Philips Takes a Firm Stand in the DCB Market with ILLUMENATE
This study will look at findings that continue to demonstrate the benefits of the Stellarex 0.014 Drug-Coated Balloon for BTK PAD and its safety and durability for patients. Given the challenging chronic nature of BTK PAD, we are hoping to find that through sustained patency using Stellarex, we can improve healing, and reduce target lesion revascularization and major amputation." Layout of the Land C.R. Bard once held the crown in the DCB market, having gained approval for its Lutonix technology in 2014. The Murray Hill, NJ-based company began losing share when Medtronic launched the IN.PACT Admiral in early 2015. (Ed...
Source: MDDI - November 13, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Wireless Wearables: Challenges to Tackle
Wearable medical device usage by healthcare consumers has almost quadrupled in the past four years. It is up from nine percent in 2014 to 33 percent today, according to a survey released by Accenture. And the global market for these devices is projected to reach $12.1 billion by 2021, according to a study conducted by Markets and Markets, with the United States representing the largest market worldwide. These products increasingly rely on wireless communications to transmit and receive data from controllers or smartphones. Those wireless technologies include something familiar to those who use consumer electronics, Bluetoo...
Source: MDDI - November 13, 2018 Category: Medical Devices Authors: Susan Shepard Tags: BIOMEDevice San Jose Digital Health Source Type: news

AliveCor Heats up Mobile ECG Market with New Data
A research version of AliveCor’s mobile ECG technology could help rapid diagnosis and treatment of heart attacks, according to a study presented at the 2018 American Heart Association’s Scientific Sessions in Chicago. The ST LEUIS International Multicenter Study determined that the Mountain View, CA-based company’s smartphone technology can identify the condition with good correlation and high sensitivity compared to a standard-lead ECG. A total of 204 subjects (age = 60 years, males = 57%, STEMI activation = 45%) were enrolled from 5 international sites. For all interp...
Source: MDDI - November 12, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news

Abiomed ’s Successful Pilot Study Leads to Pivotal Trial
Abiomed shares were down as much as 17% despite announcing positive data for its Impella CP. The Danvers, MA-based company presented the data from the 50-patient pilot trial at the American Heart Association annual conference in Chicago and said because of the favorable data it would now move to a pivotal trial. The results of the FDA STEMI Door-to-Unloading safety and feasibility randomized controlled trial, show unloading the left ventricle with Impella CP for 30 minutes prior to reperfusion in patients presenting with anterior ST-segment elevation myocardial infarction (STEMI) without cardiogenic shock is safe and feasi...
Source: MDDI - November 12, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Triggered Doctors Fire Back at NRA: This Is Our Lane
The National Rifle Association's ruffled an awful lot of feathers last week on Twitter by telling doctors to "stay in their lane" rather than to publish studies pushing for gun control. The medical community is certainly not taking the comment laying down, however. Within a matter of days, a new Twitter account was born using the handle @ThisIsOurLane, and the account already has more than 8,000 followers. It all started with this NRA editorial accompanied by the organization's tweet that says, "Someone should tell self-important anti-gun doctors to stay in their lane. Half of the art...
Source: MDDI - November 12, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

BTG Rides High on 2-Year Sentry Data at VIVA
Two-year results from BTG’s SENTRY trial paint a positive picture of the company’s bioconvertible inferior vena cava (IVC) filter. The London-based company unveiled the data at the Vascular Intervention Advances conference in Las Vegas. The prospective, multicenter trial of the BTG Sentry, found that in addition to providing protection against pulmonary embolism (PE) during the transient risk period, the device also had zero instances of tilt, perforation, migration and embolization through two years of imaging-intensive follow-up. In the long-term data, 85 patients were followed for 24 ...
Source: MDDI - November 9, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Cardiva Medical Has Strong Showing at AHA
Cardiva Medical’s vascular closure system has met its clinical endpoints in the AMBULATE randomized pivotal trial. The Santa Clara, CA-based company’s VASCADE MVP, a vascular closure system designed specifically for multi-access venous closure following electrophysiology procedures such as arrhythmia ablation was evaluated in the study. Results from the trial were presented at American Heart Association 2018 Scientific Sessions, held in Chicago. AMBULATE enrolled 204 patients who underwent arrhythmia ablation procedures by 28 physicians at 13 sites across the US. The treatment group had ...
Source: MDDI - November 9, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news

Supplier Stories for the Week of November 4
(Source: MDDI)
Source: MDDI - November 9, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Packaging Source Type: news

Device Implementation Sets the Stage for Successful Adoption
For clinicians, the use of new devices can represent significant solutions for their patients. However, if there’s a lack of education on the provider benefit or subpar training, a new vendor/provider relationship may fall flat before the device is able to see consistent use. Many times, one of the first interactions with a device company’s clinical team is during a product evaluation. Consequently, medical device manufacturers should develop an exceptional and methodically mapped out implementation program. Although these programs should aim to establish adaptable processes, they must a...
Source: MDDI - November 9, 2018 Category: Medical Devices Authors: Susan Brown Tags: Business Source Type: news

Do You Need a “Warehouse of Stuff” Anymore?
Leonard Koren has been 3D printing for 20 years, and he’s seen a lot of progress over time. Future progress in manufacturing will depend upon more than just technology—a new mindset is needed, Koren believes. Koren started his first 3D printing company in 1998 with a Stratasys FDM 2000, and in 2003 he founded International Mold and Production LLC to provide injection molding and 3D printing/additive manufacturing services. IMAP has been producing consumer goods and automotive parts for years, and the company recently exhibited at MD&M Minneapolis 2018 to introduce its cap...
Source: MDDI - November 8, 2018 Category: Medical Devices Authors: Daphne Allen Tags: 3-D Printing Source Type: news

Eximis Working on a New Surgical Platform
Eximis Surgical has secured $7.5 million in financing to help develop a surgical platform for the removal large specimens through small laparoscopic incisions. The financing was led by Questa Capital with participation from Venture Investors. The Louisville, CO-based company said it will use the new capital to fund U.S. regulatory approval and the commercial launch of the Eximis Laparoscopic Specimen Removal System. The firm said its platform uses specimen removal technique to have multiple, integrated containment bags for increased confidence and a novel cutting technology that eliminates the need for sharps during segmen...
Source: MDDI - November 8, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Another Chance for Medtronic ’s Renal Denervation Therapy
Medtronic has yet another chance to prove its renal denervation therapy can treat uncontrolled hypertension. The Dublin-based company has received FDA approval to begin a clinical trial to evaluate the Symplicity Spyral renal denervation system with patients on medication for high blood pressure. The ON MED Trial is a 2:1 randomized, sham-controlled study and will randomize up to 340 patients at 55 centers in the U.S., Japan, Europe, Australia and Canada. Patients will be followed out to three years. Primary safety endpoints will include major adverse events at one month and new renal artery stenosis at six months. The pri...
Source: MDDI - November 8, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

DexCom Continues to Shine Despite Growing Competition in CGM
Even though competition in the Continuous Glucose Monitoring (CGM) market is growing, DexCom continues to have momentum. The San Diego, CA-based company beat out 3Q18 expectations. Revenue for the quarter came in at $266.7 million vs. the consensus estimate of $241.3 million. The company said there was an increase of revenue by 44% in 3Q18, up from the $184.6 million in revenue earned in 3Q17. DexCom said it now expects to have sales of $975 million, which are up from the prior expectation of $925 million. Wall Street consensus was $930.83. DexCom has been facing increasing competition lately as its chief rival, Senseonic...
Source: MDDI - November 8, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Senseonics ’ CGM Becomes More Effective with Latest FDA Nod
Senseonics Holdings has received a nod from FDA to make its Eversense Continuous Glucose Monitoring (CGM) system more accessible to patients. The agency’s approval allows qualified healthcare providers to be trained and certified to insert patients with Eversense, which lasts up to three months. Previously, the sensor insertion and removal procedure could only be performed by trained physicians. “We are pleased with this FDA approval, we can now include nurse practitioners and physician assistants in the growing list of diabetes care professionals who can be certified to place the Everse...
Source: MDDI - November 7, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

8 Things You Should Know about the EU MDRs
A recent survey by the Regulatory Affairs Professionals Society (RAPS) and KPMG revealed some shocking statistics. According to “The Race to EU MDR Compliance,”a solid majority (78%) of medical device companies responding to the survey do not have a sufficient understanding of EU MDR. And even more shocking: more than half of respondents (58%) have no strategy in place to remediate gaps in their clinical data or processes for collecting data, despite the new regulatory expectations for such data. Education is clearly still needed to help companies prepare for May 2020, when the EU MDRs b...
Source: MDDI - November 7, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Regulatory and Compliance Source Type: news

Intact Vascular Has Strong Data from TOBA II
One-year results from Intact Vascular’s Tack Optimized Balloon Angioplasty II (TOBA II) successfully achieved both its primary and secondary endpoints. The Wayne, PA-based company announced the results at the 15th annual VIVA conference in Las Vegas. The company said this is the first peripheral vascular study to enroll patients with 100% dissected vessels, the TOBA II study, was conducted at 33 U.S. and European sites to investigate the Tack Endovascular System for the repair of post-angioplasty dissections in femoropopliteal arteries. All patients enrolled (n=213) suffered from peripheral arterial disea...
Source: MDDI - November 7, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Should You Develop Your Own Material Specification and Skip ASTM ’s?
The basic format for an ASTM standardized metal alloy for medical uses includes a specification of the required elements as well as one or more undesirable elements for which there is a maximum allowable amount. For example, ASTM F2886, last approved in 2017, covers Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications. While the name gives part of the recipe, a more-detailed list of elements specifies that chromium must be between 27 and 30%, and molybdenum between 5 and 7%. Thus, these major required alloying elements together constitute 32 to 37% of the mix. Twelve other eleme...
Source: MDDI - November 6, 2018 Category: Medical Devices Authors: William A. Hyman Tags: Regulatory and Compliance Source Type: news

Nevro Excels in Sales, but Misses on EPS Consensus
You win some, you lose some. Nevro might have been able to beat analysts’ estimates in sales, but the neuromodulation specialist failed to meet consensus of earnings per share for this most recent quarter. The Redwood City, CA-based company said 3Q18 EPS ($0.37), $0.08 worse than the analyst estimate of ($0.29). Revenue for the quarter came in at $95.6 million vs. the consensus estimate of $94.28 million. The company said the increase in revenue was primarily attributable to the continued adoption of the Senza system. Nevro said it expects worldwide revenue to be at the low end of its previously stated ra...
Source: MDDI - November 6, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Digital Health Source Type: news

NinePoint Keeps AI Offerings Fresh with IRIS
FDA has just given a nod to NinePoint Medical’s Intelligent Real-time Image Segmentation (IRIS) software upgrade for the NvisionVLE Imaging System. The Bedford, MA-based company said IRIS is an artificial intelligence-based platform for image feature segmentation is the first tool of its kind approved for use in imaging of esophageal tissue. The NvisionVLE Imaging System allows physicians to perform a Volumetric Laser Endomicroscopy (VLE) procedure that produces real-time, high-resolution cross-sectional images. This system enables gastroenterologists to thoroughly evaluate the esophageal tissue surface a...
Source: MDDI - November 5, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Digital Health Source Type: news

Surgical Robotics Market Due for a Shake Up?
For years, Intuitive has been recognized as the leader of the surgical robotics market. But there are more competitors on the horizon and the entry level for the surgical robotics’ market is far easier than it used to be. Roger Smith, MD, the Chief Technology Officer for the Florida Hospital Nicholson Center, spoke with MD+DI about the state of the surgical robotics market and what could possibly lie ahead for the space. “When you look at the volume of procedures that are conducted with devices that are considered robotic, probably 70% are conducted with da Vinci,” Smit...
Source: MDDI - November 5, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Are You Ready for the Factory of the Future?
There’s a lot of data tied up in medical device manufacturing processes—but it’s been challenging to capture and process this information from historically independent and disjointed machines and processes, say experts. In addition, skilled operators with a deep understanding of such processes have often served as the keepers of the knowledge. Connecting those processes and machines so that they can communicate with each other and then collecting and analyzing the data from those processes could yield several benefits. Such connected, highly automated environmentsâ...
Source: MDDI - November 5, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Assembly and Automation Source Type: news

ResMed to Boost Portfolio with MatrixCare
ResMed is expanding its out-of-hospital software portfolio with the acquisition of MatrixCare. The San Diego, CA-based company will pick up MatrixCare for about $750 million. The deal is expected to close in ResMed’s 2Q19. MatrixCare, is a specialist in long-term post-acute care software, serving more than 15,000 providers across skilled nursing, life plan communities, senior living and private duty. These care settings are complementary to ResMed’s current software-as-a-service (SaaS) offerings in home medical equipment, home health and hospice, delivered through Brightree and HEALTHCAR...
Source: MDDI - November 5, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Illumina Shows That Big Medtech Deals Are Far from Over
Just when it looked like the year would end without another mega-merger, Illumina has swooped in to acquire its rival, Pacific Biosciences (PacBio), for $1.2 billion. The move would solidify San Diego, CA-based Illumina’s position in the genetic sequencing market. The acquisition is expected to close in mid-2019. Under the deal, which has been approved by both firms’ boards, Illumina would buy Menlo Park, CA-based PacBio at a price of $8 a share. This price represents a premium of 71% to Pacific Biosciences’ 30 trading day volume weighted average share price as of the m...
Source: MDDI - November 3, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Halfway to the New European Medical Device Regulation, U.S. Manufacturers Feel the Pinch
The regulators are coming! The regulators are coming! In the swirling waters of the global economy, it can be hard to keep up with every new development. However, this October marks an important regulatory milestone that should not pass by unnoticed. While the reference at the top of this article may be a little misplaced (thanks to Brexit), please allow the proverbial Paul Revere to direct your attention to the following: We are now halfway through the three-year transition period between the European Union’s old directive for regulating medical devices, and the new Medical Device Regulation. The new dir...
Source: MDDI - November 2, 2018 Category: Medical Devices Authors: Dan Zondervan Tags: Regulatory and Compliance Source Type: news

Breaking Through the Bias: Debunking Common Misconceptions About Usability Studies
Conclusion When you are lifting weights, you hire a coach to make sure you are using the proper form. The concept is easy to understand, but if you don’t know what you are doing, it’s easy to mess up. In the same way, use-trained UX researchers or usability professionals help you map out an ideal path to extract the most amount of information in the shortest amount of time. They are well versed in understanding what questions should be asked and how to achieve rich results. It’s easy to listen to the echo chamber, but when conducted with the right attitude, user studies...
Source: MDDI - November 2, 2018 Category: Medical Devices Authors: Greg Martin Tags: Design Source Type: news

New Blood Test Makes the Autism Picture a Bit Clearer
NeuroPointDx is launching a blood plasma-based test that might be able to give a clearer picture of the prevalence of autism in children. The Madison, WI-based company said the NPDX AA Test, identifies metabolic subtypes associated with the autism spectrum disorder (ASD) and can be used to screen children as young as 18 months. The test detects amine imbalances in the blood plasma of children with very precise thresholds that were identified and validated based on patient samples from the Children’s Autism Metabolome Project (CAMP), a 1,100-subject study, the largest one to date focused on the metabolism ...
Source: MDDI - November 1, 2018 Category: Medical Devices Authors: Omar Ford Tags: IVD Source Type: news

How Smart are Your Design Inputs?
Design inputs, and design controls in general can be challenging to get right, according to Jessica Lyons, a customer success expert at Greenlight Guru. "There's almost an art to it.  I find that most of the people I talk to struggle the most with how to define user needs and design inputs," Lyons told MD+DI. "They tend to fall into two camps - those who over specify their inputs and those whose inputs feel more like user needs. It's a very important distinction." Lyons spoke at MD&M Minneapolis about the importance of design inputs and shared some tip...
Source: MDDI - November 1, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: MD & M Minneapolis R Design Source Type: news

One of the Top 25 Medtech M & amp;A Targets Has Strong Quarter
Abiomed dominated in its recent quarterly earnings. The Danvers, MA-based company posted revenues of $181.8 million topping analyst consensus of $175.2 million. The cardiac device maker also had $1.09 per share edging out analysts’ consensus of 74 cents EPS. As a result, Abiomed said it is again increasing the low end of its fiscal year revenue guidance to $765 million to $770 million (up 29% to 30% over the prior fiscal year). This compares to the post fiscal first quarter guidance of $755 million to $770 million (up 27% to 30% over the prior fiscal year) and the company's initial forecast of $740 millio...
Source: MDDI - November 1, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news

Another Hold up for NxStage ’s Merger with Fresenius
Fresenius Medical Care’s $2 billion acquisition of Waltham, MA-based NxStage Medical has been delayed yet again. The Bad Homburg, Germany-based company made plans to pick up NxStage in August of 2017 and the deal was supposed to close sometime this year. However, NxStage said in a regulatory filing that the pending merger could come in February of 2019. The issue around the delay seems to center around Fair Trade Commission concerns. Earlier this year, to help satisfy FTC’s antitrade concerns surrounding the deal, NxStage sold its Blood Lines business to B.Braun for an undisclosed sum. &...
Source: MDDI - November 1, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

How Video Games Can Be Used to Improve Diagnosis and Treatment Methods
These days when it comes to improving the process of diagnosing and treating patients, medtech companies are always looking for explore the unexplored. Level Ex, an innovative medical technology company based out of Chicago, may be taking the most unique approach with the release of their latest mobile game designed to train, educate, and improve the diagnosis and treatment skills of physicians. The new mobile game, known as Pulm Ex, was designed for pulmonologists and aims to bring to life the most challenging patient cases for physicians around the country to help improve their diagnosis and treatment skills using highly...
Source: MDDI - October 31, 2018 Category: Medical Devices Authors: Kristopher Sturgis Tags: Digital Health Source Type: news

How Are Engineers Actually Using VR for Human Factors Review?
We've been hearing for some time now that virtual and augmented reality technologies are poised to revolutionize medtech, but can a VR system actually help R&D teams develop a medical device? It absolutely can, according to engineers at Cincinnati, OH-based Kaleidoscope Innovation. "When we've got a team that's maybe across the country or across the world, we can get in here and actually be in the same room virtually around the same product," Ben Ko, a biomedical engineer at Kaleidoscope, told MD&M Minneapolis attendees on Wednesday. Ko's colleague Jerry Sch...
Source: MDDI - October 31, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: MD & M Minneapolis R Source Type: news

Say Hello to Hospital ’s New Fully Autonomous Service Robot
Swisslog Healthcare, a global supplier of solutions and services for material transport, announced earlier this month the full market launch of their flagship technology, the Relay robot. The new autonomous service robot was designed for deployment in various healthcare settings and is set to debut for pharmacy and laboratory pick-up and delivery to help hospitals improve labor productivity. The new Relay robot was manufactured by Savioke, a robotic engineering firm based out of California. The two companies decided to partner with one another in 2017 in a move to come together to develop an innovative new technology that ...
Source: MDDI - October 31, 2018 Category: Medical Devices Authors: Kristopher Sturgis Tags: Business Digital Health Source Type: news

New York State Initiative Hopes to Stop the Spread of Super Bugs
Each year in the United States, at least two million people become infected with antibiotic-resistant infections--so-called super bugs. And at least 23,000 of those people will end up dying from them, according to the Centers for Disease Control and Prevention. One of the deadliest super bugs, carbapenem-resistant Enterobacteriaceae (CRE) bacteria, has become resistant to all or nearly all the antibiotics available today. Almost half of hospital patients who get bloodstream infections from CRE bacteria die from them. The problem is so serious that CDC has classified CREs as one of three urgent threats to the public health....
Source: MDDI - October 31, 2018 Category: Medical Devices Authors: Susan Shepard Tags: IVD Source Type: news

98point6 Uses AI to Help Redefine Primary Care
98point6 is on a mission to make primary care more efficient with the use of artificial intelligence. The Seattle, WA-based company said it raised $50 million in a series C round, bringing the total amount raised to $86.1 since the company’s inception in 2015. The Merchant Banking Division of Goldman Sachs was an anchor investor in the Series C round, which was further supported by existing investors. The funding will enable 98point6 to scale and fulfill strong commercial demand of its text-based primary care service, grow its product and physician teams, expand the capabilities of the platform, and conti...
Source: MDDI - October 30, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Digital Health Source Type: news

Ghosts of Medtech: What Ever Happened to These 7 Medical Devices?
(Source: MDDI)
Source: MDDI - October 30, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Amazon ’s Latest Move in Medtech Is a Big Deal
Amazon is continuing its deep dive into the healthcare market. This time the Seattle, WA-based company is teaming up with Arcadia, a consultancy group, to launch an exclusive brand of consumer-use medical devices for diabetes and hypertension management. Dubbed, the Choice Brand, Amazon’s medical device offerings will start with a range of blood glucose monitors and blood pressure monitors both with supporting mobile apps which offer measurement tracking, data mobility, and reminders. Amazon’s partner, Arcadia, will help develop the brand. Arcadia has extensive experience in brand develo...
Source: MDDI - October 30, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Digital Health Source Type: news

What Will Be Your Next Move in the In Vitro Diagnostic Space?
When it comes to in vitro diagnostic (IVD) technologies, medical device and diagnostic companies have been chomping at the bit to produce the next big innovation. The last few years have seen a surge in IVD technologies in the market, as device makers expand their knowledge and resources surrounding IVD technologies. With new products in the marketplace for direct-to-consumer tests (DTC), point-of-care diagnostics, and next-generation sequencing, we may be on the threshold of a new wave of diagnostic technologies that could have an impact on other diagnostic areas as well, such as gene sequencing and editing. These new IVD...
Source: MDDI - October 30, 2018 Category: Medical Devices Authors: Kristopher Sturgis Tags: BIOMEDevice San Jose IVD Source Type: news

Winning Competition Entry Could Improve Documentation Process for Administering Drugs
Vetter, a global contract development and manufacturing organization based in Ravensburg, Germany, has announced the winner of its first Open Innovation Challenge — Injection 2.0. The competition, which kicked off in June, brought together four different teams to submit ideas on how digital trends can be used to develop innovative and sustainable solutions for new drug injection therapies. Claudia Roth, vice president of innovation management at Vetter, said the competition was designed to help the company explore new pathways to further the development of the injection process. Sh...
Source: MDDI - October 29, 2018 Category: Medical Devices Authors: Kristopher Sturgis Tags: Contract Manufacturing Digital Health Source Type: news

New Surgical Mesh Is & #039;There When You Need It, Gone When You Don & #039;t & #039;
  Let's face it, "mesh" has become a four-letter word in more ways than one, given the number of long-term complications and lawsuits surrounding surgical cases in which mesh was used. But that doesn't mean that doesn't mean that mesh doesn't have its place in surgery. "It's not like mesh is bad or mesh is good. There are many procedures in which its very good, very beneficial, and there are procedures in which it is not necessary. Then there are procedures in the middle, where mesh serves a clinical use but has been hampered by clinical problems," said Alexei Mlodinow, president and foundin...
Source: MDDI - October 29, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Materials Source Type: news

Should Stryker Worry About Zimmer & #039;s New Robotics Offering?
Stryker's Mako Total Knee offering continues to gain traction and drive growth for the Kalamazoo, MI-based orthopedics company, but the company faces imminent competition in the space from Warsaw, IN-based Zimmer Biomet. During Stryker's third-quarter earnings call, CEO Kevin Lobo said the company is approaching 600 robots globally, and Lobo said he feels bullish about the future of robotic-assisted surgery.  Katherine Owen, vice president of strategy and investor relations at Stryker, said 37 Mako robots were installed globally during the third quarter, with 26 of those installs being in the United...
Source: MDDI - October 28, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Orthopedics Source Type: news

Bringing Precision Diagnostics Home
Patients living with autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus (SLE), or multiple sclerosis must see their health practitioners frequently to check the progression of their conditions and their responses to therapies. Monitoring disease activity and severity is crucial so that physicians can help patients get to or stay in remission before long-term damage is done. And since these chronic diseases require a lifetime of care, the testing and doctor visits add up over time. This can be inconvenient and costly. But one company may be changing that dynamic. DxTerity is developing a low-cost...
Source: MDDI - October 26, 2018 Category: Medical Devices Authors: Susan Shepard Tags: IVD Source Type: news

Zimmer Has to Reduce the Size of Its Portfolio, CEO Says
Zimmer Biomet is making progress toward the company's supply recovery goals, but CEO Bryan Hanson says he is still not happy with where the company is at.  "The fact is, we need to continue to focus on bringing up our service levels to our customers. We need to be best-in-class in this area," Hanson said during the company's third-quarter earnings call, as transcribed by SeekingAlpha.  While Zimmer Biomet's portfolio is "absolutely unmatched" in terms of scale, Hanson said the size of the portfolio creates a very complex supply chain for the company. Reductions won't happen right...
Source: MDDI - October 26, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Orthopedics Source Type: news

Boston Scientific Keeps Us Guessing on Recent Legal Victory
Boston Scientific has a big decision to make in Germany, and the clock is ticking. Earlier this week, a German court sided with Boston Scientific in a patent case involving its transcatheter aortic valve replacement technology. The court decided that Edwards Lifesciences' Sapien 3 Ultra device infringed on a patent by Boston Scientific subsidiary Symetis that has to do with the fabric used on the valve seal. Edwards plans to appeal the decision and said the German court will hold a full hearing on the dispute next year. In the meantime, Boston Scientific has the right to prevent sales of the Sapien 3 Ultra in Germany. It i...
Source: MDDI - October 26, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

List of Medtech Divestitures Is Quickly Growing
Sometimes it just comes down to finding the right fit. That seems to be the story in the medtech industry these days as companies are stepping up to acquire divested assets. The latest chapter in the divestitures story comes from Becton Dickinson & Co. The Franklin, Lakes, NJ-based company divested the assets of its Cardial business to LeMaitre Vascular for $2 million. Cardial's product lines, including knitted and woven vascular grafts, valvulotomes and surgical glue, are now available through LeMaitre Vascular. Sales of the business during the latest 12-month period were €3.3 million, concentrated mo...
Source: MDDI - October 25, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Adhesives Source Type: news

Supplier Stories for the Week of October 21
(Source: MDDI)
Source: MDDI - October 25, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Contract Manufacturing Source Type: news

Could Reimbursement for AI Solutions Really Be That Tricky?
It would be almost impossible to ignore the recent artificial intelligence explosion in healthcare. There have been numerous approvals, clearances, and companies that are developing various solutions with AI capabilities. Some firms have taken the forefront with solutions that could really impact the healthcare landscape. While AI is being readily accepted – there are still some questions surrounding its reimbursement from the Centers for Medicare and Medicaid Services. During Cleveland Clinic’s 2018 Medical Innovation Summit, which was held earlier this week, Eric Hargan, Deputy Secreta...
Source: MDDI - October 25, 2018 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Source Type: news

Expect Boston Scientific to Keep Rounding Out Its Portfolio with M & amp;A
 Boston Scientific has been on quite the shopping spree in 2018. The Marlborough, MA-based company has announced eight acquisitions since the beginning of the year, plus a hefty investment in Millipede, which is likely to lead to an acquisition within the next year or so. Naturally, the company's aggressive M&A strategy has attracted attention from industry analysts who are eager to see if this spree will continue in 2019. During the company's third-quarter earnings call on Thursday, CFO Daniel Brennan said Boston Scientific still has a "tremendous amount" of financial flexibility. Loo...
Source: MDDI - October 25, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

5 Steps to Move 3D Printing Processes from Prototyping to Production
Advances in 3D printing could make medtech mass customization a reality. Matt Sand, president of 3DEO, will discuss the role of 3D printing in medtech in the MD&M Minneapolis session, “3D Printing: The Journey from Prototyping to Production to Metal 3DP.” His October 31 talk will include five tips for moving from prototyping to production. “Mass customization is the capability of producing in volume in an efficient manufacturing flow, instead of ‘one at a time,’ while still being able to offer options in color, size, a...
Source: MDDI - October 24, 2018 Category: Medical Devices Authors: Daphne Allen Tags: MD & M Minneapolis 3-D Printing Source Type: news

Top 10 Medical Innovations for 2019
(Source: MDDI)
Source: MDDI - October 24, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

A Truly Epic CEO Rocks the Cleveland Medical Innovation Summit
When Judy Faulkner launched Epic Systems from a Wisconsin basement in 1979, the medical software company was worth about $70,000. Speaking at the Cleveland Clinic Medical Innovation Summit, Faulkner told the audience about the firm's "Epic" journey.  According to Forbes, Faulkner has come a long way since founding the company. The CEO now has  a net worth of about $3.5 billion and is the third richest self-made woman on Forbes' list. Epic specializes in electronic health records and had sales of $2.7 billion in 2017. “When we started, we had about ...
Source: MDDI - October 24, 2018 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Source Type: news