Egalet wins tentative FDA nod for intranasal abuse-deterrent pain-killer

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Egalet (NSDQ:EGLT) said today that the FDA tentatively approved an expanded label for its Arymo extended-release pain-relief tablets. The new label includes data from a intranasal human abuse potential study and an intranasal abuse-deterrent claim.

The FDA previously excluded this data from Arymo ER’s label due to exclusivity given to another company, Egalet reported. The FDA is slated to give full approval to Arymo ER’s new label when that exclusivity period ends on Oct. 2, 2018.

Get the full story at our sister site, Drug Delivery Business News.

Chemence Medical wins FDA nod for Exofin Fusion skin closure system

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Chemence Medical's Exofin Fusion

Chemence Medical said today it won FDA clearance for its Exofin Fusion skin closure system designed for medium to large wounds.

The Exofin Fusion skin closure system features a self-adhering mesh strip, mesh anchors and a fast-curing 2-octyl cyanoacrylate topical adhesive to close and seal large incisions and form a microbial barrier to protect from infections, the company said.

Alpharetta, Ga.-based Chemence said the Exofin Fusion is designed for multiple uses, but is most applicable for orthopedic procedures including total hip and knee replacements, cardiovascular procedures, plastic surgery, spinal procedures and obstetrics for C-section closures.

“Our new skin closure system can really improve the operating room experience for doctors and patients when closing larger wounds. The self-adhering mesh and anchor system allows for easy application and enables surgeons to close incisions faster than sutures, while the adhesive cures in less than a minute. Meanwhile, the waterproof microbial barrier reduces the patient’s likelihood of readmission due to infection, allows them to shower immediately after surgery, and the innovative anchor system improves comfort during removal. Exofin Fusion brings the features doctors and patients love about topical wound closure adhesives to a whole new array of procedures. Chemence Medical is excited to introduce the next step in topical skin adhesives,” prez Jeff Roberson said in a press release.

Last February, Chemence said it won FDA 510(k) for its Exofin topical skin adhesive designed for wound closure.

FDA panel votes against recommending Intrinsic Therapeutics’ Barricaid spinal prosthesis

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Intrinsic Therapeutics

An FDA advisory panel voted 5 to 8 against recommending approval for Intrinsic Therapeutics’s Barricaid prosthesis designed for partial annulus replacement in patients with herniated discs, according to a MedPage Today report.

The negative recommendation came based on concerns over the safety of the device, including breakage rate and certain endplate lesions of unknown origin. The same panel voted 12 to 1 in favor of the device’s efficacy, according to the report.

“There was a high rate of breakage of the device, a high rate of migration, and [there was] the unknown nature of [some endplate] lesions,” panel member Dr. Eli Baron of the Cedars Sinai Spine Center in Los Angeles said, according to the report.

Other panel members disagreed, and saw the device as having some minor concerns.

“[The device is] reasonably safe, and I think the major concerns centered around the endplate lesions and while there were some theoretical concerns about harbingers of device failure … the number of lesions observed was sufficient to reassure me that there is nothing catastrophic about the devices,” Dr. Ty Subhawong of the University of Miami who voted in favor of the device said, according to the report.

The Barricaid implant is a polymeric mesh that is designed to sit at the posterior intervertebral disc space and is connected to a metal anchor that is attached to the vertebral body, according to an FDA briefing document.

The device is intended an adjunct for lumbar limited discectomy to replace missing or damaged parts of the anulus to prevent re-herniation, disc collapse, the return of sciatica and potentially to help stave off low back pain.

The system was tested in a nearly seven-year-long study, spanning from December 2010 to May 2017, which enrolled 554 patients at 21 sites across northwestern Europe, MedPage Today reports.

Intrinsic Therapeutics had originally sought investigational device exemption from the FDA for a US trial, but the application was denied due to safety concerns, according to the report.

Results from the European trial indicated that 50.8% of Barricaid patients had no reherniation at 24 months, higher than the 30.1% rate in the control group. A total of 27.8% of Barricaid patients also achieved the composite endpoint when compared to 18.1% in the control cohort, according to MedPage Today.

Patients who received interventions with the Barricaid had an 93.1% rate of adverse events, higher than the 78% reported in the control group. Serious adverse events were 38% for Barricaid patients and 41% in the control, according to the report.

A major concern amongst the panel was endplate lesions, which were reported in 88% of Barricaid patients but only 39% in the control cohort, MedPage Today reports.

In May, Intrinsic Therapeutics said it raised a $49 million debt-and-equity round for the Barricaid annular closure device for discectomies that it’s developing.

Acorda resubmits NDA for inhaled Parkinson’s disease therapy

  • Solvay releases new PEEK polymer for implantable devices

    Solvay has launched its new Zeniva ZA-600 CF30 polyetheretherketone (PEEK) designed for use in implantable device applications. Zeniva ZA-600 CF30 PEEK is a 30% carbon fiber-reinforced, radiolucent polymer that offers modulus that is similar to cortical bone. The polymer helps implants minimize bone density reduction while maintaining normal stress on surrounding bone tissues. The polymer […]

  • Lexington Biosciences moves forward with its affordable heart diagnostic device

    Lexington Biosciences (Vancouver, British Columbia) said today that it has brought on reimbursement experts as it seeks FDA clearance for its HeartSentry device. The strategic business relationship with a San Francisco arm of Chicago-based Navigant Consulting, is meant to help Lexington(CSE: LNB) (OTCQB: LXGTF) better work with relevant authorities to develop a coverage policy to support the commercial […]

  • Tobii and RightEye partner to create eye-tracking system

    RightEye and Tobii announced that they have forged a partnership to develop new hardware solutions for RightEye vision tests and training games for healthcare, vision and sports markets. “We’re excited to be partnering with Tobii to advance our product and offer customers a more portable, integrated eye-tracking system to further enhance their users’ experience with […]

  • How Smith & Nephew’s InVentures program is promoting innovation

    For nearly a decade, Smith & Nephew’s InVentures program has worked with surgeons who have innovative ideas but aren’t starting their own companies. The program provides a third innovation route on top of the major two for big medical device companies: internal R&D and acquisition of smaller companies with new technologies. “A company the size of Smith […]

  • Promenade Software to showcase medical device software at DeviceTalks West

    Promenade Software is a company comprised of highly skilled and experienced medical device software engineers with expertise spanning from low-level firmware to embedded applications, mobile applications and cloud services. Its engineers are on-site in Irvine, Calif. Featured technology and services: Parlay, professional services, cybersecurity Parlay: Parlay accelerates the development of medical device software, while simultaneously enabling testing and […]

  • Zeiss launches new imaging software

    Zeiss has launched its newest imaging software called the Zeiss Zen 2 core for improving laboratory workflow and efficiency. Zeiss Zen 2 core is a lab infrastructure solution designed to connect systems, data and workflows, helping laboratories become more efficient. The imaging software is used as a tool for image analysis and interactive control of […]

  • Overmolding: 2 types to know

    MTD Micromolding Some micro projects require specialty micro injection molding processes, such as overmolding. Overmolding involves two or more materials molded together to become one part. Examples include molding plastic over plastic or molding plastic over a preformed part, such as a metal insert. (See examples of common polymers and substrates below.) MTD specializes in […]

  • 3D printed organ models are getting way better: Here’s how

    University of Minnesota researchers are taking 3D printed organ models to the next level: They look and feel like the real thing, and integrated sensors help surgeons train. There’s even the potential that such artificial models may someday become the real deal – “bionic organs” used to replace damaged biological organs. The Minnesota researchers published […]

  • How BioSig is using plug and play as a medtech startup strategy

    Startups, as a rule, should have a plan for their technology to grow. But it is rare that a medical technology startup aims to be plug and play, fitting into many therapeutic areas from cardio to Alzheimer’s to diabetes. BioSig’s Pure EP, an electrophysiology signal recording and processing system, could potentially provide valuable insight during […]

  • PEEK formulations for new implantable devices

    Since the late 1990s, polyether ether ketone has become a go-to material for companies that manufacture orthopedic implants, thanks to its radiolucency and anatomical properties. Now, custom formulations of PEEK are enabling new potential applications for the polymer. Lawrence Acquarulo, Foster Corp. Polymers have always played a role in modern implantable medical devices. But until […]

  • Materialise and Formlabs want to bring more 3D printing labs to hospitals

    Materialise (Leuven, Belgium) and Formlabs (Somerville, Mass.) have forged a partnership to help deliver cost-effective solutions to hospitals that want to start in-house 3D printing labs. The partnership combines Materialise’s Mimics inPrint medical imaging software with Formlabs’s Form 2 printers to create a complete 3D printing package that will help implement patient-specific care that is an affordable price-per-print. Using […]

  • Insightec wins FDA nod for Exablate Neuro glioblastoma trial

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    Insightec

    Insightec said today it won FDA approval to launch a safety and feasibility trial of its Exablate Neuro, testing its ability to disrupt the blood brain barrier in patients with glioblastoma.

    The Exablate Neuro device, which won FDA approval last July for treating essential tremor, uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by continuous magnetic resonance imaging; the procedure can be performed non-invasively through an intact skull.

    In the trial, a research team will inject commonly used a sonographic microbubble solution into the bloodstream of a patient with a malignant brain tumor, after which ultrasound will be used to oscillate the microbubbles to cause temporary disruption of the blood brain barrier.

    “Clinical research is critical for pushing the boundaries of MR-guided focused ultrasound technology. Insightec continues to collaborate with leading researchers to trial new clinical applications that may have significant impact where it matters most – patient lives,” CEO & chair Dr. Maurice Ferré said in a press release.

    The study is set to enroll up to 15 subjects with suspected glioblastoma who are scheduled to undergo a tumor resection, with Dr. Graeme Woodworth of the University of Maryland School of Medicine acting as principal investigator.

    Last month, Insightec said it won FDA approval for a pivotal trial of its Exablate Neuro device in treating refractory Parkinson’s disease.

    Pavmed files FDA 510(k) for CarpX carpal tunnel device

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    PAVmed

    Pavmed (NSDQ:PAVM) said today it filed a 510(k) application with the FDA for its CarpX minimally invasive device designed to treat carpal tunnel syndrome.

    The CarpX is a percutaneous device designed to allow the operating physician to relieve compression of the median nerve without a surgical incision. The system combines a balloon catheter with bipolar radio-frequency cutting electrodes and is positioned through guidance with ultrasound, the company said.

    “I have had the opportunity to use Pavmed’s highly innovative CarpX device in pre-submission testing and am very impressed with its performance. As a busy hand surgeon, I strongly believe that CarpX will be a game-changer in the treatment of carpal tunnel syndrome, providing patients with a much less invasive option and significantly shorter recovery times than traditional open carpal tunnel surgery. I eagerly await CarpX’s regulatory clearance and the opportunity to offer this ground-breaking innovation to my patients suffering from carpal tunnel syndrome,” Dr. David Kelly of Gilbert, Ariz.’s Center for Dermatology and Plastic Surgery said in a press release.

    Upon activation, the CarpX device creates a space within the tunnel to confirm the nerve is protected from the cutting electrode and decompresses the median nerve by dividing the transverse carpal ligament.

    “We designed CarpX to closely mimic the anatomic results of traditional invasive carpal tunnel surgery but to do so much less invasively, using catheters, balloons, radiofrequency energy and other established tools that have contributed to the percutaneous and minimally invasive revolutions in the treatment of other conditions. Our balloon catheter device is designed to be inserted under the scarred ligament in a minimally invasive fashion, while pushing the nerve and tendons away. When activated, bipolar radiofrequency electrodes precisely cut the ligament from the inside out in a matter of seconds. The device design provides physicians with ongoing feedback to optimize the safety and completeness of the procedure,” Pavmed chief medical officer Dr. Brian deGuzman said in prepared remarks.

    Pavmed said it is hopeful that the CarpX device can decrease costs and move procedures out of operating rooms, as well as decreasing postoperative pain and hospital stays before patients can return to their day-to-day lives.

    “We are very excited to have reached this most important milestone in Pavmed’s corporate history. CarpX has become the most commercially promising and clinically exciting product in our pipeline and we believe it will revolutionize the treatment of carpal tunnel syndrome, a widely prevalent condition that exacts a significant clinical and economic burden on society in the U.S. and worldwide. Based on epidemiological and market research data we estimate CarpX’s addressable market opportunity to exceed $1 billion,” Pavmed chair & CEO Dr. Lishan Aklog said in a prepared statement. “As with all of our products, CarpX’s development and regulatory testing were performed using our unique business model focused on speed to market and capital efficiency. We are proud to have achieved this milestone within a timeframe and with capital expenditures to date that beat our model’s benchmarks. We believe we have assembled a strong submission and are targeting clearance in the first half of 2018. Upon successful regulatory clearance, we anticipate an aggressive commercialization strategy using well-established independent sales channels targeting the appropriate physician specialties.”

    Earlier this month, Pavmed saw shares rise after the medical device maker beat expectations on Wall Street with its third quarter results

    Masimo wins FDA nod for NomoLine capnography sampling lines

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    Masimo

    Masimo (NSDQ:MASI) said today it won FDA clearance for its NomoLine capnography sampling lines.

    The newly cleared NomoLine sampling lines are compatible with both Masimo and third-party OEM NomoLine monitors to allow for sidestream capnography and gas monitoring the Irvine, Calif.-based company said. The lines are designed for both intubated and non-intubated patients in low and high humidity applications.

    Masimo touted that the NomoLine sampling lines feature no-moisture sampling technology designed to eliminate issues associated with conventional sidestream gas sampling line systems. The NomoLines feature the company’s patented polymer and allow water in sampling lines to continuously evaporate into the surrounding air and leave oxygen, carbon dioxide and anesthetic gases unaffected.

    “With NomoLine, we’ve developed innovative moisture-wicking technology – and then applied that breakthrough to an entire line of cannulas, including neonatal airway adapter sets. Masimo continues to automate noninvasive monitoring with solutions such as NomoLine that are reliable and easy to use,” founder & CEO Joe Kiani said in a press release.

    Earlier this month, Masimo reported third-quarter results that crushed the consensus earnings forecast and raised its sales and earnings outlook for the rest of the year.

    Repro-Med clears FDA warning letter, shuffles C-suite

  • Philips announces innovations around imaging, pediatrics and more

    Philips today announced new imaging products and services, as well as a 10-year, strategic partnership with Children’s Hospital & Medical Center of Omaha, Neb. The news is latest of a slew of announcements out of Philips during the Radiological Society of North America (RSNA) conference that is taking place this week in Chicago. Philips yesterday announced three new […]

  • River blindness successfully treated using smartphone-based microscope

    A California research team has developed a smartphone-based microscope technology that can help diagnose and treat river blindness. River blindness is a disease that is caused by parasitic worms. The END Fund reports that about 37 million people had the disease in 2010 with more than 102 million people being at risk in Africa alone. […]

  • 3 ways to integrate UVC LEDs into medical devices

    Adding disinfection with UVC LEDs is a viable alternative to chemicals, according to Crystal IS. Here are three examples of how they can make a difference. Rajul Randive, Crystal IS In 2017, the Centers for Disease Control & Prevention (CDC) reported significant progress in many areas commonly associated with hospital acquired infections (HAIs). However, on any […]

  • Fluid Metering has new STF1-9 valveless 400 µl dispensing pump

    Fluid Metering Inc.(FMI) is touting its new 400 µl Dispensing Pump, which it says is ideal for medical, analytical and biotech instrumentation. Having the identical compact design dimensions as their STH & STF OEM Pump lines, the STF1-9 expands dispense and metering capabilities of previous STH designs by 100% while maintaining 0.5% precision, according to […]

  • Medical device startups: Here are the secrets of success

    Bill Betten, Betten Systems Solutions It’s tough enough to be a startup developing and launching innovative products. For medical device startups, there’s the added burden of operating in a highly-regulated industry. The cost of developing a medical device ranges from $25 million to $100 million, according to a 2010 research study out of Stanford University. […]

  • Tegra Medical announces new Mississippi general manager

    Tegra Medical has announced that it has appointed Randy Sible as the general manager of its Hernando, Miss. facility. Sible will be responsible for the local management team and plant operations and will report to the company’s president and CEO J. Mark King. “We are delighted to have Randy lead operations in our Hernando facility, […]

  • Phillips-Medisize showing off respiratory device capabilities at DDL2017

    Phillips-Medisize will be exhibiting at the Drug Delivery to the Lungs Conference in Scotland next month, providing a chance to further tout its respiratory device capabilities. The Hudson, Wis.–based contract manufacturer boasts more than 30 years at the forefront of inhalation technology. The company’s experience ranges from feasibility to selecting the right components – all the way through […]

  • How Igus bearings helped create an exoskeleton to support surgeons

    Igus bearings are helping to take the load off of surgeons by way of Airframe exoskeletons from Levitate Technologies. Airframe exoskeletons are designed to support the arms of those who encounter repetitive motions or stationary arm elevation for an extended period of time. The exoskeletons help transfer the weight of the arms from the shoulders, […]

  • New harmonized standards for medical devices, IVD in Europe

    By Stewart Eisenhart, Emergo Group The European Commission has issued updated lists of harmonized standards for medical devices and in-vitro diagnostic (IVD) products in the Official Journal of the European Union (OJEU). Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do […]

  • Philips is expanding its radiology offerings: Here’s how

    Philips today announced three new products and services related to its radiology offerings, including 3D printed models, a new CT scanner and an extension of a partnership with Banner Health. On the 3D printing front, agreements with industry leaders 3D Systems and Stratasys will enable Philips customers through Philips’s IntelliSpace Portal 10 to have a seamless […]

  • How hydrogels could repair intestinal injuries

    Hydrogels have already shown promise creating soft robotics and regrowing skull bones. New research suggests the water-based material could also help deliver stem cell treatment to repair damages caused by gastrointestinal diseases. Hydrogels have been permeating medtech recently – with researcheres using them for tasks as varied as gluing detached retinas back together to stopping bleeding. Now, […]

  • Advanced Bionics wins FDA nod for HiFocus Slimj cochlear implant electrode

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    Advanced Bionics

    Advanced Bionics said late last week it won FDA approval for its HiFocus SlimJ electrode designed for use with the company’s HiRes Ultra cochlear implant.

    The Valencia, Calif.-based company touts the new electrode as featuring a thin, straight design for easier insertion during procedures and a slim profile to protect the delicate structures of the cochlea during insertion.

    “The HiFocus SlimJ electrode addresses the surgeon need for an alternate type of electrode whilst still offering full spectrum coverage and maintaining the performance potential of the individual. And surgeons have commented that it is easy to handle and to insert,” Advanced Bionics medical marketing & product management director Mark Downing said in a prepared statement.

    Advanced Bionics said the addition of the new electrode along with its HiFocus Mid-Scala electrode provides surgeons with personalized choices during procedures to accomodate individual patient anatomy and surgical preferences.

    “I am very pleased with the successful implantations in Europe following the TÜV approval. This marks an important milestone not only for Advanced Bionics but for all future CI candidates,” Sonova cochlear implants group VP Hansjuerg Emch said in a press release.

    Last November, a federal appeals court overturned a win for Cochlear Ltd. (ASX:COH) in its patent spat with Advanced Bionics over hearing implant technology, sending the case back to district court for reconsideration in light of a recent U.S. Supreme Court decision.

    Medtronic wins FDA nod for Azure remote monitoring equipped pacers

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    Medtronic logoMedtronic (NYSE:MDT) said today it won FDA approval for its portfolio of Azure pacemakers with BlueSync patient monitoring technology.

    The clearances cover both the Azure XT MRI and Azure S MRI pacers including single chamber and dual chamber models, the Fridley, Minn.-based company said. The newly cleared pacers have estimated lifespans of 13.7 years for dual chamber pacers, which Medtronic estimates is 27% longer than the earlier-gen devices.

    The Azure portfolio of pacers feature the company’s BlueSynch technology which allows for automatic remote monitoring through the company’s CareLink network, and its Azure XT device features the Reactive ATP algorithm intended to slow the progression of atrial fibrillation.

    “With the approval of Azure, clinicians managing patients with bradycardia now have pacemakers with improved longevity, and better ability to detect and reduce atrial fibrillation. BlueSync technology with Azure also enables secure and automatic wireless data transmission to clinicians. Remote monitoring with automatic data transmissions can result in earlier clinical decisions and improved patient monitoring compliance,” cardiac rhythm & heart failure division prez Dr. John Liddicoat said in a press release.

    Medtronic said that in connection with the approval, its Percepta line of cardiac resynchronization therapy pacers now include BlueSync tech for remote monitoring through the CareLink network.

    Earlier this month, Medtronic released its preliminary second quarter earnings, estimating the impact of Hurricane Maria at approximately $55 to $65 million, or 3¢ on its second quarter non-GAAP earnings per share.