Nominate Young Medtech Pioneers for Our 2018 Rising Stars List
We want to raise the profile of the young people doing groundbreaking work in the medical device and diagnostic industry. Do you know any industry innovators under the age of 30? Tell us who should make the 2018 list!  Email nominations to amanda.pedersen@ubm.com with the subject line: Medtech's Rising Stars. The deadline for submitting nominations is June 29.  Check out last year's list here. (Source: MDDI)
Source: MDDI - June 15, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business R & D Source Type: news

CDH Beats Varian in Bid for Embattled Sirtex
Money talked and Sirtex Medical listened. The New South Wales, Australia-based medical device company that provides a targeted internal radiation therapy for certain liver cancers, said its board decided that the competing bid from CDH Investments was superior to the earlier bid it received from Varian. In January, Palo Alto, CA-based Varian offered to pay about $1.3 billion (A$28 a share) to acquire Sirtex, and the two companies entered into an agreement, which Sirtex shareholders were expected to approve on May 7. That was until CDH, a major alternative asset management firm based in Beijing, Chi...
Source: MDDI - June 14, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Your Design Validation Questions, Answered
(Source: MDDI)
Source: MDDI - June 14, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Design R & Source Type: news

OmniVision Sees Its Future in Medtech Clearly
Tazeeb Gunja holds up a case containing a dot the size of a period at OmniVision’s booth during MD&M East. This “dot” is a highly functional imaging technology created by OmniVision to be used in medical devices. “We plan to make some even smaller,” Gunja, who serves as principal market and development manager at OmniVision. The Santa Clara, CA-based company had a full display at MD&M East, showcasing its technology as it seeks to increase its market share in the medical device industry. The company, which was founded in 1995, revealed two new partnerships that could help give it a str...
Source: MDDI - June 14, 2018 Category: Medical Devices Authors: Omar Ford Tags: Imaging Electronics Source Type: news

Stryker Strikes Out Rumors of Boston Scientific Merger
After two days of speculation based on a Wall Street Journal report published Monday, Stryker disclosed on a regulatory form that it is "not in discussions with Boston Scientific Corporation regarding a potential acquisition." On Monday, in response to questions regarding the WSJ report, a Stryker spokesperson told MD+DI that the company does not comment on potential M&As. The rumored deal boosted Boston Scientific shares by nearly 10% Monday while Stryker's stock dropped about 3%. As of 1 PM Eastern Time on Wednesday, Stryker's stock was trending in the green, up nearly 3% ($4.79) to $167.33. Meanwhile,...
Source: MDDI - June 14, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Supplier Stories for the Week of June 10
(Source: MDDI)
Source: MDDI - June 14, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Packaging Source Type: news

CleanCision Wins Readers ’ Choice Award in MDEA Competition
There was much pomp and circumstance at the Medical Design Excellence Awards Tuesday as the best technologies were honored at the Jacob K. Javits Convention Center in New York. For one technology, however, it was a strong call of validation. CleanCision, earned the overall Reader’s Choice Award, which spans all categories in the competition. The active cleansing technology also earned the 2018 Medical Device Excellence Award Bronze Medal in the ER and OR Tools Category. CleanCision was developed by San Carlos, CA-based Prescient Medical. “We’re thrilled and we’re honored for validation of what we&rs...
Source: MDDI - June 13, 2018 Category: Medical Devices Authors: Omar Ford Tags: Design Source Type: news

Can You Smell a Bidding War Brewing Over Boston Scientific?
Monday's headlines that Stryker may be making a play for Boston Scientific prompted industry analysts to play the "what if" game, dissecting potential benefits of such a marriage, how a deal of that size might impact the broader medical device industry, and the potential of other bidders to emerge. Just to be clear though, we still do not know at this point if Stryker really has approached Boston Scientific about a potential takeover, or if Boston Scientific is even receptive to the idea. Both companies declined to comment on the speculation Monday, citing their respective company policies. Canaccord Genuity's Ja...
Source: MDDI - June 13, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

J & amp;J Agrees to $2.1B Sale of LifeScan
It's official, Johnson & Johnson is pulling out of the blood glucose monitoring space.  The New Brunswick, NJ-based company reported Tuesday afternoon that it has accepted Platinum Equity's $2.1 billion offer for J&J's LifeScan business. As MD+DI previously reported, J&J has been entertaining the offer since March and was expected to respond by June 15. LifeScan is known to diabetes patients worldwide for its OneTouch brand of glucose meters, insulin pumps, and related products. J&J said the deal is expected to close by the end of the year, assuming it clears regulatory requirements and other...
Source: MDDI - June 12, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

The Biggest Medtech M & amp;As So Far This Year
(Source: MDDI)
Source: MDDI - June 12, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Is Stryker Trying to Strike a Deal with Boston Scientific?
The Wall Street Journal shook things up in the medical device industry Monday morning with a report that Stryker has approached Boston Scientific with a takeover bid. Boston Scientific shares soared nearly 10% after the news broke, but Stryker's shares dropped about 3%. The report cited sources familiar with the deal but it is unclear if Boston Scientific is receptive to the bid. If the deal actually happens, it would easily be the largest M&A the industry has seen so far this year and would create a formidable medical device company with a combined value of more than $110 billion. A spokesperson for Boston Scientific ...
Source: MDDI - June 11, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

SetPoint Brings Bioelectronic Market to the Forefront with Study
SetPoint Medical’s open-label study support the use of the company’s bioelectronic therapy for Crohn’s Disease. The Valencia,CA-based company’s study was conducted at five European sites and included 16 patients with moderate to severe Crohn’s Disease with inadequate responses to tumor necrosis factor (TNF) antagonist drugs and other non-TNF targeted biologic agents. The data, presented in a poster session at the Digestive Disease Week meeting in Washington, D.C., showed that more than 60% of patients achieved significant reductions in their disease activity as assessed by the Crohn’s Di...
Source: MDDI - June 11, 2018 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Implants Source Type: news

Is There an End in Sight for J & amp;J Divestitures?
Johnson & Johnson has received an offer for its sterilization unit. The New Brunswick, NJ-based company said Fortive is seeking to acquire the business for $2.7 billion. The sterilization business is part of the Ethicon division and earned about $775 million in sales in 2017. J&J has 120 days to accept the offer and if the deal goes through it could close no later than early 2019. Fortive said it would finance the acquisition through debt or equity and with available cash. The company said it expects the deal to add to adjusted earnings in the first full year after the transaction. "As we balance the interests...
Source: MDDI - June 11, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Sterilization Source Type: news

Beta Bionics and Senseonics Collaborate on AI-Driven Pancreas
Just a few weeks after Beta Bionics made headlines with an IDE approval for its artificial intelligence (AI) driven iLet bionic pancreas system, the company is in the spotlight again. This time, Beta Bionics is teaming up with Senseonics Holdings, a company that is developing an implantable continuous glucose monitoring (CGM) system. Under this agreement, Beta Bionics will integrate Germantown, MD-based Senseonics’ Eversense CGM system with the iLet. Real-time data generated by Eversense could serve as one CGM option to drive the fully autonomous iLet Bionic Pancreas system. The iLet consists of a dual-chamber, auton...
Source: MDDI - June 8, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Digital Health Source Type: news

Keep Your Medtech Game On Point at MD & amp;M East
It is time once again for medical device engineers, R&D managers, product design professionals, and medtech executives to convene at the Javits Center in New York for Medical Design & Manufacturing (MD&M) East, June 12-14. This guide is just a sample of how this must-attend industry event will help you keep your medtech game on point. Not registered? No problem, you can register right here.   Meet a Medtech Rock Star The opportunity to meet an industry pioneer isn't one to take for granted. This year, during the 20th annual Medical Design Excellence Awards (MDEA) ceremony, Robert Jarvik will be a...
Source: MDDI - June 7, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: MD & M East (New York) Business Source Type: news

Clearing the Smoke in the Operating Room
Las Vegas aside, you’d be hard-pressed to find any employer in the United States that permits smoking in the workplace. The dangers of inhaling cigarette smoke have been well known for decades. But there is a place that harbors something even more hazardous in the air, and it is probably one you would have never expected—your local hospital’s operating room. This harmful substance is known as surgical smoke, and it is made up of toxic vapors, bioaresols that contain dead and living cell material, blood fragments, and viruses. It is generated by any surgery that uses instruments such as electrocautery and ...
Source: MDDI - June 7, 2018 Category: Medical Devices Authors: Susan Shepard Tags: Business Source Type: news

Supplier Stories for the Week of June 3
(Source: MDDI)
Source: MDDI - June 7, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Materials Source Type: news

Does Medtronic ’s Delay Ensure That Intuitive Will Stay on Top?
Intuitive Surgical – considered the frontrunner in the surgical robotics market - has a bit longer to maintain its position in the space. During its investor day, Dublin-based Medtronic reaffirmed plans it originally announced in February, to delay its surgical robotics platform for about a year. Medtronic’s system could now come sometime in 2019 and is expected to be a direct competitor to Sunnyvale, CA-based Intuitive’s da Vinci platform. In 2016, Medtronic initially said the device would launch sometime this year. However, the company has been scant with the details surround the technology. “We v...
Source: MDDI - June 7, 2018 Category: Medical Devices Authors: Omar Ford Tags: Electronics Source Type: news

How Autoinjector Technologies Could Change Drug Delivery
Autoinjector technologies have come a long way over the years, and recent advancements are paving the way for an exciting new generation of devices that can be used for a variety of different therapies. Epinephrine autoinjectors are one of the most common iterations of the technology, but lately, device makers have been expanding the realm of possibility for autoinjector technologies, specifically through new devices that can communicate with patients and incorporate user feedback. Of course with new technologies, comes new challenges. Device developers still struggle with ensuring dose accuracy, minimizing discomfort, and...
Source: MDDI - June 6, 2018 Category: Medical Devices Authors: Kristopher Sturgis Tags: MD & M East (New York) Design Source Type: news

Turning Surgeons Into Innovators Without Taking Them Out of the OR
Academic hospitals have all the makings for rich medical device development. They have physicians to identify surgical needs, researchers to test theories, bioengineers to design and create devices and patients to participate in clinical trials. However, disconnect between engineering and surgical departments makes innovation a challenge. So does surgeons' all-consuming job Number One—treating patients. Surgical Innovations, part of the University of California, San Francisco's Department of Surgery and Bioengineering & Therapeutic Sciences, aims to open communication between clinical academic surgeons and bioeng...
Source: MDDI - June 6, 2018 Category: Medical Devices Authors: Heather R. Johnson Tags: R & D Source Type: news

Bet You & #039;ve Never Seen a Fashion Show Like This Before
It's no secret that New York is known for its fashion sense, but did you know the Big Apple has also emerged as a hotbed for digital health companies? At MD&M East in New York, attendees will have an opportunity to see a one-of-a-kind fashion show featuring cutting-edge wearable health devices and have an opportunity to learn about the materials, sensors, batteries, and other cool technologies that make these gadgets tick. The Fashion Show: Digital Health Wearables in Action kicks off at 12 pm Tuesday, June 12. Participating companies include:  CloudDx, a provider of remote patient monitoring hardware, softw...
Source: MDDI - June 6, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: MD & M East (New York) Digital Health Source Type: news

Shark Tank ’s Mark Cuban Helps Invest in Biomagnetic Imaging Firm
Genetesis is developing CardioFlux, a noninvasive and accurate chest pain triage, and has closed on an oversubscribed round of $7.5M in series A financing. CincyTech led the round with participation from existing investors including Mark Cuban’s Radical Investments, and new investors including Ohio Innovation Fund and Raptor Group. “For millions dealing with the risks and anxiety of heart disease, this technology has the potential to be a game changer,” said Cuban, who leads Radical Investments, in a release. “I’m encouraged by the Genetesis team’s progress and by the promise this techno...
Source: MDDI - June 5, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Imaging Source Type: news

Can Digital Health Companies Avoid the Pitfalls of Bluetooth?
Bluetooth technology has become the wireless technology of choice for digital health devices – and for good. "It's very easy to implement into a device, and there's virtually no cost, it's an open-source technology," Cliff McIntosh, CEO of Smart Meter, told MD+DI. “But if you talk to the patients and providers there are a number of pitfalls with Bluetooth technology, and we’ve heard it over and over." Those pitfalls are the reason Smart Meter decided to go the less-common route and make its device for diabetes management cell-enabled instead of using a Bluetooth connection to transmit ...
Source: MDDI - June 5, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Digital Health Source Type: news

Philips Bets Big on Image-Guided Therapy with Latest Acquisition
Royal Philips is seeking to expand its image-guided therapy solutions with the acquisition EPD Solutions. Philips is set to acquire the Tortola, British Virgin Islands-based company for about $292 million upfront. The deal could close in July, Philips said. EPD’s cardiac imaging and navigation system has received CE mark and is used in diagnostic and therapeutic procedures for cardiac arrhythmias. The system has not been given a nod from FDA and is currently under review by the agency. Philips said its interventional imaging systems, such as Azurion, and EPD’s cardiac imaging and navigation system could more ef...
Source: MDDI - June 5, 2018 Category: Medical Devices Authors: Omar Ford Tags: Imaging Cardiovascular Source Type: news

More Patients Are Dead After Weight-Loss Balloon Surgery
FDA is still keeping tabs on two liquid-filled intragastric balloon systems used to treat obesity as at least a dozen patients have died in the past two years after receiving one of the devices. The agency first alerted physicians about deaths possibly associated with the devices last year after five patient deaths had been reported. FDA has also approved labeling changes to reflect this information. The agency said it also continues to monitor complications related to the placement and use of these devices, including perforation of the stomach wall or esophagus, inflammation of the pancreas, and the balloon filling with a...
Source: MDDI - June 5, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

AI & #039;s Big Move into Healthcare Not Slowing Down
The promise of artificial intelligence (AI) in healthcare is rapidly taking shape. Pharmaceutical and medical device companies are tapping into the ability of machine learning to make their products more efficient and effective for patients. Even FDA is becoming more comfortable with AI and has recently given approval to several technologies that have embraced machine learning. ThinkGenetic, a digital health startup, has leveraged the power of AI to help patients understand themselves and the likelihood if they have a genetic disease. The company’s CEO and co-founder David Jacob will be at MD&M East, moderating t...
Source: MDDI - June 4, 2018 Category: Medical Devices Authors: Omar Ford Tags: MD & M East (New York) Digital Health Source Type: news

Medtronic Recalls HeartWare VADs Again Due to an Electrical Problem
Medtronic has encountered another problem with the HeartWare ventricular assist device (HVAD) it acquired in 2016. FDA gave the recall a Class I designation, making it the most serious type of recall, however, the patient risk appears to be very low. The company recently penned a "dear doctor" letter about the potential for an interruption of the electrical connection between the device's power source (battery, AC adapter, or DC adapter) and the HVAD controller. This interruption may cause the device to switch to a secondary power source and/or emit a beeping sound. Medtronic said the interruption is caused ...
Source: MDDI - June 4, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

Are You Letting Fear of Missing Out Dictate Your Requirements?
This article is all about the biggest worry I see over and over again in our clients’ eyes, and what we can do to alleviate those fears both as designers and as managers. A Component-Level Example Here’s how the nightmare goes: a medical device design engineer is working away on a product feature—let’s say an internal battery. The requirements document states that the battery life must be at least 4000 mAh and weigh no more than 300 grams, so they search around with a few vendors and cobble together two options: Option #1 is a 4500 mAh battery that costs $10 and weighs 250 grams. Option #2 is an 80...
Source: MDDI - June 2, 2018 Category: Medical Devices Authors: Nigel Syrotuck Tags: Design Source Type: news

Will Medtech Rise to FDA & #039;s Challenge in the War on Opioid Abuse?
It isn't the first time FDA has turned to medtech for solutions to opioid misuse and abuse, but now the agency is officially challenging the medical device and diagnostics industry to step up in the ongoing war on opioids. FDA recently launched an innovation challenge to spur the development of devices, digital health technologies, and diagnostic tests that could provide novel solutions in response to the opioid epidemic. That's not to say the industry hasn't already put forth some effort in this area. Manufacturers of naloxone products – a drug designed to potentially save a person's life in the event of an opioid o...
Source: MDDI - June 1, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: R & D Digital Health Source Type: news

Cefaly in Hot Pursuit of a Migraine Prevention Indication
Each year migraines are estimated to impact about 39 million people in the U.S. and about 1 billion worldwide. Chronic migraines are characterized by 15 or more headache days per month for at least three months.  Cefaly Technology has developed an electroceutical treatment platform that can tackle the neurological disease. However, the Belgium-based company is working on a new application for the Cefaly Prevent Device to focus on the chronic migraine population. “When we received [FDA] approval for the device in 2014, it was mainly based on the trials that were executed for acutely migraine sufferer – so p...
Source: MDDI - June 1, 2018 Category: Medical Devices Authors: Omar Ford Tags: Electronics Source Type: news

Why Neurotech Will Be the Gold Rush of the 21st Century
It seems leading scientists and industry specialists are not alone on their quest to rewire the human brain. Over recent years, neurotech has also sparked interest from businesses and individuals well outside the medical sector. Now, advancements in the industry are on track to offer humans—and businesses—endless new opportunities that will not only benefit our health, but also take us beyond human limits. Neurotech is moving quickly. In 2015, the U.S. neurostimulation devices market was valued at $2 billion, and Grand View Research estimates it to exceed $12 billion by 2023. While the primary aim is to tr...
Source: MDDI - June 1, 2018 Category: Medical Devices Authors: Beth Rosellini Tags: Business Source Type: news

Get Answers to Your Usability Testing Questions
Even though it’s been a couple years since FDA published its human factors guidance, some medtech developers still wonder exactly how to conduct usability studies. At MD&M East, attendees will get to see such testing performed live at the Medtech Education Hub as the UL LLC human factors consulting team demonstrates a medical device usability test. Allison Strochlic, research director for UL Human Factors Engineering (HFE), Wiklund R&D, tells MD+DI that the team will demonstrate typical aspects of a formative test. These include a test session introduction, the presentation of representative “use s...
Source: MDDI - June 1, 2018 Category: Medical Devices Authors: Daphne Allen Tags: MD & M East (New York) Design Source Type: news

Supplier Stories for the Week of May 27
(Source: MDDI)
Source: MDDI - June 1, 2018 Category: Medical Devices Authors: Daphne Allen Tags: 3-D Printing Source Type: news

Will CMS Reverse Its Stance on LivaNova & #039;s VNS for Depression?
A device that previously received an unfavorable coverage decision for treatment-resistant depression from the Centers for Medicare & Medicaid Services will get a second shot after more than a decade. CMS said it will reconsider its national coverage determination for LivaNova's Vagus Nerve Stimulation (VNS) Therapy for treatment-resistant depression (TRD). LivaNova's implantable VNS devices are FDA approved for both drug-resistant epilepsy and treatment-resistant depression, but CMS currently only covers VNS for drug-resistant epilepsy. Although the outcome of the reconsideration process remains to be s...
Source: MDDI - June 1, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Finding the Best Battery for Your Device
When it comes to exciting new developments in medtech, you might not need to look much further than battery technologies. The demand for battery technologies may have always been high, but the diversity in the type of batteries on the market continues to expand as innovative new developments require more than just your standard double A. Whether it’s a flexible battery for a wearable device, or a biocompatible battery that can power new implantable devices, emerging technologies require much more than just power from their batteries. The importance of finding the right battery technology for your device can literall...
Source: MDDI - May 31, 2018 Category: Medical Devices Authors: Kristopher Sturgis Tags: Components Design News Source Type: news

JC Medical Becoming Serious Challenger in TAVR Fray
Edwards Lifesciences and Medtronic have been at the forefront of the transcatheter aortic valve replacement (TAVR) market for a few years now. However, as time goes on, the two companies are facing increasing competition from a  number of challengers. These companies aren’t necessarily new – but they have passed the test of time to put them on the field of being relevant in the market. The latest company to show margins of success is privately held firm, JC Medical, which was formed in 2009. On Thursday, the Burlingame, CA-based company said it had treated the first patient with the J-Valve TF System ...
Source: MDDI - May 31, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Implants Source Type: news

Layoffs at IBM Watson Health Spark Concern
IBM is laying off some of its Watson Health employees, but it may not be quite the "bloodbath" that online commenters and several other news reports have made it out to be. "IBM is continuing to reposition our team to align with our focus on the high-value segments of the IT market. We continue to hire aggressively in critical new areas that deliver value for our clients and IBM," Edward Barbini, vice president of corporate communications at IBM, told MD+DI. However, Barbini declined to answer questions related to the specific number of layoffs in Watson Health, or the significant percentages that have ...
Source: MDDI - May 31, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

FDA Approves First Artificial Iris
A German company has become the first to score FDA approval for a stand-alone prosthetic iris in the United States. The agency said Wednesday afternoon that it approved the CustomFlex Artificial Iris, made by Erlangen, Germany-based HumanOptics. The device, which is surgically implanted, is approved to treat adults and children whose iris is completely missing or damaged due to a congenital condition called aniridia or other damage to the eye. “Patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye,” said Malvina Eydelman, MD, dire...
Source: MDDI - May 30, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Implants Source Type: news

Combining AI and Wearables to Track Fertility in Women
A startup has made fertility tracking mobile through the use of artificial intelligence (AI).  Ava has developed a wearable that uses big data and analytics to track a woman’s cycle. The company, which has a presence in both San Francisco, CA and Zurich, Switzerland, has raised about $30 million in a series B round. The majority of the financing came from existing investors including Polytech Ventures, BtoV and SVC Ltd., an investment vehicle of Credit Suisse, along with a few selected new investors to further strengthen the company’s investor base. Ava said its cycle-tracking sensor bracelet, can det...
Source: MDDI - May 30, 2018 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Source Type: news

It Turns Out Stapler Choice Matters in Lung Cancer Surgery
Video-assisted lobectomies performed with powered staplers resulted in nearly half as many patient bleeding complications as those conducted with manual staplers, according to a recent study. Patients treated with powered staplers were released from the hospital one day earlier than those whose surgeons used manual staplers. The retrospective study, funded by powered-stapler maker Ethicon, also indicated shortened hospital stays and 10% lower costs among the patients treated with the powered devices, most of which were manufactured by Ethicon, part of Johnson & Johnson. Most of the manual devices were made by Medtronic...
Source: MDDI - May 30, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: R & D Source Type: news

Are Medtech Ethics Codes Up to Snuff?
The rapid evolution of medtech has left many aspects of the industry scrambling to keep up, including its business ethics. The scramble is evident worldwide and in the United States. At the recent Global MedTech Compliance Conference in Paris, 26 international and regional medtech associations that make up the Global Medical Technology Alliance announced they had adopted “globally harmonized ethical business principles across their respective member associations.” The principles cover: Consulting arrangements; Company support for third-party educational programs; Company-organized training and educational even...
Source: MDDI - May 29, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Business Source Type: news

RenalGuard Scores High at ESC-HF with Feasibility Results
A feasibility study could help put RenalGuard on the path to commercialization in the U.S. for its diuretic therapy. The Milford, MA-based company presented the results of the RenalGuard-Guided Diuretic Therapy, during a late-breaking presentation at the European Society of Cardiology Heart Failure conference in Vienna. The company’s technology is comprised of a Console and a RenalGuard Single Use Set for infusion and urine collection. The Single Use Set contains a urine collection set which connects to a patient's Foley catheter and an infusion set which connects to a standard IV catheter. The console measures the v...
Source: MDDI - May 29, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular IV Products Source Type: news

Breaking Through FDA ’s New “Accelerated” Pathway
Discussion and Collaboration The BDP is consistent in vision to the EAP program but has been modified based upon the applicable provisions of the Cures Act. Devices granted designation under the EAP program have been automatically incorporated in the BDP. FDA is currently addressing public comments on a draft guidance that was proposed last year[1]. Regardless, the provisions of the BDP are already effective per the Cures Act. Unlike the EAP, which only allowed IDE, PMA and De Novo applications, the BDP also applies to Q-submissions (Q-Sub), Investigational Device Exemptions (IDE) and 510(k) premarket notifications. Furthe...
Source: MDDI - May 29, 2018 Category: Medical Devices Authors: Kerri-Anne Mallet Tags: Regulatory and Compliance Source Type: news

Collaboration Needed to Fight Antimicrobial Resistance
Antimicrobial resistance (AMR) is one of the greatest threats to human health throughout the world, warns Gary Cohen, executive vice president of global health for BD. “There is an increasing risk of going back to the pre-antibiotic era,” he told MD+DI. “Resistance is not a new issue—it is just a bigger problem, at an accelerated pace. Because antibiotics have been overprescribed for humans as well as overused in food production, antimicrobial resistance is not just a theoretical threat.” Everyone needs to play a role, including diagnostics manufacturers and even medical device innovators, he ...
Source: MDDI - May 26, 2018 Category: Medical Devices Authors: Daphne Allen Tags: IVD Source Type: news

An Affordable Prosthetic Hand
Arm and hand amputees may soon have a prosthetic that lets them type, shake hands, and use a computer mouse—and they won't have to refinance their home to get one. Brain Robotics, a startup led by Bicheng Han, a Ph.D. candidate at Harvard University, is developing an Electromyography (EMG)-controlled upper-limb robotic prosthesis that can be directly controlled using muscle signal. Where similar devices cost between $40,000 and $60,000, Brain Robotics plans to sell the device for around $3k-5k. "We want to help more people live the life they want where they couldn't before because a prosthetic was so expensive,&...
Source: MDDI - May 25, 2018 Category: Medical Devices Authors: Heather R. Johnson Tags: 3-D Printing Source Type: news

Medtronic Gets Huge Surge in Sales from Diabetes and Valves
Medtronic topped estimates in its latest earnings, fueled by sales from valves and diabetes products. For the Dublin-based company’s 4Q18 earnings it brought in about $8.14 billion, a 6.5 percent increase. The firm’s Cardiac and Vascular group (CVG) earned $3.1 billion and grew by 10.1 percent. Within CVG group, the Coronary & Structural Heart businesses had the best showing. “Coronary & Structural Heart delivered impressive 12.8% growth, driven by the rollout of our Resolute Onyx, drug-eluting stent in the U.S. and Japan as well as, low 20s growth in the transcatheter aortic valves,” said O...
Source: MDDI - May 25, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

Pulmonx Closing in On Approval for Valve to Treat Emphysema
Pulmonx has some additional ammunition in its bid to get its severe emphysema treatment valve FDA approval. The Redwood City, CA-based company released positive one-year-results from the LIBERATE pivotal trial of the Zephyr Endobronchial Valve, which shows the study met all primary and secondary endpoints in treating emphysema patients. Emphysema falls under the umbrella of chronic obstructive pulmonary disease (COPD) and is characterized by damage to the walls of the lungs between the air sacs, according to the National Emphysema Foundation. This damage causes the sacs to lose their shape and often, the destruction of tho...
Source: MDDI - May 25, 2018 Category: Medical Devices Authors: Omar Ford Tags: Implants Source Type: news

How AI Will Impact Patients, Care Providers, and Even Payers
Artificial intelligence (AI) is rapidly spreading throughout the realm of medtech as companies from every corner of the market look to adapt to the latest in innovation. Whether you’re an industry giant, or a shiny new startup, advancements in AI technologies are forcing companies to embrace and adapt to new developments—all while altering the medtech landscape in the process. So what’s new with artificial intelligence? How are companies beginning to tap their potential, and when will we begin to actually see the impact they can have on the world of healthcare? These are some of the questions that Gioel M...
Source: MDDI - May 24, 2018 Category: Medical Devices Authors: Kristopher Sturgis Tags: MD & M East (New York) Software Source Type: news

Supplier Stories for the Week of May 20
(Source: MDDI)
Source: MDDI - May 24, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Software Source Type: news

How Orthopedics Innovation Doesn ’t Get Lost In Shuffle
What are some of the growing trends and unmet needs in the orthopedics market? If you’re a surgeon, just how do you convince the CEO of a hospital to invest in these technologies? During MDM East, held in New York from June 12-14,  Michael Levy, MD will be a part of two panels that will touch on some of these subjects. The panels are titled “Prominent Physicians Address Unmet Needs in Orthopedics” and “Selling Your Idea to Upper Management.” Levy is an expert in the field and has been involved in orthopedics for 34 years including basic research, orthopedic product development, and c...
Source: MDDI - May 24, 2018 Category: Medical Devices Authors: Omar Ford Tags: Orthopedics Source Type: news