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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 Device News

8 Ingredients To Look For When Searching For The Best Fat Burner

Losing weight can be a long and annoying process...

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.

Cardiovascular Systems, Inc. Announces Development of Intravascular Lithotripsy Technology for the Treatment of Coronary and Peripheral Artery Diseases

Scott R. Ward, Chairman, President and CEO, said, “The development of an IVL system for the treatment of coronary and peripheral artery disease will uniquely position CSI to provide the right device, for the right lesion, for all physicians.

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,

Vios Fertility Institute – St. Louis and TMRW Life Sciences Launches State-of-the-Art Cryo Management Technology for Fertility Specimens

TMRW’s technology provides the world’s first and only fully automated specimen management platform (CryoRobot) that identifies, tracks, and manages frozen eggs and embryos - central to almost every IVF journey.  Vios Fertility Institute’s Chicago lab was the first in the world to adopt this revolutionary technology in early 2021.  

LG Announces U.S. Launch of CLOi ServeBot, World’s First Service Robot to Achieve UL Certification

“The LG CLOi ServeBot is truly a breakthrough for all kinds of consumer-focused businesses, from restaurants to retail stores to hotels,” Jeffrey Weiland, B2B robotics team leader at LG Business Solutions USA

iSTAR Medical Shows Initial Positive Progress of US STAR-V Trial for MINIject

Pivotal trial of MINIject, STAR-V, now initiated in 13 sites across the US. Positive feedback from world-leading glaucoma surgeons involved in the trial. MINIject is the only commercially available MIGS device targeting the supraciliary space. Commercial rollout continues following European approval in 2021

Regulators Approve Impella 5.5 With SmartAssist in Japan and Hong Kong; US FDA Grants Impella BTR Conditional IDE Approval for First-in-Human Early Feasibility Study

“The Japanese market is ideal for Impella 5.5 with SmartAssist because the technology provides minimally invasive, longer-term unloading support, enabling native heart recovery in a country that is more resistant to invasive sternotomies and heart transplants,” said Michael R. Minogue, Abiomed’s Chairman, President and Chief Executive Officer.

━ Diagnostic Imaging

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.

MUSC Health Executes a Contract with Sectra for Enterprise Imaging

The contract, signed in December 2021, includes radiology and breast imaging modules.

Perimeter Medical Imaging AI Announces First Commercial Installation of Perimeter S-Series OCT in North Texas and Ongoing Market Development Activities Across the U.S.

Jeremy Sobotta, Perimeter’s Chief Executive Officer stated, “We are extremely pleased to announce the first commercial installation of our Perimeter S-Series OCT system. This meaningful validation of our ‘go-to-market’ strategy is an historic event for the Perimeter team, our shareholders, the physicians with whom we collaborate, and the patients in their care.

━ Noteworthy

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,

A Must-Have Medical Supplies for Home Health Care

To help you out, we have compiled a list that can help you learn what medical supplies are a must-have for home health care and where you can find them.

How Simulation is Revolutionizing Surgery for Both Surgeons and Patients

by Raimundo Sierra, Ph.D., Co-Founder, VirtaMed. He writes, "As the world continues to advance technologically, medical education must follow suit."

━ Clinical Trials

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.

Published VITAL Study on Bactiguard’s Endotracheal Tube

The study data indicates that by using a Bactiguard endotracheal tube the risk of this complication is significantly reduced", says Professor Pierre Damas.

Leman Micro Devices: World-first Clinical Trial Update

Dr. K. Saumya, Principal Investigator for the trial, said “This device will be a real life-saver in India. It is small and affordable and will alert people to the need to consult a doctor about their blood pressure before they have symptoms and before it gives rise to awful consequences such as stroke, kidney damage, heart attack or blindness”.

HeartPoint Global Announces Successful Pre-Clinical Trial of New Implant System

“It is encouraging to see that our Implant System has seen significant results in pre-clinical testing, especially as we prepare for our first clinical trials,” said Seth Bogner, Chairman & CEO of HeartPoint Global.


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━ FDA Updates

FDA Approves Cochlear Nucleus Implants for Unilateral Hearing Loss/single-sided Deafness

Cochlear implants are already FDA approved for those with moderate to profound bilateral sensorineural hearing loss. With this approval, for the first time Cochlear can expand implantable treatment options for those with UHL/SSD to include cochlear implants.

Lazurite™ Announces FDA 510(k) Submission for its ArthroFree™ Wireless Camera System

“This FDA submission marks an important milestone in our commitment to bring an advanced wireless surgical camera to market," said Eugene Malinskiy, chief executive officer and co-founder of Lazurite.

FDA Pre-Submission Filed for Cardio inCode-SCORE

Matthew Walls, CEO of GENinCode Plc, said: "Despite the delays driven by the pandemic, the filing of the Cardio inCode FDA Pre-Submission marks the start of the U.S. regulatory approval pathway and ongoing preparation for the launch of Cardio inCode-SCORE later this year.

BD Introduces Smart Connected Robotics to Automate Microbial Identification (BD Kiestra™)

"The BD Kiestra™ IdentifA system transforms the manual workflow into one that is standardized, automated and digitized," said Greg Miziolek, vice president and general manager of the U.S. region for BD Integrated Diagnostic Solutions.

━ Mergers ━ Acquisitions ━ Funding

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.

Akura Medical, A New Shifamed Portfolio Company, Closes $25M in an Oversubscribed Series A1 Financing

The financing was led by Cormorant Asset Management, with participation from The Capital Partnership (TCP), PA MedTech VC Fund and Shifamed angel investors.

Medtronic to Acquire Affera

The acquisition expands the Medtronic portfolio of advanced cardiac ablation products and accessories to meet physician needs within a growing patient population.

━ Market Reports

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...

Drug-Eluting Implants Market – Global Outlook 2021 to 2026

The global drug-eluting implants market is expected to reach US$8.483 billion by the end of 2026, increasing from US$6.050 billion in 2019, growing at a CAGR of 6.28% during the forecast period.

━ Executives

Jason F. Gorel Appointed Interim CFO at Covalon

"Jason brings financial leadership skills, operational experience, and knowledge of asset management and information systems to Covalon," said Brian Pedlar, CE) of Covalon.

Dr. Erica Bisson Joins Proprio As Research Advisor

“I look forward to advising Proprio on the development of their technology and discussing how it can positively impact the surgical suite of today,” noted Dr. Bisson. “Proprio has an opportunity to improve both surgeon and patient outcomes by blending new technologies with surgical expertise, and I am eager to take part in this exciting endeavor.” 

Dr Cory Calendine Appointed to Osso VR Advisory Board

Justin Barad, MD, CEO and co-founder of Osso VR said, “Dr. Calendine not only brings his unique expertise to Osso VR, but he also has a passion for democratizing healthcare which is a core part of our mission.” 

Meghan Fitzgerald and Leslie Norwalk Appointed to QUANTA Dialysis Technologies BOD

Meghan Fitzgerald is a global healthcare strategist, investor, academic, and author. Leslie Norwalk is strategic counsel to Epstein Becker Green, P.C., EBG Advisors and National Health Advisors.

━ 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.


━ Health


━ Articles of Interest

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