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Monday, December 10, 2018

In the Spotlight



Welcome!  Medical Device News Magazine reports breaking news including clinical trial updates, product launches, profiles of device companies, acquisitions, executives on the move, non-profit and medical society news and more. Read by by practicing medical specialists, industry executives, investors and other allied health professional. We invite you to visit our magazine daily!

12/7/18: BluePrint reclassified 85 percent of tumors identified as HER2-amplified by IHC/FISH to non-HER2 molecular subtype and clarified the biology of HER2 "equivocal" breast cancer. 46 percent of women under 50 years of age with an intermediate recurrence score identified as MammaPrint Low Risk enabling greater certainty in treatment management approaches
12/7/18: Professor Thomas Zeller, Director of the Department of Angiology at Unversitaets Herzzentrum, Freiburg in Bad-Krozingen, Germany and Principal Investigator of the ENTRAP Study notes, "The Vanguard IEP System is designed to protect patients at high risk for embolization during peripheral angioplasty, such as those with acute limb ischemia, severe calcification, and chronic total occlusions if crossed intraluminally. It is also well suited to protect patients at high risk for complications should embolization occur, such as those with poor distal run-off."
12/6/18: More than 240 leading rehabilitation centers in over 30 countries helped their patients walk 50,000 miles in the EksoGT exoskeleton during rehab sessions— the distance of walking around the world twice.
12/6/18: Dr David Tuch, CEO of Lightpoint Medical commented “We’re pleased to have secured this growth finance to prepare the company for commercial scale-up. In particular, it’s a pleasure to see the substantial number of our previous investors following on as well as to welcome our new shareholders. With this new funding, we’re looking forward to commercial launch of our laparoscopic probe which we believe will be game-changing for minimally invasive surgery.”
12/5/18: This PMA filing submitted by Axonics is referred to as a “literature-based PMA”. While most PMAs are supported by original clinical investigations, in rare cases, literature-based evidence may be accepted as the sole basis for approval of a PMA to establish reasonable assurance of safety and effectiveness when the literature is sufficient, detailed, objective, and directly applicable to the subject device. In this PMA filing, Axonics has submitted existing literature reporting on InterStim II®, manufactured by Medtronic plc, the only currently approved SNM device.
12/4/18: The study will evaluate the safety and effectiveness of HELIOSTAR Multi-electrode Radiofrequency (RF) Balloon Ablation Catheter in treating symptomatic drug refractory recurrent paroxysmal (intermittent) atrial fibrillation (AF). Up to 640 patients will be enrolled in as many as 40 clinical sites worldwide.
12/4/18: Journal of Surgical Research published study shows that reductions in surgical site infection (SSI) lead to substantial cost savings for hospitals.
12/4/18: Jonathan Glenn, Chief Executive Officer of Consort Medical, commented, “Consort has delivered profit growth and improved margins in both divisions. Bespak has grown its respiratory business while Aesica margins and profits have improved. We are committed to driving continued growth in the business.
12/4/18: Journal of Surgical Research published study shows that reductions in surgical site infection (SSI) lead to substantial cost savings for hospitals.
12/4/18: Jonathan Glenn, Chief Executive Officer of Consort Medical, commented, “Consort has delivered profit growth and improved margins in both divisions. Bespak has grown its respiratory business while Aesica margins and profits have improved. We are committed to driving continued growth in the business.
12/4/18: De Novo Classification Proposed Rule builds on FDA’s earlier work to provide structure, clarity, & transparency to the De Novo classification pathway.
12/3/18: FDA's Breakthrough Devices Program was established in late 2016 to help patients gain timely access to breakthrough technologies that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases, for which no approved or cleared treatment exists or that offer significant advantages over existing or cleared alternatives.
12/3/18: "We take compliance with FDA regulatory requirements seriously and we took immediate action following the July notice to work with the FDA to review and resolve their questions," said Lior Dayan, CEO of Alma Lasers, Ltd.
12/3/18: The TERMINATE AF trial, a multi-center study evaluating two surgical ablation devices - the Cardioblate(TM) Irrigated RF (IRF) System and the CryoFlex(TM) Surgical Ablation System - for the treatment of non-paroxysmal (persistent or longstanding persistent) atrial fibrillation (AF) in patients undergoing open-heart surgical procedures.
11/28/18: “Stanley InnerSpace is a long-established business with a strong brand presence,” said Solaire Medical President Ben Barber. “Combining the brand recognition of InnerSpace with the innovative, best-in-class design of Solaire Medical products brought us to a redesigned new product line that we call InnerSpace by Solaire Medical.”
11/28/18; Korean-American med-tech company NEOFECT today officially began trading on the KOSDAQ, securing more than $17 million in funding.
11/28/18: "We recognized that the OR supply chain is not only one of the most expensive areas in a hospital, it's also one of the most challenging. By ensuring that resources are in the right place and available when needed, we help our customers maintain their focus on improving on improving patient care," said John Roy, vice president and general manager of WaveMark™ at Cardinal Health. "The sheer scale, complexity and unique requirements of the OR call for a supply chain solution developed specifically for the OR, which considers aspects of people, process and technology."

Market Reports

Global Guidewires Market Outlook to 2023

12/5/18: The rise in the global guidewires market is attributed to rapid growth in the interventional procedures using guidewires for the device delivery.

Global Neurostimulation Devices Market Forecasts (2018-2023): Projected to Register a CAGR of 10.29%

12/5/18: The growth in the neurostimulation devices market may be attributed to the increasing prevalence of chronic neuro-muscular disorder and rising adoption of these devices by the physicians.

Global Medical Lasers System Market Analysis 2017-2018 and Forecast to 2026

11/9/18: Medical Lasers System Market accounted for $1.87 billion in 2017 and is expected to reach $6.11 billion by 2026 growing at a CAGR of 14.1% during the forecast period.

The Global Spinal Fusion Devices Market is Forecast to Grow at a CAGR of 3% During 2018-2024

11/4/18: High cost of treatment is hampering growth outlined in this report.

Global Ureteroscopes Market Outlook 2018-2024

11/2/18: The report predicts the global ureteroscopes market to grow with a CAGR of 4.3% over the forecast period of 2018-2024. The study on ureteroscopes market covers the analysis of the leading geographies such as North America, Europe, Asia-Pacific and RoW for the period of 2016 to 2024.

Service Robotics Worldwide Markets to 2026

11/1/18: According to this report, the Global Service Robotics market accounted for $10.77 billion in 2017 and is expected to reach $44.68 billion by 2026, growing at a CAGR of 17.2% from 2017 to 2026.

Cardiac Biomarker Diagnostic Test Kits Market Would Reach US$ 2,540.8 Mn by 2028

10/16/18: the global cardiac biomarker diagnostic test kits market is projected to expand at a CAGR of 5.1% during the forecast period 2018-2028 and reach US$ 2,540.8 Mn by the end of 2028.

Urolithiasis Management Devices Market to Earn US$1.78 Billion by 2024 With Rising Number of Geriatric Population

10/5/18: As per the TMR report, the global urolithiasis management devices market is estimated to earn US$1.78 bn by the end of 2024. The market is presumed to expand to 4.5% CAGR within the forecast period of 2016 to 2024.


12/7/18: "Mike's understanding of our business and his experience handling complex matters at publicly-traded companies positions him strongly to add value to our board," said Gregory Kenny, chairman of the board for Cardinal Health.
12/4/19: “Bob Paulson and Phil Soran are both accomplished business leaders and experienced board members, and we feel fortunate to have them join our Board of Directors,” said John Booth, Spineology’s Chief Executive Officer. “We think they’ll add great value to the board and we look forward to leveraging their unique skill sets as we continue to scale the business.”
12/3/18: Ms. Winowiecki serves as the executive director of research strategy and portfolio management at Zoetis, the leading global animal health company.
11/28/18: Genevieve Morris served as the Chief Health Information Officer for the VA's Office of EHR Modernization and Principal Deputy National Coordinator for the Office of the National Coordinator.

Non-Profit News

12/6/18: “The AAOS is encouraged by the recommendations made by the Administration to reform the American health care system through increased choice and competition. We share the mutual goal of delivering high quality care at affordable prices and want to emphasize our support for the following recommendations—many of which the AAOS has long advocated for at both the state and federal level on behalf of our members and their patients.
12/5/18: The surgical procedure, 'Unicondylar knee Arthoplasty', performed as outpatient orthopaedic surgery, by Dr. Vetri Kumar, Consultant Orthopaedic Surgeon, Parvathy Hospital and his team of orthopaedic surgeons is considered as a major milestone in the history of Orthopaedic surgeries in Asia. Parvathy Hospital has named this milestone as M.I.N.O.R.S - Morning In Night Out Replacement Surgeries.
12/5/18: The patient, a 68-year old university mathematics professor from the Democratic Republic of Congo, was becoming blind in his one sighted (left eye) after he had already lost vision in his other (right) eye, following unsuccessful cataract surgery in his home country.
12/1/18: Heart attacks reoccurred more frequently in younger patients with several modifiable risk factors, including smoking and high blood pressure. Researchers on the new study, presented at the American College of Cardiology Asia Conference 2018 in Shanghai, suggested secondary preventive programs for younger patients should target modifiable risk factors.