Kleresca wins CE Mark for biophotonic dermatological system
Dermatological device developer Kleresca said yesterday it won CE Mark approval in the European Union for its biophotonic dermatological technology platform. The Kleresca biophotonic system uses fluorescent light energy to stimulate biological processes and repair mechanisms in the skin, the company said. Kleresca said that hte clearance will allow it to “consolidate its business on the European market as an independent company and paves the way for future market actirivites in the US, Australia and Canada.” The company added that it expects to apply the Medical Deisng Single Audit Program on top of the CE Mark...
Source: Mass Device - August 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cosmetic/Aesthetic Regulatory/Compliance kleresca Source Type: news

ValenTx raises $10.3 million for implantable gastric bypass device
Startup ValenTx has attracted nearly $10.3 million from 32 investors, according to a filing with the Securities & Exchange Commission. The Maple Grove, Minn. company is developing a removable gastric bypass device as an alternative to Roux-en-Y gastric bypass surgery. It raised $10,271,050 in the round begun July 18, 2018. The ValenTx endoluminal bypass therapy mimics the attributes of a Roux-en-Y gastric bypass and is implanted through a non-surgical, endoscopic procedure, according to the company’s website. This procedure does not require gastric stapling or permanent changes to the patient&...
Source: Mass Device - August 17, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Diabetes Endoscopic / Arthroscopic Securities & Exchange Commission (SEC) valentx Source Type: news

Brainsway wins FDA nod for OCD-treating TMS system
The FDA today said it granted de novo approval for Brainsway‘s deep transcranial magnetic stimulation system, now indicated for treating obsessive compulsive disorder. The TMS system uses magnetic fields to simulate nerves in the brain, and has been shown to reduce the severity of OCD in patients. A 100-patient randomized, multi-center study of the device indicated that patients who received TMS treatment alongside medical management had a higher response rate, at 38%, than those treated with medical management and a sham device, at 11%. The most frequent adverse reaction was headache, which was reported by 37.5% of ...
Source: Mass Device - August 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Neurological Neuromodulation/Neurostimulation Regulatory/Compliance Brainsway Source Type: news

Accuray shares rise on Street-topping Q4, FY2018 earnings
Shares in Accuray (NSDQ:ARAY) rose today after the medical device maker beat expectations on Wall Street with its fourth quarter and full fiscal year 2018 earnings. The Sunnyvale, Calif.-based company posted losses of $946,000 or 1¢ per share, on sales of $113.8 million for the three months ended June 30, seeing losses shrink 82% while sales grew 1.5% compared with the same period last year. Losses per share were just ahead of the 2¢ consensus on Wall Street. For the full year, Accuray posted losses of $23.9 million, or 28¢ per share, on sales of $404.9 million, seeing losses shrink 19.2% while sales gr...
Source: Mass Device - August 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat Accuray Inc. Source Type: news

BoneSupport wins Canadian approval for Cerament G bone graft substitute
BoneSupport said today it won Health Canada approval for its Cerament G bone graft substitute. The Lund, Sweden-based company touted it as the first and only CE Marked gentamicin-eluting injectable ceramic bone graft substitute on the market. Bonesupport said it is currently engaged in a trial of Cerament G exploring it’s ability to improve standard-of-care management of patients with open fractures of the tibial diaphysis. The study is slated to enroll 230 patients at 30 centers in the US and Europe, with primary endpoints including the absence of deep infection at the fracture site and a lack of secondary proc...
Source: Mass Device - August 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Orthopedics Regulatory/Compliance Bonesupport Source Type: news

Magnolia Medical, Kurin trade lawsuits
Magnolia Medical Technologies said yesterday it filed a lawsuit against blood-culture-focused device developer Kurin claiming the company “mischaracterized its clinical data as well as the functionality and ease of use of its device.” The suit comes in response to a similar suit filed by Kurin in the Southern District of California in May which claimed that Magnolia violated the Lanham Act based on false and misleading statements. Kurin claims that Magnolia falsely implied that “its Steripath device is FDA approved/cleared, and misrepresents product performance data by selecting only the most favorable re...
Source: Mass Device - August 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Legal News kurin Magnolia Medical Technologies Source Type: news

KFx inks Zimmer licensing deal, sues Stryker over patent infringement
KFx Medical said yesterday it inked a licensing agreement with Zimmer Biomet (NYSE:ZBH) for patents used in knotless double row rotator cuff repair and that it filed a lawsuit against Stryker (NYSE:SYK) which it claims infringes on patents also related to knotless double row rotator cuff repair. Through the licensing agreement, Zimmer Biomet and its affiliates will have the right to use and promote products for knotless double row rotator cuff repair. The technology had previously been licensed to Smith & Nephew (NYSE:SNN), Johnson & Johnson (NYSE:JNJ) and its Mitek subsidiary, Wr...
Source: Mass Device - August 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Legal News Patent Infringement KFx Medical Stryker zimmerbiomet Source Type: news

Voluntis launches upgraded insulin dosing therapeutic
Voluntis this week launched an upgraded version of Insulia, its digital therapeutic designed to give automated basal insulin dose recommendations and coaching messages for people with Type 2 diabetes. The company touted that its upgraded version of Insulia improves user experience and offers Spanish programming. Get the full story at our sister site, Drug Delivery Business News. The post Voluntis launches upgraded insulin dosing therapeutic appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - August 17, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Pharmaceuticals Voluntis Source Type: news

FDA approves first generic Epipen
The FDA this week approved the first generic version of Mylan‘s (NSDQ:MYL) Epipen emergency allergy auto-injector. Teva Pharmaceuticals (NYSE:TEVA), which won the historic approval, plans to market the generic epinephrine auto-injector in 0.3mg and 0.15mg doses. There are other epinephrine auto-injectors on the market in the U.S., but Teva’s is the first that’s approved to directly substitute the Epipen. Get the full story at our sister site, Drug Delivery Business News. The post FDA approves first generic Epipen appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - August 17, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat Mylan Teva Pharmaceuticals Source Type: news

Appeals court shoots down Medtronic win in IRS feud
A federal appeals court yesterday shot down a U.S. Tax Court decision in a longrunning transfer prcing dispute between Medtronic (NYSE:MDT) and the Internal Revenue Service. The IRS maintains that Fridley, Minn.-based Medtronic owes $1.4 billion in back taxes for transfer pricing arrangements among the company’s various units during the tax years 2005 and 2006. In transfer pricing, income is allocated among branches in different countries. It’s a legal tax maneuver companies can use to attribute profits from a product made and sold in the U.S. to a unit in a foreign country. The federal...
Source: Mass Device - August 17, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Legal News Wall Street Beat Medtronic U.S. Internal Revenue Service (IRS) Source Type: news

Second Sight inks $5m private placement deal
Second Sight Medical (NSDQ:EYES) said today it inked a $5 million private placement deal with funds slated to support continued development and testing of its implantable visual prosthetic technology. The Los Angeles-based company said it is selling approximately 3.2 million shares of common stock at $1.55 per share to entities owned by its board chair Gregg Williams, effective on August 14. Second Sight said it expects to net gross proceeds of approximately $5 million to help support a feasibility study of its Orion cortical visual prosthesis system, continued development of its Argus 2s next-gen devices and collecti...
Source: Mass Device - August 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Optical/Ophthalmic Wall Street Beat Second Sight Source Type: news

Electromed touts SmartVest non-cystic fybrosis bronchiectasis study data
Electromed (NSDQ:ELMD) today released results from an independent clinical study exploring the use of high frequency chest wall oscillation therapy with its SmartVest, touting that it significantly reduced severe exacerbations and hospitalizations for non-cystic fibrosis bronchiectasis patients. Findings from the study were presented at the World Bronchiectasis Conference in Washington D.C., the New Prague, Minn.-based company said. “Preventing exacerbations and maintaining pulmonary function is vital to the health and well-being of bronchiectasis patients. This independent study builds on previously publis...
Source: Mass Device - August 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Electromed Source Type: news

Lessons learned: How Jeff Karp stays at the forefront of innovation
Serial entrepreneur Jeff Karp has a philosophy for his laboratory: find important problems and get solutions to people quickly. To learn about the exciting technologies emerging from Karp’s lab, join us at DeviceTalks Boston on Oct. 8-10. After Jeff finished his PhD in chemical and biomedical engineering at the University of Toronto, he knew he wanted to work with Robert Langer. “He’s the intergalactic translational superstar,” Karp said. Langer, a professor at the Massachusetts Institute of Technology and one of the most cited engineers of all time, receives thousands of applications per year ...
Source: Mass Device - August 16, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Research & Development DeviceTalks Boston Frequency Therapeutics Source Type: news

Viveve launches woman-focused stress urinary incontinence device trial
Viveve (NSDQ:VIVE) said on Tuesday it launched a trial exploring the safety and efficacy of its cryogen-cooled monopolar radiofrequency tech designed to treat stress urinary incontinence in women. The new Liberate trial will look to enroll 100 subjects at up to 10 sites in Canada, with patients randomized in a two-to-one ratio for active and sham treatments. The Englewood, Colo.-based company said that the first subject in the trial has had their first visit under an approved Investigational Testing Application with the Canadian Ministry of Health and central investigatioal review board approval. “Initiatio...
Source: Mass Device - August 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Urology Women's Health Viveve Source Type: news

Masimo, Dominion bury the hatchet in blood monitoring IP infringement suit
Diagnostic tech developer Masimo (NSDQ:MASI) and rival Dominion have settled a suit over blood monitoring patents, according to recently released court documents. The two companies said they reached a settlement deal over a suit brought against Masimo by Dominion claiming it infringed on patents related to noninvasive blood monitoring technology. The agreement does not include payments from either company, and leaves both sides to pay for their own legal costs, according to court documents. The settlement deal was signed by US District Judge Beth Freeman on Tuesday. Earlier this week, Masimo released results from a st...
Source: Mass Device - August 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Diagnostics Legal News Dominion Assets Masimo Source Type: news

Bone Index wins CMS coverage for osteoporosis diagnostic device
Finnish orthopedic device manufacturer Bone Index said it has won Medicare and Medicaid coverage for its Bindex point-of-care osteoporosis measurement device for ambulatory surgical and outpatient settings. Bindex measures the cortical bone thickness of the tibia and an algorithm calculates the density index, a parameter that estimates bone mineral density at the hip as measured with a bone-density (DXA) scan. The device detects osteoporosis with 90% sensitivity and specificity and will significantly help physicians with diagnosis, according to the Helsinki-based company. The FDA approved Bindex in January 2017. ...
Source: Mass Device - August 16, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Diagnostics Orthopedics Bone Index Centers for Medicare and Medicaid Services (CMS) FDA Source Type: news

FDA finalizes streamlined bundled, quarterly MDR reporting system
The FDA today announced it finalized its new Voluntary Malfunction Summary Reporting Program intended to streamline medical device manufacturer malfunction reporting. The program was created in part through public comments received by the FDA and is intended to allow manufacturers to report “certain device malfunctions in summary form on a quarterly basis” instead of an an individual basis for certain devices. The federal watchdog said it had previously piloted the program and found it allowed for more efficient reviews and better understanding of malfunction issues. The system also made it easier to identify r...
Source: Mass Device - August 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

SPR Therapeutics ’ new PNS system wins FDA nod
The FDA has approved SPR Therapeutics’ (Cleveland) Sprint endura (single lead) and extensa (dual lead) peripheral nerve stimulation (PNS) systems. The minimally invasive Sprint system is the only FDA-approved percutaneous PNS system that is indicated for up to 60 days in the back and/or extremities for both chronic and acute pain and is the industry’s only dual lead capable PNS platform, according to the company. Get the full story on our sister site, Medical Design & Outsourcing. The post SPR Therapeutics’ new PNS system wins FDA nod appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - August 16, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Food & Drug Administration (FDA) Neuromodulation/Neurostimulation Pain Management SPR Therapeutics Source Type: news

IntriCon prices $83m offering
IntriCon (NSDQ:IIN) today priced an upcoming public offering looking to raise approximately $82.5 million. The Arden Hills, Minn.-based company said it is looking to float 1.5 million shares of common stock at $55 per share, and that the offering is expected to close on August 20. The offering includes a 30-day underwriter’s option to purchase an additional 225,000 shares of common stock at the same price, according to a press release. Intricon said it expects to see net proceeds of approximately $77.3 million after discounts and expenses, which it plans to use to repay debt, fund capital expenditures and repurc...
Source: Mass Device - August 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat IntriCon Corp. Source Type: news

GN Hearing inks deal with Google, launches Beltone Amaze
GN Hearing (CPH:GN) this week announced it inked a partnership with Google (NSDQ:GOOG) to enable its hearing aid devices to directly stream audio from Android devices, and said it launched its Beltone Amaze hearing solution. With the Google deal, users will be able to connect and monitor their hearing aids on Android devices as well as stream audio, without the need for an intermediate device. The service will initially be available on the company’s ReSound LiNX Quattro and Beltone Amaze devices. “According to the World Health Organization, around 466 million people worldwide have disabling hearing loss. T...
Source: Mass Device - August 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Otolaryngology Ear, Nose & Throat GN Store Nord google Source Type: news

How an integrated data platform can reshape the medical device industry
By Medidata Solutions As big data grows and competition rises, stricter regulatory guidance looms Today’s medical device industry is being transformed by the generation and analysis of vast amounts of data. However, the traditional approaches to data collection and analyses in clinical trials don’t necessarily apply. Along with this massive volume of siloed, disparate data comes unique challenges — from unstructured datasets and data ownership and privacy issues to storing global post-market surveillance data and adhering to evolving regulatory definitions and requirements. These challenges demand the ado...
Source: Mass Device - August 16, 2018 Category: Medical Devices Authors: Medidata Solutions Tags: Sponsored Content Medidata Solutions Source Type: news

How to meet clinical trial monitoring goals
John Lehmann, Director of Business Development at IMARC Research In order to comply with applicable regulations and requirements, the intention of clinical trial monitoring is to protect the rights and well-being of study subjects, ensure data integrity, and ensure that the trial conduct is in compliance with the clinical investigational plan (CIP), agreements, GCP, requirements of the Institutional Review Board (IRB) / Ethics Committee (EC), and all applicable regulations.  In addition, the goals of monitoring should include: identifying and addressing non-compliance improving quality and promoting high standards ...
Source: Mass Device - August 16, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news

Invuity launches PhotonGuide Adapt vaginal surgical illuminator and retractor system
Invuity (NSDQ:IVTY) said yesterday it launched the PhotonGuide Adapt system featuring a flexible illuminator and retractors for vaginal surgical procedures. The devices are designed for use in procedures including pelvic organ prolapse repairs and vaginal hysterectomies, the San Francisco-based company said. The PhotonGuide Adept’s waveguide is designed to conform to different sizes and shapes of retractors and allows for illumination adjustment along the length of the retractor. “The PhotonGuide Adapt launch marks a major milestone in our commitment to advancing surgical procedures in women’s health...
Source: Mass Device - August 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Surgical Women's Health Invuity Source Type: news

ReShape Lifesciences shares plunge on Q2 release, withdrawn offering
Shares in ReShape Lifesciences (NSDQ:RSLS) have fell 30% today after the weight loss device maker posted second quarter earnings that missed expectations on Wall Street and announced it terminated plans for an upcoming offering. The San Clemente, Calif.-based company posted losses of $35.3 million, or $14.23 per share, on sales of $653,369 for the three months ended June 30, seeing losses grow 415.3% while sales grew 602.1% compared with the same period last year. Losses per share were significantly behind the $1.79 consensus on Wall Street. “We have made a lot of meaningful progress this quarter at ReShape, wit...
Source: Mass Device - August 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat reshapelifesciences Source Type: news

MolecuLight wins FDA de novo nod for handheld fluorescence wound imager
MolecuLight said yesterday it won FDA de novo clearance for its MolecuLight i:X designed to assess wound surface area and help visualize harmful bacteria within the wounds. The device is designed to improve wound assessments, which are currently made without tools, the Toronto-based company said. The system uses fluorescence to help visualize potentially harmful bacteria which may other be missed. The device won indications from the FDA as a handheld imaging tool that allows for the diagnosis and treatment of skin wounds at the point of care. The system also allows for the viewing and digital recording of wounds traditiona...
Source: Mass Device - August 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Wound Care moleculight Source Type: news

OrthoPediatrics expands Indiana-based headquarters
OrthoPediatrics said yesterday it is planning a $1 million expansion of its Warsaw, Ind.-based headquarters, looking to double its warehouse space and add administrative spaces. The expansion will include the addition of open-concept offices and dedicated training and education facilities, the company said. A ground-breaking on the expansion is being held on August 16. “Indiana is known as one of the leading hubs for orthopedics, and we are excited to see this trend not only continue but strengthen with the commitment of companies like OrthoPediatrics. Our industry leaders are innovating new products and develop...
Source: Mass Device - August 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News OrthoPediatrics Corp. Source Type: news

Report: FDA ’ s Gottlieb says pediatric device approvals are lagging
FDA head Scott Gottlieb said that over the past 10 years there have been “far too few” devices hitting the US market designed specifically for a pediatric population, according to a recently posted Regulatory Affairs Professionals report. The statement came at a two-day FDA workshop this week, according to the report. Barriers including sample size issues, regulatory concerns and problems with research infrastructure are keeping such devices from hitting the market, according to an audience poll from the workshop. While the number for adult devices approved by the FDA grew at a rate of 3.8 per year between 2008...
Source: Mass Device - August 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Pediatrics Source Type: news

ViewRay prices $150m offering
ViewRay (NSDQ:VRAY) yesterday priced an upcoming offering looking to raise $150 million. The Cleveland-based company plans to float approximately 16.2 million shares of common stock at $9.25 per share, bringing in $150 million gross before offering-related payments. The offering, slated to close on August 17, will also include a 30-day underwriter’s option to purchase an additional 2.4 million shares at the same price. ViewRay said it plans to use funds raised to support working capital and general corporate purposes, including R&D, clinical trials, capital expenditures and infrastructure expenses, acco...
Source: Mass Device - August 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat ViewRay Inc. Source Type: news

Report: Apple is exploring custom health sensor tech
Apple (NSDQ:AAPL) may be looking to develop its own health sensor chip technology, according to a new report from CNBC. The tech giant posted a job opening in mid July looking for “sensor ASIC architects to develop ASICs for new sensors and sensing systems for future Apple products,” according to the report. A separate posting from August showed that Apple is looking for someone to “help develop health, wellness, and fitness sensors,” according to CNBC. An additional earlier posting from June mentioned that the company was also looking to continue working with optical sensors, which the company...
Source: Mass Device - August 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Diagnostics mHealth (Mobile Health) Research & Development Apple Source Type: news

Judge tosses Zimmer Biomet hip suit over statute of limitations issues
A US District Judge for the Pennsylvania Federal Court yesterday dismissed a plaintiff’s claims of injury related to a Zimmer Biomet (NYSE:ZBH) metal-on-metal prosthetic hip because it passed the statute of limitations. Plaintiff Marilyn Adams was implanted with a Zimmer hip prosthesis in 2011, and claimed to suffer pain and complications for years after. She underwent a second surgery in 2015 to replace the prosthesis with a ceramic device. Adams claims in the case that the metals used in the first prosthesis, alongside “an unreasonably dangerous design” resulted in significant health complications,...
Source: Mass Device - August 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Legal News Orthopedics zimmerbiomet Source Type: news

Medtronic launches In.Pact Admiral drug-coated balloon in Japan
Medtech titan Medtronic (NYSE:MDT) said today that it launched its In.Pact Admiral drug-coated balloon in Japan. The company won approval and reimbursement for its device last year from the Japanese Ministry of Health, Labor and Welfare for the treatment of peripheral artery disease in the upper leg. Get the full story at our sister site, Drug Delivery Business News. The post Medtronic launches In.Pact Admiral drug-coated balloon in Japan appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - August 15, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Vascular Wall Street Beat Medtronic Source Type: news

Hologic will distribute analgesic system to aesthetic providers
Hologic (NSDQ:HOLX) has inked an agreement between its Cynosure division and Porter Instrument to distribute Porter’s nitrous oxide and oxygen system, Nitronox, in the United States and Canada. Nitronox is a self-administered nitrous oxide and oxygen delivery system that provides a fast-acting inhaled analgesic to help patients manage discomfort and anxiety while remaining alert and conscious during their aesthetic procedures. Nitrous oxide and oxygen have been used safely and effectively for more than 100 years for pain management. More recently, Nitronox devices’ non-invasive delivery system has been cat...
Source: Mass Device - August 15, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Source Type: news

Join Cognition Corporation in Boston September 20-21 for NAVIGATE2018
By Nick Schofield, Content Creator Interested in networking with and learning from top voices in life science industries about the latest topics and challenges in product development? Are you looking to learn more about how organizations use Cognition’s products and services to help bolster regulatory compliance from premarket to postmarket environments? Then come to NAVIGATE2018, Cognition’s annual user conference! NAVIGATE2018 will features talks, panels, and discussions from industry leaders about the latest topics, ideas, and concerns in life science product development. Topics include: Risk management Cyb...
Source: Mass Device - August 15, 2018 Category: Medical Devices Authors: Nick Schofield Tags: Sponsored Content Cognition Corporation Source Type: news

AngioDynamics acquires Surgical Specialties ’ BioSentry sealant, updates on Bard antitrust suit
AngioDynamics (NSDQ:ANGO) said today it acquired Surgical Specialties’ BioSentry Tract Sealant assets for an undisclosed amount, and touted a recent legal win in a case against Becton Dickinson & Co. (NYSE:BDX) subsidiary C.R. Bard. The newly acquired BioSentry system is designed to prevent the occurrence of pneurmothorax during CT-guided percutaneous lung biopsies using a proprietary hydrogel plug which prevents air leakage during the procedure. The sealant has both FDA clearance and CE Mark approval in the European Union. As part of the acquisition, AngioDynamics said that Surgical Specialties&rs...
Source: Mass Device - August 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Legal News Mergers & Acquisitions Respiratory AngioDynamics Source Type: news

What you need to know about medical device packaging
Image courtesy of Packaging Compliance Labs. A recent study about recalls of foot and ankle implants included a portion that likely drew less attention than the headline. Some of these implants were recalled because they arrived at the hospital in an unsterile condition, and the authors said faulty packaging may have been the cause. Poor packaging can cause a host of problems for medical device companies and their customers. A package that holds a sterile medical device not only has to arrive at the hospital or clinic free of holes, tears and broken seals, it also has to withstand sitting on a shelf, possibly for...
Source: Mass Device - August 15, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Contract Manufacturing Materials Testing keystonesolutionsgroup packagingcompliancelabs Source Type: news

Novocure inks collaboration for pivotal pancreatic cancer trial
Novocure (NSDQ:NVCR) and US Oncology Research said today that the groups are collaborating on a phase III pivotal trial designed to test Novocure’s Tumor Treating Fields with nab-paclitaxel and gemcitabine in patients with unresectable locally advanced pancreatic cancer. Using a network of community-based oncology practices, US Oncology Research plans to open 10 clinical trial sites to enroll patients in Novocure’s Panova-3 trial, the companies reported. Get the full story at our sister site, Drug Delivery Business News. The post Novocure inks collaboration for pivotal pancreatic cancer trial appeared firs...
Source: Mass Device - August 15, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Oncology Pharmaceuticals Wall Street Beat NovoCure Source Type: news

BioSig wins FDA nod for Pure EP system
BioSig Technologies (OTCQB: BSGM) said today it won FDA 510(k) clearance for its Pure EP electrophysiology system. The Santa Monica, Calif.-based company said the PureEP system is designed for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology procedures. The newly cleared system is intended to reduce noise and artifacts to produce high-fidelity cardiac signals, which the company claims could increase the diagnostic values of the signals. Initial Pure EP systems were prod...
Source: Mass Device - August 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Cardiovascular Regulatory/Compliance BioSig Technologies Source Type: news

Micro Molding with Bioabsorbables: Not Your Average Thermoplastics
This whitepaper explores Micro Molding with Bioabsorbables. Across the board with plastics, the rules are different when you mold it so small. But when it comes to bioabsorbable resins, they require a much more extensive and specialized approach than thermoplastics. By learning how processing bioabsorbables differs from thermoplastics, medical OEMs can understand the key factors needed for optimizing the design and production of their bioabsorbable products. The post Micro Molding with Bioabsorbables: Not Your Average Thermoplastics appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - August 14, 2018 Category: Medical Devices Authors: MassDevice Tags: White Papers MTD Micro Molding Source Type: news

Report: Med device recalls in Q2 highest since 2005
Medical device recalls during the second quarter hit 360, the highest amount seen since 2005, according to a new Stericycle Expert Solutions report. Recalls were up 17, or 5% from the previous quarter, according to the report. Recalled units decreased 80% to approximately 42.4 million, lower than eight of the previous 13 quarters, according to the report. A total of 16 companies reported at least five recalls, the largest number since the third quarter of 2013, according to Stericycle. Software issues, followed by mislabeling, quality issues and manufacturing defects made up the top four issues causing recalls for the quar...
Source: Mass Device - August 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Recalls stericycleexpertsolutions Source Type: news

Capillary Biomedical raises $3m to support insulin infusion tech
Capillary Biomedical said today that it raised $2.9 million in a seed funding round to support regulatory filings and the launch of its insulin infusion technology. The company is gearing up for clinical trials to support a 510(k) filing and hopes to bring its SteadiSet infusion set to the market in 2019. Get the full story at our sister site, Drug Delivery Business News. The post Capillary Biomedical raises $3m to support insulin infusion tech appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - August 14, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Funding Roundup Pharmaceuticals capillarybiomedical Source Type: news

Masimo touts study exploring pulse oximetry pre-screening for OSA in children with down syndrome
Masimo (NSDQ:MASI) yesterday released results from a study exploring home pulse oximetry monitoring’s ability to serve as an initial screening method to determine which children with Down syndrome should be recommended to undergo sleep studies to diagnose obstructive sleep apnea. The Irvine, Calif.-based company said that children with Down syndrome are at high risk of obstructive sleep apnea, which can only be reliably diagnosed using multichannel sleep studies, which are expensive and time-consuming. A total of 161 children with DS between 0.5 and 6 years old were selected for the trial, 25 of which were separ...
Source: Mass Device - August 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Diagnostics Masimo Source Type: news

Avinger posts loss on disappointing sales
Avinger (NSDQ:AVGR) today posted a second-quarter losses-per-share that missed an analyst’s expectation, sending its share price down on Wall Street despite nearly halving its losses. The Redwood City, Calif.-based medical device maker reported losses of -$6.6 million, or -98¢ per share, on sales of $2.1 million for the three months ended June 30, 2018. That compares with losses of -$12.8 million during Q2 2017 and amounts to a -14% top-line slide. An analyst on The Street was looking for losses per share of -0.48¢ on sales of $2.6 million. Positive news for the quarter included FDA clearance and ...
Source: Mass Device - August 14, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Cardiovascular Catheters Avinger Source Type: news

BARDA, J & J launch ‘ reimagined ’ emergency respiratory device challenge
The Dept. of Health and Human Services’ Biomedical Advanced Research and Development Authority and Johnson & Johnson‘s (NYSE:JNJ) Janssen R&D are launching a new crowdsourced tech development challenge looking to support innovative respiratory protection devices, according to a recently listed government posting. The new contest, dubbed the QuickFire Challenge, will look to award up to $100,000 to developers of “reimagined, transformative respiratory protection” devices, according to the release. Both J&J’s Janssen and BARDA will collaborate on the challenge, alongside J&J&rsqu...
Source: Mass Device - August 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Research & Development Respiratory Dept. of Health & Human Services (HHS) johnsonandjohnson Source Type: news

Conavi Medical touts first investigational use of Novasight hybrid IVUS-OCT system
In this study, we are collecting the first human images with this novel imaging system to confirm the functionality of the technology in the clinical environment and to help inform future studies. We have been able to identify some early examples of the synergies between these two modalities in our clinical experience so far. Ultimately, hybrid IVUS/OCT imaging has the potential to overcome the limitations of IVUS or OCT alone in accurately characterizing atherosclerotic tissue and in guiding coronary interventions,” Dr. Sheth said in a prepared statement. Conavi Medical said the technology behind the Novasight syste...
Source: Mass Device - August 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Imaging Vascular Conavi Source Type: news

“Snake oil” BP app got high user marks despite inaccurate results
People may like mobile blood pressure apps better when the apps reveal positive results, even if those results are inaccurate 80% of the time, according to a recent study. A team of researchers who previously revealed the inaccuracy of the Instant Blood Pressure (IBP) app returned to the topic to study 81 adults who compared the app’s readings against their own BP estimates. Those whose systolic BP measured lower on the IBP app than they expected reported that they were more inclined to use the app again than those whose systolic blood pressure was higher than they estimated, the study showed. Get the ...
Source: Mass Device - August 14, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiovascular News Well Research & Development auralabs Federal Trade Commission (FTC) Johns Hopkins University universityofvermont Source Type: news

7D Surgical wins FDA nod for MvIGS nav system Cranial Module
Canadian medical device firm 7D Surgical said yesterday it won FDA 510(k) clearance for a Cranial Module for its Machine-vision Image Guided Surgery system. The Toronto-based company’s 7D Surgical System uses 3D optical technologies which require only natural light, as well as machine vision algorithms. The system’s navigation technology is embedded in an overhead surgical light to reduce line of sight issues, and is controlled by the surgeon using a foot pedal to eliminate the need for non-sterile personnel for operation. “We are incredibly excited to expand the MvIGS technology to cranial surgery.&...
Source: Mass Device - August 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Imaging Regulatory/Compliance Surgical 7D Surgical Source Type: news

IBM pushes back on negative Watson Health stories
IBM Watson Health (NYSE:IBM) is pushing back against reports that its artificial intelligence powered products deliver less than promised, claiming that the reports are unfair and ignore its capabilities. A number of news outlets, including The Wall Street Journal and STAT News, have recently published criticisms of IBM’s Watson Health offerings, claiming that its capabilities fall short of the company’s large promises. “Unfortunately, some media reports, including an August 11th story published in The Wall Street Journal, distort and ignore facts when suggesting IBM has not made ‘enough’...
Source: Mass Device - August 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Software / IT IBM Watson Health Source Type: news

In midst of Epipen shortage, Kaleo confirms ‘ sufficient supply ’ of Auvi-Q auto-injectors
Kaleo said today that despite ongoing manufacturing delays reported by epinephrine auto-injector manufacturers, Kaleo’s Auvi-Q device is available via prescription and that the privately-held company has ‘sufficient supply to meet any anticipated demand.’ Kaleo’s epinephrine auto-injector features voice instructions that guide users through the drug-delivery process and an auto-retractable needle system, according to the company. Get the full story at our sister site, Drug Delivery Business News. The post In midst of Epipen shortage, Kaleo confirms ‘sufficient supply’ of Auvi-Q auto...
Source: Mass Device - August 14, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Respiratory Hospira Inc. Impax Laboratories Kaleo Inc Mylan Source Type: news

Report: Women in Australia to pursue class action over Bayer ’ s Essure
A group of women in Australia will be joining other women worldwide in pursuing a class action lawsuit against Bayer (ETR:BAYN) for medical problems allegedly associated with its Essure permanent birth control device, according to a report from The Guardian. The suit, which will be led by law firm Slater and Gordon, joins similar suits against Bayer in the US, Canada and the UK, according to the report. Slater & Gordon associate Ebony Birchall said the suit will examine whether the product is inherently defective, according to The Guardian. “Essure was hailed as the new wave of contraceptive devices. Unlike ...
Source: Mass Device - August 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Legal News Women's Health Bayer Source Type: news

Augmedics launches first-in-human Xvision-spine AR nav system trial
Surgical VR developer Augmedics said last week it began the first-in-human clinical trial of its Xvision-spine augmented reality surgical navigation center. The trial was launched at at Israel’s Sheba Tel Hashomer Medical Center and Asaf Harofeh Medical Center, led by co-principal investigators Dr. Ran Harel and Dr. Yigal Mirovsky. The Xvision-spine system is an AR surgical navigation system intended to allow surgeons to see internal anatomy during surgery with intentions to make surgeries safer and faster. The system includes a transparent near-eye display headset, with navigation data projected onto the s...
Source: Mass Device - August 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Spinal Surgical augmedics Source Type: news