-Dahlfors lab. [Image from Laurent Mekul/Karolinska Institutet]Swedish researchers have developed a way to use silver nanoparticles and electrical currents to prevent bacteria from growing on plastic surfaces – helping to prevent hospital infections in the process. Large electric currents and high silver concentrations are known to kill bacteria but pose a risk to humans. Before the Swedish Medical Nanoscience Center at Karolinska Institutet’s development, both components were never used in hospitals. Led by professor Agneta Richter-Dahlfors in Ka...
Source: Mass Device - August 22, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Research & Development karolinskainstitutet Source Type: news

Preceptis launches trial of its Hummingbird ear tube system
Preceptis Medical said today that it launched trial of its Hummingbird tympanostomy tube system. The Plymouth, Minn.-based company’s Hummingbrid TTS tympanostomy tube system is designed to reduce pain for pediatric patients undergoing ear tube procedures, allowing moderate, conscious sedation with no need for general anesthesia. The 1st patient in the prospective, office-based study was enrolled by principal investigator Dr. Frank Rimmel at St. Paul, Minn.’s Health Partners Clinic, Preceptis said. “The company has taken a careful approach to establishing the safety of the Hummingbird in a hospital se...
Source: Mass Device - August 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Otolaryngology Ear, Nose & Throat Preceptis Medical Source Type: news

Medtronic supply woes buoy insulin device makers
Share prices for makers of insulin management devices got a bump today after Medtronic (NYSE:MDT) reported today that supply problems pushed sales down -1% for its diabetes division. The Fridley, Minn.-based company, which released its fiscal 2018 first-quarter results this morning, posted diabetes revenues of $449 million for the three months ended July 28. The decline was driven by strong demand for Medtronic’s CGM-enabled insulin pumps, especially the MiniMed 670G hybrid closed-loop device. Get the full story at our sister site, Drug Delivery Business News. The post Medtronic supply woes buoy insulin dev...
Source: Mass Device - August 22, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Diabetes MassDevice Earnings Roundup Wall Street Beat Dexcom Insulet Medtronic Tandem Diabetes Care Source Type: news

Omeros closes $68m public offering
Biopharma company Omeros (NSDQ:OMER) said that it closed a $68.3 million underwritten public offering last week, selling 3 million shares of its common stock at $22.75 apiece. After deducting fees and other expenses, Omeros said it is slated to reel in $63.6 million from the offering. The company plans to use its newly-acquired funds to support R&D for its clinical-stage programs and for costs associated with BLA and NDA submissions. Get the full story at our sister site, Drug Delivery Business News. The post Omeros closes $68m public offering appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - August 22, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Funding Roundup Pharmaceuticals Surgical Wall Street Beat Omeros Corp. Source Type: news

Getinge launches Biotronik ’ s Pulsar-18 SES in the US
Getinge (PINK:GETI B) said today it launched Biotronik‘s Pulsar-18 self-expanding stent in the US, operating as Biotronik’s distributor in the region for its portfolio of peripheral artery disease devices. Biotronik claims that the Pulsar-18, which won FDA clearance in March, is the only approved superficial femoral artery self-expanding stent with a 4-French delivery system, which it said makes the device and associated procedures simple and more efficient. “As more patients are diagnosed with PAD due to our aging population, interventional and surgical teams need access to innovative, proven p...
Source: Mass Device - August 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Distribution Stents Biotronik Getinge Source Type: news

Novartis launches MS study using data collected from smartphones
Novartis (NYSE:NVS) said today that it is launching a research study to better understand the daily challenges facing people with multiple sclerosis. The study is designed to collect data from physical tasks and symptoms using participants’ smartphones. The company said it hopes to find new potential ways to measure treatment effectiveness. Get the full story at our sister site, Drug Delivery Business News. The post Novartis launches MS study using data collected from smartphones appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - August 22, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Neurological Pharmaceuticals Research & Development Software / IT Wall Street Beat Novartis Source Type: news

Titan Medical adds French hospital site to future Sport feasibility & validation study
Titan Medical (TSX:TMD) said today it inked a deal with the French Institut Hospitalo-Universitaire de Strasbourg to participate in feasibility and validation studies of its Sport robotic surgical system as the company seeks regulatory clearance for the platform. Toronto-based Titan Medical said it expects to initiate studies of its Sport system in the 4th quarter of this year, continuing into next year. “We are thrilled to partner with IHU Strasbourg, one of Europe’s premier research and training centers, for continued feasibility and validation studies for the Sport system. IHU Strasbourg is well kn...
Source: Mass Device - August 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Robot-Assisted Surgery Robotics Titan Medical Inc. Source Type: news

Dexcom touts continuous glucose monitoring for Type II diabetes patients
Dexcom (NSDQ:DXCM) touted data today showing that people with Type II diabetes who are using multiple daily injections of insulin can benefit from the use of continuous glucose monitoring. Those in the 158-patient study using Dexcom’s G4 Platinum CGM system experienced significant A1C reduction and spent more time in target range compared to a control group that used a standard meter to test glucose. Get the full story at our sister site, Drug Delivery Business News. The post Dexcom touts continuous glucose monitoring for Type II diabetes patients appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - August 22, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Diabetes Pharmaceuticals Wall Street Beat Dexcom newtag Source Type: news

UPDATE: Medtronic logs fiscal Q1 earnings beat, but sales miss the mark
UPDATED August 22, 2017, with segment results, share price. Medtronic (NYSE:MDT) beat the consensus forecast on Wall Street with its fiscal 2018 first-quarter earnings, but missed the mark when it came to sales. The world’s largest medical device operation today posted profits of $1.02 billion, or 74¢ per share, on sales of $7.39 billion for the three months ended July 28, for a bottom-line gain of 9.4% on sales growth of 3.1% compared with fiscal Q1 2017. Adjusted to exclude one-time items, earnings per share were $1.12, 4¢ ahead of The Street, where analysts were looking for sales of $7.45 billion. MDT sh...
Source: Mass Device - August 22, 2017 Category: Medical Devices Authors: Brad Perriello Tags: MassDevice Earnings Roundup Wall Street Beat Medtronic Source Type: news

Medtronic logs fiscal Q1 earnings beat, but sales miss the mark
Medtronic (NYSE:MDT) beat the consensus forecast on Wall Street with its fiscal 2018 first-quarter earnings, but missed the mark when it came to sales. The world’s largest medical device operation today posted profits of $1.02 billion, or 74¢ per share, on sales of $7.39 billion for the three months ended July 28, for a bottom-line gain of 9.4% on sales growth of 3.1% compared with fiscal Q1 2017. Adjusted to exclude one-time items, earnings per share were $1.12, 4¢ ahead of The Street, where analysts were looking for sales of $7.45 billion. MDT shares, which closed up slightly yesterday at $83.52 apiece, t...
Source: Mass Device - August 22, 2017 Category: Medical Devices Authors: Brad Perriello Tags: MassDevice Earnings Roundup Wall Street Beat Medtronic Source Type: news

FDARA: Making a difference for industry and patients
Peter Marks, M.D., Ph.D., Director of FDA’s Center for Biologics Evaluation and Research By: Peter Marks, M.D., Ph.D., Jeffrey Shuren, M.D., J.D., and Janet Woodcock, M.D. For decades, user fees paid by the medical products industry have provided critical resources needed to conduct product reviews in a timely fashion and to help ensure the safety and effectiveness of medical products that American patients depend upon. Since passage of the first medical product user fee act in 1992, the user fee laws and corresponding performance goals and program enhancements have helped evolve the drug and device review process in...
Source: Mass Device - August 22, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog FDA Voice Source Type: news

BioVentrix wins FDA IDE nod, launches Revivent TC trial
BioVentrix said today it received FDA investigational device exemption approval and launched a safety and efficacy trial of its Revivent TC transcatheter ventricular enhancement system designed to treat patients suffering from ischemic cardiomyopathy. The Revivent system is designed to eliminate the need for cardiopulmonary bypass or incisions in the heart by enabling the placement of small titanium anchors along the heart’s outer surface and along one of the inside walls, according to the San Ramon, Calif.-based company. The San Ramon, Calif.-based company said it enrolled the 1st patient in the Alive trial, wi...
Source: Mass Device - August 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) BioVentrix Source Type: news

J & J ’ s Ethicon launches ProxiSure laparoscopic suturing device
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said today it launched the ProxiSure laparoscopic suturing device. Ethicon said the device features its endomechanical, suture and curved needle technologies to improve suturing precision in tight spaces. The device allows surgeons to reach desired angles, control bites and secure nots during suturing and knot tying to reduce the risk of needle loss, the company added. “With the patient’s health at the forefront of our thinking, we aimed to introduce a suturing device that will help reduce the margin of error in minimally-invasive surgery. Surgeons will n...
Source: Mass Device - August 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blog Ethicon johnsonandjohnson Source Type: news

Fujifilm announces U.S. customer wins for Synapse imaging system
Fujifilm Medical Systems U.S.A. said today that seven U.S. healthcare systems are picking up various products from the company’s Synapse enterprise imaging portfolio. The health systems includeHackensack Meridian Health and West Virginia University Health System – two of the largest healthcare networks in the mid-Atlantic region. Products bought include the Synapse 5 PACS, Synapse VNA, Synapse Mobility Enterprise Viewer, and Synapse Cardiovascular and Synapse Cloud services. “Fujifilm is excited that all of these organizations have chosen Synapse 5 as their new radiology PACS. The speed of server-sid...
Source: Mass Device - August 21, 2017 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News Imaging fujifilm Source Type: news

Tool identifies diabetes patients at risk for severe hypoglycemia
Researchers have developed a tool used to identify diabetes patients who are at-risk for being admitted to the hospital due to severe hypoglycemia, according to a study published today in JAMA Internal Medicine. “Sometimes a person with diabetes is unaware that their blood sugar is dropping and can progress quickly into severe hypoglycemia, which has been associated with falls, automobile accidents, heart attacks, coma, and even death,” Andrew Karter, senior research scientist at Kaiser Permanente, said in prepared remarks. “Hypoglycemia is often preventable with the proper clinical attenti...
Source: Mass Device - August 21, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Hospital Care Pharmaceuticals Research & Development Kaiser Permanente Source Type: news

Medtronic wins CE Mark for MRI-safe Attain Stability quad CRT leads
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its Attain Stability quad magnetic resonance imaging-safe left heart leads designed for cardiac resynchronization therapy defibrillators and pacemakers. The leads feature MRI SureScan technology and are cleared for use with 3 Tesla and 1.5T MRI scans, the Fridley, Minn.-based company said. The leads also feature a side-helix designed to be fixated in veins of various sizes, the company said. Medtronic said it has initiated a limited European launch, with the 1st commercial implants recently performed at Bergen, Norway’s Haukeland U...
Source: Mass Device - August 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Medtronic Source Type: news

MassDevice.com +5 | The top 5 medtech stories for August 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. Medical device product development: pitfalls you need to avoid Managing your medical device product development project can be a daunting task. There are regulations and paperwork to manage, along with expectations such as dead...
Source: Mass Device - August 21, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Battelle touts improved control with NeuroLife neural bypass system
This study demonstrates the significant potential and capabilities of brain computer interface technology to improve function and help patients with disabilities,” Dr. Ali Rezai of Ohio State University, who implanted the system’s Utah array chip into Burkhart’s brain, said in prepared remarks. Last April, MassDevice.com spoke to NeuroLife electrical engineering task lead Nick Annetta about the project, the system and Burkhart’s willingness to invest in the multi-year project. The post Battelle touts improved control with NeuroLife neural bypass system appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - August 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Neurological Prosthetics Research & Development Battelle Source Type: news

Researchers progress towards vaccine against fentanyl, heroin combo
Researchers reported at the 254th National Meeting & Exposition of the American Chemical Society today that they are developing a vaccine to guard against the effects of fentanyl in combination with heroin – a deadly duo that is claiming a growing number of lives as the opioid crisis worsens in the U.S. “There is an urgent need to discover effective medications to treat substance use disorders. Increasingly, drug users are turning to opioids and powerful synthetic versions of these drugs that can sometimes be as much as 100 times more potent than heroin,” lead researcher Kim Janda said in pr...
Source: Mass Device - August 21, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Pain Management Pharmaceuticals Research & Development Scripps Research Institute Source Type: news

Pediatric medical device competition extending its deadline
The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) is extending its “Make Your Medical Device Pitch for Kids” competition deadline to Aug. 24 at midnight Pacific time. “We’ve had unprecedented interest in the competition this year and we want to accommodate as many pediatric medical device innovators as possible, so we want to give everyone a bit more time to finalize their submission,” said Kolaleh Eskandanian, executive director of the Sheikh Zayed Institute and NCC-PDI. The fifth annual Pediatric Device Innovation Symposium is scheduled to take place on Sept. 24 in Sa...
Source: Mass Device - August 21, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Pediatrics Children's National Health System nationalcapitalconsortium forpediatricdeviceinnovation universityofmaryland Source Type: news

Biotronik launches Edora HF-T MRI-safe CRT-P, touts as smallest in US
Biotronik said today it launched its Edora HF-T magnetic resonance-conditional quadripolar cardiac resynchronization therapy pacemaker, touting it as the smallest device of its type available in the US. The German medical device company said the Edora HF-T QP has a volume of 15 cc, making it the smallest MR conditional CRT-P available in the US. The device has a lifespan of 10 years and features MRI Autodetect, Closed Loop Stimulation and Biotronik Home Monitoring technology, the company said. “Patient care is a constant journey. It doesn’t end when the patient leaves my office or recovers from a procedure...
Source: Mass Device - August 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Assist Devices Cardiac Implants Cardiovascular Biotronik Source Type: news

Judge: BD owes nothing in Retractable Technologies false advertising case
Retractable Technologies (NYSE:RVP) shares are off more than -50% since a federal appeals court last week ruled that nemesis Becton Dickinson & Co. (NYSE:BDX) owes nothing for making false advertising claims about its syringes. The dispute dates back to 2001, when Little Elm, Texas-based RTI sued BD for patent infringement that settled for $100 million in 2004. RTI sued again barely 3 years later, alleging further patent infringement and anti-trust violations. That case was split, with the anti-trust portion stayed while the patent infringement claims were litigated. A federal appeals court&nbs...
Source: Mass Device - August 21, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Hospital Care Legal News bectondickinson Retractable Technologies Inc. Source Type: news

Gamida Cell launches severe aplastic anemia trial
Gamida Cell said today that the first patient has been transplanted in a study of its CordIn product for patients with severe aplastic anemia or hypoplastic myelodysplastic syndrome. The product is designed for patients with rare genetic diseases who have no fully-matched donors for a bone marrow transplantation. Gamida Cell said it is also evaluating its CordIn therapy for patients with sickle cell disease. Get the full story at our sister site, Drug Delivery Business News.   The post Gamida Cell launches severe aplastic anemia trial appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - August 21, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Research & Development Stem Cells Gamida Cell Source Type: news

Acelity touts lowered complications, narcotic use in Prevena NPWT cesarean trial
This study adds to the growing body of evidence that demonstrates a potential reduction in post-operative wound complications in a variety of surgical incisions,” chief medical officer Dr. Ron Silverman said in a press release. In May, Acelity said it launched its Prevena Duo incision management system in the US. The Prevena Duo is a single use negative pressure wound therapy system specifically designed for the simultaneous management of 2 closed surgical incisions, the company said. The post Acelity touts lowered complications, narcotic use in Prevena NPWT cesarean trial appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - August 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Surgical Wound Care Acelity Source Type: news

Carl Zeiss acquires cataract surgery planning software dev Veracity Innovations
Carl Zeiss Meditec (ETR:AFX) said today it is acquiring cloud-based ophthalmological tech developer Veracity Innovations for an undisclosed amount. Veracity Innovations developed and produces a cloud-based surgical planning platform for cataract surgeries, covering initial planning, management and analysis of the procedures. The system is designed to interface directly with multiple electronic medical records and diagnostic devices, covering patients from initial consultation through post-operation, Carl Zeiss said. “Digital technology is fundamentally changing our world and has a major impact in healthcare. Eff...
Source: Mass Device - August 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Mergers & Acquisitions Optical/Ophthalmic Software / IT Carl Zeiss Meditec veracityinnovations Source Type: news

Trump signs FDA user fee bill into law
President Donald Trump last week signed a bill to re-up the agreement between the FDA and the medical device and pharmaceutical industries, putting medical device companies in line for a collective $1 billion in user fees. Companies pay user fees to help cover the cost of the safety watchdog’s reviews of their products. The bill to renew the agreement, the “FDA Reauthorization Act of 2017,” also calls for pharma firms to put up $8 billion for drug reviews. The Congressional Budget Office in June estimated that the measure would add $740 million to the budget and a negligible amount to the deficit. The CBO...
Source: Mass Device - August 21, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Capitol Hill User fees Source Type: news

Study: Annual mammograms would prevent the most deaths
Credit: National Cancer Institute (Reuters) – Yearly mammograms starting at age 40 would prevent the most deaths from breast cancer, U.S. researchers reported on Monday in a challenge to more conservative recommendations that take into account both the harms and the benefits of screening. The study, led by Dr. Elizabeth Arleo, a radiologist specializing in mammography at Weill Cornell Medicine and New York-Presbyterian, found that yearly mammograms between the age of 40 and 80 could cut breast cancer deaths by 40%. That compares with a reduction of 23 to 31% with current screening recommendations that call for less f...
Source: Mass Device - August 21, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Diagnostics Imaging Oncology Research & Development Women's Health Source Type: news

BTG helps fund immuno-oncology drug-device research programs
BTG (LON:BTG) and the Society of Interventional Oncology said today that it expanded its immuno-oncology/interventional oncology research grant program. The group launched a second round of funding, designed help evaluate minimally invasive, image-guided therapies that use the body’s own immune system to treat cancer. Get the full story at our sister site, Drug Delivery Business News. The post BTG helps fund immuno-oncology drug-device research programs appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - August 21, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Funding Roundup Imaging Oncology Pharmaceuticals Research & Development BTG Source Type: news

Ex-ArthroCare CEO Baker convicted again in fraud case
A federal jury in Texas last week handed former ArthroCare CEO Michael Baker another loss in his second trial over an alleged $750 million fraud scheme, after a federal appeals court last year overturned his first conviction. Baker and ex-ArthroCare CFO Michael Gluk were convicted in June 2014 on charges that they ran a scheme to generate false revenue numbers by dumping inventory, first with a distributor called DiscoCare and eventually via free shipments to end-users. ArthroCare was DiscoCare’s only client until it acquired DiscoCare in December 2007. Although Baker was ...
Source: Mass Device - August 21, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Legal News Orthopedics ArthroCare Corp. Source Type: news

MiMedx divests Stable Biologics subsidiary in transition to focus on biopharma
MiMedx (NSDQ:MDXG) said today it inked a definitive agreement with the former shareholders of Stability Inc. to divest itself of Stability Biologics, which it acquired last January. The Marietta, Ga.-based company said the divestiture is part of its plan to transition back into a biopharmaceutical-focused company. “The transaction is expected to be completed in the 3rd quarter of 2017, and the consideration will include a promissory note issued by Stability Biologics in the principal amount of $3.5 million in favor of MiMedx and a waiver by the former stockholders of Stability, Inc. ...
Source: Mass Device - August 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Regenerative Medicine MiMedx Group Inc. Stability Biologics Source Type: news

Study: New tech “ lights up ” nerves to identify, reduce accidental damage
Researchers have developed a new nerve-illuminating tool they claim makes nerves stand out from other tissue, lighting it up to help surgeons avoid accidentally injuring nerves and identify nerves in need of repair. The tool, developed by Kenneth and Patrick Chin, uses an optical technique known as collimated polarized light imaging to help identify nerves during surgery. The system uses rotating polarization which is reflected off nerve tissue’s unique internal structure in a way that makes the reflection appear to switch on and off. Results from a study of the device was published in the journal Biomedical Optics E...
Source: Mass Device - August 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Research & Development Surgical Source Type: news

IBM partners to identify risk factors for Type I diabetes
IBM (NYSE:IBM) plans to develop and apply machine learning techniques to years of research data in the hopes of identifying factors that trigger the onset of Type I diabetes in children, with the support of JDRF. Scientists at IBM are slated to assess three different data sets using machine learning algorithms to find patterns and factors that could one day help delay or prevent Type I diabetes. Get the full story at our sister site, Drug Delivery Business News. The post IBM partners to identify risk factors for Type I diabetes appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - August 18, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Big Data Diabetes Wall Street Beat IBM Juvenile Diabetes Research Foundation (JDRF) Source Type: news

MassDevice.com +5 | The top 5 medtech stories for August 18, 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. Study: New infrared imaging technique could help detect heart attack, stroke risk A new near-infrared diagnostic technique could help improve early detection for patients at risk of heart attacks or strokes, according to a new ...
Source: Mass Device - August 18, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Medical device product development: pitfalls you need to avoid
Jon Speer, Greenlight.guru [Image from Unsplash]Managing your medical device product development project can be a daunting task. There are regulations and paperwork to manage, along with expectations such as deadlines or goals for getting the device to market. I sat down recently to chat with Peter Sebelius about our thoughts on project management best practices for medical device product development. Sebelius is the founder of Gantus.com, where he helps medical device companies with quality assurance, risk management and project management. He is a certified project manager and member of joint working groups on ISO 13485 ...
Source: Mass Device - August 18, 2017 Category: Medical Devices Authors: Chris Newmarker Tags: Research & Development greenlight.guru Source Type: news

South Carolina becomes latest state to sue opioid-maker Purdue
On Tuesday this week, South Carolina became the latest state to sue Purdue Pharma, accusing the drugmaker of deceptively marketing their addictive products in a way that fueled the ongoing opioid crisis. The state’s attorney general said that Purdue told doctors that opioids are not addictive and patients who appear to be addicted were only “pseudoaddicted” and simply needed more drugs. Get the full story at our sister site, Drug Delivery Business News. The post South Carolina becomes latest state to sue opioid-maker Purdue appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - August 18, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Legal News Pain Management Pharmaceuticals Wall Street Beat purduepharma Source Type: news

Women ’ s urinary incontinence device startup Elidah looks to raise $2m
Women’s health device start-up Elidah is looking to raise $2 million to support its Elitone stress urinary incontinence-treating device, according to a Connecticut Post report. The Elitone device, developed by the Newtown, Conn.-based company, is designed to be worn during the day and provides 20 minutes of electrical stimulation to strengthen pelvic muscles and aid women with stress urinary incontinence, according to the report. So far, Elidah has won backing from the state-backed Connecticut Innovations venture fund for up to $750,000, as well as an undisclosed amount of funding from the NSF’s Small Business ...
Source: Mass Device - August 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Urology Women's Health elidah Source Type: news

Becton Dickinson blood tubes under investigation in FDA probe of faulty lead tests
(Reuters) – Blood collection tubes made by Becton Dickinson & Co. (NYSE:BDX) that were used in conjunction with Magellan Diagnostics‘ lead-testing devices are still being investigated as a potential cause of inaccurate lead test results. The FDA in May had warned that Magellan’s LeadCare test systems performed on blood samples might provide inaccurate results. Prior to that, Magellan, a unit of Meridian Bioscience Inc, had said that inaccurate blood test results could potentially be related to a change in the composition of the tops of certain blood collection tubes made by Becton Dickinson....
Source: Mass Device - August 18, 2017 Category: Medical Devices Authors: MassDevice Tags: Blood Management Diagnostics Food & Drug Administration (FDA) bectondickinson Source Type: news

7 medtech stories we missed this week: Aug. 18, 2017
[Image from unsplash.com]From Nemaura’s new Oceania distribution deal to Sanuwave’s promissory note expansion, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Nemaura inks Oceania distribution deal for SugarBeat patch Nemaura announced in an Aug. 15 press release that it has signed a non-binding distribution deal with Device Technologies for exclusive rights to market the SugarBeat glucose monitoring system in Australia and New Zealand. The SugarBeat is a disposable, adhesive skin patch that is used by diabetics, providing a non-invasive and needle-free method of c...
Source: Mass Device - August 18, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Diabetes Diagnostics Implants Orthopedics Research & Development Surgical Brenner Medical Clinical Innovations Device Technologies K2M Masimo MedTech Nemaura Medical Sanuwave Si-Bone Source Type: news

Study: New infrared imaging technique could help detect heart attack, stroke risk
A new near-infrared diagnostic technique could help improve early detection for patients at risk of heart attacks or strokes, according to a new multi-center study. Researchers at the University of Warwick’s WMG, the Baker Institute and Monash University reported that when they increased the wavelength of light currently used to visualize athereosclerotic plaques, they were able to selectively identify rupture-prone deposits, which can lead to blood clots, heart attacks and strokes. Data from a study of the technique was published in the journal Nature Communications. Current imaging techniques are able to identify c...
Source: Mass Device - August 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Research & Development Source Type: news

Drug blocked by European regulators improves quality of life for MS patients
A study by researchers at the Queen Mary University of London has found that a drug blocked by European regulators can improve the quality of life for people with multiple sclerosis. The team of researchers reached this conclusion after uncovering previously unpublished clinical trial data from the European Medicines Agency. The European Commission is currently considering whether it will reverse its decision to deny a license for the oral formulation of the drug, cladribine. Get the full story at our sister site, Drug Delivery Business News. The post Drug blocked by European regulators improves quality of life f...
Source: Mass Device - August 18, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Pharmaceuticals Regulatory/Compliance queenmaryuniversityoflondon Source Type: news

Portable x-ray company MinXray wins $100m DoD contract
Portable X-ray company MinXray has been awarded a maximum $100 million firm-fixed-price, indefinite delivery and indefinite quantity contract from the US Department of Defense, according to a release published yesterday. Northbrook, Ill.-based MinXray produces portable x-ray and digital imaging systems for use in medical, veterinary and military field operations, according to the company’s website. The 5-year contract was awarded for the supply of radiology systems and training, and contains an additional 5-year option period. A total of 27 applications for hte contract were received, according to the DoD. Through th...
Source: Mass Device - August 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blog MinXray Source Type: news

Nanotech, immunotherapy combo vaccinates mouse against cancer
Researchers from Duke University combined an FDA-approved cancer immunotherapy with gold nanostars to boost the cancer-killing abilities of both therapies, according to a study published this week in Scientific Reports. The combination therapy cured two mice and vaccinated one against bladder cancer, the team reported. Get the full story at our sister site, Drug Delivery Business News. The post Nanotech, immunotherapy combo vaccinates mouse against cancer appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - August 18, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Oncology Pharmaceuticals Research & Development Duke University Source Type: news

Senseonics prices $25m offering
Senseonics (NYSE:SENS) today priced an upcoming offering, looking to raise approximately $25 million to support its Eversense long-term implantable continuous glucose monitoring system. The Germantown, Md.-based company said it will look to float 11.6 million shares in the offering at a price of $2.15 per share. The offering will also include a 30-day underwriter’s option to purchase an additional 1.7 million shares, which could net the company an additional $3.8 million. Net proceeds from the offering are slated to support initial commercialization of the Eversense in the US, contingent upon its FDA approval, a...
Source: Mass Device - August 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Diabetes Wall Street Beat Senseonics Source Type: news

10 reasons to keep your printed circuit board production in the U.S.
Although the lure of low-cost labor is tempting, offshoring production of printed circuit boards can lead a company into a host of problems. Firms can find themselves dealing with increased costs, regulatory hurdles and pitfalls relating to quality control. Here are 10 reasons why: Intellectual property: It is very difficult to defend IP piracy abroad. U.S. firms lose 1$ for every $3 gained due to stolen IP. Counterfeit parts: This is a huge problem worldwide and out of the companies control. Most companies will find out after the parts have been utilized in their product. FDA shipment delays: All products having 510...
Source: Mass Device - August 18, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Lockheed Martin Corp. Source Type: news