FDA Investigating Paclitaxel Coated Balloons and Eluting Stents
A meta-analysis of randomized trials recently concluded that there is an increased risk of death for patients treated with paclitaxel‐coated balloons and paclitaxel-eluting stents in the femoral and/or popliteal arteries of the lower limbs. The analysis, which was published in late December in the Journal of the American Heart Association, has prompted FDA to investigate. The agency issued a letter last week recommending that doctors continue to monitor patients who have been treated with these devices and discuss the benefits and risks of all av...
Source: MDDI - January 22, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

Can a Polymer Help Reduce Deaths from Sepsis?
Sepsis is one of the leading causes of death in hospitals, and incidences are on the rise, according to the National Institute of General Medical Sciences (NIGMS). Two independent cohort studies published in JAMA found that sepsis contributed to 1 in every 2 to 3 deaths.1 Harshu Musunuri wants to help prevent such deaths. Majoring in Chemical Engineering at Stanford, the 18-year-old student is developing a synthetic (polymer) material that could act as both a diagnostic and a therapeutic agent for the bacterial toxins involved in the infections associated with sepsis. She has just won the first Pion...
Source: MDDI - January 19, 2019 Category: Medical Devices Authors: Daphne Allen Tags: R & D Source Type: news

Medtronic ‘Embraces’ its Role in the Opioid Crisis Fight
Not many medtech companies have the reach and scale of Medtronic. Yet, the Dublin-based firm is in the same position as any other device firm when it comes to the awareness and acceptance of alternatives to oral opioids. Medtronic is hoping to change this with the help of its newly-launched Embrace Targeted Drug Delivery (TDD)clinical study. The 100-patient trial is a post-market study set to evaluate the use of the SynhroMed II intrathecal drug delivery system for patients with chronic intractable non-malignant primary back pain with or without leg pain. The first patient was enrolled in Embrace TDD last week. â ...
Source: MDDI - January 18, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

A Newly Developed Nanosensor Quickly Detects Disease
A new enzyme biomarker test, developed by Researchers at the Institute for Global Food Security at Queen’s University Belfast, has the potential to indicate diseases and bacterial contamination. The nanosensor test can detect enzyme markers of disease known as proteases in humans, animals, and food products. Proteases are a necessary component for microorganism growth and are responsible for the progression of many diseases. Are you ready for MD&M West? Join us from Feb. 5 - Feb. 7 for medtech's premiere event in Anaheim, CA.   Current methods of protease detection ...
Source: MDDI - January 18, 2019 Category: Medical Devices Authors: Omar Ford Tags: IVD Source Type: news

Sleep Apnea Device Maker Raises $11.5M with Private Placement
Electrophysiologists (EPs) who are managing atrial fibrillation (AF) patients who also suffer from sleep apnea have found that catheter ablation is most effective when used in conjunction with a CPAP regimen, yet there is a huge disconnect between the EPs and the sleep experts. That disconnect is what inspired Itamar Medical to develop SleePath, an integrated digital health sleep apnea care pathway monitoring system that allows cardiologists to monitor patients with AF sleep apnea status and compliance with CPAP devices on demand. The Caesarea, Isreal-based company unveiled SleePath last May at Heart Rhythm 201...
Source: MDDI - January 18, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

How Can Medtech Help with the Opioid Crisis?
Pain control is one of the biggest challenges facing America today, believes Dr. Peter Staats, co-founder and chief medical officer of electroCore. Chronic pain is an ongoing, debilitating problem for many patients, but for some, overuse of opioid treatments has led to addiction. Such a condition has led to an increasing number of U.S. deaths—one study published in the JAMA Network Open1 found that the percentage of all U.S. deaths attributable to opioids increased 292% between 2001 and 2016. This same study reported that in 2016, 20% of deaths of adults aged 24 to 35 years involve...
Source: MDDI - January 18, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Business Source Type: news

Will a New J & amp;J and Apple Collaboration Lead to Better AFib Outcomes?
Johnson & Johnson’s Janssen Pharmaceuticals is teaming up with Apple for a research study to look at how to help improve atrial fibrillation (AFib) outcomes, including stroke prevention, through the use of wearables. The partnership will use an app developed by J&J along with the Cupertino, CA-based company’s Apple Watch. Recall in September of 2018, Apple received FDA clearance for an ECG app and another software-only mobile medical app analyzing pulse rates for irregular rhythms. Both companies said the multi-year research program will be launched later in 2019. This large-sca...
Source: MDDI - January 17, 2019 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Cardiovascular Source Type: news

How Is the Government Shutdown Impacting Medtech?
If you think medical device companies are not impacted by the U.S. federal shutdown, think again. FDA commissioner Scott Gottlieb, MD, took to Twitter this week to highlight agency employees who are working unpaid to perform mission-critical activities. FDA cannot legally accept any new medical device or drug submissions until the government shutdown ends because the user fees that are collected with these submissions cannot be processed during the lapse period. The agency is able to support activities funded by carryover user fee balances from FY 2018, but medical device user fee programs only have...
Source: MDDI - January 17, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Supplier Stories for the Week of January 13
(Source: MDDI)
Source: MDDI - January 17, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Tubing Source Type: news

Abbott Finally Pulls the Trigger on Cephea Acquisition
It was only a matter of time before Abbott Laboratories exercised its option to acquire Cephea Valve Technologies, a company it first invested in back in 2015. The Abbott Park, IL-based company announced on Wednesday it would acquire the mitral valve maker for an undisclosed sum. Cephea's technology is being developed to provide an option for people whose diseased mitral valves need to be replaced. The artificial valve is designed to be delivered through a vein in the leg, forgoing the need for open-heart surgery. Replacement of the diseased mitral valve restores normal blood flow through the heart. "The acquisition o...
Source: MDDI - January 17, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

Edwards and Boston Sci End TAVR Patent Dispute
Edwards Lifesciences is resolving its longstanding dispute with Boston Scientific over transcatheter aortic valve replacement (TAVR) patents. However, this time the Irvine, CA-based company is on the other side of the lawsuit coin and is poised to dole out a one-time payment of $180 million to Boston Scientific. Both companies said that no further royalty fees will be owed by any company. In addition, both companies said that all pending cases or appeals in courts and patent offices will be dismissed, and the parties will not litigate patent disputes related to current portfolios of transcatheter aortic valves, certain mit...
Source: MDDI - January 15, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news

FDA Approves Abbott & #039;s Device for Treating Premies with an Opening in Their Hearts
Born at 27 weeks, twin babies Irie and Judah Felkner of Columbus, Ohio, were both fighting for their lives in the neonatal intensive care unit when an echocardiogram revealed Irie had a patent ductus arteriosus (PDA) that required immediate treatment. "The doctor thought Abbott's Amplatzer Piccolo device was the best solution for Irie, and after learning more about the procedure we decided to move forward," said Crissa Felkner, Irie's mother. "You have to live it to fully appreciate what that device did for our daughter. Three days after the procedure, she was making great progress and is now a normal toddle...
Source: MDDI - January 14, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Using Artificial Intelligence to Predict Flu Activity
Researchers from the Computational Health Informatics Program (CHIP) at Boston Children’s Hospital combined forecasting methods with artificial intelligence (AI) to predict flu activity. Results from the research study were published in Nature Communications. The Approach is called ARGONet and was applied to flu seasons from September 2014 to May 2017. Results show that it made more accurate predictions than the team's earlier high-performing forecasting approach, ARGO, in more than 75% of the states studied. Are you ready for MD&M West? Join us from Feb. 5 - Feb. 7 for medtech's premiere ...
Source: MDDI - January 14, 2019 Category: Medical Devices Authors: Omar Ford Tags: Software Source Type: news

SyncThink Goes for Magic Leap to Get into AR
Neuro-technology specialist, SyncThink is finding its way into the realm of augmented reality (AR) through a new collaboration with Magic Leap, a special computing technology company. Under the agreement, the Palo Alto, CA-based company will bring its brain health assessments and therapy applications to Magic Leap’s One Platform. SyncThink has developed an eye tracking solution that can give insight on the brain’s health. “We use eye tracking to assess a person's brain health status,” Laura Yecies, SyncThink CEO, told MD+DI. â€&#...
Source: MDDI - January 14, 2019 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Testing Source Type: news

Can AI Really Be a Game Changer in Cervical Cancer Screenings?
An artificial intelligence solution (AI) can accurately identify precancerous changes that could require medical attention in images from a woman’s cervix. Researchers from the National Institutes of Health and Global Good developed the computer algorithm, which is called automated visual evaluation. Researchers created the algorithm by using more than 60,000 cervical images from a National Cancer Institute (NCI) archive of photos collected during a cervical cancer screening study that was carried out in Costa Rica in the 1990s. More than 9,400 women participated in that population study, with follow up t...
Source: MDDI - January 12, 2019 Category: Medical Devices Authors: MDDI Staff Tags: Software Imaging Source Type: news

Impact of the USMCA on the Medical Device Industry
Since the inception of the North American Free Trade Agreement (NAFTA), trade in medical products expanded nearly 760 percent with 16.5 billion dollars made in 2016. When President Trump announced the re-negotiation of NAFTA, many were concerned about a negative impact on trade. Negotiations have finished, and the “new NAFTA,” re-named the United States-Mexico-Canada Agreement (USMCA)1, remains largely similar to the old agreement. However, the medical device industry has secured victories including recognition of international standards, elimination of duplicative regulatory...
Source: MDDI - January 11, 2019 Category: Medical Devices Authors: Debra Doby and Michael Siem Tags: Regulatory and Compliance Source Type: news

Are UVC LEDs Driving & #039;Digital Cleaning & #039;?
Hospitals do a lot to kill microbes, but there is a gap in disinfection coverage, said Nick Connelly, application engineer for Crystal IS. “There is a missing layer of protection,” he said, pointing to high-touch surfaces and equipment in healthcare settings such as keyboards. “Consider all the devices being used, including roll-in devices and medication carts.” In addition to using a range of chemical-based disinfectants, hospitals are looking to UV light as a disinfection solution. But some of these UV-light emitting devices, such as mercury lamps, c...
Source: MDDI - January 11, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Sterilization Source Type: news

Another Device Gets Added to the Peritoneal Dialysis Mix
AWAK Technologies has been granted a breakthrough device designation from FDA for a wearable and ultra-portable peritoneal dialysis (PD) device. The Singapore-based company’s AWAK PD device allows dialysis to be performed "on-the-go", overcoming the challenge of long hours of therapy and connection to large-size dialysis machines, currently faced by renal patients. The company said FDA’s designation was granted after reviewing the results from the First-In-Human safety trial of AWAK PD device, which was successfully completed in October 2018 at the Singapore General Hospital, S...
Source: MDDI - January 11, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

8 MD & amp;M West Sessions You Won & #039;t Want to Miss
It's hard to believe it's that time of year again but MD&M West is upon us once again. Taking place Feb. 5-7 in Anaheim, CA, this year's conference lineup covers the hottest medtech topics as well as technical advice for professionals involved in every level of medical device development and commercialization. Below we highlight eight conference sessions attendees won't want to miss. You can also click here for a complete list of sessions. 1. How AI Could Revolutionize Medtech Artificial intelligence is one of the hottest topics in medtech these days, and there will be no...
Source: MDDI - January 11, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

AdvaMed Updates Ethics Code for Industry-Doctor Interactions
AdvaMed has updated its longstanding Code of Ethics on Interactions with Health Care Professionals (HCPs) in the United States. The last time the code was updated was in 2008. The revisions will be effective Jan. 1, 2020. AdvaMed President and CEO Scott Whitaker said the updates reflect evolving legal standards, care delivery models, and best practices over the past decade. He said the revisions are designed to ensure the code's continued effectiveness as a "premier foundational document for ethics and compliance across the medtech industry." Key changes include: new sections guiding education and marketing progr...
Source: MDDI - January 11, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

National Geographic Takes an Interest in Organs-on-Chips Research
Biomedical researchers at Cedars-Sinai Medical Center in Los Angeles, CA have caught the attention of National Geographic. The magazine published a special edition this month covering "The Future of Medicine" that highlights the innovative stem-cell science of Cedars-Sinai, showing how investigators there are seeking to use stem cells and organs-on-chips to tailor personalized medical treatments. The cover photo of the special issue features research being conducted at Cedars-Sinai in collaboration with Boston, MA-based Emulate, a startup developing a tissue-based technology designed to replicate human organ-leve...
Source: MDDI - January 11, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: R & D Source Type: news

What We Learned about 7 Standout Companies at JP Morgan
(Source: MDDI)
Source: MDDI - January 10, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Supplier Stories for the Week of January 6
(Source: MDDI)
Source: MDDI - January 10, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Packaging Source Type: news

Glaukos Keeps Its Eye on the Prize at J.P. Morgan
Glaukos is probably at the top of its game when it comes down to maintaining a presence in the micro-invasive glaucoma surgery (MIGS) market. The San Clemente, CA-based company reaffirmed its laser-like focus on the market during a presentation at the 37th annual J.P. Morgan Healthcare Conference earlier on Wednesday. Glaukos’ CEO Thomas Burns began his presentation speaking on the strengths of the firm and its goals going forward. “Our mission is aspirational,” Burns said. “As a company we are seeking to transform glaucoma therapy, and in doing so we ...
Source: MDDI - January 10, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

New Data Boosts Value Proposition of AlloSure
When our kidneys fail to function as they should, our treatment options generally begin with dialysis and end with a kidney transplant. Unfortunately, transplanted kidneys last, on average, between 12 years and 15 years (depending on if the donor is living or deceased, and if they are a relative or not). Some recipients are lucky if they even get five good years out of their transplanted kidney. CareDx has already established the clinical value of AlloSure, a donor-derived cell-free DNA test designed to assess allograft health in kidney transplant patients, and new data demonstrates the test's clinical utility in patients ...
Source: MDDI - January 9, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: IVD Source Type: news

Scanner Helps Find Areas Most at Risk to Develop Pressure Ulcers
Bruin Biometrics (BBI) is looking to shake up the way patients are assessed for pressure ulcers with its SEM scanner. FDA granted de novo marketing authorization for the device which can help uncover a patient’s risk for bedsores and gauge whether there is tissue damage. The current standard for assessing pressure ulcers requires clinicians or healthcare givers to visually inspect patients' skin and remember to turn them over in their beds every few hours. The current standard also relies on risk assessment scales that judge which patients are most at risk for developing pressure ulcers and monitor them. ...
Source: MDDI - January 9, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Sterilization Source Type: news

Antibiotic-Resistance-Screening Diagnostic Wins CE Mark
Novodiag CarbaR+, a test for detecting carbapenemase-producing enterobacteriaceae (CPE) in just 80 minutes, has been issued CE Marking for an IVD. CPE are bacteria that are resistant to the carbapenem class of antibiotics, and early detection could help clinicians quickly identify affected patients. “The rapid diagnosis of CPE enables early-decision making for the selection of appropriate treatment (with or without antibiotics) at an early stage for the infected patient, increasing the likelihood of positive outcomes,” Tuomas Tenkanen, CEO of Mobidiag, the developer and marketer of Novod...
Source: MDDI - January 9, 2019 Category: Medical Devices Authors: Daphne Allen Tags: IVD Source Type: news

It ’s Time to Meet the Users of Medical Devices
In the last five years, design has taken on a larger and more focused role in medtech, said Stuart Karten, principal of Karten Design. Such a trend has been driven in part by the consumerization of healthcare, he explained. “Many more devices that would have been in a clinical setting are now being pushed into patients and other users' hands. It all ties back to the Affordable Care Act and getting hospitals penalized for readmissions. Patients have become more empowered in the actual execution of their healthcare.” T...
Source: MDDI - January 8, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Design Source Type: news

Dexcom Dominates 2018 with Phenomenal Earnings
Dexcom, which was also a finalist for MDDI’s Medtech Company of the Year, just reported monumental earnings for 2018 despite growing competition in the continuous glucose monitoring market. “We achieved [$1.025] billion in revenue in 2018,” Kevin Sayer, president, CEO and chairman of Dexcom said. “That’s up 43% over what we did in 2017 and that’s over $300 million in growth in a single year for us. I can’t tell you how many things have to go right to make that happen, but a lot of them did.â&#...
Source: MDDI - January 8, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

ArcherDx Seeking Broader Reach for Cancer Diagnostic
ArcherDx just got put on the fast track in getting its companion diagnostic on the market. The Boulder, CO-based company said it has been granted a Breakthrough Device Designation for its liquid biopsy and tissue specimen diagnostic application. The Breakthrough Device Designation will allow for an expedited approval pathway and would allow the company to have more frequent interactions with FDA in an effort to get to market faster. Executives from the Boulder, CO-based company found the time to speak about the test with MD+DI on Tuesday, while they were attending the very busy 37th Annual J.P. Morgan Healthcare Conference...
Source: MDDI - January 8, 2019 Category: Medical Devices Authors: Omar Ford Tags: Testing IVD Source Type: news

Noninvasive Test for Colon Cancer Screening Offered as an Alternative to Colonoscopy for Screening
“The only real cure for cancer is finding it early,” said Padma Sundar, vice president of strategy and market access at CellMax Life, in an interview with MD+DI. In terms of colorectal cancer, she said it takes a long time for an adenoma to develop into cancer, so early detection of these adenomas can be lifesaving. But colonoscopy, although the gold standard of adenoma and colon cancer detection, has issues with patient compliance. There are about 125 million Americans, 45 years old and older, who are advised to have routine screening for colorectal cancer. “Unfortunat...
Source: MDDI - January 8, 2019 Category: Medical Devices Authors: Susan Shepard Tags: IVD Source Type: news

New Method Could Lead to Materials to Promote Natural Healing
A team of researchers from the Imperial College in London have created a new process known as traction force-activated payloads (TrAPs) that could have an impact on the body’s ability to heal. The method, developed by Dr. Ben Almquist and a team at Imperial College London, allows materials to speak to the body’s natural repair systems to drive healing. In the TrAPs process, researchers folded DNA segments into 3-D shapes known as aptamers that cling tightly to proteins. Then, the researchers attached a customizable ‘handle’ that cells can grab onto on ...
Source: MDDI - January 8, 2019 Category: Medical Devices Authors: MDDI Staff Tags: Materials Source Type: news

iRhythm Finds Its Groove at the Intersection of Cardiology and AI
iRhythm Technologies has the distinct feature of being at the intersection of some of the hottest markets in medtech – cardiology, wearables, and artificial intelligence. The San Francisco-based company has developed, the Zio Patch XT, a wearable technology to monitor heart rate activity for up to 14 days and is set to present at the 37th Annual J.P. Morgan Healthcare Conference this week. Tim King, iRhythm’s president and CEO spoke to MD+DI ahead of the company’s presentation about the company's success and its goals going forward. “The tool of choice...
Source: MDDI - January 8, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Digital Health Source Type: news

New Study Finds Discrepancies in Cervical Cancer Screening Rates
A new Mayo Clinic study shows that the percentage of women who are screened for cervical cancer could be far lower than national data suggests. The researchers' findings were published in the Journal of Women’s Health and show that less than two thirds of women ages 30 to 65 were up-to-date with cervical cancer screenings in 2016. What’s telling is the percentage is even lower for women ages 21 to 29, with just over half current on screenings. Mayo Clinic Researchers said those figures are well below the 81% screening compliance rate that was self-reported in the 2015 National Health Int...
Source: MDDI - January 7, 2019 Category: Medical Devices Authors: MDDI Staff Tags: IVD Testing Source Type: news

10x Genomics Brings Total Funding to $243M with Latest Round
10x Genomics is kicking off the year with a $35 million extension to its series D round. This brings the Pleasanton, CA-based company’s total financing to date to $243 million. Meritech Capital led the round and Fidelity along with Wells Fargo participated. As a company, we’ve seen tremendous growth and expansion in the last year,” Serge Saxonov, CEO and co-founder of 10x Genomics, said in a release. “We’ve released new products, announced new facilities, and welcomed two incredible companies to the 10x team. Today’s...
Source: MDDI - January 7, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

It ’s a Good Time to False Claims Act-Proof Your Marketing Practices
Conclusion The New Year is an excellent time to review your company’s marketing and sales practices in light of lessons learned from recent enforcement activity in the industry and to set a plan to review them throughout the year.   References 1. In 2012, the Second Circuit overturned a pharmaceutical sales representative’s criminal conviction under the Food, Drug & Cosmetic Act (FDCA) for promoting off-label use of a drug on First Amendment grounds. United States v. Caronia, 703 F.3d 149 (2d Cir. 2012). Several years later a district court in the Second Circu...
Source: MDDI - January 7, 2019 Category: Medical Devices Authors: Stephanie L. Carman and Rebecca H. Umhofer Tags: Regulatory and Compliance Source Type: news

Endologix Voluntarily Recalls Nellix
Endologix said it was initiating a voluntary recall of the existing inventory of its Nellix endovascular aneurysm sealing system. The Irvine, CA-based company said it was limiting the device to only be available for use under clinical protocol with pre-screened patients that adhere to the current indications. Endologix said it was taking these steps in order to ensure optimal outcomes for patients. This decision is one of several actions taken by Endologix following a new management mandate in August 2018 to ensure the most appropriate use of each of its devices and is in alignment with a recent publication by the European...
Source: MDDI - January 6, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Regulatory and Compliance Source Type: news

What Does Verily Have up Its Sleeve with New Financing Round?
If there’s one thing you can count on, it’s that Verily, Alphabet Inc.’s life sciences division, won’t stay quiet for long. Only a few days into 2019 and Verily, formerly Google’s life sciences arm, is already announcing a $1 billion investment round. The South San Francisco, CA-based company said the hefty round was led by Silver Lake, and proceeds would be used to support growth in key strategic areas, including investments in strategic partnerships, global business development opportunities, and potential acquisitions. Other new in...
Source: MDDI - January 4, 2019 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Business Source Type: news

New DVT Device Designed to Tackle Stubborn ‘Wall-to-Wall’ Clot
Vetex Medical recently completed the first-in-man case in a multicenter study of a new deep vein thrombosis (DVT) device that has the potential to reduce hospital stays and costs associated with DVT treatment. The Galway, Ireland-based company said the Vetex Thrombectomy Catheter is the first device to combine rotational and grasping action to quickly and gently remove large volumes of stubborn wall-adherent clot in a single session, without thrombolytic drugs. The first patient was treated by the study’s principal investigator Stephen Black, MD, Narayan Thulasidasan, MD, and their team at Guyâ€...
Source: MDDI - January 4, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: R & D Source Type: news

Veracyte Finds Ally in J & amp;J for Early Lung Cancer Detection
A new collaboration between Johnson & Johnson Innovation and Veracyte, a genomic diagnostics company, will focus on the detection of lung cancer. The long-term agreement will be used to advance the development and commercialization of novel diagnostic tests to detect lung cancer at its earliest stages, when the disease is most treatable. Under terms of the agreement, South San Francisco, CA - based Veracyte and the Lung Cancer Initiative at Johnson & Johnson, whose mission is to prevent, intercept, and cure lung cancer, will combine clinical study cohorts involving more than 5,000 patients with multiple years of cl...
Source: MDDI - January 4, 2019 Category: Medical Devices Authors: Omar Ford Tags: IVD Testing Source Type: news

Angel Medical Systems Goes Bankrupt
Less than nine months after winning FDA clearance for its implantable cardiac monitor system, Eatontown, NJ-based Angel Medical Systems appears to be struggling financially.  Court documents show that the company recently filed for Chapter 11 bankruptcy and is seeking up to $2.5 million in post-petition financing for its bankruptcy plan. Of that, a total of $2 million will convert into Series A preferred shares at a price equal to 78% of the original purchase price. BioInfo Accelerator Fund is the company's largest creditor and Angel Medical owes the firm roughly $43 million total, according to the ...
Source: MDDI - January 3, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Forget Baseline Tests, Eye-Tracking Brings Greater Clarity to Concussion Diagnosis
A hockey player goes to the emergency room with his coach to get checked out for a possible concussion. The clinicians can clearly see that the athlete has been badly hurt but there's another game coming up and all the player can think about is getting back out onto the ice so he tries to game the test.  This is a real example from a patient who was enrolled in a clinical trial evaluating a new concussion diagnosis device that uses an eye-tracking algorithm and does not rely on a baseline measurement for comparison. In this case, the athlete knew the answers he needed to give on the standard symptom checklist i...
Source: MDDI - January 3, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Supplier Stories for the Week of January 1
(Source: MDDI)
Source: MDDI - January 3, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Assembly and Automation Source Type: news

Is Ablative Solutions ’ Latest Financing a Positive Sign for Renal Denervation?
Ablative Solutions latest financing might have just significantly improved investor faith in renal denervation procedures for the treatment of uncontrolled hypertension. The Kalamazoo, MI-based company revealed the first close of its $77 million series D round, which will be used to get its Peregrine System kit through regulatory trials. The firm’s device is a minimally invasive renal denervation technology designed to help reduce blood pressure for people with uncontrolled hypertension, while taking antihypertensive medication. The Peregrine System kit is engineered to target nerves known to influence th...
Source: MDDI - January 3, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

Will Drug-Eluting Devices Suffer from JAHA Publication?
A meta-analysis of randomized clinical trials concluded that there is an increased risk of death for patients treated with paclitaxel‐coated balloons and stents in the femoral and/or popliteal arteries of the lower limbs. At least two drug-eluting device trials have been paused since this analysis was published late last month in the Journal of the American Heart Association (JAHA). Investigators of the BASIL-3 trial and the SWEDEPAD 1 and SWEDEPAD 2 trials have paused recruitment efforts in response to the published findings. Konstantinos Katsanos, MD, PhD ...
Source: MDDI - January 3, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Business Source Type: news

Can a New Tiny Sensor Really Monitor Heart Cells?
A team of engineers and scientists have developed a new sensor that can monitor heart cells with minimal disruption. Researchers from the University of Tokyo, Tokyo Women’s Medical University and Riken in Japan produced the device, which is a soft nanomesh sensor that comes in direct contact with the heart tissue. The idea behind the sensor was conceived by Sunghoon Lee, a researcher at the University of Tokyo. Lee along with other collaborators supplied a healthy culture of cardiomyocytes derived from human stem cells. The researchers placed the nanomesh sensor on the top of the cell culture in a complex...
Source: MDDI - January 2, 2019 Category: Medical Devices Authors: MDDI Staff Tags: Implants R & D Source Type: news

New Technique Could Be a Breakthrough for Motility Research
In this study, we showed a mitigation of these common problems with optogenetic muscle control,” said Hugh Herr, who led the research team and heads the Media Lab’s Biomechatronics group. “This has great promise for the development of solutions for patients suffering from debilitating conditions like muscle paralysis.” The group's research paper was published in the Dec. 13 issue of Nature Communications. Doctors already use electrical nerve stimulation to treat patients with spinal cord injury, and to improve muscle conditionin...
Source: MDDI - January 2, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: R & D Source Type: news

What Will 2019 Bring for Medtech?
(Source: MDDI)
Source: MDDI - December 31, 2018 Category: Medical Devices Authors: Daphne Allen Tags: Business Source Type: news

Edwards Heats up TAVR Market with New Approval
Edward Lifesciences’s long-awaited Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) System has received a nod from FDA. The Irvine, CA-based company had received CE mark for the valve in November. The Sapien 3 Ultra valve features a heightened outer skirt designed to eliminate paravalvular leak. The new delivery system introduces an "on balloon" design, removing the need for valve alignment during the procedure. "The advanced Sapien 3 Ultra system features enhancements on the valve and a new delivery system to address the needs of both patients and clinicians, building on our be...
Source: MDDI - December 28, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

Obalon Scores Funding on the Heels of Obesity Market Shift
Two new funding deals could give Obalon the added firepower needed for it to more effectively compete in the obesity treatment market. The San Diego-based company said it has garnered $30 million from a stock purchase agreement with Lincoln Park Fund and an At-the-market equity sales agreement with Canaccord Genuity. The agreement with Lincoln Park Fund would net up to $20 million while the firm’s agreement with Canaccord Genuity could help bring in about $10 million. Obalon said it could use the proceeds for sales and marketing costs, clinical studies, research and development costs, manufacturing develo...
Source: MDDI - December 28, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news