New Expanded Indication Could Change the TAVR Narrative
The transcatheter aortic valve replacement market received one of the biggest jolts of the year when FDA expanded indications of both Edwards Lifesciences and Medtronic’s valves. FDA’s measure would open up the valves to be used in younger and low-risk patients. The agency said these transcatheter valves – Edwards’ Sapien 3, and Sapien 3 Ultra, with Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO – were previously indicated only for patients at intermediate or higher risk for death or major complications duri...
Source: MDDI - August 20, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Regulatory and Compliance Source Type: news

Age Well with Smart HealthTech
America is going gray. According to U.S. Census data, in 2030 even the youngest Baby Boomers will have reached 65, and older Americans will make up 21 percent of the population. That’s up from 15 percent today. By 2060, nearly a quarter of Americans will be at least 65 and a half million will reach age 100. These changing demographics give urgency to the concept of “aging in place.” Nobody wants to lose their independence, but that’s the reality for many who are forced from their homes by cardiovascular disease, stroke, cancer, diabetes or other chron...
Source: MDDI - August 19, 2019 Category: Medical Devices Authors: Stephanie Van Ness Tags: Digital Health Source Type: news

FDA Approval & #039;Finally & #039; Recognizes Vertebral Body Tethering as a Mainstream Scoliosis Treatment
A first-of-its-kind FDA approval represents a major win for Zimmer Biomet and, most importantly, the field of scoliosis treatment. Called The Tether – Vertebral Body Tethering System, the device is intended to treat growing children and adolescents whose spinal curves are approaching or have reached the range where surgical treatment is an option. It is intended to correct the most common form of scoliosis (idiopathic scoliosis) that has not responded to conservative treatment options, such as external bracing. “This decision takes an innovative surgical approach, vertebral body tetherin...
Source: MDDI - August 17, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Orthopedics Implants Source Type: news

Avoid These Headaches During Regulatory Submissions
Our technical consulting group at Nelson Laboratories acts as a bridge between medical device companies and regulatory bodies, putting us in a good position to understand both sides and what they need from each other. This also creates an opportunity for us to recognize the typical deficiencies, mishaps, or errors that are identified by regulatory agencies during the submission process and to provide our expertise to medical device manufacturers about how to structure and document their submission paperwork to avoid some of these common mistakes. Oftentimes we receive feedback from FDA or a notified body that a submission ...
Source: MDDI - August 16, 2019 Category: Medical Devices Authors: Helin R äägel Tags: Regulatory and Compliance Source Type: news

August Is Hot with New FDA Breakthrough Device Designations
V-Wave is joining the growing list of companies that have been granted breakthrough device designation by FDA this month. The Caesarea, Israel-based company gained the designation for its interatrial shunt for heart failure. Miniature and minimally invasive, the interatrial shunt relieves increased left atrial pressure, which in turn, decreases fluid build-up in the lungs. “The interatrial shunt allows a small amount of blood volume from the left side of the heart to flow into the right side of the heart,” Murtaza Mogri, PhD Director, Business Development & Market Access V-Wave, tol...
Source: MDDI - August 16, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

Could Medicare Change Expand Demand for Blood Pressure Monitors?
The Centers for Medicare and Medicaid Services (CMS) recently announced an expansion in coverage for Ambulatory Blood Pressure Monitoring (ABPM). This extension expands to all Medicare beneficiaries who have abnormal blood pressure rates when in a clinical setting. Not only is this great news for patients but for manufacturers as well. With an increase in approvals for beneficiaries, manufacturers can expect to help provide many more of these medical devices to clinical facilities. Coverage for Ambulatory Blood Pressure Monitors Previously, CMS only covered use of the monitors for patients with blood pressure readings with...
Source: MDDI - August 16, 2019 Category: Medical Devices Authors: Lindsay Engle Tags: Business Source Type: news

7 Types of Medtech CEOs in The Lion King
Now that you've had a little fun (hopefully), here are some of our most popular medtech career-oriented articles: What Does It Take to Be a Medtech CEO? Medtech Salary Survey 2018 10 Tips to Boost Your Medtech Career Your Most Pressing Medtech Career Questions Answered Why Do You Love Your Job in Medtech?​​​​​​​ 10 Pros and Cons of Working in Medtech​​​​​​​â...
Source: MDDI - August 15, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Nikomed Develops Recyclable Lead Wire
Nikomed USA Inc. has unveiled a non-metal disposable and universal lead wire system, BioWire. Thanks to a construction of polyethylene terephthalate (PET) and a printed conductive silver ink, the lead could be recycled. “The idea for a recyclable lead came from seeing the extremely high volume of inexpensive disposable metal lead wires being thrown away by hospitals,” Stephen Epstein, Nikomed’s president, told MD+DI. “In order to help fight cross contamination, hospitals began looking for alternatives to cleaning/reprocessing traditional, reusable lead...
Source: MDDI - August 15, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Cardiovascular Source Type: news

Abbott Targets Drug and Alcohol-Impaired Drivers in New Collaboration
Abbott Laboratories has developed a portable tool to help law enforcement agencies crack down on people driving under the influence. The Abbott Park, IL-based company looks to expand the reach of the diagnostic tool – SoToxa Mobile Test System- through a marketing agreement with Intoximeters. SoToxa is an oral fluid roadside testing solution that rapidly detects recent drug use. The device tests for marijuana, cocaine, opiates, methadone, amphetamine, and benzodiazepines. Abbott inherited the device when it acquired Alere in 2017 for $5.3 billion. Under the agreement, St. Louis, MO-based Intoximeters will...
Source: MDDI - August 14, 2019 Category: Medical Devices Authors: Omar Ford Tags: IVD Source Type: news

Concept Medical Has the ‘MagicTouch’ to Treat PAD
Concept Medical just received a huge burst of speed in its quest to get its drug-coated balloon for the treatment of peripheral artery disease (PAD) commercially available in the U.S. The Tampa, FL-based company has received breakthrough device designation from FDA for the MagicTouch PTA, a Sirolimus drug-coated balloon (DCB) catheter, for the treatment of Peripheral Artery Disease (PAD) in Below-the-Knee (BTK). So far, Concept Medical said MagicTouch has been performing extremely well. In the XTOSI pilot study, the majority of patients enrolled had major comorbidities (diabetes and end-stage renal failure) and the indicat...
Source: MDDI - August 14, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

Supplier Stories for the Week of August 11
(Source: MDDI)
Source: MDDI - August 14, 2019 Category: Medical Devices Authors: MD+DI Staff Tags: IVD Source Type: news

Is Software the & #039;Weak Link & #039; in Medical Device Safety?
Software is a weak link for medical devices, according to Stericycle Expert Solutions' second-quarter recall index. The report found software issues to be the top cause of medical device recalls for the 13th straight quarter . "As we become increasingly reliant on AI and data collection, software becomes an even bigger vulnerability for patients, physicians, and wrongdoers," said Chris Harvey, director of recall solutions at Stericycle. "If the software that is used to operate a device is inadequate, how can we be sure that it is protected from cybersecurity vulnerabilities? Add to th...
Source: MDDI - August 14, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

Size Does Matter (for Lab Equipment)
It's true, size really does matter when it comes to laboratory space. But a UK-based company has introduced a solution that could save precious lab space that would otherwise be dedicated to a bulky MRI scanner. MR Solutions said its liquid helium free, pre-clinical, high field MRI scanner is now available in a range of MRI, and multi-modality MRI scanners (with PET and SPECT modules) from 3T up to 9.4T. The company claims to be the only one with an installed base of liquid helium free, high field scanners. As the image above shows, the size and weight comparisons between liquid helium f...
Source: MDDI - August 14, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Imaging Components Source Type: news

MIT Model Automates AI for Medical Decision-Making
Over the past two years, artificial intelligence has proven to be a transformative technology in the medical device industry, and one of the biggest promises of AI is the technology's role in predictive analytics or medical decision-making. But in order to use AI to guide diagnosis or treatment decisions, someone has to train datasets and then weed out the features in the datasets that will be important for making predictions. This process, known as feature engineering, is often laborious and expensive, especially with the popularity of wearable sensors, according to a recent MIT news story. That's why MIT rese...
Source: MDDI - August 14, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: R & D Digital Health Source Type: news

10 Events in Medtech That We Didn ’t See Coming This Year
(Source: MDDI)
Source: MDDI - August 14, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Pursuing a Path of Regulatory Rigor: Taking Medtech, Regenerative Medicine to the Next Level
The medical device industry is facing a generational change in the regulation and validation of its products. Today, more than ever, physicians, patients, and payers are demanding solid evidence that the devices they prescribe, use, and pay for performs to the highest standards and is backed by significant clinical data. In many cases, these standards are being driven by hospital value analysis committees, who increasingly act as gatekeepers for their institutions. This trend, combined with a more stringent regulatory approach by the FDA, particularly with regards to regenerative medicine technologies, means that the famil...
Source: MDDI - August 13, 2019 Category: Medical Devices Authors: Randy Hubbell Tags: Regulatory and Compliance Source Type: news

AI Mines Clinical Data for Thyroid Cancer Therapeutic Targets
The Helomics division of Predictive Oncology and Interpace Diagnostics Group Inc. have announced a cooperative research agreement. Helomics has developed an AI bioinformatic platform, known as “D-CHIP,” while Interpace has collected an impressive cache of clinical data from next-generation sequencing (NGS) and microRNA testing of thyroid tumor samples from its combination ThyGeNEXT panel and ThyroMIR classifier. By analyzing the Interpace datasets on the D-CHIP platform, Helomics and Interpace plan to improve diagnosis of thyroid cancer and identify druggable targ...
Source: MDDI - August 13, 2019 Category: Medical Devices Authors: Jenevieve Blair Polin Tags: Software Source Type: news

Will This Be a Busy Summer for M & amp;A in Medtech?
A company from the list of the Most Attractive Medtech Firms on the M&A Radar is making an acquisition as medtech’s hot M&A summer continues. Atrial Fibrillation (Afib) specialist, AtriCure has entered into a definitive agreement to acquire SentreHEART, a developer of percutaneous left atrial appendage management solutions. SentreHEART is developing the Lariat left atrial appendage (LAA) closure device. Lariat is being evaluated in aMAZE, a pivotal clinical trial evaluating the use of the device for closure of the LAA as an adjunctive treatment to ablation in patients with persistent or longstandi...
Source: MDDI - August 12, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

How a Brain-Computer Interface Could Help Paralyzed Veterans at Home
Ten years ago, an athletic college student from Dublin, Ohio was on vacation with his friends when he dove into a wave, hit the top of his head on a sandbar, and was instantly paralyzed. That young man was Ian Burkhart, the first participant in a five-year study of Battelle's NeuroLife neural bypass technology, a project Battelle has worked on in conjunction with doctors at The Ohio State University Wexner Medical Center. Burkhart completed NeuroLife sessions two to three times a week for five years. The proof of concept of direct neural interface technology has only emerged in the last ...
Source: MDDI - August 12, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Implants Source Type: news

Taking the Guesswork Out of Self-Injection Devices
Chronic illnesses are on the rise, which means there are more and more patients who need to self-inject treatments at home. The problem is that patients who lack confidence in using their drug-delivery device or are inadequately familiar with the device tend to use it incorrectly and may not be receiving the full dose every time. This is where Orlando, FL-based Noble International comes in. "About 10 years ago we began to recognize a need for patient device training," Joe Reynolds, research manager at Noble, told MD+DI. "So patients learning how to use autoinjectors, pre-filled syringes, and inha...
Source: MDDI - August 12, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Design Source Type: news

Disinfecting Devices at the Point-of-Care
Could non-critical medical devices and other items used at the patient bedside present infection risks? Richard Shea, CEO of Sterifre Medical Inc., thinks so. His company has just raised $8 million in a Series B private equity round of financing to market products for rapid, point-of-care device disinfection in healthcare facilities. Shea was previously the CEO of Olympus Respiratory America, a provider of COPD treatment products, and was one of the founding executives of Stericycle Inc. “Initially we will be focused on three areas: non-critical, point-of-care medical devices, environment-of-c...
Source: MDDI - August 9, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Business Source Type: news

Endologix Takes a Step Forward with Nellix IDE
Endologix has received investigational device exemption (IDE) approval from FDA for a new pivotal study to evaluate the safety and effectiveness of the Nellix Chimney Endovascular Aneurysm Sealing System for the endovascular treatment of complex abdominal aortic aneurysms (AAA). The system is an endovascular abdominal aortic aneurysm therapy designed to combine the Nellix 3.5 endograft with parallel visceral stents to enable treatment of patients with juxta-renal, para-renal, and suprarenal AAA. The application of endovascular aneurysm sealing for patients with complex aneurysms will offer innovativ...
Source: MDDI - August 9, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Regulatory and Compliance Source Type: news

The Challenges of Securing and Protecting Medical Devices
With increasing cyber-attacks and lives (literally) at stake, the medical device community is taking a serious look at how manufacturers can embed security best practices into their processes and devices. In fact, the medical device makers we talk to recognize the need for a security-first approach. Security doesn’t happen by mistake, but rather by design. That design ensures data protection, flexibility to support product longevity and unique device identification. Cryptographic considerations have become critically important in medical devices to guard data streams that travel to and from connected medi...
Source: MDDI - August 9, 2019 Category: Medical Devices Authors: Chris Hickman Tags: Business Digital Health Source Type: news

Glaukos Continues its Evolution with Avedro Acquisition
Glaukos has been open about a plan to go beyond being a “just” a medical device company. During a presentation to investors at the 37th annual J.P. Morgan Healthcare Conference, San Clemente, CA-based Glaukos’ CEO Thomas Burns said the company was transforming into a “hybrid surgical/pharmaceutical/medical device” firm. Glaukos is the frontrunner in Micro-invasive glaucoma surgery (MIGS) and was the first to have an approved device in the space. MD+DI named Glaukos’ plan to become a hybrid company as one ...
Source: MDDI - August 9, 2019 Category: Medical Devices Authors: Omar Ford Tags: Implants Business Source Type: news

Roche Expands Global Access to Viral Assays to Aid Eradication Efforts
Roche has expanded the Global Access Program, originally established to increase availability of HIV diagnostics in underserved countries, to include diagnostic tests for tuberculosis, hepatitis, and human papillomavirus (HPV). Increased access to reliable diagnostics will allow early, possibly life-saving, detection and decrease the spread of these diseases. Roche launched the program in 2014 and began offering the added tests in July. The molecular diagnostics available include tests for determination of HIV-1 viral load, early diagnosis of HIV-1 and -2 in young infants, Mycobacterium tuberculosis (MTB) and rifampin/ison...
Source: MDDI - August 9, 2019 Category: Medical Devices Authors: Jenevieve Blair Polin Tags: IVD Source Type: news

Supplier Stories for the Week of August 4
(Source: MDDI)
Source: MDDI - August 9, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Components Source Type: news

Tiny Implant Can Control Neural Circuits in the Brain via Smartphone
A tiny implant developed by researchers in the U.S. and Korea can control neural circuits in the brain. Researchers from the Korea Advanced Institute of Science and Technology (KAIST) and the University of Washington in Seattle, publishing in Nature Biomedical Engineering, said they believe the device, which is controlled by a smartphone can speed up efforts to uncover brain diseases such as Parkinson's, Alzheimer's, addiction, depression, and pain. The device, using Lego-like replaceable drug cartridges and powerful Bluetooth low-energy, can target specific neurons of interest using drug and light for prolonged periods. &...
Source: MDDI - August 8, 2019 Category: Medical Devices Authors: MDDI Staff Tags: Implants R & D Source Type: news

Wright Medical Defends Clinical Performance of Cartiva Implant
Wright Medical reported weaker-than-expected sales of its recently-acquired Cartiva implant in the second-quarter, prompting the company to reduce its guidance for the year. The news comes amid some investor concerns and analyst commentary regarding the clinical performance and market opportunity for Cartiva. Wright shelled out $435 million to acquire Cartiva last year. FDA approved the Cartiva Synthetic Cartilage Implant (SCI) for treating arthritis at the base of the great toe in July 2016. The implant is composed of a biocompatible, durable, low-friction organic polymer designed to function simil...
Source: MDDI - August 8, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Orthopedics Business Source Type: news

Siemens Set to Jump into Robotics with Proposed Acquisition of Corindus
It looks like Siemens Healthineers is keen on diving into the medical robotics space. The Erlangen, Germany-based company said its subsidiary Siemens Medical Solutions is set to acquire Corindus Vascular Robotics for about $4.28 per share in cash or$1.1 billion. The transaction has been approved by Corindus’ board and is expected to close in 4Q19, subject to approval by the company’s stockholders. “Corindus has established a leading position in vascular robotics with a compelling technology platform for robotic-assisted coronary, peripheral, and neurovascular procedures...
Source: MDDI - August 8, 2019 Category: Medical Devices Authors: Omar Ford Tags: Imaging Source Type: news

Share Your Opinion to Improve Our Coverage & amp; Win $500
Create your own user feedback survey (Source: MDDI)
Source: MDDI - August 8, 2019 Category: Medical Devices Authors: Jamie Hartford Tags: Business Source Type: news

Your Medtech Download List
We've put together a list of the latest how-to medtech whitepapers and Webcasts available from Qmed. You’ll find expertise on catheter technologies for TAVR procedures, EU Medical Device Regulations, biomaterials, electroplating, and more. We also share news on upcoming educational offerings at upcoming MD&M and BIOMEDevice events. If you’re looking for education on a topic you don’t see, please feel free to let us know at daphne.allen@ubm.com. We welcome suggestions from our medtech community. Whitepapers Repairing the Heart With...
Source: MDDI - August 7, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Materials Source Type: news

FDA Eases Up on Paclitaxel Device Recommendations
  Medical device companies that sell paclitaxel-coated balloons or paclitaxel-eluting stents have been waiting to see what action FDA would take to address the late mortality signal associated with these devices. The agency provided some clarity around the issue on Wednesday that could drive a rebound in the utilization of paclitaxel devices. Paclitaxel devices came into the spotlight in late December 2018 after a meta-analysis showed an increased risk of death for patients treated with these devices. After a two-day meeting of the CirculatoryÂ&n...
Source: MDDI - August 7, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Regulatory and Compliance Source Type: news

Organovo Resets by Restructuring and Exploring Strategic Alternatives
Organovo Holdings is hitting the hard-reset button after failing to generate decisive scientific data to support prolonged functionality and therapeutic benefit of its liver tissue candidate. On Wednesday, the San Diego-based company put out a release indicating it was exploring strategic alternatives and implementing a restructuring plan. Roth Capital Partners has been tapped as a financial advisor to help with the exploration of alternatives. In the release, the company said these “alternatives include the potential for an acquisition, merger, reverse merger, business combination, sale of assets, licens...
Source: MDDI - August 7, 2019 Category: Medical Devices Authors: Omar Ford Tags: 3-D Printing Source Type: news

Trauma Surgeon: Enough America, This Should Be Everyone ’s Lane
A video tweeted by This Is Our Lane, a group that was born last year after the National Rifle Association (NRA) told doctors to stay in their lane, triggered an uproar while also reinforcing the point that trauma surgeons and first responders don't have the luxury of looking away from the horrific aftermath of gun violence. Several people begged the group to take the video down, concerned that it glorified the events and the perpetrators. Others said that the public needs to see footage like this to understand what This Is Our Lane members face all too often: "They don't have the luxury of not ...
Source: MDDI - August 7, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

How 2019 Will Define TAVR for Years to Come
There have been some pretty significant developments in the transcatheter aortic valve replacement market over the past few months. It’s safe to say it’s not going to be business as usual for TAVR in the coming years. One of the biggest developments in the market was FDA’s approval of Boston Scientific’s Lotus Edge valve in April. The approval did not come as a shock as the Marlborough, MA-based company communicated in August of 2018 that the nod from FDA would come near the middle of 2019. The approval was truly a game-changer because it meant there w...
Source: MDDI - August 6, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

FDA Rejects BD & #039;s Lutonix Submission for Below-the-Knee PAD
Drug-coated balloons and drug-eluting stents that use paclitaxel as the drug have been heavily scrutinized this year, which likely played a role in FDA's decision to reject  Becton, Dickinson and Company's (BD) Lutonix paclitaxel-coated balloon for below-the-knee (BTK) peripheral artery disease (PAD). BD inherited the device through its $24-billion acquisition of C.R. Bard, a deal that closed at the tail end of 2017. FDA originally approved the Lutonix DCB in October 2014 for patients with above-the-knee PAD (the first FDA approval in the DCB category), and in 2017 the agency...
Source: MDDI - August 6, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Cardiovascular Source Type: news

Osso VR Expands Its Reach, Shares Study Results
Virtual reality surgical training solution Osso VR is already impacting reality. A just-released study conducted by UCLA’s David Geffen School of Medicine shows that the surgical performance of Osso VR users “improved by 230% and their speed was 20% faster,” Justin Barad, MD, CEO and co-founder of Osso VR, told MD+DI. “These are not subtle differences. Research is showing that VR users are faster and more competent.” He added that just after 30 minutes of VR training, the “effect is startling.” Such...
Source: MDDI - August 6, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Orthopedics Source Type: news

Is It Your Design or Your Molder?
Molding projects sometimes don’t go as planned. Design-to-manufacture transitions might take longer than expected, projects may exceed budgets, production parts may fail testing (or worse, in the field), and sometimes a design simply can’t be molded and you’ve got to go back and redesign. Lindsay Mann, director of sales and marketing for MTD Micro Molding, tells MD+DI that a common request over the years has been to figure out why another molder couldn’t execute a customer’s design successfully. This can be particularly troublesome fo...
Source: MDDI - August 6, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Molding Source Type: news

Guardant Brings Home Strong Results as Liquid Biopsy Space Heats Up
Guardant Health is one of the biggest names in liquid biopsy and after Monday its presence in the space can only increase. The Redwood City, CA-based company revealed results of a study conducted by it along with researchers from The University of Texas MD Anderson Cancer Center, the Samsung Medical Center, and other institutions. Results show the Guardant360 assay can accurately detect microsatellite instability status (MSI) as accurately as tissue biopsy. The company said this is the largest comparison of MSI testing to traditional tissue methods across multiple solid tumor types. Findings were reported in Cl...
Source: MDDI - August 5, 2019 Category: Medical Devices Authors: Omar Ford Tags: IVD Source Type: news

Abbott & #039;s Ellipse Recall Is the 33rd U.S. Medical Device Recall This Year
Abbott is recalling the Ellipse Implantable Cardioverter Defibrillators (ICDs) because electrical failures have been identified and determined to be due to a faulty manufacturing process causing some aluminum wires to be partially exposed. ICDs, which contain aluminum wires that are not fully insulated are prone to electrical shorting of the capacitor.  The potential patient impact could be the inability to deliver high voltage therapy. There is currently no available method or procedure to determine which of these devices have this issue prior to failure. Abbott said it is not aware of any reports of this fail...
Source: MDDI - August 5, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

LFI Devices: 3 Reasons for OEMs and Developers to Consider Automation
In conclusion, automation plays an essential role in enabling LFI device OEMs to achieve not only their product goals around quality, consistency, and performance, but also their overarching business goals for growth, market share, and responsiveness. By partnering early with a CMO with highly automated operations already in place, OEMs and device developers can focus on activities that add the greatest value to their evolving LFI product portfolios and their customers’ current and future requirements. Reference: 1. Source: Kinematic Automation. (Source: MDDI)
Source: MDDI - August 5, 2019 Category: Medical Devices Authors: Claudio Hanna and Jennifer Ponti Tags: IVD Source Type: news

Exo Has a Plan to Make Ultrasound Imaging Available Everywhere
Exo Imaging wants to make ultrasound available everywhere – in developing countries; in rural areas in the U.S.; and wearables. The Redwood City, CA-based company came a little bit closer to achieving this goal this week, announcing it had raised $35 million in a series B round. Exo (pronounced “Echo”) is developing a device that combines both ultrasound and artificial intelligence for enhanced imaging in patients. The company said its Exo ultrasound platform combines advances in nano-materials, novel sensor technologies, advanced signal processing and compu...
Source: MDDI - August 5, 2019 Category: Medical Devices Authors: Omar Ford Tags: Imaging Source Type: news

Medtech Engineers and Regulatory Experts Invited to Speak at MD & amp;M West
Eri Hirumi, regulatory affairs specialist at MicroVention, a rapidly growing medical device company that has pioneered the development of catheter-based, minimally invasive, neuroendovascular technologies, spoke earlier this year at MD&M West about EU MDR/IVDR device certification and recertification and about how post-market surveillance and clinical follow-up data to could help meet FDA and EU MDR requirements. She found that the conference allows participants and speakers alike to "come be a creative force in the medical device industry, as the conference provides an exciting opportunity to efficiently get up t...
Source: MDDI - August 5, 2019 Category: Medical Devices Authors: Laurie Lehmann Tags: Design Source Type: news

Compostable splint can be reshaped multiple times as patient heals
A newly developed medical splint can be repeatedly reshaped as the patient recovers from a bone injury and can be composted when it is no longer needed. The device is made from a PLA-based biopolymer formulated by the Fraunhofer Institute for Applied Polymer Research IAP (Potsdam, Germany) and was developed by injection molder Nölle Kunststofftechnik GmbH (Meschede, Germany). Conventionally designed splints cannot be adjusted as the healing process runs its course, creating complications and discomfort as the swelling subsides. Also, they are not biodegradable, creating up to 150 metric tons of waste per year...
Source: MDDI - August 2, 2019 Category: Medical Devices Tags: Plastics Today Source Type: news

May the Best Spine Robot Win
One of the most promising areas of robotic-assisted surgery is in spine procedures. But hospital executives are taking longer to purchase robotic systems because they have more options to choose from in the marketplace, Globus Medical executives noted during the company's second-quarter earnings call. In fact, CEO Dave Demski said the company closed several deals in the second quarter that were expected to close in the first quarter. Each deal is being hard-fought, Demski said, but the company has hired more sales reps to account for the longer cycle. On the bright side, Demski said the company has won "an...
Source: MDDI - August 2, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Orthopedics Business Source Type: news

A Wearable Device Is Changing the Way Clinicians Manage Parkinson & #039;s Patients
A recently published study in Functional Neurology suggests that using data from an FDA-cleared watch-like device called the Personal KinetiGraph (PKG) provides an objective and more effective approach to assessing motor fluctuations in patients with Parkinson's disease (PD) compared with patient-reported motor diaries. “Motor fluctuations, including 'wearing-off' and dyskinesia, are associated with increased disease severity and disability, and PD patients experience decreased quality of life as their response to medical therapy becomes less predictable,” said EchoÂ&nb...
Source: MDDI - August 2, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Digital Health Source Type: news

The Future of (Digital) Surgery
Conclusion At first glance, the future prospects for the hospital industry’s surgery business look promising. Profit margins for most procedure lines remain solid, and an aging population will fuel growth in a broad array of surgical interventions. However, demographic trends are not the sole driver of surgery volumes—technological and competitive forces will also exert a significant influence on the future course of surgery. On the technology front, advances in biomedical engineering will create new surgical interventions while rendering existing surgical procedures obsolete. Technologi...
Source: MDDI - August 2, 2019 Category: Medical Devices Authors: Partha S. Anbil, Michael T. Ricci, and Stephanie Sarofian Tags: Digital Health Source Type: news

Medical Device Manufacturing Trends: Finding Simplicity Amid Complexity
Manufacturing trends for medical applications using pressure-sensitive adhesives (PSAs) can be as diverse as the products the PSAs hold together, whether wearables, wound care solutions, diagnostic instruments, or ostomy devices. Yet there is some common ground. One of the overarching trends can be summed up as follows: The simpler the supply chain, the better. Device manufacturers and their supply chain partners are always looking for ways to leverage manufacturing strategies that are stable, scalable and efficient. Yet at the same time, device performance requirements can be quite complex. It may seem paradoxical, but so...
Source: MDDI - August 1, 2019 Category: Medical Devices Authors: Deepak Prakash Tags: Contract Manufacturing Source Type: news

Dexcom CEO: The Future Is CGM First, and That Future Is Here
While attending the American Diabetes Association (ADA) conference in June, two conclusions became increasingly clear, said DexCom CEO Kevin Sayer. First, awareness of real-time continuous glucose monitoring (CGM) is quickly progressing and driving CGM toward standard-of-care status. Second, DexCom is just scratching the surface of the potential for CGM, he said. "We have gone on record for years telling [people] that the future is CGM first and we believe that future is here," Sayer said during the company's second-quarter earnings call, transcribed by SeekingAlpha.Â&nbs...
Source: MDDI - August 1, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Supplier Stories for the Week of July 28
(Source: MDDI)
Source: MDDI - August 1, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Electronics Source Type: news