Labelling Recall: Automation is the Answer
The heavy reliance that companies place on manual processes and disparate labeling systems is more times than not at the route of product recalls. In 2018 alone, labelling issues made up 9% of all medical device recall events, which comprised of the return of over a million units. For a business, the consequences are costly, with the average label change sitting at $350,000. However, despite the availability of automated technologies created to tackle these very issues, numerous companies still persevere with out-dated processes which leave labels exposed to error. As regulations tighten, the cost of non-compliance is hig...
Source: MDDI - May 17, 2019 Category: Medical Devices Authors: Craig Jones Tags: Labeling Packaging Source Type: news

Aidoc ’s AI Solution to ID Pulmonary Embolism Cleared
A newly FDA-cleared artificial intelligence solution could help give greater insight on patients that pulmonary embolisms (PE). New York-based Aidoc has developed the PE application that works with radiologists to flag and triage PE cases in chest CTs. Aidoc's solutions analyze medical images directly after the patient is scanned and notify the radiologists of cases with suspected findings to assist with prioritization of time-sensitive, and potentially life-threatening cases. Get up to speed on all things AI with this new guide from MD+DI.  In an email, Aidoc told MDDI that without its solution, â€&...
Source: MDDI - May 17, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Most Provocative Statements Heard at BIOMEDevice Boston 2019
See you at BIOMEDevice Boston 2020! (Source: MDDI)
Source: MDDI - May 16, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: R & D Design Source Type: news

It & #039;s Harder Than Ever to Find Truly New Customer Insights
Regardless of the industry that you're in, it is harder than ever to find truly new customer insights. Research budgets are smaller, the low-hanging fruit has already been picked so you need to dig deeper to find new insights, and traditional research can be expensive and time-consuming. But artificial intelligence, or machine learning, is changing the game, according to John Mitchell, president and managing principal at Applied Marketing Science, a Waltham, MA-based research and marketing firm that helps its clients better under and incorporate the voice of the customer into product development. Between social...
Source: MDDI - May 16, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: R & D Source Type: news

Illumina Files a 2nd Patent Lawsuit Against BGI
Illumina is filing yet another patent lawsuit against one of BGI Group’s subsidiaries, BGI Europe A/S. The San Diego-based company has filed the suit in the Martime & Commercial High Court of Denmark. Illumina is alleging that BGI’s sequencing products including the BGISeq-500, MGISeq-2000, and related chemistry reagents, infringe EP 3 002 289 B1. Illumina said this patent covers its sequencing-by-synthesis chemistry. The complaint also alleges that BGI’s use of the MGISEQ mark infringes Illumina’s registered EU Trademark No. 8972127 for the MISEQ ...
Source: MDDI - May 16, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

You & #039;re a Physician with a Great Product Idea. Now What?
Many of the best products on the medical device market stemmed from a nurse or a physician recognizing an unmet clinical need. Something that would make their jobs easier and improve the quality of care for their patients. But navigating the product development landscape is easier said than done, especially if you don't have a lot of time or funding. During the BIOMEDevice Boston Conference, a panel of industry experts offered advice on this challenge in response to two physicians' questions. The first question, from a Mayo Clinic physician, was how might a physician such as himself appr...
Source: MDDI - May 15, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: R & D Design Source Type: news

Abbott and NIH Join Forces to Advance Neuroscience Research
Abbott Laboratories and the National Institutes of Health have formed an alliance to evaluate applications that could help treat chronic pain and progressive movement disorders, like Parkinson’s disease. The collaboration is a part of NIH’s BRAIN (Brain Research through Advancing Innovative Neurotechnologies) initiative to accelerate advancements in neuroscience research. The agreement specifically calls for NIH to use the Abbott Park, IL-based company’s neuromodulation technologies for research related to these NIH initiatives to explore their application for chronic p...
Source: MDDI - May 15, 2019 Category: Medical Devices Authors: Omar Ford Tags: R & D Source Type: news

7 Reasons to Use Robotics in Assembly and Packaging
The most recent data available from the International Federation of Robotics (IFR) states that global sales of industrial robots doubled during the five-year period 2013-2017. Sales in 2017 alone increased by more than 30 percent. According to the IFR, “Robot installations in the United States continued to increase to a new peak in 2017—for the seventh year in a row—and reached 33,192 units. Since 2010, the driver of the growth in all manufacturing industries in the U.S. has been the ongoing trend to automate production in order to strengthen U.S. industries in both dom...
Source: MDDI - May 15, 2019 Category: Medical Devices Authors: Sam Weller and Chris Jurik Tags: Assembly and Automation Source Type: news

Supplier Stories for the Week of May 12
(Source: MDDI)
Source: MDDI - May 14, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Packaging Source Type: news

New Approval Extends Impella ’s Support Time
Abiomed has received a nod from FDA to expand the Impella 5.0 and Impella LD PMA’s labeling for the treatment of cardiogenic shock. The agency has approved the Danvers, MA-based company’s Impella to provide support 10 to 14 days. Prior to the expansion, the pump was only at six days. Abiomed’s Impella 5.0 and the Impella LD are forward flow heart pumps that deliver up to 5 L/min, stabilizing a patient’s hemodynamics, unloading the left ventricle, and perfusing the end organs, allowing for the potential of native heart recovery or return to heart functi...
Source: MDDI - May 14, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Another Day, Another Medtech Deal
In a month filled with medtech deal news, CrossRoads Extremity Systems reports a merger agreement with HealthpointCapital.  HealthpointCapital will take a controlling interest in the Memphis, TN-based medical device company in exchange for providing access to operating capital for continued organic growth, market expansion, and bolt-on acquisitions. Using advanced technology and materials since its inception in 2014, CrossRoads has differentiated itself in the foot and ankle sector with its Active Stabilization technology. The technology is designed to simultaneously offer enhanced stabi...
Source: MDDI - May 14, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Orthopedics Source Type: news

Is Your Testing Program Ready for the EU MDRs?
The European Union’s new Medical Device Regulations (EU MDR) will require that all medical devices – even legacy products – have updated clinical data and technical documentation to support device safety and conformity with the new regulatory standards, Sandi Schaible tells MD+DI. Schaible is the senior director of analytical chemistry at WuXi AppTec, where she specializes in extractables and leachables studies. She is a U.S. delegate and international delegate for ISO 10993 part 18 in chemical characterization. She is also a U.S. delegate for ISO 10993 part...
Source: MDDI - May 14, 2019 Category: Medical Devices Authors: MDDI Staff Tags: Testing Source Type: news

Boston Sci ’s Emblem Results Are ‘Untouched’ at HRS 2019
Boston Scientific unveiled 30-day results from a study evaluating the safety and efficacy of its Emblem Subcutaneous Implantable Defibrillator (S-ICD) system. The Marlborough, MA-based company revealed results from the UNTOUCHED study this past weekend at the 2019 Heart Rhythm Society annual meeting. UTOUCHED specifically looked at Emblem being a system for the primary prevention of sudden cardiac death specifically in patients with a left ventricular ejection fraction (LVEF) ≤35%, the most common population to be indicated for ICD therapy. The global, prospective, non-randomized study evaluated data fr...
Source: MDDI - May 14, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

Edwards Continues to Innovate in Surgical Valve Space
This study, a prospective, single-arm observational clinical trial of 133 patients conducted at two clinical sites in Europe, also yielded positive results. There were no events of SVD throughout the study period, Edwards noted. The company also plans to further evaluate the new tissue platform through the RESILIENCE trial, a longer-term study that will follow 250 patients under the age of 65. That study will examine calcification levels, hemodynamic deterioration, and valve failure at years five, seven, nine and 11 as early potential predictors of valve durability. (Source: MDDI)
Source: MDDI - May 13, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Implants Source Type: news

Varian Is in Bold New Territory with Acquisition
Varian Medical Systems’ latest acquisition has the cancer care solutions-specialist entering into new territory. The Palo Alto, CA-based company is picking up CyberHeart, a firm with intellectual property (IP) that covers the use of radiation in the heart (cardiac radioablation) and other forms of radiosurgery for cardiovascular disease. The two companies did not disclose the amount. “This is a new area and Varian is excited about the potential application of stereotactic radioablation to the cardiac space – specifically treating patients who are suffering from irregula...
Source: MDDI - May 13, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news

Grail Sets Fast Pace in Liquid Biopsy with New Milestones
Grail has hit a major milestone as the liquid biopsy company is reporting it has been granted Break Through Device Designation by FDA. The Menlo Park, CA-based company is developing an investigational next-generation sequencing (NGS) blood test for the early detection of multiple cancer types in individuals 50 or older. In addition, Grail will share new data from the Circulating Cell-free Genome Atlas (CCGA) study, at the 2019 American Society of Clinical Oncology Annual Meeting. The CCGA study is a prospective, observational, longitudinal study that has completed enrollment of about 15,000 people with and without cancer a...
Source: MDDI - May 13, 2019 Category: Medical Devices Authors: Omar Ford Tags: IVD Source Type: news

Yet Another Significant Acquisition in the Orthopedics Market
Tis the season for M&A in the orthopedics market. This time out Medtronic is acquiring Titan Spine for an undisclosed sum. Mequon, WI-based Titan Spine markets a full line of Endoskeleton interbody devices featuring its textured surface in the U.S., Europe, and Australia through its sales force and a network of independent distributors. Dublin-based Medtronic said interbody implants are spacers that can be inserted between the vertebrae during spinal fusion surgery to help relieve pressure on nerves and hold the vertebrae in place while fusion occurs. Implant material and shape is thought to play a role in the bone gro...
Source: MDDI - May 11, 2019 Category: Medical Devices Authors: Omar Ford Tags: Orthopedics Source Type: news

2019 Medtech Startup Showdown
(Source: MDDI)
Source: MDDI - May 10, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Supplier Stories for the Week of May 5
(Source: MDDI)
Source: MDDI - May 10, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Contract Manufacturing Source Type: news

HRS: Ear Clip Uses Neurostimulation to Effectively Reduce AFib Burden
A trial evaluating Parasym’s neurostimulation technology shows the ear-clip like device can help reduce the atrial fibrillation burden. The results were presented at the Heart Rhythm Society’s 40th Annual Scientific Sessions held in San Francisco. The TREAT AF trial is a sham-controlled, double-blind, randomized clinical trial designed to examine the effect of low-level transcutaneous electrical stimulation of the auricular branch of the vagus nerve at the tragus (LLTS) on AFib burden over a six-month period. LLTS was delivered using an ear clip attached to either tragus (active; n=26) o...
Source: MDDI - May 9, 2019 Category: Medical Devices Authors: MDDI Staff Tags: Cardiovascular Source Type: news

J & amp;J & #039;s Ethicon Spends $400M for Takeda ’s Fibrin Sealant Patch
Johnson & Johnson’s Ethicon is set to acquire Takeda Pharmaceutical’s Fibrin Sealant Patch for $400 million. The deal is set to close in the second half of 2019. The TachoSil is a surgical patch designed to achieve safe fast and reliable bleeding control. Upon close, about 80 employees will transition to Ethicon. Takeda said net sales for TachoSil were about $155 million for the 2018 fiscal year. Terms for the deal call for Ethicon to acquire the assets and licenses that support the manufacturing, licensing and commercialization of TachoSil, while Takeda maintains ownership of the ma...
Source: MDDI - May 9, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Will Vertiflex Boost Boston Scientific & #039;s Pain Portfolio?
Boston Scientific has slowed its M&A pace considerably this year compared to 2018, but that doesn't mean the company won't take advantage of tuck-in opportunities that come its way. Case in point, the company's pending $465 million cash acquisition of Vertiflex, announced on Wednesday. Carlsbad, CA-based Vertiflex is a private company that sells the Superion Indirect Decompression System, a device designed to improve physical function and reduce pain in patients with lumbar spinal stenosis (LSS). The procedure, which is primarily performed by doctors who treat chronic pain patients with therapies including spinal cord ...
Source: MDDI - May 9, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Orthopedics Source Type: news

Neural Analytics Continues Its Journey with $22M Financing
When Neural Analytics won CE mark and a Nod from FDA for its ultrasound guidance device last year, that was only the start of the company’s journey. The Los Angeles-based company is now on a quest to launch its neurocare solution in the U.S. and develop a strategy to help push adoption rates for the technology. The company kicked off the latest part of its journey with a $22 million financing from the sale of Series C shares led by Alpha Edison. Neural Analytics has also issued warrants to purchase stock in connection to the financing. Leo Petrossian, PhD., Co-Founder and CEO of Neural Analytics said the...
Source: MDDI - May 9, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

10 Things to Do at BIOMEDevice Boston
(Source: MDDI)
Source: MDDI - May 9, 2019 Category: Medical Devices Authors: MD+DI Staff Tags: Design Source Type: news

Corindus Misses Expectations, But Still Embraced by Wall Street
Corindus Vascular Robotics missed earnings per share expectations by one cent, but Wall Street didn’t seem to mind as shares of the medtech company, which was a 2015 MDEA finalist, soared on Wednesday. At one-point shares were up by as much as 23%. The surgical robotics maker reported 1Q19 EPS of $0.05 against the analyst estimate of $0.04. Revenue for 1Q19 was $3 million vs. the consensus estimate of $3.11 million. The Waltham, MA-based company recorded purchase orders for 11 CorPath GRX Systems, an increase of 83% compared to purchase orders received in 4Q18 and 267% growth compared to the purchase orde...
Source: MDDI - May 8, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Velano Draws $10M Growth Funding for Needle-Free Blood Collection Technology
Velano Vascular has secured $10 million as the initial tranche of a growth financing to fuel commercialization and the launch of new vascular access solutions. But perhaps most telling about this funding news is the notable investors who kicked in for it. In addition to strategic investor Intermountain Healthcare, individual investors include Edward Ludwig, former chairman and CEO of Becton Dickson; Marc Benioff, a notable entrepreneur, investor, and health sector philanthropist; Robert Parkinson, former chairman and CEO of Baxter. Other undisclosed investors also participated. Velano was recently recognized by Fast Compan...
Source: MDDI - May 8, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: IV Products Business Source Type: news

FDA Flags Battery Issue Impacting Some Medtronic Pacemakers
FDA alerted patients and physicians on Tuesday to a problem that may cause batteries in certain Medtronic implantable pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) to drain more quickly than expected or without warning. Implanted pacemakers and CRT-Ps have electronics and are powered by lithium-ion batteries. One of the key electronic components is a capacitor, which stores electrical energy. Medtronic said there have been three medical device reports in which one of a Medtronic implantable pacemakers or CRT-P battery had fully drained without warning because of a crack in the ...
Source: MDDI - May 8, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

Improving Preterm Infant Health Through AI
Astarte Medical is working to protect the lives of newborns much like the goddess its name is derived from. The Yardley, PA-based company is focused specifically on premature babies and hopes to improve their health outcomes through the use of artificial intelligence and electronic health records. On Tuesday, executives from Astarte Medical spoke with MD+DI about the company’s mission and the $5 million raised during a series A financing. The company was founded in April of 2016 by venture capitalists and serial entrepreneurs Tracy Warren and Tammi Jantzen, Together, they are applying their expertise and ...
Source: MDDI - May 7, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Earnhardt to Leave CEO Position at Intersect ENT
Intersect ENT is about to go through some pretty significant changes. The company, which was named one of 25 Attractive M&A targets in Medtech, said its president and CEO Lisa Earnhardt would be leaving June 5 for a new opportunity. Shares of the Menlo Park, CA-based company dropped as much as 17% on Monday after the announcement was made. “After more than 11 years at Intersect, I will be stepping down from my role in early June as I have accepted another opportunity,” Earnhardt said during an earnings call, according to a transcript from Seeking Alpha. “Kieran Gall...
Source: MDDI - May 7, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

How Endologix Renewed One Doctor & #039;s Confidence in the Ovation Device
It's been a turbulent couple of years for Endologix, but as MD+DI reported in February, the company has been working hard to win back customers. During the company's first-quarter earnings call, CEO John Onopchenko shared a story about a physician at an academic medical center in the Western United States (he did not disclose the name of the physician or the center) who had used Ovation only twice over the course of 2017 and 2018.  Irvine, CA-based Endologix acquired the Ovation platform through its merger with TriVascular in February 2016. It's a low-profile device that has broadened the company's portfolio in...
Source: MDDI - May 7, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Boston Scientific Launches New Stent for Venous Obstructive Disease
Boston Scientific has won FDA approval for its Vici Venous Stent System for the treatment of iliofemoral venous obstructive disease. The device received CE mark in 2013, and was developed by Veniti, one of the many companies Boston Scientific acquired last year. The company paid $108 million for Veniti last August, and FDA approval of the Vici Stent System satisfies one of the milestones for up to another $52 million. Iliofemoral venous obstructive disease occurs when the flow of blood through the veins located deep in the pelvic region becomes blocked by a blood clot or compressed by anatomical anomalies. Endo...
Source: MDDI - May 6, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Teaching by Touch
The devices and tools used by medical professionals today certainly appear a lot different than from just a short time ago. In general, medical professionals—and their patients—have become much more accepting of smart, data-driven medical technologies that streamline and improve the accuracy of a treatment process. Wearable therapeutic and drug-delivery devices, robotic surgical systems, and telehealth monitoring devices represent some of the many recent advancements that have changed the medical device industry for the better. However, even with the introduction ofÂ&nb...
Source: MDDI - May 6, 2019 Category: Medical Devices Authors: Rob Podoloff and  Andy Dambeck Tags: Design Source Type: news

What Makes Two Materials “Identical”?
On April 26, FDA released a final guidance on Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices1. The draft of this guidance was issued on February 12, 2016. The guidance addresses four different types of UHMWPE: conventional, highly crosslinked, highly crosslinked containing antioxidants, and non-conventional. The parameters of characterization include material description, sterility, biocompatibility, mechanical properties, and chemical properties. For the base material, FDA “recommends” the inclusion of information on starting ...
Source: MDDI - May 4, 2019 Category: Medical Devices Authors: William A. Hyman Tags: Materials Source Type: news

RenalytixAI Hits Milestone with Break Through Designation
RenalytixAI has won  Break Through Device designation from FDA for KidneyIntelX a technology that could help diagnose kidney disease. This is the first such designation for an AI-enabled diagnostic for kidney disease publicly announced by any company. KidneyIntelx was designed in an effort to curtail the estimated $114 billion annual cost of chronic and end-stage kidney disease to the U.S. healthcare system. “The technology is a combination of a multiplex lab-based test measuring three biomarkers (sTNFR1, sTNFR2 and KIM1) that are shown to be prognostic in nature for rapid progress...
Source: MDDI - May 3, 2019 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Source Type: news

3 Medical Device Packaging Tips for a Successful Outcome
In conclusion, while it’s acceptable to begin packaging design off a 3D model, it is imperative to provide your frozen device as early as possible in the package design process. Avoid the hassle, cost, and delays of a potential package redesign by utilizing a device-specific “inside-out” approach vs. an outside-in approach with off-the-shelf packaging components. And lastly, consider and understand the needs of all stakeholders who will interact with your device and incorporate those needs into the design process. This will help ensure that you have designed a safe, eff...
Source: MDDI - May 3, 2019 Category: Medical Devices Authors: Brian Whalen Tags: Packaging Source Type: news

How CareDx Is Bringing AI to Transplant Care
Brisbane, CA-based CareDx has partnered with Cibiltech, a French company that develops artificial intelligence-based products for predictive medicine, to commercialize Predigraft.  Predigraft is a data analysis tool designed to provide an early prediction of a patient's risk of allograft rejection and transplant loss. It was developed from Cibiltech’s software algorithm called iBox, which is built off the outcomes data from tens of thousands of transplant patients. The deal is yet another example of how AI is disrupting the status quo in medtech. MD+DI recently publishe...
Source: MDDI - May 3, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Software Source Type: news

Could Better Materials Lead to Better Outcomes with DCBs?
Boston University School of Medicine (BUSM) researchers are examining drug-coated balloon catheters at a microscopic level in hopes of producing more efficient alternatives for treating arterial disease. The researchers are specifically looking at the coatings of the devices. Obstructive arterial disease is a clinical challenge affecting millions of people in the world. Devices such as stents and balloon catheters are the primary choice for treating these narrowed vessels. While the use of stents is beneficial in many cases, once implanted, they remain in the body permanently. Presence of such foreign bodies inside an arte...
Source: MDDI - May 3, 2019 Category: Medical Devices Authors: MDDI Staff Tags: Cardiovascular Materials Source Type: news

FDA Bans Summary Reporting for Breast Implants
FDA appears to be making good on its promise to make all adverse event reports public. The agency ended all summary reporting of breast implant medical device reports in an effort to promote greater transparency.  This is part of a larger effort to end the alternative summary reporting program for all medical devices, which FDA said it intends to complete in the coming weeks. The agency was accused earlier this year of hiding millions of adverse event reports from the public under what is known as the alternative summary reporting program, which was established in 1997. Making all of the data regarding adverse ...
Source: MDDI - May 3, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

Should Patients Have a Say in Medical Device Regulatory Matters?
FDA continues to make surprising moves in 2019. On Thursday, the agency opened a docket to receive input from the public on a new priority list of patient preference-sensitive areas that may impact the design and conduct of premarket medical device clinical studies, benefit-risk assessments, and postmarket evaluation. The priority list, developed based on public input the agency previously received, is intended to provide greater clarity about areas in which FDA would find patient preference information most informative for medical device regulatory decisions. “Patients are the exp...
Source: MDDI - May 2, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

Supplier Stories for the Week of April 28
(Source: MDDI)
Source: MDDI - May 2, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Contract Manufacturing Source Type: news

3M to Acquire Acelity for $6.7B
3M is set to acquire Acelity Inc. and the KCI subsidiaries for about $6.7 billion. The deal is set to close in the second half of 2019. Acelity is focused on advanced wound care and specialty surgical applications marketed under the KCI brand. Acelity was formed in September 2014, when Kinetic Concepts was combined with LifeCell Corp. and Systagenix Wound Management Ltd. In December of 2016, the company withdrew plans to launch an IPO that could have netted up to $1 billion, citing “public market conditions,” as the reason. The company’s affiliate KCI was planning to fi...
Source: MDDI - May 2, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

LivaNova Disappoints with 1Q19 Earnings
Weak sales from LivaNova’s Neuromodulation business could be one of the main culprits behind the company posting disappointing earnings for 1Q19. The London-based company posted revenues of $250.8 million, vs. the consensus estimate of $255.87 million. As a result, the firm slashed its 2019 outlook. In addition, LivaNova said its 2019 earnings per share came in between $3 and $3.10 vs. the consensus of $3.41. “We are disappointed by our first quarter performance in U.S. Neuromodulation and Perceval sales. As a leadership team, we are implementing a series of actions to counteract the mar...
Source: MDDI - May 2, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Widespread Concern Over Europe & #039;s Uncertain Regulatory Future Highlights Region & #039;s Importance
Concern has been mounting about the future of Europe’s regulatory environment for medicines and medical technology, but the growing anxiety isn’t limited to Brussels, London or Munich. Companies from Boston to Tel Aviv to Singapore have a lot riding on Europe. For better or worse, the unease being felt around the world is a mark of both how important the healthcare products sector is to Europe and how important Europe is to the global healthcare products sector. Europe’s Position as Key Hub for Medicine, Healthcare Europe comprises about 29% of the global medtech market...
Source: MDDI - May 1, 2019 Category: Medical Devices Authors: Paul Brooks Tags: Regulatory and Compliance Source Type: news

2 Devices That Could Clean Up the Dirty Scope Problem
Contamination on duodenoscopes after reprocessing continues to be a major concern in the United States. FDA recently reported that up to 5.4% of samples in postmarket studies tested positive for "high concern" organisms (those more often associated with disease, such as E. coli, and Pseudomonas aeruginosa), updated culturing results show that up to 5.4% of samples testing positive. On the bright side, at least two medical device manufacturers are actively trying to combat the issue. During Boston Scientific's first-quarter earnings call, CEO Mike Mahoney said the company is on ...
Source: MDDI - May 1, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: R & D Sterilization Source Type: news

Fixating on PEEK: The Implant Advantage
It’s difficult to talk about spinal devices today without mentioning the popularity of polyetheretherketone, the thermoplastic more commonly known as PEEK. It was originally introduced by Victrex PLC, then Imperial Chemical Industries (ICI) in the early 1980s. PEEK is based on the polyaryletherketone (PAEK) family and is commonly used in various engineering and medical applications. PEEK has been used for the development of medical devices as far back as the 1980s, but in 1999, Invibio Biomaterial Solutions developed the first implantable PEEK polymer: PEEK-OPTIMA. Invibio was the sole supplier of the imp...
Source: MDDI - May 1, 2019 Category: Medical Devices Authors: John MacDonald Tags: Materials Source Type: news

“FDA Approved” in OTC Advertising
Medical devices may be described as “approved” if they are Class III and have gone through the PMA process, or they may be “cleared” if they are Class II and used the 510(k) process. If they are Class I, there is no particular term to describe their marketability. There is also the DeNovo pathway for new low- to moderate-risk devices that would otherwise have to go through the PMA process. A successful De Novo application results in permission to market and classification as Class I and Class II. It is generally agreed that obtaining approv...
Source: MDDI - April 30, 2019 Category: Medical Devices Authors: William A. Hyman Tags: Regulatory and Compliance Source Type: news

2019 Medical Design Excellence Awards Finalists
The Medical Design Excellence Awards competition is the medical technology industry's premier awards program. Since 1998, the MDEAs have recognized achievements in medical product design and engineering that improve the quality of healthcare delivery and accessibility. Each year, a panel of jurors comprised of designers, engineers, and clinicians awards bronze, silver, gold, and best-in-show honors to the most innovative products on the market in nine categories. Take a look at this year's finalists. We'll announce the winners June 11, 2019, in a special ceremony at MD&M East. 1. Digital Health Products and...
Source: MDDI - April 30, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Digital Health Plays Larger Role in MDEA for 2019
For more than 20 the Medical Design Excellence Awards have celebrated medtech products that improve the quality of healthcare and accessibility. From prosthetic legs to breast pumps, over the years, MDEA has always been a spotlight of the greatest innovation in medtech. This year was no different – with a wide variety of innovations coming from all segments of medtech. Just like any other year, jurors from all over the country shuffled into a conference room at the Anaheim Convention Center to see which products would be finalists for the MDEA. One trend seemed to stand out – the increas...
Source: MDDI - April 30, 2019 Category: Medical Devices Authors: Omar Ford Tags: Design News Source Type: news

2 of Edwards & #039; Pediatric Catheters Face Class I Recall
Two of Edwards Lifesciences’ pediatric catheters are facing a Class I recall. The Irvine, CA-based company’s Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter are in a Class I recall because of the possibility of difficulty in balloon deflation after deployment. The balloon deflation could lead to balloon fragmentation or detachment upon attempted retrieval. Edwards said it has received reports of balloon fragmentation or detachment, which may cause serious adverse health consequences including: damage to the heart, the inferior vena cava, and/or the f...
Source: MDDI - April 30, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Regulatory and Compliance Source Type: news

5 Reasons This Will Be Zimmer Biomet & #039;s Comeback Year
Bryan Hanson had a tall order to fill when he accepted the job of CEO of Zimmer Biomet in December 2017. The company was dealing with complex challenges that involved quality control and supply chain problems that began a year earlier, which created distrust among the sales organization for corporate, and a culture gap between the "Zimmer camp" and "Biomet camp." But Hanson quickly identified several short-term priorities that Zimmer Biomet (ZB) has been working toward for the past 15 months and it appears that 2019 will be Zimmer Biomet's comeback year. Here are five reasons why. 1. Shiftin...
Source: MDDI - April 29, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Orthopedics Source Type: news