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Biotechnology News Magazine

Medical Device News Magazine, (division of PTM Healthcare Marketing, Inc., is located in the United States.  We are a digital publication reporting the latest medical device, clinical trials, product launches, funding, mergers/acquisitions and biotech/diagnostic industry news.

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Breaking News

Medline Unveils New CLABSI Prevention Solution

The need for standardization in the vascular access health space is significant, especially with CLABSI incidents rapidly increasing since the onset of the pandemic. According to the Centers of Disease Control and Prevention (CDC), CLABSIs have increased about 24% since the onset of the pandemic.

University of Colorado School of Medicine Will Work with DreaMed Diabetes to Deploy Its Advisor System as a New Resource for Diabetes Device Initiation

“We are truly honored to be part of this project,” said Ryan Hovey, general manager for North America at DreaMed. “We have been able to demonstrate the ability to support endocrinology practices by centralizing patient device data as well as providing evaluation reports and FDA cleared treatment recommendations.

Carestream Continues Drive to Improve Image Quality and Workflow With 45 Patents in 2021

“Carestream continuously strives to deliver cutting-edge technologies worldwide, and these patents demonstrate our commitment to meet the evolving needs of providers and patients alike,” said Eugene Shkurko, Intellectual Property Counsel at Carestream.

Dynamic Technology Solutions Introduces a Self-Diagnostic Tool that Measures Product End-of-Life Risk Exposure

Dynamic's CEO and President, Farida Ali, noted that, "For companies that do not have any EOL risk management disciplines in place, that task can seem complex and daunting. Conversely, for companies that do have relevant EOL-related processes and procedures, there is always the risk of operating with outdated or insufficient protections. In both cases, application of our EOL PrepSM provides a fast and effective way to either design or strengthen an effective risk management strategy."

Semtech’s LoRa® Devices and Ontex Enhance Smart Hospitals and Elder Care

Ontex developed and owns the smart diaper concept, and worked with Belgian medical device agency Zenso Electronics to seamlessly integrate Semtech’s LoRa® devices and the LoRaWAN® standard to alert caregivers via an app when the pad needs to be changed.

ETQ Announces General Availability of a New Advanced Lab Investigation Application; New Version of Reliance NXG to More Easily Identify, Resolve and Analyze Quality Issues

As part of its new release and offerings, ETQ launched new capabilities in its mobile solution, which is now available on the Reliance NXG cloud-native platform. It also expanded its analytics offering, ETQ Insights; and added key usability features to Reliance NXG, ETQ’s market-leading QMS. The new features significantly improve the user experience and boost productivity with streamlined data input, easier system navigation and enhancements that advance ETQ’s market-leading configurability.

WellSky® to Deliver In-Home Protocols for Patients With Heart Failure

Dr. Brent Lampert and Dr. Raymond Benza will lead the program at Ohio State Wexner Medical Center.

- Mergers - Acquisitions

PathGroup Acquires Pathology Consultants, Continuing Expansion Across the Southeastern United States

“PathGroup and Pathology Consultants are complementary partners with shared values. Together we will provide the highest-quality pathology services to our clients and patients,” said David P. Schammel, M.D., Medical Director of Pathology Consultants. “We look forward to working with PathGroup to continue to exceed the expectations of our health systems and physician clients.”

Arsenal Acquires Automation Solutions Provider Eckhart from LFM Capital

Daniel Burseth, Vice President of Eckhart, remarked, "The partnership with Arsenal comes at an opportune time as our customers invest at a record rate in automation for their operations.

- Funding

Enable Injections Announces $215 Million in Series C Financing

The funding from Magnetar will help enFuse continue to redefine intravenous drug delivery by meaningfully scaling development and commercialization efforts.

Diagnostic Imaging

Carestream Continues Drive to Improve Image Quality and Workflow With 45 Patents in 2021

“Carestream continuously strives to deliver cutting-edge technologies worldwide, and these patents demonstrate our commitment to meet the evolving needs of providers and patients alike,” said Eugene Shkurko, Intellectual Property Counsel at Carestream.

About Medical Device News Magazine: Who We Are and What We Do: 1, 2 3 Easy Read!

The publication is one of the industry’s leading sources of medical device and biotech industry updates.

Aidoc Partners with Novant Health

By incorporating Aidoc's AI platform, which includes seven FDA-cleared solutions for triage and notification of patients with acute medical conditions, Novant Health is taking proactive steps to improve patient outcomes and reduce emergency department (ED) length of stay amid resource constraints inflicted by the Omicron variant.

Philips Integrates Cloud-based AI and 3D Mapping into its Mobile C-arm System Series – Zenition

“By partnering with Philips to bring our Cydar EV Maps solution to Philips’ user-friendly Zenition platform of mobile C-arms, we are a step closer to achieving our mission to ensure every image-guided minimally-invasive surgical procedure goes exactly as planned,” said Paul Mussenden, CEO of Cydar.

Clario and XingImaging Expand Partnership

The new expanded offering leverages the joint resources and neuroscience experts of Clario and XingImaging to expedite the startup of clinical trials and drug discovery in China, including amyloid, tau, and other targets.

Mesuron Announces Know-How License Agreement & Stock Purchase Agreement With Mayo Clinic

As part of the agreement, Mayo Clinic became a shareholder in Mesuron Inc.

iMediSync Unveils World’s 1st Integrated Wireless Brain EEG at CES 2022 – iSyncWave™

iMediSync has been selected as a part of the CTA VIP Tour Program and will operate an island booth in the Health & Wellness zone, Tech East-North Hall of Las Vegas Convention Center, booth #8455.

Philips Receives FDA De Novo Clearance for IVC Filter Removal Laser Sheath – CavaClear – with Breakthrough Device Designation

“With the FDA’s clearance of our IVC Filter Removal Laser Sheath – CavaClear – more than one million patients and their physicians now have access to a safe, effective and efficient option for advanced IVC filter removal,” said Chris Landon, Senior Vice President and General Manager Image Guided Therapy Devices at Philips.


A Conflict in the Interpretation of the Medical Device Amendments: Developing a Preemption Test for Hybrid Medical Devices

In 1976, Congress passed the Medical Device Amendments (MDA) to charge the FDA with reviewing the safety and effectiveness of medical devices. The MDA heavily regulates high-risk medical devices that are capable of supporting human life through a premarket approval process. Read what a litigation associate in BakerHostetler’s Houston office advises.

Growing Trends and Solutions for Improving Liver Health Management

Author Jon Gingrich, CEO, Echosens North America writes, "Nonalcoholic fatty liver disease (NAFLD) is an asymptomatic and underdiagnosed disease that affects 37% of U.S. adults and 70% of individuals with Type 2 diabetes. Nonalcoholic steatohepatitis (NASH), the more severe form of NAFLD marked by inflammation and ballooning, can lead to hepatic fibrosis, cirrhosis, and hepatocellular cancer (HCC) if left untreated." Read more.

Exploring the Future of Bluetooth Hearing Aids

Pauline Dinnauer is the VP of Audiological Care at Connect Hearing, which provides industry-leading hearing loss, hearing testing, and hearing aid consultation across the US. Read what she has to say.

The Fifth Cardio-Vascular Revolution?

Artificial Intelligence and unsupervised Machine Learning and Role of the “COMENDA” physiCian, cOMputer ENgineer, DAta scientist! Prof Sherif Sultan, MD FRCS FACS Ph.D. writes, As cardiovascular specialists and key opinion leaders, we must prepare to meet the technological demands and beyond. We must develop, deliver and learn how to survive the future of technology as innovators and early adaptors and lead through the "Fifth Cardiovascular Revolution". Read more about what Professor Sultan has to say.

The Burden of Venous Leg Ulcers and Limited Health Literacy

Successful medical recovery often relies on a patient’s ability to independently manage and actively improve their own health condition. Being able to do this effectively requires an adequate level of health literacy (HL) – the ability to understand and act on healthcare advice to help oneself recover effectively. Read Bernard Ross, CEO and founder, Sky Medical Technology views.

Types of Urinary Incontinence and When to See a Doctor

Considering your age, you might think that you don’t have to worry about urinary incontinence. While it’s true that it usually affects the elderly, it can happen to anyone. This article provides several types of urinary incontinence and when you should see a doctor. Read on to learn more.

Clinical Trials, Studies, Registries, Data

TRANSFORM II Randomized Controlled Trial Underway

TRANSFORM II RCT, determined to explore and evaluate the treatment options in native coronary vessels, enrolled the index patient on the 16th December 2021 at Sandro Pertini Hospital, Rome, by the team of Dr. Alessandro Sciahbasi.

FX Solutions, SAS. [FX Shoulder, Inc.] Completes Easytech Reversed® Stemless IDE Enrollment in the USA

"This is not only a major milestone for FX, but for the next generation of stemless shoulder arthroplasty and the way we think about reverse total shoulder arthroplasty. As a small company, we are excited and humbled to lead the way and be the first to complete this historic study that may bring a novel device to the U.S. market which has already seen over 2000 implanted in Europe since 2015," said Baptiste Martin, CEO of FX Shoulder USA.

NEJM: New Data on COVID-19 Lung Transplants

The analysis of more than 3,000 lung transplants in the U.S. between Aug. 1, 2020, and Sept. 30, 2021, showed that during the pandemic, 7% of the nation’s lung transplants were performed to treat severe, irreversible lung damage caused by COVID-19. More than half of these patients needed ventilators or extracorporeal membrane oxygenation, or ECMO, before their transplant.

Preclinical Study Provides Guidance for Optimizing Safety and Efficacy of Endovascular Hepatic Denervation Devices to Treat Diabetes

“This study leveraged our deep experience in preclinical evaluation of denervation therapies and could not have been performed in a timely manner without the digital morphometry techniques we developed in-house. We remain excited about the potential of neuromodulation technologies and are committed to supporting further innovation in this space,” explained Rami Tzafriri, PhD, lead author and Director of Research and Innovation at CBSET.

Checkpoint Surgical Enrolls First Patient in Nerve Regeneration Clinical Study

The patient was enrolled at The Ohio State University, one of four sites actively enrolling patients in the double-blind, randomized clinical trial.

Real-World Evidence Study Demonstrates Intersect ENT’s PROPEL® Sinus Implant Reduces Healthcare Resource Utilization

Patients receiving PROPEL® following endoscopic sinus surgery had statistically significant lower healthcare resource utilization over a postoperative period of 18 months, including all-cause otolaryngologist, ER/urgent care and outpatient visits, as well as sinus-related endoscopies

IMPRESSION Randomized Trial: Past the Halfway Mark and Progressing Rapidly

The sirolimus coated balloon thus seems to be a promising option as the Magic Touch - AVF was granted breakthrough device designation by FDA in 2019, and the IMPRESSION RCT will provide the much-needed data.

FDA Updates

FDA Accepts Label Update for Plasma IQ™, the First FDA-Cleared Handheld Plasma Energy Device

The removal of this specific contraindication was due in part to a compilation of literature provided to the FDA showing the safety and efficacy of the ablative device on skin tissue, particularly around the eye area. This label update allows Suneva to address treatment around the eye with patients in the United States.

Insulet Announces FDA Clearance of its Omnipod® 5 Automated Insulin Delivery System

Omnipod 5 is the first tubeless automated insulin delivery (AID) system that integrates with the Dexcom G6 Continuous Glucose Monitoring (CGM) System and a compatible smartphone to automatically adjust insulin and help protect against highs and lows.

Medtronic Reports FDA Approval of Spinal Cord Stimulation Therapy for Treating Chronic Pain Resulting from Diabetic Peripheral Neuropathy

This new indication enables us to apply Medtronic's more than 40 years of proven SCS experience, as well as the company's deep diabetes expertise, to deliver better care to even greater numbers of diabetes patients.

Cardiovascular Systems, Inc. and OrbusNeich Announce FDA PMA Approval of Scoreflex® Scoring Balloon

Scott Ward, CSI’s Chairman, President and Chief Executive Officer, said, “We remain committed to expanding our portfolio of differentiated products that help physicians deliver improved outcomes for patients with complex coronary artery disease.

Nevro Reports FDA Approval for Expanded Labeling for Senza® Spinal Cord Stimulation System

This approval is specific to Nevro's proprietary 10 kHz Therapy and differentiates Nevro's Senza System as the only SCS system with specific labeling to treat NSRBP patients.

Endomina System, a New Suturing Tool for Use by Gastroenterologists Receives FDA Clearance

“This technology is a very meaningful addition to our armamentarium for performing procedures requiring suturing,” said Dr Ivo Boškoski from Policlinico Gemelli, Rome, Italy.

VUZE Medical Announces U.S. FDA 510(k) Clearance for Its VUZE System

VUZE Medical, a privately held medical technology company aimed at transforming image guidance and verification in minimally invasive spine surgeries, has received 510(k) clearance...


US Med-Equip Appoints 4 New Chief Executives

"We sought out superstars and brought in the best executives in their fields to join our burgeoning team. They will be instrumental in building on the growth of our company and our community of employees and healthcare partners we support," Salario said. Read who they are.

Perineologic Appoints Jim Fortune as President and Promotes Matthew Allaway, DO, to Chief Executive Officer

Mr. Fortune served as chief operating officer at Ocular Therapeutix, Inc. Dr. Allaway is the founder of Perineologic and has been a practicing urologist and managing partner at Urology Associates in Cumberland, Maryland.

OKAY Industries Promotes Danielle Koonz to Strategic Accounts Manager

“Danielle is a dedicated team member, adept at fostering relationships with our strategic business partners and internal customers while exemplifying our company values,” said Sean Stowik, Director of Sales and Marketing. 

Dr. Yehia Hashad New EVP of R & D & CMO at Bausch + Lomb Corporation

Dr. Yehia Hashad will join Bausch + Lomb from Allergan/AbbVie, where for the past 11 years he held various roles, including leading Allergan's global clinical development program for its eye care portfolio.

Babson Diagnostics New Executive Hires

“I am excited with the level of passion, talent, and expertise we have brought to Babson,” said David Stein, chief executive officer. “These executives all possess strong backgrounds in healthcare, as well as a passion for advancing our values. They will help us achieve our vision of making routine blood testing easier, more accessible and less invasive.”

Professor Daniel Brodie Joins the Inspira Technologies’ Advisory Board

Prof. Brodie is the Section Chief for Critical Care within the Division of Pulmonary, Allergy and Critical Care Medicine, the Director of the Adult ECMO Program and the Director of the Center for Acute Respiratory Failure at the Columbia University/New York-Presbyterian Hospital.

Market Reports

Healthcare BPO Market Is Projected to Reach $468.5 Billion. Here’s What America Is Outsourcing

According to Indian-based market research firm Markets and Markets, the healthcare BPO industry is seen to grow at $468.5 billion before 2026 from the projected $296.4 billion in 2021, at a compound annual growth rate (CAGR) of 9.6% in the five-year period. Learn more.

Market Reports

ACI Donates 500,000 N95 Respirators to Project N95

“Throughout this pandemic our focus has been on protecting healthcare workers and our general population by providing an affordable, quality American-made N95 for as many Americans as possible.

Intelligent Implants Taps Leading Medical Device Entrepreneur, Benjamin A. Hertzog, PhD, as CEO

Dr. Hertzog will lead the progression of product development, clinical, and commercial activities for the company’s novel and proprietary smart orthopedic implant platform.

Earning A DNP Degree: Is It Worth It?

A DNP degree isn't for everyone - the average cost of a four-year DNP program can be upwards of $100,000, which can take decades to pay off. Learn more

Strong Writing Skills for Practicing Nurses – Is It a Necessary One for a Nursing Student?

Prominent writing skills are crucial for any scientific industry, particularly for future nursing experts who should establish trusting communication with patients and colleagues. Good...

- Robotics

Surgeons Complete Robotic-Assisted Lung Transplant

Unlike routine lung transplantations, where surgeons usually create a “clamshell” incision which involves cutting apart the breastbone, the Smidt Heart Institute developed a technique requiring only a small incision between the ribs—just large enough to remove a patient’s old, deflated lungs and then, insert and inflate the new donor lungs.  

Hospitals in the News

Genetic and Lifestyle Calculator Reveals Which Younger Adults Are Most at Risk of Colorectal Cancer

Led by researchers at NYU Langone Health and its Laura and Isaac Perlmutter Cancer Center, the new study showed that those with the highest, or top third, combined polygenetic and environmental risk scores were four times more likely to develop colorectal cancers than men and women who scored in the bottom third.

Peerbridge Health & Northwell Health Launch Pilot Program to Optimize Treatment for AFib Patients at Lenox Hill Hospital

The pilot aims to help cardiology and sleep physicians better understand the critical link between the two conditions, and how best to quickly and effectively treat AFib and OSA concurrently.

Good Samaritan Medical Center Brings New Technology and Services to the Newly Redesigned Norma E. & Miles M. Zisson Comprehensive Breast Center of the...

The Palm Beach Health Network invested nearly a quarter of a million dollars into the center, bringing a sleek and calm aesthetic look, along with some of the newest high-end technology for patients being treated for their breast health.

With a $50 Million Gift, USC and UC San Diego Join Forces in Alzheimer’s Research

The gift will be split evenly, with $25 million going to each institution. The funding will support existing research at each university and will spark new collaborative efforts to discover effective therapies for Alzheimer's disease.

ALYN Hospital Receives a $2.2M Grant

"The new research center will allow us to expand our research and clinical trials, recruit additional professionals in the field, and continue to advance pediatric and adolescent rehabilitation in Israel and around the world," says ALYN Hospital's Director General Dr. Maurit Beeri.

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