Building a Better Insulin Infusion System
Capillary Biomedical is looking to develop a safer more reliable and accurate insulin infusion device. The Irvine, CA-based company has closed on $2.9 million in a series seed financing to help get its SteadiSet infusion set on the market. The Series Seed financing involved several Angel groups, including Tech Coast Angels, New York Angels, HBS Alumni Angels of New York, Pasadena Angels and the Mass Medical Angels, making the financing one of the broadest and most successful syndications among Angel investor groups. Other investors included the ACE Fund, PA Fund and NYA Fund. Financing proceeds will be used for clinical tr...
Source: MDDI - August 17, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Tubing Source Type: news

Selfie Medicine Is a Thing, But Should It Be?
At a time when taking and sharing selfie photos and videos have become commonplace, it's no surprise that someone would come up with the idea of "selfie medicine." Selfie medicine requires using a mobile app to record a video of themselves taking prescribed medication for the sake of proving adherence. On one hand, it seems like an innovative solution to a major healthcare problem, as statistics show that up to 50% of U.S. adults do not take their medication as prescribed. But the practice also raises some valid concerns. "I think it can be part of an acute care adherence plan," Shital Mars, CEO of Prog...
Source: MDDI - August 17, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Digital Health Source Type: news

Getting the Most Out of Your Design Review
Conclusion Brad’s story is common. One of the biggest mistakes made when faced with a time crunch is to short cut design reviews. In fact, discovering and solving issues after fabrication of the design typically ends up costing much more in time and budget than a design review. And Brad’s next project? Armed with a process and a plan for communication, Brad successfully completed and delivered his schematic to team members on time, resulting in a well-executed design review, on schedule! (Source: MDDI)
Source: MDDI - August 15, 2018 Category: Medical Devices Authors: Mike Kahn Tags: Design Source Type: news

Supplier Stories for the Week of August 12
(Source: MDDI)
Source: MDDI - August 14, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Materials Source Type: news

NanoMedical Tackles Opioid Abuse with Combination Device
NanoMedical Systems has received a nearly $3 million grant from the Department of Defense to develop a combination device for the long-term treatment of opioid use. The grant provides $2,993,398 over three years to support formulation development, device development and manufacturing, preclinical studies, and initial human factors assessments in conjunction with the DeBakey, VA Medical Center in Houston, TX. The Austin-based company develops drug-delivery devices based on its nStrada nanofluidics platform for sustained release (up to six months) of chronic therapies. These devices can be loaded with a variety of drugs incl...
Source: MDDI - August 14, 2018 Category: Medical Devices Authors: Omar Ford Tags: Implants Business Source Type: news

Vaginal Rejuvenation Manufacturers Land in Hot Water with FDA
 Back in February, MD+DI got the low down from an obstetrics and gynecologist specialist in Lubbock, TX on a new vaginal rejuvenation device that her patients have been raving about.  Now it seems the manufacturer of that particular device, along with other companies selling laser- or energy-based devices for vaginal rejuvenation failed to get FDA's blessing. "We've recently become aware of a growing number of manufacturers marketing 'vaginal rejuvenation' devices to women and claiming these procedures will treat conditions and symptoms related to menopause, urinary incontinence, or...
Source: MDDI - August 14, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

Is IBM Really Making Progress with Watson in Healthcare?
Recent media reports have cast doubt on the benefits of IBM's Watson computing system in healthcare, but the company isn't taking the criticism lying down. "I feel it is imperative to set the record straight," John Kelly III, senior vice president of cognitive solutions and IBM research, wrote in a blog post for IBM. IBM has placed a big bet on healthcare, Kelly said.  "We know that AI can make a big difference in solving medical challenges and supporting the work of the healthcare industry," he said, adding that the company also sees an enormous business opportunity in this area as the adop...
Source: MDDI - August 14, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Digital Health Source Type: news

Creating New Compounds For 3D Printed Medical Devices
A new biomaterial company,  FibreTuff, has announced plans to begin manufacturing cellulose-based biomaterials that are biocompatible, absorbable, and nondegradable for Class I and II medical devices. The company’s PAPC ingredients can be compounded into pellets to make 3D printing filament that can be used to print a variety of medical devices and implants. “FibreTuff compounds biomaterials that contain cellulose and blends them with thermoplastics branded as PAPC (polyamide, polyolefin, and cellulose) compositions for use in Class I [and] ...
Source: MDDI - August 14, 2018 Category: Medical Devices Authors: Kristopher Sturgis Tags: 3-D Printing Source Type: news

Device Safety and Regulations Questioned in The Bleeding Edge
Netflix’s movie, The Bleeding Edge, is about allegedly unsafe medical devices, how they got to market, and how difficult it is to get them off the market. Living in New York, I actually saw it in a movie theater. It has also received a modest amount of press with various radio, print, and online interviews. The principals behind the movie, Kirby Dick, Amy Ziering, and Amy Herdy, are established documentary filmmakers as is evidenced by the high production values that go well beyond talking heads and statistics. The issue of faulty medical devices is approached through the personal stories of v...
Source: MDDI - August 14, 2018 Category: Medical Devices Authors: William A. Hyman Tags: Regulatory and Compliance Source Type: news

Declining Sales Prompts Endologix to Hit the Strategic Reset Button
John Onopchenko has had his work cut out for him since being promoted to CEO of Endologix in May. The company's revenue dropped 6.1% in the fiscal year 2017 compared to the fiscal year 2016 after a manufacturing glitch interrupted sales of its top-selling device for abdominal aortic aneurysms (AAA). This and other issues led CEO John McDermott to resign earlier this year. "The leadership team and I have been working hard on reestablishing Endologix's credibility and reputation with our physicians and customers and building a culture of accountability, with the ultimate goal of deliv...
Source: MDDI - August 13, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Ivantis Now Has Its MIGS Stent Approved
The competition in the microinvasive glaucoma surgical (MIGS) space is certainly heating up after today’s news. FDA has given a nod to Ivantis’ Hydrus Microstent, which will undoubtedly compete against Glaukos’ iStent. Irvine,CA-based Ivantis’ approval comes on the heels of Glaukos winning a nod from FDA for the iStent inject Trabecular Micro-Bypass System. The Hydrus Microstent is used to treat patients with mild to moderate primary open-angle glaucoma in conjunction with cataract surgery. The device’s approval is based on the HORIZO...
Source: MDDI - August 13, 2018 Category: Medical Devices Authors: Omar Ford Tags: Implants Source Type: news

What Should You Expect with Enforcement of the False Claims Act?
Gibson Dunn’s 2018 Mid-Year False Claims Act Update includes several notable developments of interest to medical device manufacturers. In addition to covering recent enforcement activity, the update explains this year’s memorandum from then-Associate Attorney General Rachel Brand (known as the “Brand Memo”) that "prohibits DOJ attorneys from bringing civil enforcement actions based on alleged noncompliance with informal agency guidance," explains Jonathan Phillips, a partner in the office of Gibson, Dunn & Crutcher. To dig dee...
Source: MDDI - August 13, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Regulatory and Compliance Source Type: news

GID Gets 2nd Lease on Life with New Trial
GI Dynamics has won a nod from FDA to begin a pivotal trial of the embattled EndoBarrier, a technology used to treat patients with type 2 diabetes. The pivotal trial could be a significant turning point in the life of the Lexington, MA-based company, which was founded in 2004. The firm has been approved for staged enrollment with initial approval for treatment of up to 67 study participants including 50 EndoBarrier and about 17 control participants. GI Dynamics said it expects to complete enrollment of Stage I of the study during the first half of 2019. “This IDE approval is the result of more than two ye...
Source: MDDI - August 13, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Implants Source Type: news

6 AI Companies Set to Rock the Medtech World
(Source: MDDI)
Source: MDDI - August 10, 2018 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Source Type: news

Using the Natural Birth Control Method? There & #039;s an App for That!
Image credit: NaturalCycles Nordic AB A mobile app developer just became the first to score FDA permission to market its product as a method of contraception to prevent pregnancy.  The app, called Natural Cycles, contains an algorithm that calculates the days of the month a woman is likely to be fertile based on daily body temperature readings and menstrual cycle information, a method of contraception called fertility awareness. Designed for mobile devices, it is intended for use in pre-menopausal women 18 and older. Natural Cycles, developed by NaturalCycles Nordic AB, requires women to...
Source: MDDI - August 10, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Digital Health Source Type: news

In Vivo Sensors: More than a Space-Age Fantasy?
Why don’t we have in vivo sensors sprinkled around our bodies? How long until we stop investing in temporary ex vivo sensors and start investing in permanent in vivo ones? What technological barriers are in the way? Where would they go for maximum usefulness? What would be the benefit? Numerous medical device developers are investing in ex vivo sensors for a variety of applications, from wearables that support wellness, to outpatient tracking or non-invasive single-use diagnostics. I’ve been on a bit of a sci-fi kick lately, and it seems a pretty common motif that in the (fictional) futu...
Source: MDDI - August 9, 2018 Category: Medical Devices Authors: Nigel Syrotuck Tags: Digital Health Source Type: news

Will the Extravascular Method be a Game Changer for ICD Therapy?
Medtronic is aiming for a slightly different approach for implantable defibrillator therapy. Instead of using a transvenous approach the firm is looking at an extravascular method for ICD therapy. On Thursday, the Dublin-based company said it was beginning a pilot study of its Extravascular Implantable Cardioverter Defibrillator (EV ICD) system, in which a lead is placed outside of the heart and veins to deliver lifesaving defibrillation and antitachycardia pacing therapy all in one system. EV ICD’s size is similar to transvenous ICDs. The first patient implant was performed at Christchurch Hospital in Ne...
Source: MDDI - August 9, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news

Supplier Stories for the Week of August 5
(Source: MDDI)
Source: MDDI - August 9, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Testing Source Type: news

Could a New Imaging Device Curb Thyroid Cancer?
A new development out of Taiwan could improve thyroid cancer screening after doctors unveiled a new diagnostic imaging tool last month. The AmCAD-UT Detection technology developed by AmCad BioMed Corp. is being hailed as the world’s first ultrasound CAD for thyroid cancer detection. For years, doctors have relied on traditional ultrasound imaging devices that produce black-and-white images to help doctors get a view of the thyroid nodules for abnormalities. With this new AmCAD-UT Detection device, doctors would now be able to view images of the thyroid nodules in better resolution with full color, an adva...
Source: MDDI - August 9, 2018 Category: Medical Devices Authors: Kristopher Sturgis Tags: Imaging Source Type: news

Medical Guardian Designs Smartwatch for Aging Population
The International Data Corporation is saying that worldwide shipments of wearable devices are on track to grow 15.1% this year totaling more than 132.9 million units. The concept of wearables is gaining traction especially in healthcare. Medical Guardian is going after older adults, a segment of the population that is quickly opening up to the concept of wearable devices. The Philadelphia, PA-based company has developed the Freedom Guardian, a smart watch of sorts that serves as a medical alert system for users. “We wanted them to have a device that was lightweight and discreet that they could wear,â...
Source: MDDI - August 8, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Big Strides in Miniaturization
MD+DI has been tracking miniaturization for some time, as we’ve seen trends deepen in minimally invasive surgeries, wearable devices, advanced drug delivery, and more. Lindsay Mann, director of marketing for MTD Micro Molding, tells MD+DI that about 25% of the micro medical device components they produce are for miniaturized devices. We asked her for an update on miniaturization, including recent advancements in materials and manufacturing.   What is driving the current trend toward medical device miniaturization? Mann: As less invasive procedures and technology-driven advancements...
Source: MDDI - August 8, 2018 Category: Medical Devices Authors: Daphne Allen Tags: MD & M Minneapolis Molding Source Type: news

Boston Scientific & #039;s Lotus Valve Could Get FDA Approval in Mid-2019
Boston Scientific is on a roll today. Not only has the company announced yet another acquisition, but it also said it plans to submit the final technical module of the Lotus Edge aortic valve system premarket approval (PMA) application to FDA next week. This could put the device on track for a mid-2019 approval. The Lotus Edge for TAVR may be one of the most watched products in Boston Scientific's pipeline. The device has drawn interest from the medical and financial analyst communities because the current generation of the valve is known for having low rates of paravalvular leak (PVL). The Lotus Ed...
Source: MDDI - August 8, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Cardiovascular Source Type: news

Another Day, Another Boston Sci Acquisition
Boston Scientific is proving itself to have more stamina than the Energizer Bunny when it comes to making acquisitions. The Marlborough, MA-based company is now picking up Veniti, a firm that has developed a stent system for treating venous obstructive disease. The deal consists of $108 million up-front cash as well as up to $52 million in payments contingent upon FDA’s approval of the VICI stent system. Boston Scientific had been an investor in Veniti since 2016 and owns 25% of the company. Fremont, CA-based Veniti’s self-expanding, nitinol VICI stent system was developed specifically f...
Source: MDDI - August 8, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Implants Source Type: news

This Medtech Company Is Rocking Cleveland with New Hires
Cleveland does indeed seem to "rock", at least for one medtech company that has set up shop in the city.  Goleta, CA-based Inogen, which makes portable oxygen concentrators (POCs) is planning to grow its presence in Cleveland. CEO Scott Wilkinson said the company expects to have 500 Cleveland-based employees by the end of 2020, which up from the company's original target of 240 employees. Wilkinson said at least two-thirds of these employees will be sales reps. The company generated $97.2 million in revenue, reflecting record results in all three of its sales channels. Inogen's direct-to-consumer sale...
Source: MDDI - August 8, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

New Thinking Informs Soft-Material 3D Printing
As 3D printing evolves, researchers have gone beyond mere fabrication processes to developing techniques for optimizing how particular materials can be printed. To that end, researchers at Carnegie Mellon University’s College of Engineering have developed a new approach to optimizing the 3D printing of soft materials. This approach combines expert judgment with an algorithm designed to search parameter combinations relevant for 3D printing, they said. Images of 3D prints made using a new method developed by researchers at Carnegie Mellon. Their approach combines expertise with an algorithm an...
Source: MDDI - August 8, 2018 Category: Medical Devices Tags: Design News Source Type: news

Putting Fat Cells to Use in Orthopedics
Arthroscopic knee surgery for degenerative knee disease is a common orthopedic procedure, reportedly performed more than two million times a year globally. And these are just the statistics for knee procedures. The shoulder, hip, wrist, elbow, and ankle joints are all also candidates for arthroscopic surgeries. A few studies have cast doubt about whether such surgeries are necessary. It is true that most of the time, patients report lessening of pain after the procedures. But could this be just a placebo effect? In the case of osteoarthritis in the knee, there is no evidence that arthros...
Source: MDDI - August 8, 2018 Category: Medical Devices Authors: Susan Shepard Tags: Orthopedics Source Type: news

Viveve Developing Device to Improve Sexual Function in Women
Viveve Health has received a nod from FDA to continue enrollment in a clinical trial to evaluate a technology to improve sexual function in women following vaginal childbirth. The Viveve Treatment of the Vaginal Introitus to EValuate Safety and Efficacy (VIVEVE II) trial is a randomized, double-blinded, and sham-controlled trial with a planned enrollment of about 250 patients at up to 25 study sites in the U.S. and Canada. The primary efficacy endpoint is intended to be the mean change from baseline in the total Female Sexual Function Index (FSFI) at 12 months. Subjects will also be assessed for safety over the 12 months. ...
Source: MDDI - August 7, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Pfizer Is Keeping Details of New & #039;Rescue Pen & #039; Low Key, for Now
Antares Pharma has agreed to help Pfizer develop a combination drug-device rescue pen using Antares' QuickShot auto injector. The companies have not yet disclosed what drug the device will deliver, but Antares CEO Bob Apple shared a few details about the agreement during the company's second-quarter earnings call on Tuesday. He said Pfizer will pay for the design and development cost of the device. Then, the companies intend to sign a separate commercial supply agreement calling for Antares to provide fully packaged finished product to Pfizer at a cost plus margin, and Pfizer will pay royalties on net sales of the rescue p...
Source: MDDI - August 7, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: R & D Source Type: news

How EchoNous Turned the Nursing Stand into an AI Station
With the goal of reinventing what has historically been an afterthought medical device element, EchoNous commissioned an iconic industrial designer and solicited advice from clinicians and biomedical leaders at one of the nation's top health systems to create a new docking station for nurses. The result is the AI Station, an expandable platform that integrates the company's current intelligent tools, the Uscan bladder scanner and the EchoNous Vein, as well as devices still in development. EchoNous said the new station will use emerging artificial intelligence methods along with the company'sÂ&...
Source: MDDI - August 7, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Design Software Source Type: news

Could Ozone Emerge as Sterilization Method of Choice for Advanced Medtech?
Anacail Ltd., a start-up spun out of the University of Glasgow, is developing a new approach to sterilizing medical devices using ozone. The company reported that it has been awarded a grant through Innovate UK to develop a high-throughput, scalable, and environmentally benign process. During the two-year project, Anacail aims to integrate ozone sterilization and packaging into a single process. Dick Barton, senior product engineer for Anacail, tells MD+DI that alternatives to traditional technologies such as EtO, radiation, and steam sterilization are needed for today’s medtech technologies. â€...
Source: MDDI - August 7, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Sterilization Source Type: news

Boston Scientific to Layoff 85 Massachusetts Workers by Year End
Boston Scientific, which has been making acquisitions left and right this year, plans to lay off 85 workers at a Burlington, MA-based facility that came with the company's acquisition of Cosman Medical in 2016. Cosman developed radiofrequency ablation technology for the treatment of chronic pain and was integrated into Boston Scientific's neuromodulation business. The company submitted a Worker Adjustment and Retaining Act (WARN) report in Massachusetts disclosing the layoffs. The headcount reduction is expected to begin Sept. 28 and continue through December. When Boston Scientific acquired Cosman in July 2016, the financ...
Source: MDDI - August 7, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Scout Marks the Spot in Soft Tissue for Cancer Treatment
Cianna Medical celebrated another regulatory milestone this week after FDA cleared its Scout reflector for an extended indication, allowing the tiny device to be used to mark soft tissue sites, including lymph nodes.  The non-radioactive wire-free localization device is smaller than a grain of rice (4mm) and won the gold award in the 2017 Medical Device Excellence Awards for the category of ER and OR tools, equipment, and supplies. Last year FDA cleared the device for implantation in breast cancer patients without restrictions on the length of time that it can remain in the breast. The reflector is completely p...
Source: MDDI - August 6, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Imaging Implants Source Type: news

LivaNova Looking to Be a Standout Firm in TMVR
LivaNova is getting closer to becoming a major player in the transcatheter mitral valve replacement (TMVR) space. The company, which was formed when Sorin Group and Cyberonics merged back in 2015, said it has concluded, PRELUDE, the U.S. feasibility study of its TMVR technology. With the conclusion of PRELUDE, the London-based company will now focus on enrolling patients into its INTERLUDE CE mark trial and finalize the protocol for, ENSEMBLE, the U.S. pivotal trial. PRELUDE is a first-in-human study that evaluates the Caisson TMVR system to treat moderate to severe mitral regurgitation, using a transseptal approach. This ...
Source: MDDI - August 6, 2018 Category: Medical Devices Authors: Omar Ford Tags: Implants Cardiovascular Source Type: news

Stryker Touts 3D-Printed Tritanium Cages for Spinal Fusion
A recently published pre-clinical animal study highlights the expanding role that 3D printing is playing in medicine, particularly in orthopedics. The study, published in the July issue of The Spine Journal demonstrated that Stryker's 3D-printed Tritanium cages, used in spinal fusion, exhibited significantly greater bone in-growth and biological fixation capabilities compared to traditional PEEK cages, and plasma-sprayed titanium-coated PEEK cages in sheep. According to the researchers, the 3D-printed Tritanium cages exhibited significantly greater total bone volume within th...
Source: MDDI - August 6, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: 3-D Printing Orthopedics Source Type: news

General Data Protection Regulation: What Does It All Mean?
Every day more and more electronic devices are “connected” and medical devices are no exception. Medical devices are connected to network servers for many end outcomes including, preventative diagnostics, patient-care management, medication adherence, and remote health monitoring. While connectivity is revolutionizing the healthcare industry, protecting patient privacy and safeguarding data against obvious and non-obvious adversaries has been challenging. Free market economies have a history of under-valuing user privacy aspects to improve user convenience. In response to this, the Europ...
Source: MDDI - August 6, 2018 Category: Medical Devices Authors: Sagar Patel Tags: Software Source Type: news

Pentax Bets on PlasmaBiotics in the Fight Against Scope-Related Infections
Pentax Medical, a division of the Hoya Group, acquired a controlling interest in PlasmaBiotics this week, an investment that is expected to strengthen Pentax's hygiene portfolio and help it reduce cross-contamination risks associated with endoscopy devices. Paris, France-based PlasmaBiotics makes devices designed for drying and storing endoscopes. Endoscope hygiene has been a hot-button topic in the gastroenterology sector and FDA has been cracking down on Pentax and other scope makers to make sure these manufacturers are doing sufficient post-market surveillance to assess contamination risks associated with th...
Source: MDDI - August 3, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Sterilization Source Type: news

Roche is on the “SurePath” for Cervical Cancer Screening with Approval
Roche has won a monumental approval from FDA that stands to enhance its cervical cancer detection offerings. The Basel, Switzerland-based company has received a nod for its cobas Human Papillomavirus (HPV) Test as a first-line screening test for cervical cancer in women 25 and older using cervical specimens collected in SurePath preservative fluid. "Before today, laboratories did not have an FDA-approved HPV test available that could cover all of the HPV screening options supported in professional guidelines and be used with both of the primary Pap test collection media," Ann Costello, Head of Roche Tissue Diagno...
Source: MDDI - August 3, 2018 Category: Medical Devices Authors: Omar Ford Tags: IVD Source Type: news

JenaValve Getting Closer to its U.S. TAVR Goal
JenaValve Technology is continuing to make progress in bringing its transcatheter aortic valve replacement (TAVR) system to the U.S. market. The Irvine, CA-based company has initiated patient enrollment in an early feasibility study (EFS) of its next generation JenaValve Pericardial TAVR system. The EFS is a prospective, single-arm study of the JenaValve Pericardial TAVR System being conducted at several centers U.S. under an FDA-approved IDE. It is part of a larger, ongoing CE mark clinical program investigating the JenaValve Pericardial TAVR System for the same indications at centers in Europe and New Zealand. â...
Source: MDDI - August 3, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

Pricing Headwinds Make Mazor-Medtronic Pact a Double-Edge Sword
You have to give some to get some, as the saying goes, and that certainly appears to be Mazor Robotics' attitude toward its partnership with Medtronic. The smaller robotics company's revenue slipped 14% to $13.2 million during the second quarter, compared to $15.5 million in revenue for the same period last year, even though the number of robotic guidance systems sold reflected a 25% increase compared to the second quarter of 2017.  This is because the company has an agreement with Medtronic that allows the larger company to get Mazor X robotic systems at a discount. The agreement is also saving mon...
Source: MDDI - August 3, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

V-Go Shown to Have Improved Benefit for Insulin Patients
This study demonstrated that patients treated by Advanced Practitioners experienced improved A1c levels while lowering insulin total daily dose (TDD) after switching to V-Go from MDI of insulin. Patients in this study were evaluated after a mean duration of three and seven months. At three months, the mean change in A1c was -1.1% from the mean baseline of 9.1%, and mean insulin TDD decreased to 58 units per day from a mean baseline of 87 units per day. At seven months, the mean change in A1c was also -1.1%, while the mean insulin TDD was 61 units per day. Change in the mean weight was less than 1 kg at both time points. &a...
Source: MDDI - August 3, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

MDxHealth ’s Liquid Biopsy Test Proven to Be Cost-Effective
This study demonstrated that routine use of SelectMDx to guide biopsy decision-making improves health outcomes and lowers healthcare costs associated with prostate cancer risk assessment in a population of U.S. men," Dr. Matthew Resnick from the departments of Urologic Surgery and Health Policy at Vanderbilt University Medical Center, Nashville, TN, said in a release. "We believe that this strategy improves the value of conventional risk assessment strategies through improvements in both quality and cost, the numerator and denominator of the health care value equation." Liquid biopsy has been an extremely ho...
Source: MDDI - August 2, 2018 Category: Medical Devices Authors: Omar Ford Tags: Testing Source Type: news

Supplier Stories for the Week of July 29
(Source: MDDI)
Source: MDDI - August 2, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Materials Source Type: news

Will Investors Rescue Brazos & #039; Migraine Management Device?
A startup company trying to develop a new wearable migraine management therapy device is realizing that getting a new medical device to market can be a financial headache, pardon the pun. Southlake, TX-based Brazos Biomedical, an operating unit of American Diversified Holdings Corporation, said it needs about $2 million to complete all prototype development and FDA requirements to bring its Auracis wearable migraine device to market. Brazos hopes to work with institutional investors to devise a financing strategy to bring the device to market. The Auracis is designed to be worn on the he...
Source: MDDI - August 2, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

ElectroCore Is Changing the Game in Bioelectronics
electroCore, a player in the bioelectronic’s market is on a mission to redefine the way patients are treated for migraines. The Basking Ridge, N.J.-based company recently launched the gammaCore Sapphire, a second-generation device that is non-invasive vagus nerve stimulator for the acute treatment of pain associated with migraine and episodic cluster headache. The gammaCore Sapphire was cleared in December of 2017 but electroCore delayed the product’s launch. “We were waiting to launch the gammaCore Sapphire after we launched into migraine, which happened on July 1&Acir...
Source: MDDI - August 1, 2018 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Source Type: news

DexCom Surpassed Analyst Expectations in the Second Quarter
Diabetes patients are clamoring to get their hands on DexCom's newest gadget, the G6 continuous glucose monitoring (CGM) system. FDA approved the device in March and the company decided to get the product into customer's hands as soon as possible, even though it had originally planned to launch the device in the second half of the year, CEO Kevin Sayer explained Wednesday during DexCom's second-quarter earnings call. The company ended up launching the new device with about three weeks left in the second quarter. The device is the CGM to score approval as an interoperable CGM, meaning that it can work with other automated i...
Source: MDDI - August 1, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Could Faxitron Really Be the Perfect Tuck-in for Hologic?
In a move to broaden and further strengthen its breast health portfolio, Hologic said it has acquired digital specialist Faxitron Bioptics for $85 million. Tucson, AZ-based Faxitron markets a broad portfolio of products across major categories including digital specimen radiography, breast lesion localization, and sentinel lymph node biopsy. The company most recently launched the VisionCT. The technology is a 3-D breast specimen-designated CT system to offer 360-degree images of excised lesions. “Faxitron's market-leading products, which span from digital specimen radiography to breast lesion localization...
Source: MDDI - August 1, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Medtronic Fires up SynchroMed II System for New Collaboration
Medtronic is partnering with United Therapeutics to launch a therapy that could help treat patients with pulmonary arterial hypertension (PAH). The Dublin-based company said it has received FDA approval for the Implantable System for Remodulin (ISR). In the collaboration, Medtronic’s SynchroMed II drug delivery system and cardiac catheter technologies were used to deliver the PAH medication Remodulin (treprostinil) Injection developed by United Therapeutics. PAH is a severely debilitating and progressive disease that causes high blood pressure in the pulmonary arteries, ultimately resulting in right-heart...
Source: MDDI - August 1, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news

How Alexa is Changing Healthcare
(Source: MDDI)
Source: MDDI - July 31, 2018 Category: Medical Devices Authors: Sherree Geyer Tags: Business Digital Health Source Type: news

SCHOTT Acquires Primoceler to Advance Next-Gen Implantable Devices
Implantable devices are advancing at some pretty impressive rates, as devices are quickly becoming more intelligent and versatile. These days implantable devices are designed to not only serve a medical need, but also capture and transmit data in real time. Despite the benefits that some of these features provide, the very nature of this kind of technology can create a challenge when it comes to encapsulating these sensitive components in a device that can survive the harsh conditions of the human body. That’s where SCHOTT comes in — an international technology group that specializes in ...
Source: MDDI - July 31, 2018 Category: Medical Devices Authors: Kristopher Sturgis Tags: Implants Packaging Source Type: news

Are Bioresorbable Stents Destined for a Comeback?
The excitement around bioresorbable stents might have calmed down considerably over the last year, but all that could change. Reva Medical, a San Diego, CA-based company is bringing the technology back into the spotlight with a recent approval. The company has received a CE mark for its Motiv bioresorbable scaffold to be used for the treatment of below-the-knee (BTK) peripheral artery disease (PAD). The CE mark is also significant for Reva because it marks the company’s entry into the PAD space. The company already has CE mark for its Fantom bioresorbable scaffold, which treats patients for coronary arter...
Source: MDDI - July 31, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news