J & amp;J ’s Device Unit Fails to Meet Sales Expectations
Johnson & Johnson beat Wall Street expectations in 3Q18, fueled mostly by its pharmaceutical unit, but that doesn’t mean every business from the New Brunswick, NJ-based company is firing on all cylinders. J&J noted its medical device unit was a bit behind and actually missed expectations. Total medical device sales came in at about $6.59 billion missing expectations of $6.64 billion.  Overall, J&J reported third-quarter net income of $3.93 billion, or $1.44 per share, up from $3.76 billion, or $1.37 per share a year earlier. The performance pushed the company to adjust ...
Source: MDDI - October 17, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Interrupting the Medtech Status Quo
As a facial trauma surgeon, Dr. Alan Johnson hated using wires and arch bars to immobilize jaws to help heal jaw fractures. “This is commonly known as ‘having your jaw wired shut,’ "Johnson told MD+DI. “It’s miserable for patients, time consuming and risky for surgeons, and an inefficient use of healthcare resources for the health system. The wires are painful to patients’ gums. The application of the wires puts surgeons and their teammates at risk for sharps injuries. And, the techniques used to app...
Source: MDDI - October 16, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Design Source Type: news

What & #039;s Next for Bioresorbable Scaffolds?
Even with new data, the future of bioresorbable scaffolds remains in flux. At TCT 2018 in September, Reva Medical and Abbott Laboratories painted differing pictures with their respective bioresorbable scaffold studies. What now? Dr. Lukasz Koltowski from the Medical University of Warsaw in Warsaw, Poland, presented new data from Reva Medical's "Fantom STEMI" pilot study. The study showed procedural success and clinical utility of the Fantom bioresorbable scaffold in nine patients with acute ST-segment elevated myocardial infarction (“STEMI”) heart attacks. "Many heart atta...
Source: MDDI - October 16, 2018 Category: Medical Devices Authors: Heather R. Johnson Tags: Business Cardiovascular Source Type: news

ConvaTec CEO Departs Suddenly as Company Slashes Profit Forecast
ConvaTec shares plunged 33.10% ($74.20) Monday after the company slashed its revenue guidance and announced the departure of CEO Paul Moraviec. The advanced wound care company said Moraviec informed the board that he "wishes to retire." He stepped down as CEO and ceased to be a company director immediately, ConvaTec noted. Rick Anderson, a non-executive director, will step in as the interim CEO and will be based at the company's headquarters in Reading, United Kingdom. “We have made significant progress during my time as chief executive officer and I am confident that ConvaTec now has the strong...
Source: MDDI - October 16, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Zimmer Biomet to Use Apple Watch in Clinical Trial
Can the Apple Watch and iPhone really be effective tools in healthcare? That question might be answered sooner than we think. The Cupertino, CA-based company is teaming up with Zimmer Biomet by using the Apple Watch and iPhone to change the patient journey for two of the most common surgeries Americans undergo each year – knee and hip replacement. This collaboration has yielded Zimmer Biomet mymobility, an app that uses Apple Watch to facilitate a new level of connection between patients and their surgical care teams, which can immediately impact the journey patients experience when they undergo these pro...
Source: MDDI - October 15, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Orthopedics Source Type: news

Microsoft Dives Deeper into Genomics with AI Collaboration
Microsoft is looking to strengthen its commitment to genomics and is partnering with Genoox, a healthcare technology company, to accomplish this goal. The collaboration will combine the performance of Microsoft Genomics’ Azure Cloud with Tel Aviv, Israel-based Genoox’s comprehensive cloud-based advanced framework for Next-Generation DNA Sequencing (NGS). The companies said that the collaboration will advance the fields of genomics, healthcare and Artificial Intelligence (AI) and benefit clinicians and scientists who require rapid delivery of clinically actionable insights and...
Source: MDDI - October 15, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Do Minutes Count in the Fight Against Antimicrobial Resistance?
Abbott claims its point-of-care ID NOW testing platform offers the fastest-ever time to influenza A and B test results. Formerly called Alere i, ID Now can provide results in 13 minutes or less, with positive results available in about five minutes. Dr. Norman Moore, Abbott’s director of scientific affairs for infectious diseases, believes such a rapid result could help fight antimicrobial resistance. “Point-of-care testing enables clinicians to make more confident and informed treatment decisions during a single patient visit. Within minutes of administering a flu test, clinicians will ...
Source: MDDI - October 13, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Business Source Type: news

Vital Therapies Evaluating Options After Clinical Trial Failure
Vital Therapies is reviewing strategic options including a potential sale or merger of the company, according to an SEC filing. The decision to review its position comes after the San Diego-based company failed to meet the endpoints in a clinical trial evaluating its cell-based ELAD System, designed to treat patients suffering from liver disease. In addition to the potential sale or merger, the company said it would reduce the number of people serving on its board from nine to four members. The firm said it has retained Ladenburg Thalmann & Co. Inc. as its strategic financial advisor. Vital Therapies' ELAD ...
Source: MDDI - October 12, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

What Could the Midterm Elections Mean for Medtech?
Speakers at The Medtech Conference from AdvaMed shared their thoughts about the midterm elections in “DC Download and Midterms Preview,” moderated by Greg Crist, executive vice president, public affairs, AdvaMed. The panel included Charlie Dent, former U.S. representative and now senior policy advisor for DLA Piper; Walt Rosebrough, president and CEO of STERIS Corp.; Elizabeth Pika Sharp, senior vice president and managing director, federal government affairs, at AdvaMed; and Jennifer Nieto, vice president, federal government relations and alliance development, California Life Sciences A...
Source: MDDI - October 12, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Business Source Type: news

Abiomed Responds to MedSun Report on Two Impella Pumps
Editor's note: This story has been updated from the original story to include comments from Abiomed. A report published through FDA's medical product safety network (MedSun) database describes two issues that involve Abiomed's Impella heart pumps. However, the company told MD+DI that the information in the MedSun report is inaccurate. According to the report, which is located here on FDA's website, one Impella pump reportedly had an unknown "material" inside the pump, causing it to have flows "less than expected," and another pump's housing/outlet cage and impeller we...
Source: MDDI - October 12, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Implants Source Type: news

Medtronic Issues Fix to Address Cybersecurity Vulnerabilities
Medtronic has issued a software update to address a safety risk caused by cybersecurity vulnerabilities associated with the Internet connection between two models of CareLink programmers used to download software from the company's software distribution network (SDN). The situation prompted FDA to issue a safety communication to alert patients, caregivers, and physicians. FDA said the cybersecurity vulnerabilities could allow an unauthorized user to change the programmer's functionality or the implanted device during the device implantation procedure or during follow-up visits. The vulnerability impacts the CareLink and Ca...
Source: MDDI - October 12, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Software Source Type: news

iCAD ’s AI Solution Has Exceptional Results in Study
iCAD’s digital breast tomosynthesis cancer detection software could make a big splash at the upcoming Radiological Society of North America meeting if recent study results are any indication. The solution will also be displayed at The European Society of Breast Imaging annual meeting, occurring this weekend. The Nashua, NH-based company said its software, which incorporates artificial intelligence (AI) and machine learning, had exceptional study results that demonstrated significant advantages for digital breast tomosynthesis. In the study, 24 radiologists reviewed about 260 3D exams. Of that number, 65 w...
Source: MDDI - October 12, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Imaging Source Type: news

What Does It Take to Develop a VR Solution in Healthcare
Technology is changing the face of healthcare as we know it. Virtual and Augmented Reality that once were associated only with game and film industries are now becoming a real game-changer in healthcare. Gone are the days when students practiced on real patients. Today, VR and AR solutions can not only improve medical education and training but also provide profound patient treatment, medical rehabilitation, consultation, and diagnosis. What’s next? AR & VR in Healthcare: The Industry Landscape A recent report by Research and Markets states that augmented and virtual reality in the healthcare market ...
Source: MDDI - October 11, 2018 Category: Medical Devices Authors: Marta Hlova Tags: Digital Health Imaging Source Type: news

Supplier Stories for the Week of October 7
(Source: MDDI)
Source: MDDI - October 11, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Contract Manufacturing Source Type: news

Cardialen Closes $17M Series B
Cardialen closed a $17 million Series B investment led by RiverVest Venture Partners, along with Qiming Venture Partners, HBM Healthcare Investments and Cultivation Capital. The Minneapolis-based company said it is developing the Cardialen unpinning termination (UPT) therapy, which delivers a sequence of low-energy electrical pulses designed to restore abnormally rapid heart rates to a normal rhythm. This low-energy therapy is intended to mitigate the negative effects of current high-energy defibrillators by delivering a much more tolerable, less debilitating treatment for patients with heart arrhythmias. â€...
Source: MDDI - October 11, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news

Is 2018 Boston Scientific ’s Biggest Year Ever?
Is there any other company in the medtech industry killing it like Boston Scientific is killing it right now? Solid performance and numerous acquisitions have pretty much been the story behind the Marlborough, MA-based company during 2018. (I think we’re around 8 or 9 acquisitions now.) Boston Scientific has taken a 180 degree turn since it acquired Guidant for $27 billion in 2006. The Guidant acquisition brought nothing but numerous (and we do mean numerous) lawsuits and headaches to the company. But now, Boston Scientific has put Guidant in the past, and the firm is building its product portfolio. There...
Source: MDDI - October 11, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

5 Fundamental Flaws of the Medical Device Tax
The medical device tax hurts doctors, patients, and manufacturers, according to a new study released today by the San Francisco, CA-based think tank, the Pacific Research Institute. "As the congressional session winds down, Congress has some unfinished business – taking action to repeal the medical device tax," said Wayne Winegarden, author of the report. "The medical device tax is bad tax policy that has increased patient costs, reduced access to life-saving technology, and reduced profits and jobs. Repealing the tax would bring many benefits...
Source: MDDI - October 10, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

4 Reasons Medtech Outsourcers Should Consider Cold Forming
This article covers the economic, strength, yield, and speed-to-market advantages of cold-formed components, especially compared with the capabilities of screw machining. The objective will be to provide potential new product design (NPD) engineers in outsource manufacturing environments an objective comparison from which to make informed decisions on micro-miniature component sourcing. NPD engineers rely heavily on design and manufacturing techniques learned through education, repeated application, and empirical success. Many alternate techniques are often approached with caution, particularly in medical and healthcare pr...
Source: MDDI - October 10, 2018 Category: Medical Devices Authors: Timothy Kardish Tags: Contract Manufacturing Source Type: news

Add These Medtech Resources to Your Monthly Download List
You’ve read the latest headlines on medtech movers and shakers. You’ve seen the stories on new medical devices and on regulatory developments. But have you perused the latest how-to webcasts and whitepapers from leading suppliers in the space? There’s a wealth of education waiting for you at Qmed. You’ll find expertise on everything from design and business advice to materials and adhesives to manufacturing, packaging, and outsourcing.  To help you make the most of such technical expertise, we’ve pu...
Source: MDDI - October 10, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Design Source Type: news

Could Publicly Funded Medtech Face Price Controls in NJ?
New Jersey Senate Bill 977 (S977), which seeks to prohibit “excessive charges for drugs developed by publicly funded research,” includes “other health care technology” and could therefore impact medtech. Dean J. Paranicas, president and CEO of the HealthCare Institute of New Jersey (HINJ), tells MD+DI that “S977 would apply only to medical technology approved by the FDA that was developed in its entirety or partially, directly or indirectly, with federal or State funds. The bill would not apply to technology developed without public a...
Source: MDDI - October 9, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Business Source Type: news

Could 2018 Really Be the Year of AI in Medtech?
Has there really been another topic in medtech this year that has generated more attention than Artificial Intelligence? There have been numerous approvals, clearances, and even in some cases praise from regulatory bodies about AI-based medtech. MD+DI has been on the frontlines covering the recent AI boom. That coverage spawned a webinar titled, How Artificial Intelligence Has Changed Everything for Medtech hosted by Dave Saunders CTO and Co-founder of Galen Robotics. In just a few short weeks at MD&M Minneapolis, AI will be discussed in depth at a session titled, Artificial Intelligence (AI): What You Need to Know to ...
Source: MDDI - October 9, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Digital Health Source Type: news

AdvaMed Backs Wright Medical in Hip Liability Case
A case stemming from a hip implant lawsuit against Wright Medical has caught the attention of several professional associations, including AdvaMed, as the outcome could have broad implications for the medical device industry. The lawsuit makes a strict liability design defect claim against Wright Medical, the manufacturer of the device implanted in both of plaintiff Dale Burningham's hips. The company argued the hip implants are "unavoidably unsafe" products and are therefore categorically barred from strict liability design defect claims under the exception to strict products ...
Source: MDDI - October 9, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Implants Source Type: news

Get Ready for These 4 Medtech Shifts
Healthcare has historically focused on treating the chronically ill and diseased populations, but things are changing, and it is a “global shift,” Sowmya Rajagopalan, industry principal of Frost & Sullivan, told attendees at The MedTech Conference. “Payers and providers understand that it has to be health management [in order to] to delay the onset of disease.” In addition, “consumerization in healthcare has begun,” she added. Patients “want to know how their health is managed.”...
Source: MDDI - October 9, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Business Source Type: news

FDA Congratulates Itself on Apple ’s New Medical Apps
In a recent blog post, FDA’s Commissioner Dr. Scott Gottlieb found great merit in the agency’s handling of Apple’s two “marketing authorizations” for medical apps to run on the Watch Series 4. These authorizations were via the DeNovo route to market. Thus, the apps were not “cleared,” which applies to the 510(k) process, and they certainly weren’t “approved,” which is a term reserved for Class III devices that go through Premarket App...
Source: MDDI - October 6, 2018 Category: Medical Devices Authors: William A. Hyman Tags: Regulatory and Compliance Source Type: news

8 Medtech Manufacturing Trends You Need to Know
(Source: MDDI)
Source: MDDI - October 5, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Assembly and Automation Contract Manufacturing Source Type: news

Self-Fitting Hearing Aid Receives Nod from FDA
A newly-approved device could change the way patients manage their hearing loss. Last week, FDA greenlit the Bose Hearing Aid, which is called the first such technology that doesn’t require the assistance of an audiologist or healthcare providers. The hearing aid was developed by Framingham, MA-based Bose Corp., and is intended to amplify sounds for individuals 18-years or older with perceived mild to moderate hearing impairment (hearing loss.) “Hearing loss is a significant public health issue, especially as individuals age,” Malvina Eydelman, M.D., director of the Div...
Source: MDDI - October 5, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Teleflex Makes an ‘Essential’ Acquisition
Teleflex is making a move to expand its presence in the structural heart and endovascular aneurysm repair markets. To do this, the Wayne, PA-based company is acquiring Essential Medical for an undisclosed sum. Essential Medical has developed and received a CE mark for the MANTA Vascular Closure Device. The Exton, PA-based company’s device is designed for closure of large bore arteriotomies following procedures utilizing devices or sheaths ranging in size from 10F to 18F. Teleflex said MANTA is expected to receive FDA approval in 2019. “We are very excited to announce this acquisition, wh...
Source: MDDI - October 5, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

Continuous Quality: FDA ’s Goal for the Case for Quality Program
About five years ago, when FDA started looking at the number of recalls and warning letters to medical device manufacturers, the agency realized that no matter what it seemed to do to try and make things better from a compliance perspective, those numbers weren’t changing. It determined that something different needed to be done, and so it devised the Voluntary Medical Device Manufacturing and Product Quality Pilot Program, within its Case for Quality platform. In "Using the FDA's Case for Quality to Reduce Production Inefficiencies," a presentation at the upcoming MD&M Minneapolis show, a p...
Source: MDDI - October 5, 2018 Category: Medical Devices Authors: Susan Shepard Tags: MD & M Minneapolis Regulatory and Compliance Source Type: news

Owlstone Advances Breath Biopsy Platform with $50M Round
Owlstone Medical has raised a total of $50 million for its Breath Biopsy platform. The Cambridge, England-based company said it has raised about $73 million since it was founded in 2016. The funds have been raised to expand commercial opportunities in precision medicine including through the launch of targeted Breath Biopsy kits, and to enable further investment in the technology platform to support the development of additional high value applications. “The closing of this round of financing marks a significant milestone for Owlstone Medical as it places us in a very secure financial position with a bala...
Source: MDDI - October 5, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Panel Sheds Light on DBS Electrode Design Concerns
Traditionally there has always been a great deal of conversation surrounding deep brain stimulation (DBS) systems. However, this just hasn’t been the case for one of the most important components of the technology – the electrode. A panel at MD&M Minneapolis, being moderated by Eric Sabelman, a Neurosurgery Bioengineer at Kaiser Permanente, could help change the conversation and put the focus on electrodes. The panel is titled Deep Brain Stimulation: How Will New Electrodes Improve Results? “The particular reason I think for having a panel, is the electrode itself ...
Source: MDDI - October 4, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Supplier Stories for the Week of September 30
(Source: MDDI)
Source: MDDI - October 4, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Manufacturing Equipment Source Type: news

Can Medtech Manufacturing Benefit from Deep Learning?
Given medtech’s needs for high levels of quality and precision, machine learning could be put to good use in medical device manufacturing. One particular type of machine learning called “deep learning” could offer particular benefit as it could enable machine vision systems to learn how to recognize and respond to defects much like a human could, according to Bhaskar Ramakrishnan, technical sales engineer, DWFritz Automation. Ramakrishnan will be speaking about potential manufacturing roles for deep learning in the MD&M Minneapolis October 31 presentation, â&#...
Source: MDDI - October 4, 2018 Category: Medical Devices Authors: Daphne Allen Tags: MD & M Minneapolis Assembly and Automation Source Type: news

Will Single Port Robots Revive the Perineal Radical Prostatectomy?
Designing a robotic-assisted surgery system that brings four robotic arms through a single 25mm port was far from an easy feat for Intuitive Surgical. In a recent interview with MD+DI, Intuitive's chief operating officer described it as a tremendous learning challenge that took the company on a 12-year journey.  But now that the da Vinci SP is on the market, the single-port system has the potential to revive a prostatectomy procedure that has been nearly abandoned as an open surgery. A long time ago, prostatectomy was done through the perineum by making a small incision between the patient's legs, which had the...
Source: MDDI - October 3, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Prioritizing Patients in Push Toward Value-Based Care
Previously, we discussed how medtech companies can prepare for the transition to value-based care. Specifically, these organizations need to start going beyond just providing medical devices and products to their customers and focus more on providing comprehensive and connected systems that help deliver integrated care. This, however, needs common collaboration between vendors, which are too often direct competitors and therefor pushing for their own more expensive complete solutions.   Interoperability and health data exchange have become a top priority for providers. Along with EMRs, all machines being utiliz...
Source: MDDI - October 3, 2018 Category: Medical Devices Authors: Corrina Kane Tags: Business Source Type: news

What Could Go Wrong If Designers Don ’t Understand Manufacturing?
Design for Manufacturability (DFM) entails designing products so that they are optimized for production, Steve Santoro of MICRO told MD+DI. “DFM is extremely important and allows potential problems to be identified and addressed during the design phase. This process can save time, money, and wasted resources in the long run,” he said. However, “many times, product design engineers find themselves in a dilemma, due to the pressures associated with cost, time, or other factors, and dismiss manufacturing considerations—which could prove detrim...
Source: MDDI - October 2, 2018 Category: Medical Devices Authors: Daphne Allen Tags: MD & M Minneapolis Contract Manufacturing Source Type: news

Micro Pump to Deliver Parkinson ’s Treatment, with More in the Pipeline
Sensile Medical has custom developed a wearable micro pump for a Parkinson’s disease treatment from a European pharmaceutical company. Sensile Medical is a subsidiary of Gerresheimer, and the project is just one of many, which also includes a diabetes project with Sanofi and Verily. The Parkinson’s treatment is the first commercial use of Sensile Medical’s micro pumps. The project utilized Sensile Medical’s patented SenseCore micro rotary piston pump, but the micro pump “is not a stock offering,” Jens Kuerten, Gerres...
Source: MDDI - October 1, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Pumps & Valves Source Type: news

Prepping for Value-Based Care in the Medtech Space
Value-based healthcare greatly depends on improving patient outcomes at lower cost, and the ability of healthcare providers to impact quality of care measures, such as reducing hospital readmissions or improving preventative care.   Medtech companies need to go beyond providing medical devices and products to their customers in order to remain successful and retain customers long-term. Healthcare providers no longer just need devices: they want comprehensive and connected systems that help them provide integrated care.   We spoke with several leaders in the medtech space to better gauge how compani...
Source: MDDI - October 1, 2018 Category: Medical Devices Authors: Corrina Kane Tags: Business Source Type: news

Boston Scientific Is Closing Cultural Gaps from Top to Bottom
It's easy for corporations to spin rhetoric about diversity and inclusion but in much of corporate America – and especially in medtech, as MD+DI has previously reported – these terms are just that: rhetoric. The good news, however, is that at least two major medical device companies appear to be actively trying to turn that rhetoric into reality. Last month, Medtronic ranked third on Thomson Reuters' 2018 Diversity and Inclusion (D&L) Index, putting it way ahead of its pure-play medtech peers on the D&L Index. Just a couple weeks later, Boston ...
Source: MDDI - October 1, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Can Cross-Pollination Improve Medtech Manufacturing Processes?
In a panel discussion at MD&M Minneapolis, experts will offer their insights on cross pollination, a process whereby those in the manufacturing arena can draw upon another industry’s methods to improve their own. “I would define cross-pollination as using different technologies, solutions, and knowledge from other industries to solve problems in the medical device industry,” panel member Carlos Melendez, cofounder and COO of artificial intelligence and software engineering services firm, Wovenware, told MD+DI. Melendez will be speaking in the panel discu...
Source: MDDI - September 22, 2018 Category: Medical Devices Authors: Susan Shepard Tags: MD & M Minneapolis Assembly and Automation Source Type: news

Could One Hour a Day Make the Foot Pain Go Away?
More than three-quarters of Americans have suffered from foot pain, the American Podiatric Medical Association reported a few years ago. Tendonitis and plantar fasciitis are common complaints, and treatments can include stretching and splints. Patients don’t always comply with stretching regimens, however. And night splints are not “super comfortable to sleep with,” explained podiatrist Dr. Patrick DeHeer, himself a patient with posterior tibial tendonitis. “Patients are always complaining about waking up with them. I consistent...
Source: MDDI - September 21, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Business Source Type: news

Alydia Tackles Postpartum Hemorrhage with Device
A small startup is developing a device aimed at treating and preventing maternal bleeding. Menlo Park, CA-based Alydia has raised $10 million in a series B round to help it get the technology past clinical trials and onto the market in the U.S. The technology works with the normal contractions of the uterus to rapidly stop bleeding. The concept of the device was developed in 2010 at the Cal Poly Center for Innovation and Entrepreneurship. “What is used now are drugs, which work too slowly or might not work,” Anne Morrissey, CEO of Alydia Health, told MD+DI. “They also ...
Source: MDDI - September 21, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Medtronic and Mazor will Tie the Knot in a $1.6B Deal
Medtronic made a big move back in May 2016 by inking a major multi-phased strategic and equity investment agreement with Mazor Robotics. Today the pair made that relationship even more official by announcing that Medtronic will acquire Mazor. The cash deal is valued at about $1.64 billion, or $1.34 billion net of Medtronic's existing stake in Mazor and cash acquired. Considering Mazor's revenue took a big hit in the second quarter due to lower pricing under its agreement with Medtronic, the acquisition is easily a win-win for both companies. It's also no coincidence that the deal was unveiled just d...
Source: MDDI - September 21, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Orthopedics Source Type: news

MeMed Looks to Distinguish Between Bacterial and Viral Infections
Bacterial or viral infection, that is the question. Hafai-Israel based MeMed Diagnostics is developing a point-of-care platform and immune-based test that will one day be able to provide answers. Such a test could help with the overuse and underuse in antibiotics used to treat patients. “Often what the clinician is trying to figure out, is if this is a bacterial or viral infection,” Eran Eden, co-founder and CEO of MeMed, told MD+DI. “If it’s a bacterial infection – then [the patient gets] antibiotics. If it’s antibi...
Source: MDDI - September 21, 2018 Category: Medical Devices Authors: Omar Ford Tags: IVD Business Source Type: news

Intuitive Surgical Could Help Usher in a New Era for Medtech
More than a decade ago Amazon recognized that it needed mass-cloud computing power, but didn't believe there was a third party service available to meet their needs, so they built their own cloud computing infrastructure. The online retailer also realized early on that this problem that it had solved for itself was the same problem that people and organizations all over the world were also facing, so they created the Amazon Web Services (AWS) subsidiary. Santa Barbara, CA-based InTouch Health is following Amazon's example in an effort to offer medical device companies an ability to connect to their products after they've b...
Source: MDDI - September 20, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Digital Health Source Type: news

Supplier Stories for the Week of September 16
(Source: MDDI)
Source: MDDI - September 20, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Materials Source Type: news

Could a New Biosensor Be Able to Smell Cancer?
Researchers from Aromyx Corp. announced this month that the company’s flagship technology, the EssenceChip, will be made available to select partners by the end of this year. The new biosensor technology was designed to work with a digital platform that can measure the human sense of smell and taste by placing olfactory receptors from the nose onto a disposable biochip that can then produce a digital readout. Aromyx Corp. founder and CEO Chris Hanson says that the new biosensor technology was developed using the human sense of smell and taste as a blueprint to create a digital capture of the human senses....
Source: MDDI - September 20, 2018 Category: Medical Devices Authors: Kristopher Sturgis Tags: IVD Source Type: news

How a $2M Grant Could Change the Way Autism Is Diagnosed
Early treatment of autism spectrum disorder (ASD) can significantly improve the lives of affected children and their families, but diagnosing the disorder is often a challenge. A company in Syracuse, NY has developed an epigenetic test that could facilitate the early diagnosis of ASD, however, and in turn accelerate access to treatment. The technology, developed by Quadrant Biosciences, managed to impress a panel of grant reviewers, landing the company a $2 million small business technology transfer (STTR) grant from the National Institutes of Health. The funds are expected to help the company refine the techno...
Source: MDDI - September 20, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: IVD Source Type: news

MedAutonomic Has Successful Implant of Phoenix
MedAutonomic has made significant progress with its brain neuromodulation technology. The Silicon Valley and Venice, Italy-based company said it had successfully implanted the Phoenix device into the stomach wall of a human through a digestive endoscopic procedure. The device sends signals to the brain (the limbic system)to reset an imbalance in the Autonomic Nervous System with the aim to treat functional diseases such as type-2 diabetes, hypertension, and gastroesophageal reflux disease (GERD). The company said Phoenix is able to harvest energy from the body, so it can remain in the stomach wall without the need of a bat...
Source: MDDI - September 19, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Is AI the Key to Diving Deeper into Images and Pathology?
In a tale of two studies, it appears artificial intelligence is helping researchers analyze cells in ways that weren't possible before. In one study, published this week in Nature Methods, scientists at the Allen Institute in Seattle, WA used machine learning to train computers to see parts of the cell that the human eye cannot easily distinguish. Using 3D images of fluorescently labeled cells, the team taught computers to find structures inside living cells without fluorescent labels, using only black and white images generated by an inexpensive technique known as brightfield microscopy. Fluorescence microscop...
Source: MDDI - September 19, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Imaging Source Type: news

7 Key Events That Solidified the Liquid Biopsy Market
(Source: MDDI)
Source: MDDI - September 19, 2018 Category: Medical Devices Authors: Omar Ford Tags: IVD Testing Source Type: news