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MEDICAL DEVICE NEWS MAGAZINE

A DIGITAL PUBLICATION FOR THE PRACTICING MEDICAL SPECIALIST, INDUSTRY EXECUTIVE AND INVESTOR

Medical Device News Magazine

Hello, and welcome to Medical Device News Magazine – a FAST 1, 2, 3 EASY READ!

Our publication is dedicated to bringing our readers the latest medical device news. We are proud to boast that our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy to read publication and its overall purpose and objectives! Wikipedia: A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase. Medical devices vary in both their intended use and indications for use.

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Other Industry Related News

HeartBeam Expands Patient Population for Emergency Department Software Technology Solution

Due to the expanded available patient population, HeartBeam expects to file a 510K with the full data set for clinical validation no later than August 15, 2022 and does not affect the timeline for 510K submission of the Telehealth product.

An Excerpt from Overcoming the Covid Darkness-By Brian Tyson, MD, George Fareed, MD. and Mathew Crawford

Overcoming the Covid Darkness: How Two Doctors Successfully Treated 7000 Patients is available in various formats on Amazon.

Philips Provides Update on their Respironics’ PE-PUR Sound abatement Foam Test & Research Program

"The new and used first-generation DreamStation devices passed volatile organic compound and respirable particulate emission testing." This is very encouraging said Frans van Houten, CEO of Royal Philips

Medicare Bundles See 55-70% Cost Savings with Luna’s In-Home Outpatient PT Program, New Study Reveals

The outpatient PTstudy, the first of its kind, shows that Luna outpatient in-home PT saves an average of $3,000 per case for post-surgical rehab for bundled care cases (both BPCI and CJR), equating to Medicare savings of 55%-70% per case.

GlucoTrack, Inc. Provides Development Update on its Gen 2 Non-Invasive Glucose Monitor

GlucoTrack notes the completion of bench testing and analyses of the Gen 2 clinical prototype system was followed by simulated use testing. During this in-house testing, the Company achieved better than expected accuracy and performance.
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Mergers & Acquisitions

Winner Medical Acquires 100% Stake in Guilin Latex, Expanding into Medical Latex Market

Winner Medical will also expand Guilin Latex's production capacity, boost production value, and build efficient, eco-friendly, and intelligent manufacturing facilities while enhancing its combined advantages in branding, channels, and products.

Dr. Reddy’s Laboratories Announces the Acquisition of an Injectable Product Portfolio from Eton Pharma

Under the terms of the agreement, Dr. Reddy’s acquired the Eton Pharma portfolio for an upfront payment of approximately $5 million in cash, plus contingent payments of up to $45 million.
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Executives on the Move

Rishi Grover Named BD Chief Integrated Supply Chain Officer

Rishi Grover has more than 20 years of experience in manufacturing and supply chain roles, most recently serving as senior vice president of Operations for Carrier.

annalise.ai Appoints Proven Leaders to Key Roles

New annalise.ai leadership team to drive expansion of world's first comprehensive AI radiology platform globally and entry into the US.
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Breaking Medical Device News

Inspira Technologies Develops a Non-Invasive Blood Sensor Designed to Alert Real-Time Change in Patients – Potentially Targets $2.5 Billion ABG Market

Inspira Technologies notes HYLA™ blood sensor intends to reduce the need for actual blood samples to be taken from patients.

PharmaJet Presents Multiple Partners’ Data Demonstrating Superior Immunogenicity With Their Needle-free Systems at BIO International Convention

The presentation, entitled Improved Vaccine and Therapeutic Performance…without the Jab, was presented by Paul LaBarre, MS, MBA, Vice President Global Business Development at PharmaJet, Inc.

Fairtility Granted CE Mark Under New European Medical Device Regulation (MDR) for AI Decision Support Tool, CHLOE EQ

CHLOE EQ™ is an AI decision support tool that was developed to provide Embryo Viability Assessment which supports the prediction of blastulation, the prediction of implantation and ploidy and, ranks embryos in order of priority advises Fairtility.

ColubrisMX, Inc. Announces Corporate Rebranding to ENDOQUEST Robotics™

This rebranding as ENDOQUEST Robotics reinforces their commitment to being the leader in innovation in flexible robotic technology for a wide range of needs in endoscopic surgeries in the years ahead.

Smith+Nephew Announces 1st Robotic-assisted Surgery Using its LEGION CONCELOC Cementless Total Knee System

The LEGION CONCELOC Cementless Total Knee System addresses the critical elements of the cementless total knee through its unique design.

JustLight pbc Developing Sunflower Rx™, a Breakthrough Medical Device Treatment for Alzheimer’s Disease

Sunflower Rx™ uses specific wavelengths of near-infrared light to bypass the skull and be directly absorbed by the brain notes JustLight.
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Funding

Calyxo Raises $32.7 Million in Series C Financing

Calyxo notes the investment round will fund further product development and expansion of their Team.

PhysioMedics Poised for Growth Through Capital Fundraise Following CEO Appointment

Edinburgh-based PhysioMedics secured equity and grant funding totalling £1.5m from Archangels, Scottish Enterprise and Innovate UK.

Advanced NanoTherapies Announces Closing of Oversubscribed $7.2 Million Series A Financing

Funds will be used to complete the first-in-human clinical study in Australia of the SirPlux Duo drug-coated balloon in de-novo coronary artery disease lesions notes Advanced NanoTherapies.
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Clinical Trials

New 12-month Results from RHINTRAC Randomized Controlled Trial Demonstrate Durable Safety & Efficacy of Aerin Medical’s RhinAer for Treatment of Chronic Rhinitis

These results for the trial’s active treatment arm showed that chronic rhinitis symptoms continued to improve through 12 months after treatment with RhinAer.

Two-part Study Finds That Remote Patient Monitoring with Masimo SafetyNet Reduced Length of Hospital Stay for COVID-19 Patients

Masimo SafetyNet is a remote patient management and telehealth solution, that uses tetherless Masimo Radius PPG™ SET® pulse oximetry and a smartphone app to seamlessly transmit continuous home-based patient monitoring data to hospital clinicians.

Nevro Corp Newly Released Clinical Data

D. Keith Grossman, Chairman, CEO and President of Nevro said, "In addition to the strong clinical efficacy for HFX Therapy that has already been shown in our landmark SENZA-PDN trial, these results demonstrate improvement in several important health-related quality of life metrics in patients with PDN."

NeuroVasc Technologies Announces First Patient Treated in Clinical Trial to Evaluate Its Novel Stent-Retriever

This trial will evaluate the safety and efficacy of the NeuroVasc ENVI™-SR, a stent-retriever intended for the treatment of acute ischemic stroke to reduce disability by removing blood clots in patients with stroke due to large vessel occlusion.
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Noteworthy - Views from Our Experts

HVAC Systems in Healthcare: What You Don’t Know Can Hurt You! By: Christopher Roman C.E.M.

Mr. Roman writes, HVAC air distribution systems use air-handling units designed to deliver clean, and tempered air to a specific space with the proper temperatures and relative humidity requirements met before the air is delivered. Read on to learn of it's importance.

Early, Accurate Alzheimer’s Disease Diagnosis Critical for Avoiding the Often-Devastating Impact of Misdiagnosis- By Frank Amato, President and CEO, SYNAPS Dx

Mr. Frank Amato writes, "New methods of diagnosis are needed now more than ever. The most promising breakthrough for identifying Alzheimer's Disease is an autopsy-confirmed, minimally invasive skin test to support clinicians’ definitive diagnosis of AD vs. other forms of dementia. This test has the potential to help patients and families get the right support or treatment path for improved quality of life. Learn more.

Interview with Dan Goldberger, CEO and Director at electroCore

Medical Device News Magazine had an opportunity to interview Mr. Dan Goldberger, CEO, & Director at electroCore who explains the uniqueness of GammaCore and how it differs from prescription medications and IV treatments for migraines.

RTS Tactical Rapid Deploy IFAK By Mendel Berns

Mendel Berns writes, "When treating an injury in the field, time is critical. Every second counts. You need to be ready when called upon to save the life of a team member or perhaps your own." Read what he has to say about having the best medical equipment.

Patient Payments: Top 3 Reasons Healthcare Practices Are Turning to Technology

d'Artagnan Osborne writes, "Technology has come a long way to help improve the patient payment process." He describes how adopting new technology can benefit a healthcare practice and the patient! Read on to learn more.

The Hospital at Home: A New Approach to Patient Care – By Stuart Long, CEO of InfoBionic

Mr. Long writes, "The Hospital at Home model of healthcare gives patients more freedom of choice and autonomy over their own health and treatment decisions." Read his expert views.
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FDA Updates

Xoran Technologies Submits FDA 510(k) Application for TRON

The benefits of truly mobile compact devices cannot be underscored, and now by engineering the success of our head CT systems into an open-bore system, we are able to drive a new generation of Xoran's point-of-care (POC) imaging devices," said Misha Rakic, Xoran CEO.

Renuvion Dermal Handpiece for Wrinkle-Reduction Procedures Cleared by the FDA

The Renuvion Dermal handpiece for specific dermatological procedures is for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II or III.

Hospitals

Manipal Hospitals, Delhi Reports a 27 Year Old Female Patient from Iraq Was Successfully Treated for Systemic Lupus Erythematosus

The patient had Systemic Lupus Erythematosus, a chronic autoimmune illness that can cause inflammation in the heart and other organs. The condition can influence heart ailment which can be observed in over half of lupus patients. The doctors chose to proceed with a robotic MVR as robotic surgeries have proven to be one of the most effective methods and is beneficial for the patient.

Englewood Health Introduces Robot-Assisted Spine Surgery with GPS-like Precision to New Jersey

"This technology takes us to the next era of spine surgery," says Kevin Yao, MD, chief of neurosurgery at Englewood Health. "It facilitates more precise and more minimally invasive spine surgery, which will translate into shorter patient recoveries and better outcomes."
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Imaging & Ultrasound

More Industry Expert Articles

Market Outlook Reports

KA Imaging Unveils New Brand Identify for its Patented Dual Energy Technology

KA Imaging’s SpectralDR™ technology enables dual-energy subtraction, providing bone and tissue differentiation with a single standard X-ray exposure.

Carestream Shares Path to Accelerated Delivery of AI Features at HPE Discover 2022 Conference

Carestream leverages HPE GreenLake's enterprise-grade cloud service for machine learning (ML Ops platform) to accelerate development of its AI applications for medical imaging.
HVAC Systems in Healthcare: What You Don’t Know Can Hurt You! By: Christopher Roman C.E.M.

HVAC Systems in Healthcare: What You Don’t Know Can Hurt You! By: Christopher Roman...

Mr. Roman writes, HVAC air distribution systems use air-handling units designed to deliver clean, and tempered air to a specific space with the proper temperatures and relative humidity requirements met before the air is delivered. Read on to learn of it's importance.
Early, Accurate Alzheimer’s Disease Diagnosis Critical for Avoiding the Often-Devastating Impact of Misdiagnosis- By Frank Amato, President and CEO, SYNAPS Dx

Early, Accurate Alzheimer’s Disease Diagnosis Critical for Avoiding the Often-Devastating Impact of Misdiagnosis- By...

Mr. Frank Amato writes, "New methods of diagnosis are needed now more than ever. The most promising breakthrough for identifying Alzheimer's Disease is an autopsy-confirmed, minimally invasive skin test to support clinicians’ definitive diagnosis of AD vs. other forms of dementia. This test has the potential to help patients and families get the right support or treatment path for improved quality of life. Learn more.
Medical Device News Magazine Interview with Dan Goldberger, CEO and Director at electroCore

Interview with Dan Goldberger, CEO and Director at electroCore

Medical Device News Magazine had an opportunity to interview Mr. Dan Goldberger, CEO, & Director at electroCore who explains the uniqueness of GammaCore and how it differs from prescription medications and IV treatments for migraines.
Article on The Hospital at Home: A New Approach to Patient Care - By Stuart Long, CEO of InfoBionic

The Hospital at Home: A New Approach to Patient Care – By Stuart Long,...

Mr. Long writes, "The Hospital at Home model of healthcare gives patients more freedom of choice and autonomy over their own health and treatment decisions." Read his expert views.
Technology Helps Diabetes Patients Lower Their A1C by Sid Bala

Technology Helps Diabetes Patients Lower Their A1C – By Sid Bala President of Calcium

In the United States alone, almost 40 million people with diabetes face severe health risks due to accompanying chronic conditions like heart disease, stroke, and kidney failure. There is an APP that guides diabetics through easy-to-follow pathways that contribute to increased compliance with their care team’s plan, and most importantly, improved outcomes.
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Notable Articles of Interest

Learn How To Easily Improve Your Patients’ Satisfaction With Your Work

It's no secret that patient satisfaction is a major...

How to Obtain a Position in Medical Coding With No Experience

Although they play a crucial part in the healthcare...

5 Ways To Diversify Your Earnings as a Medical Freelancer

Whether you are a medical freelancer in one specific discipline or a jack of all trades, you've got to understand the best ways to diversify your income.

Health and Lifestyle Changes

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Non-Profit

Investing In Health Could Be Key to Tackling Great Resignation, Argues New Report

The report highlights that 1 in 3 workers in the labor market is aged 50+ (34% of the workforce) and this could rise to 42% of the workforce by 2035, with the proper support and incentives.

Society of Interventional Radiology names Parag J. Patel, MD, MS, FSIR, president for 2022–2023

“As the Society of Interventional Radiology approaches its 50th anniversary, we are transforming how we do business to meet the needs of our diverse membership, giving energy to ideas to help our members thrive in their chosen practice models,” said Patel.

Vascular Quality Initiative (SVS VQI) Announces the Expansion of Medicare Coverage to Standard Surgical Risk Patients within their TCAR Surveillance Project

Effective May 31, 2022, the approval was a combined effort of the SVS Vascular Quality Initiative and the Society for Vascular Surgery Patient Safety Organization should allow for enhanced patient treatment moving forward.

Digital Medicine Society Reports Healthcare Leaders Unite to Demystify Regulatory Pathways and Strategies for Digital Health Products

Over the next few months, Digital Medicine Society and its partners will create an open access, interactive, regulatory science support tool that is based on existing FDA and other agency guidance documents.
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Articles of Interest

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