Abbott Catches Up to Peers With MRI-Compatible ICD
Abbott Laboratories acquired St. Jude Medical earlier this year knowing that the company trailed behind its peers in the cardiac rhythm management (CRM) space by not having a MRI-compatible pacemaker or implantable cardioverter defibrillator (ICD) system. It seems Abbott has officially caught up in that category though, first with FDA approval of the Assurity MRI pacemaker and the Tendril MRI pacing lead during the first quarter, and now with FDA approval of MRI-conditional labeling for the Ellipse ICD system. Abbott said the recent approval covers one of its most widely-used ICD systems and associated high voltage leads. ...
Source: MDDI - September 23, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: MD & M Minneapolis Labeling Business Source Type: news
Have You Considered the Potential of Deep Design?
How much time do medical product designers spend on understanding clinical processes? Perhaps not enough. Product designers “often don’t see their devices as part of a system,” says Kathleen Harder, PhD, director of the Center for Design in Health at the University of Minnesota. But there can be adverse ripple effects with devices, she warns. Harder also serves as director of graduate studies in the Human Factors Program at University of Minnesota. For more than 15 years, she has worked with clinicians to test ideas that guide users toward desired behaviors in healthcare delivery. With a background as an ...
Source: MDDI - September 22, 2017 Category: Medical Devices Authors: Daphne Allen Tags: R & D Source Type: news
More Than $500K in Prizes on the Line for Four Startups
It’s down to just four companies in the 2017 MedTech Innovator $500K Competition, whittled down from a field of almost 600 companies. The finalists, which emerged from the 20-company MedTech Innovator Accelerator, will vie for the top prize next week. Representatives from each company will pitch to an audience and judging panel during a session at The MedTech Conference in San Jose, CA on September 26. The panel of judges, which includes leaders from Johnson & Johnson, Baxter Ventures, Becton Dickinson, and Kaiser Permanente Ventures, will ask questions before the session audience casts their votes. The medical t...
Source: MDDI - September 22, 2017 Category: Medical Devices Authors: Marie Thibault Tags: Medical Device Business Source Type: news
Will Disposable Caps Solve Dirty Scope Problems?
Reprocessing duodenoscopes after they’ve journeyed through a patient’s GI tract has been a pain in the you-know-what for pretty much everyone involved. These flexible lighted instruments are quite complex, with a lot of small working parts that are difficult to clean. So it’s all too easy for contaminated tissue or fluid to get trapped in the crevices of the device and allow nasty little superbugs to spread to other patients. And yet, duodenoscopes enable more than 500,000 necessary procedures a year for patients with bile duct disorders and other upper GI problems, according to FDA. That’s why the ...
Source: MDDI - September 21, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: MD & M Minneapolis Sterilization Regulatory and Compliance Source Type: news
Process Isn & #039;t Just for Project Managers
Engineers love to solve problems, especially technical ones. Unfortunately, challenges in communication and planning often result in poorly understood goals and objectives. The engineering team makes one thing while the managers and marketers want something else. That leaves everyone unsatisfied. I will describe a very simply process that, when consistently applied, is extremely successful in generating consensus among stakeholders and driving the development of proof-of-concept devices. This process, outlined below, will help ensure the best possible outcome. While this discussion is focused on proof-o...
Source: MDDI - September 21, 2017 Category: Medical Devices Authors: Mark Wehde Tags: Design Source Type: news
Can You Help Prevent These Insulin-Delivery Errors?
New consensus-based guidelines may inspire ideas to curb errors. Insulin is considered a high-alert medication because it is often associated with significant patient harm when used in error. “According to a 2014 survey of pharmacists and nurses conducted by the Institute for Safe Medication Practices (ISMP), IV insulin ranked first and subcutaneous insulin ranked ninth among nearly 40 drugs and drug classes identified as high-alert medications that concerned practitioners,” Susan F. Paparella, RN, MSN, vice president, ISMP, told MD+DI. “Yet of all the high-alert medications, subcut...
Source: MDDI - September 21, 2017 Category: Medical Devices Authors: Daphne Allen Tags: Medical Device Business Source Type: news
Did NuVasive Investors Miss the Writing on the Wall?
When NuVasive shocked Wall Street in late July by announcing that two of its top executives were leaving the company, analysts ultimately concluded that the changes were unexpected but would not be all that disruptive to NuVasive’s day-to-day business. Now, a report from short-seller GlassHouse Research suggests there is more to the turnover than meets the eye. GlassHouse said the abrupt departure of former Chief Operating Officer Jason Hannon and Chief Financial Officer Quentin Blackford indicates that the clock may be running out for NuVasive, and that the company has been fooling investors with accounting tricks. ...
Source: MDDI - September 20, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: MD & M Minneapolis Medical Device Business Orthopedics Source Type: news
Boston Scientific & #039;s New Defibrillators Really Are Smarter
A suite of sensors designed to make implantable defibrillators smarter received a boost of support this week in the form of a late-breaking clinical trial presentation at the Heart Failure Society of America's annual scientific meeting in Dallas. New data confirmed that Boston Scientific's HeartLogic Diagnostic, which is slated for commercial release later this year as part of a new line of implantable heart devices, accurately enhanced the ability to classify patients at high or low risk of a future heart failure event. The Multisensor Chronic Evaluation in Ambulatory Heart Failure Patients (MultiSENSE) trial sh...
Source: MDDI - September 20, 2017 Category: Medical Devices Authors: MDDI Staff Tags: Cardiovascular Software Source Type: news
There & #039;s an App for Everything —Why Not Concussions?
Health has been a popular category ever since the arrival of the first smartphone apps. Handheld devices provide unprecedented computing to everyone, and everyone is concerned about their health. However, although concussions are a common medical condition, there are few apps designed to help patients recover. One reason is that the delivery device has an electronic screen, and physicians are well aware that screen time has the potential to delay concussion recovery. Now, this conventional wisdom is cautiously starting to evolve. If concussion apps are carefully controlled and screen time is...
Source: MDDI - September 20, 2017 Category: Medical Devices Authors: Lise Worthen-Chaudhari Tags: Digital Health Source Type: news
Q & amp;A: How to Control Development Costs for Implantables
When it comes to implantable devices, the material makeup of the technology is not only critical to the success of the device, but it also has a significant impact on the cost. Often times implantables need to be able to survive some of the harshest conditions in the body, where any kind of unexpected breakdown in materials can have critical adverse effects if they aren’t safely designed. This, of course, leaves many device makers with a very short list of potential materials. Len Czuba is president of Czuba Enterprises, a Chicago, IL-based medical device development consultancy that specializes in helping manufactur...
Source: MDDI - September 20, 2017 Category: Medical Devices Authors: Kristopher Sturgis Tags: MD & M Minneapolis Implants Materials Source Type: news
Qiagen Partners with Cell Diagnostics Company
ANGLE plc, a liquid biopsy company, has secured a valuable partnership with molecular testing giant Qiagen and an exclusive option agreement with Queen Mary University of London. ANGLE is known for Parsortix, its novel system for capturing and harvesting circulating tumor cells (CTCs) from blood. A Large Selling Opportunity with Qiagen The co-marketing partnership with Qiagen isn’t just a major win for ANGLE—it will also give Qiagen, which has more than 500,000 customers, an additional opportunity in the liquid biopsy space and the ability to offer ANGLE’s unique CTC harvesting technology alongside its ow...
Source: MDDI - September 19, 2017 Category: Medical Devices Authors: Marie Thibault Tags: IVD Source Type: news
Will Small Companies See a Bigger Impact from Hurricanes?
Cardiovascular Systems Inc. said Monday that its procedure volumes took a hit in the Houston, TX, and Florida markets, which account for more than 15% of the company’s revenue, in the aftermath of Hurricanes Harvey and Irma. To add insult to injury, the company reported that September is normally its strongest month for procedures within the quarter, which means the fiscal first quarter revenues are more heavily weighted in September. The company is based in St. Paul, MN, but has a facility in Pearland, TX, near Houston. "As recovery progresses, we will closely monitor conditions and the anticipated i...
Source: MDDI - September 19, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: MD & M Minneapolis Medical Device Business Source Type: news
Improve Radiology Departments by Adopting EMRs
In his 2004 State of the Union address, then-President George W. Bush advocated for electronic medical records (EMRs), proclaiming, “By computerizing health records, we can avoid dangerous medical mistakes, reduce costs, and improve care.” The Bush Administration pushed EMRs to the tune of billions of dollars in grants and other incentives. The trend was continued throughout the Obama Administration as well. Now, after more than a decade with EMRs as a public policy priority, EMRs have been adopted by many hospitals as primary methods of managing patient information. Almost every department shares patient infor...
Source: MDDI - September 18, 2017 Category: Medical Devices Authors: Zach Parker Tags: Imaging Source Type: news
Everything You Have to See at MD & amp;M Minneapolis
Discussion: Jumpstart Your Medtech Career Whether you’re hoping to score your first job in the medical device industry or looking for tips to advance your career, you’ll definitely benefit from the advice shared by local medtech recruiters from Abbott, Atricure, and The Walstrom Group. They’ll explain which positions are in demand at medical device companies right now, cover the pros and cons of working at a startup versus a big-name company, and answer your questions on topics ranging from how best to move your career forward to ways to maximize your earnings. Networking Opportunities With thousands of y...
Source: MDDI - September 16, 2017 Category: Medical Devices Authors: Jamie Hartford Tags: Medical Device Business Source Type: news
Data Boosts Support for Abbott, Gore PFO Closure Tech
Devices designed to lower a patient's stroke risk by surgically closing a hole in the heart known as a patent foramen ovale, have historically had a tough time in clinical trials. Data from three separate studies published in the New England Journal of Medicine could go a long way toward boosting support two market-leading PFO closure devices, but figuring out who should have the procedure and who should not continues to be a gray area for clinicians and patients. Long-term results from the RESPECT trial, which evaluated the Amplatzer device that Abbott acquired when it bought St. Jude Medical, along with new dat...
Source: MDDI - September 15, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: MD & M Minneapolis R Medical Device Business Source Type: news
Why Infusion Pumps Are So Easy to Hack
Cybersecurity is causing headaches across the industry as recent FDA guidance ensures that turning a blind eye to vulnerabilities will no longer be tolerated. And while awareness alone is not enough, as MDDI reported in late August, it is a step in the right direction. The latest example of just how widespread cybersecurity issues are in medtech involves a line of infusion pumps from Plymouth, MN-based Smiths Medical. According to the U.S. Department of Homeland Security’s Industrial Control Systems Cyber Emergency Response Team (ICS-CERT), independent researcher Scott Gayou has identified eight vulnerabilities in Sm...
Source: MDDI - September 15, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: MD & M Minneapolis Software Pumps Valves Source Type: news
FDA Blesses First App to Treat Substance Abuse
FDA has given the thumbs up to reSET, a prescription digital therapeutic from Pear Therapeutics. The offering is now cleared for use as an adjuvant to standard outpatient therapy to treat patients with substance use disorder for stimulants, cannabis, cocaine, and alcohol. This the first FDA-cleared mobile medical application system for treating patients with substance use disorders. “This is a defining moment for digital therapeutics and for patients with substance use disorder,” Corey McCann, president and CEO of Pear Therapeutics, said in a company press release. “As the first FDA-cleared Prescription D...
Source: MDDI - September 15, 2017 Category: Medical Devices Authors: Marie Thibault Tags: Digital Health Source Type: news
Medtronic Issues Voluntary Recall of Certain Insulin Pump Infusion Sets
Medtronic is telling patients that certain lots of its infusion sets for its insulin pumps are being recalled as part of a voluntary effort. The problematic infusion sets, which patients can identify by checking REF and LOT numbers on the available site, have a vent membrane that may be more likely to get blocked, possibly leading to too-high levels of insulin being delivered. This could endanger the patient and potentially cause hypoglycemia. The vulnerable vent membrane was discontinued in April 2017, so infusion sets manufactured since then include an updated component and do not fall under this voluntary recall. Patien...
Source: MDDI - September 14, 2017 Category: Medical Devices Authors: Marie Thibault Tags: Medical Device Business Source Type: news
Abbott to Stop Selling Absorb
Little more than a year after receiving FDA approval for its Absorb Bioresorbable Vascular Scaffold (BVS), Abbott has announced it will stop selling the device. The worldwide discontinuation of sales, which takes effect on September 14 and covers all sizes of Absorb BVS and Absorb GT1 BVS, is the result of “low commercial uptake,” according to the company. Though the device will no longer be sold, clinicians can continue to implant the Absorb BVS devices they already have. The company will also continue to assess patients who have already been implanted with Absorb as part of existing clinical trials. Get ...
Source: MDDI - September 12, 2017 Category: Medical Devices Authors: Marie Thibault Tags: Medical Device Business Source Type: news
Serving Ambulatory Surgery Centers: A Q & amp;A with DePuy Synthes
With interest in outpatient surgeries continuing to increase, medical device companies should be asking themselves whether their products—as well as their customer support programs—are ready for such a shift. DePuy Synthes has been equipping ambulatory surgery centers with devices and support needed for orthopedic procedures for many years as ASCs emerged as a burgeoning site of care. MD+DI recently asked Scott Zellner, Senior Director, U.S. Joint Reconstruction and Outpatient Marketing, a few questions about the shift and the company’s approach. MD+DI: How would the shift of orthopedic...
Source: MDDI - September 12, 2017 Category: Medical Devices Authors: Daphne Allen Tags: Medical Device Business Source Type: news
Why Zimmer Biomet ’s Latest Knee Launch Matters
It’s not just another orthopedic implant. Zimmer Biomet’s Persona Partial Knee System may be a symbol of the combined company’s future. In announcing the worldwide launch of its Persona Partial Knee System, Zimmer Biomet executives noted that the knee implant is the first major new product jointed developed by the combined company since the merger was finalized in June 2015. “The global introduction of the Persona Partial Knee System is the combine Company’s first major product launch and fills a significant gap in our knee portfolio,” Daniel Florin, chief financial officer and interim C...
Source: MDDI - September 11, 2017 Category: Medical Devices Authors: Marie Thibault Tags: Orthopedics Source Type: news
Left to Their Own Devices: The Promise and Dangers of IoT-Connected Medical Devices
Connected medical technology has arrived at the most opportune time. Insurance companies, now required to cover people with preexisting conditions, have needed some way to lower the costs of healthcare to balance the expense associated with higher-risk individuals. Connected devices help address this exact problem. iRhythm, for instance, manufactures a device that monitors cardiac activity and relies on machine learning for analysis. Products like these help providers treat more patients while consuming fewer resources. There are also offerings that help doctors monitor patient condition remotely so both parties can s...
Source: MDDI - September 11, 2017 Category: Medical Devices Authors: Catherine Wagner Tags: Medical Device Business Source Type: news
Is Medtronic Making Good on Its Post-Merger Promise?
Two years ago and some change, Medtronic sent shockwaves through the medical device world with the news of its $42.9 billion acquisition of Covidien through a tax inversion deal that moved the company’s corporate headquarters to Ireland and freed up $9.3 billion in cash that had previously been trapped overseas. The announcement came with a promise, however. As a direct benefit of the company’s new financial structure, Medtronic vowed to make $10 billion in U.S. technology investments over the coming decade in areas such as early stage venture capital investments, acquisitions, and R&D – above and bey...
Source: MDDI - September 8, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: MD & M Minneapolis Medical Device Business Source Type: news
Can Fitbit Help Millions of People Fight Diabetes?
Fitbit has already made a name for itself in the consumer wearables market, but the San Francisco, CA-based company has also made some noteworthy strides in the healthcare arena. Most recently, Fitbit hooked up with DexCom to add continuous glucose monitoring (CGM) data to its latest gadget – the Ionic smartwatch. Through the collaboration, DexCom CGM users on either Android or iOS devices would be able to see both activity and glucose levels, right on their wrist. “The strength of our brand and our ability to track critical health metrics continuously for up to four-plus days, coupled with DexCom’s mark...
Source: MDDI - September 8, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: MD & M Minneapolis Digital Health R Source Type: news
Siemens & #039; New Offering Could Give Heart Teams a Better View
As treatment options for structural heart disease continue to rapidly evolve, procedures increasingly involve multimodality imaging and multidisciplinary clinical teams. To reliably diagnose structural heart disease and perform these complex interventions, clinicians need detailed, real-time imaging information – such as real-time soft tissue and blood flow information from echocardiography as well as 2-D imaging information from fluoroscopy – to be visible in one view for common orientation. Siemens Healtineers has responded to that need with a new cardiovascular application designed to integrate ultrasound an...
Source: MDDI - September 8, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Imaging Medical Device Business Source Type: news
Is BioSig for Real This Time With Its Pure EP?
A couple years ago, BioSig Technologies, Inc. was poised to apply for FDA clearance to market its technology to improve treatment of atrial fibrillation and ventricular tachycardia. Then its scientific advisors advised the Minneapolis company to put more work into that technology, a hardware-software combination designed to present clearer signals during electrophysiology studies and catheter ablation. The technology, Pure EP, is designed to cut through the background noise of the lab and its equipment during cardiac recordings, enabling physicians to target and neutralize the areas of the heart that are causing atria...
Source: MDDI - September 7, 2017 Category: Medical Devices Authors: Nancy Crotti Tags: MD & M Minneapolis R Software Source Type: news
Could Targeted Medical Information Help Develop Better Devices?
Do you know how your browsing information can be used? Nigel Syrotuck Five years ago, The New York Times famously ran a piece explaining how Target sent maternity coupons to a customer that they (correctly) inferred was pregnant by examining her purchase history, before she had even told her family about it. More recently, Gizmodo ran a story about a person who was (incorrectly) targeted with a mailed letter inviting her to join a psoriasis clinical trial. Not only did she not have psoriasis, but the only relevance to her was that she had researched psoriasis and other skin ca...
Source: MDDI - September 7, 2017 Category: Medical Devices Authors: Nigel Syrotuck Tags: Design Source Type: news
Your Source for Medtech News and Analysis Is Getting Even Better
Source: MDDI - September 6, 2017 Category: Medical Devices Authors: Jamie Hartford Tags: MDDI Source Type: news
Can Next-Gen Obesity Balloon Pump Confidence in Apollo?
Apollo Endosurgery's Orbera365 weight-loss balloon works the same way as the original Orbera device, except it is designed to stay in the patient's stomach for 12 months, twice as long as the previous version. Apollo Endosurgery said it has received CE Mark approval to sell its Orbera365 weight-loss system in Europe, doubling the amount of time the balloon stays inflated in the patient's stomach. The approval comes less than a month after FDA alerted doctors of patient deaths associated with obesity balloons made by Apollo and ReShape Medical. The news deflated Apollo's stock (NASDAQ: APEN), as shares sold o...
Source: MDDI - September 6, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Your Source for Medtech News and Analysis Is Getting Even Better
Readers have turned to Medical Device and Diagnostic Industry (MD+DI) for medtech news and analysis for nearly 40 years, and now the industry’s premier resource is about to get even better. MD+DI is joining forces with Qmed, the world’s only directory of pre-qualified industry suppliers and service providers, to become a one-stop-shop to keep you up to date on medtech trends and connect you with trusted partners to speed your medical device and diagnostic innovations to market. You can still rely on www.mddionline.com for your daily dose of industry n...
Source: MDDI - September 6, 2017 Category: Medical Devices Tags: Design Source Type: news
How Teleflex Bagged a $1.1 Billion Hidden Treasure
Teleflex CEO Benson Smith expected some investors to be surprised by yet another billion-dollar acquisition, but sometimes businesses simply must strike while the iron is hot. The Wayne, PA-based company said it will buy NeoTract for up to $1.1 billion. The deal comes just seven months after Teleflex completed its $1 billion acquisition of Vascular Solutions. "I'm sure that at least some of you may be a bit surprised that Teleflex is once again active in M&A so quickly after announcing the acquisition of Vascular Solutions. Well, we are not," Smith said Tuesday during a conference call. Smith said Teleflex ha...
Source: MDDI - September 5, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Could Targeted Medical Information Help Develop Better Devices?
Source: MDDI - September 5, 2017 Category: Medical Devices Authors: MDDI Staff Tags: Design Services Source Type: news
FDA Fast Tracks New Blood Filtration System
ExThera Medical, a developer of blood filtration systems and biotechnologies, has received Expedited Access Pathway (EAP) designation from FDA for its latest technology, the Seraph 100 blood filter. The EAP designation indicates that the use for the technology will be an adjunctive treatment for bacteremia, in addition to antibiotics for patients receiving hemodialysis when the source of the infection is heparin-binding bacteria. ExThera applied for the EAP designation in June, and the company said FDA granted the designation within an accelerated timeframe. The company said its technology differs from other blood filter s...
Source: MDDI - August 31, 2017 Category: Medical Devices Tags: Business Source Type: news
Avoid the Consequences of an Experiment Gone Wrong
Source: MDDI - August 29, 2017 Category: Medical Devices Authors: MDDI Staff Tags: Quality Assurance Source Type: news
Innovating Regulation: FDA's PreCert Pilot Program
Source: MDDI - August 28, 2017 Category: Medical Devices Authors: MDDI Staff Tags: Regulatory and Compliance Source Type: news
‘Nanotransfection’ Turns Animal Skin into Blood Vessels and Brain Cells
Source: MDDI - August 25, 2017 Category: Medical Devices Authors: MDDI Staff Tags: Research and Development Source Type: news
Consolidating Strategic Suppliers? Successful Tooling Transfer is Key
Source: MDDI - August 24, 2017 Category: Medical Devices Authors: MDDI Staff Tags: Molding Services Source Type: news
A New DNA Test Could Tell You How Well You ’re Aging
Source: MDDI - August 24, 2017 Category: Medical Devices Authors: MDDI Staff Tags: IVD Source Type: news
Design Verification vs. Design Validation: Right Questions or Right Answers?
Source: MDDI - August 21, 2017 Category: Medical Devices Authors: Jamie Hartford Tags: Quality Assurance Source Type: news
Why the Big Picture Matters: The Systems-Level Approach to Product Development
Source: MDDI - August 18, 2017 Category: Medical Devices Authors: MDDI Staff Tags: Design Services Source Type: news
Device Industry Aware of Cybersecurity Risks, but Not Fortified Against a Breach
Source: MDDI - August 16, 2017 Category: Medical Devices Authors: mthibault Tags: Information Technology Source Type: news
What FDA ’s Digital Health Innovation Plan Means for Digital Diagnostics
Source: MDDI - August 11, 2017 Category: Medical Devices Authors: MDDI Staff Tags: Regulatory and Compliance Source Type: news
How to Navigate the Changing Device Manufacturing Landscape Through Financing
Source: MDDI - August 10, 2017 Category: Medical Devices Authors: MDDI Staff Tags: Medical Device Business Source Type: news
Bionik ’s Robotic Exoskeleton Gains Powerful Voice Command Capability
Source: MDDI - August 8, 2017 Category: Medical Devices Authors: mthibault Tags: Research and Development Source Type: news
Med Device Deals Dominate Other Healthcare Subsectors
Source: MDDI - August 7, 2017 Category: Medical Devices Authors: mthibault Tags: Medical Device Business Source Type: news