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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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JUNE Medical Launches Semi-Blunt Hooks for the Galaxy II® Retractor

Angela Spang, CEO of JUNE Medical, added: “The new Semi-Blunt hook brings together the best of both worlds – a strong, elastic hold and reduced tissue trauma.

Stryker Announces First Patient Case Using New Tornier Perform® Patient-Matched Primary Reversed Glenoid

The case was completed Jan. 13 by Jay Keener, M.D., in St. Louis and will be highlighted in a presentation at the 2022 Advanced Shoulder Arthroplasty (ASAP) Meeting on Jan. 21 in Snowbird, Utah.

Successful First-in-Human Use of BENDIT21 Neurovascular Catheter Performed at the University of Texas Southwestern Medical Center

Yossi Mazel, CEO of the Petach Tikva-based medical device company added, "This first-in-human case in the US together with other cases done in Israel and Europe, has demonstrated the potential of our steerable microcatheter to access torturous anatomies.

GPX Embolic Device Success in Challenging Tumor Case

“Treating a tumor with multiple feeding vessels in a controlled, thorough manner without risk of catheter entrapment can improve patient care and minimize the need for follow-on procedures,” said Libble Ginster, CEO of Fluidx Medical Technology. 

Feinstein Institutes Bioelectronic Medicine Scientists Develop First-of-its-Kind Wireless Neuromodulation Device for Research

“Neuromodulation and bioelectronic medicine hold the potential to treat a variety of diseases without the use of traditional pharmaceuticals and their potential side effects, however, scaling devices to the size needed for studies in mice has been very challenging,” said Timir Datta, PhD, assistant professor in the Institute of Bioelectronic Medicine at the Feinstein Institutes and senior author on the paper.

Sensydia Receives FDA Breakthrough Device Designation for CPSTM Non-Invasive Cardiac Monitoring Device

Through its ultra-sensitive biosensors, CPS acquires heart sound data and applies machine learning to compute multiple hemodynamic measurements, delivering all in one comprehensive report via the CPS iPad app.

2022 Catalyst Award Winners

Catalyst Awards Conference and Dinner is on March 17, 2022. Winners will be recognized for accelerating opportunities for women and increasing women’s representation and inclusion across intersections of identity within their organizations.

GORE® CARDIOFORM Septal Occluder Marks 10 Years of Improving Lives

The device is backed by the Gore REDUCE Clinical Study, a groundbreaking study in which 664 patients were enrolled to evaluate whether PFO closure with the GORE CARDIOFORM Septal Occluder or the GORE® HELEX® Septal Occluder plus antiplatelet therapy significantly reduces the risk of stroke compared to antiplatelet therapy alone.


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.


How COVID-19 Has Spurred A Shift to Broad-Spectrum Countermeasures Against Viruses

James A. Joyce writes, "On March 24, 2020, the U.S. Department of Health and Human Services declared that the emergence of COVID-19 justified the Emergency-Use Authorization of drugs, biological products, and medical devices to combat the pandemic. Read what he has to say.

What To Keep In Mind Before Starting Your Own Private Clinic

This guide demonstrates how you can build and run your own medical clinic from scratch. Read on.

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.

Concrete Action for Climate Change – Interview with a Key Opinion Leader

Jesper Jonsson, Director of Medical Devices at Owen Mumford shares his thoughts on last year’s key sustainability topics and outlines how Owen Mumford is developing its own sustainability commitments. Read on.

The FDA Just Approved Remote Care For Cochlear Implants: Here’s What That Could Mean for You

Cochlear Limited has officially announced FDA approval and clearance for remote assist capabilities on several of its implants. Here's what that means for you. Dr. Renee Flanagan is the Director of Audiological Care at Hearing Planet. Read more about what she has to say,

━ Clinical Trials

Patient Enrollment is Complete in the DOD-Funded Study of Extracorporeal Hemopurification of Critically Ill COVID-19 Patients

“We expect the first peer-reviewed PURIFY-OBS clinical trial publication soon, now that the study has concluded. We are pleased to see these consistent and very positive results and we’re pleased to know we have helped save the lives of many critically-ill COVID-19 patients,” said ExThera Medical CEO Robert Ward.

AtriAN Medical’s Clinical Data Update on the Neural AF Multi-center Study

Pioneering cardiac autonomic pulsed field ablation (PFA) technology provides a unique option for enhancing the durability of AF ablation.

Restrospective Study Finds That Masimo SET® Pulse Oximetry Has No Difference in Accuracy or Bias Between Black People and White People

By comparison to the Masimo finding of 0.15% difference in bias between black and white subjects, the 2020 letter to the editor reported a difference in bias of 8.1% in a cohort of black and white hospital patients2 – 54 times higher than the Masimo result.

1st Patient Implanted in Integrated Spinal Fusion & DRG Neuromodulation Proof-of-Concept Study

The study involves combining spinal fusion with the implant of a neurostimulator to provide stimulation of the DRG, a key nerve structure along the spine that can be targeted with neuromodulation to treat chronic neuropathic pain.

Robocath Concludes 1st European R-Evolution Clinical Study

The study was aimed at assessing the safety and efficacy of the R-OneTM robotic assistance platform. Sixty-two patients across six European hospital centers participated

Breakthrough in Device Therapy for Patients with Late-Stage Heart Disease

The trial was conducted at the internationally recognised Centre of Excellence at the Catholic University of Leuven, in Belgium. The success of this ground-breaking study marks a further step in the integration of the two companies who are committed to taking this life changing innovation in partnership to patients across the globe.


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━ FDA Updates

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 from the U.S. Food and Drug Administration (FDA) for its VUZE™ System. Using proprietary image processing,...

━ Mergers ━ Acquisitions ━ Funding

PolyPhotonix Secures Multimillion Pound US Investment and Strategic Alliance for Sight Saving Mask

Prevail Partners, LLC, an affiliate of InfoWorks, has agreed to invest significantly in PolyPhotonix upon the commencement of the FDA clinical trial as lead investor in a $10M Series A investment round. Successful completion of the FDA clinical trial will open the US market to the treatment.

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.

ENPICOM Secures Series B Funding

BOP Capital leads investment round supported by ENPICOM’s existing investors

ACON Exits iiMED Medical Solutions and Completes Full Exit of its IIMAK Investment

"ACON's experience and resources were instrumental in fueling iiMED's accelerated organic growth over the past three years. Our partnership with ACON was highly collaborative and critical to our success. We are excited to partner with TEAM to further build upon our exciting growth trajectory," said Bill Flaherty, CEO of iiMED.

━ Executives

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

Insights on the Refractive Surgery Devices Global Market to 2027 – Featuring Alcon, Avedro and Certara Among Others

The "Refractive Surgery Devices Market Research Report by Product Type, by End-user, by Application, by Region - Global Forecast to 2027 - Cumulative Impact...

Insights on the Ophthalmic Equipment Global Market to 2027

The "Ophthalmic Equipment Market Research Report by Product, by End-user, by Region - Global Forecast to 2027 - Cumulative Impact of COVID-19" report has...

Global Point-of-Care Molecular Diagnostics Market, Forecast to 2028

The "Point-of-Care Molecular Diagnostics Market Forecast to 2028 - COVID-19 Impact and Global Analysis" report has been added to ResearchAndMarkets.com's offering. The global point-of-care molecular...

Global Wearable Injectors Market (2021 to 2026) – by Type, Technology, Application, End-user and Region

The "Wearable Injectors Market By Type, By Technology, By Application, By End-User, And By Regions - Global & Regional Industry Perspective, Comprehensive Analysis, and...

━ Non Profit Updates

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.

Londoners Learn to Smell Again

bScent is a charity registered in England and Wales since 2019 and has created an unrivalled resource of trusted information delivered by a distinguished advisory board and working with the latest scientific and clinical evidence. AbScent advocates to increase understanding and raise awareness of the conditions and their impacts supporting research into smell conditions.

Higher Olive Oil Intake Associated with Lower Risk of CVD Mortality

The study found that replacing about 10 grams/day of margarine, butter, mayonnaise and dairy fat with the equivalent amount of olive oil is associated with lower risk of mortality as well.

The Great Composites Ride to JEC 2022 for Mind

Geraint Havard said “I am delighted to support Gemma on this ride. The longest I have ridden a bike for in the past is probably 2 hours, so to do 3 days straight riding will be a huge challenge, but one we both relish.

━ Hospitals

Capital Health Licensed to Perform Elective Cardiac Catheterization

Capital Health now has two licensed cardiac catheterization labs at its Hopewell campus and expanded offerings in its Heart and Vascular Institute. This expansion is the result of a New Jersey law signed by Gov. Phil Murphy in early 2021 that allows all qualifying hospitals to perform non-emergency angioplasty.

Delray Medical Center Is 1st Hospital in Palm Beach County to Use Ensite X System

“This is just another way we are providing top notch cardiovascular services to our patients who can get the highest quality care right here in Palm Beach County,” said Dr. Jean-Pierre Awaida, medical director of the catheterization-lab at Delray Medical Center.

Innovaccer Offers New ‘Public Health Command Center’ at No Cost to Public Health Departments and Hospitals to Assist with Omicron Surge

nnovaccer offers a ready-to-deploy solution that provides operational analytics, actionable insights, and clinically contextual patient engagement to help hospitals manage capacity, optimize operations, and improve care experiences and outcomes.

Softhread Announces Successful Completion of a Pilot with the MDEpiNet Coordinating Center at Weill Cornell Medicine

The ecosystem has been built using High-performance Integrated Virtual Environment (HIVE) as provided by DNAHIVE and Blockchain data provenance and smart contract-driven permissioning system as provided by Softhread.


━ Articles of Interest

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