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Biotechnology News Magazine

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

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In the Spotlight

Medical Device News

ICI’s New Biorisk Cloud Platform Helps Organizations Protect their Workforces from Biorisk Threats

“Throughout the COVID-19 pandemic, organizations have realized tens of millions of lost operational hours due to outbreaks within their facilities,” said Gary Strahan, Chief Executive Officer at ICI.

Vivistim System for Stroke Rehab Awarded 2021 Gold Electrode Award

"Our editors selected MicroTransponder's Vivistim System as the best new product of 2021 because it breaks new ground in stroke neurorehabilitation and helps open the door for funding and commercialization of new neurorehabilitation systems," said James Cavuoto, editor and publisher of Neurotech Reports, the leading source of news and analysis for the neurotechnology industry.

Movia Robotics Launches Its TheraPal Digital Health Aide with FDA Registration

MOVIA's TheraPal Progress Tracker, TheraPal Home and TheraPal Clinical Assist Aides will be the first of their kind to the market, further cementing MOVIA's mission, innovation, and dedication as an industry leader.

Vivo Surgical’s KLARO™ In vivo Lighting Device Provides Unparalleled Illumination of Surgical Cavities

The single-use KLARO has been developed specifically for surgical use, offering up to four hours of consistent in vivo illumination while maintaining a safe operating temperature of below 38 °C/100°F.

Boston Scientific Initiates Trial to Evaluate Industry’s First Modular CRM System

"Since the EMPOWER MPS device can be delivered percutaneously via a minimally invasive approach without the use of leads, the mCRM System could preserve many of the benefits of the S-ICD System while offering an option for patients who subsequently develop a pacing requirement," said Kenneth Stein, M.D., FACC, FHRS senior vice president and chief medical officer, Rhythm Management and Global Health Policy, Boston Scientific.

Ophthalmic Sciences Unveils World’s 1st AI Contactless Device for Measuring Eye Fluid Pressure

The IOPerfect™ can be used at home, at eye-care clinics, in emergency rooms, primary care physicians’ offices for at-risk patient screening, nursing homes, and by pharmacies offering health services.

First Successful Total Knee Replacement Performed in the U.S. Using Pixee Medical’s Knee+ Augmented-Reality Platform

The surgery was performed by Dr. Antonia F. Chen, M.D., M.B.A., an orthopedic surgeon at Brigham and Women’s Hospital in Boston, MA, using MicroPort Orthopedics Evolution® Medial-Pivot Knee system, designed to deliver a high degree of stability and motion, leading to increased patient satisfaction and survivorship.

First Hip and Knee Surgeries With ARVIS Augmented Reality Navigation System Completed

"ARVIS is exciting because it's computerized navigation that uses the principles of minimalization, accuracy, and currently available equipment (helmets) with minimal footprint in the OR. The navigation camera moves from a large stationary apparatus to be the surgeon. This is the next step we were looking for," said Ayal Segal, M.D.

INVO Bioscience Obtains Regulatory Approval to Commercialize INVOcell In Thailand

"Following months of efforts and interactions with the governmental authorities in Thailand, we are thrilled to have received approval by FDA Thailand to commence commercialization of the INVOcell solution within Thailand," commented, Steve Shum, CEO of INVO Bioscience.

RAYUS Radiology Partners With the U.S. Ski & Snowboard, Speedskating & Bobsled and Skeleton Teams Nationwide

"With a long-standing and highly successful local partnership in Utah with Ted Kyle and the RAYUS Team, formerly U.S. MRI, it's the right time to expand our partnership nationwide," said Ted Morris, Executive Director of U.S. Speedskating.

Hologic’s COVID-19 Tests Detect Omicron Variant

“We fully expect that SARS-CoV-2 will continue to evolve, as that is the natural path for viruses,” said Kevin Thornal, president of the Diagnostic Solutions Division at Hologic. “We designed our assays with this in mind, and as a result, we are confident that the Omicron variant will not impact the performance of our assays.”

Diagnostic Imaging

Carestream Mobile Imaging Systems Enhance Patient Care, Improve Workflow at Midwest Hospital

The hospital has three CARESTREAM DRX-Revolution Mobile X-Ray Systems and one retrofitted portable unit that typically function as independent X-ray rooms. One unit is dedicated for imaging patients at their bedside in the emergency room.

FTG Adds Protections for its Wireless X-Ray Sensor

The updates to the included warranty are reported to be effective immediately and apply retroactively to all current users. In addition, the company is offering a risk-free trial of the sensor to dental offices.

Philips Recognized with ‘A’ Score for its Climate Action Leadership

“With health systems and consumers increasingly committed to making more sustainable choices and to climate action, we remain convinced that doing business sustainably is the only way forward,” said Frans van Houten, CEO of Royal Philips.

LG and Lenovo Announce Collaboration, Driving Innovation in Radiology and Imaging

On the heels of RSNA 2021, the annual meeting of the Radiological Society of North America, the Lenovo-LG bundle will provide diagnostic and clinical solutions in key imaging areas through the combination of Lenovo ThinkStation workstations and LG Medical Monitors.

Xoran’s VetCAT 3D CT Imaging Implemented at Chicago Exotics Animal Hospital

Xoran Technologies announced that the first VetCAT IQ™ has been installed at an exotics-only animal hospital. Chicago Exotics Animal Hospital, serving Chicago and the surrounding Illinois area,...

RIVANNA® Announces Partnership With BOMImed to Increase Distribution of Accuro® in Canada

RIVANNA®, developers of world-first, imaging-based medical solutions, announced they have entered into a partnership with BOMImed, a recognized manufacturer of anesthesia and critical care related consumables to...

CT Uncovers Bone Disease in Tyrannosaurus Rex Jaw

The imaging method could have significant applications in paleontology, researchers said, as an alternative to fossil assessment methods that involve the destruction of samples.

Arterys Signs Global Distribution Agreement With iCAD

Arterys, the world's leading vendor-neutral AI platform, today announced it signed a global distribution agreement with iCAD, a global medical technology leader providing innovative cancer detection and...

NeuroLogica’s OmniTom® Elite CT Scanner Now Available – See it at RSNA 2021

The OmniTom Elite’s ability to provide versatile, real-time mobile imaging enables healthcare providers to administer point-of-care CT to critical patients without the need to transport them to a separate department

ClariPi to Showcase its AI Medical Imaging Solutions at RSNA 2021

"With the Nuance AI Marketplace, we are one step closer to our vision- implementation is simplified, having the ClariCT.AI on the Nuance AI Marketplace will insure easy accessibility through cloud-based distribution and deployment." said Jong-Hyo Kim, CTO and co-CEO of ClariPi.

Philips Rxtends AI-enabled CT Imaging Portfolio at RSNA 2021

New CT 5100 – Incisive – with CT Smart Workflow applies artificial intelligence* (AI) at every step in the CT imaging process to help customers meet financial, clinical, and operational goals.

Clinical Trials, Studies, Registries, Published Papers, Other Data

Roam Robotics Launches Partnership with the San Francisco VA Health Care System

Ascend, from Roam Robotics, leverages robotics and proprietary algorithms to improve mobility and dramatically improve daily life for those experiencing knee pain.

Saranas® Announces Initial Enrollment of SAFE-MCS Clinical Trial

The first patient was enrolled at Atlantic Health System’s Morristown Medical Center in Morristown, NJ, by Dr. Philippe Généreux, Co-Director of the Structural Heart Program, and Dr. Dimitrios Karmpaliotis, Medical Director of the Cardiovascular Rescue and Recovery Program and the Advanced Coronary Therapeutics and Chronic Total Occlusions Program, at Morristown Medical Center.

Cancer Patients Overlooked in COVID-19 Vaccine Rollout

For the new study, researchers sought to determine the proportion of states that elected to follow CDC recommendations. They identified every states’ COVID vaccination webpage through keyword-based internet search and set out to identify information about vaccination for cancer patients.

MRI Reveals Altered Brain Structure in Fetuses Exposed to Alcohol

For the study, researchers recruited 500 pregnant women who were referred for a fetal MRI for clinical reasons. On an anonymous questionnaire, 51of the women admitted to consuming alcohol during their pregnancy.

Popular Blood Thinners May Lead to Brain Bleeding after Head Injury

A three-year study of more than 1,000 patients found that the risk of delayed intracranial hemorrhage and death following head trauma was significantly higher for adults taking older blood-thinning medications.

Enrollment Completed for Multi-Center Study for Diabetic Foot Ulcers

The data collected from the study will bolster the existing clinical database of DFU images and clinical data to train and increase the current 83.3% decision support accuracy of the DeepView® algorithm for DFU.

Nevro Announces Three Important Clinical Data Publications for Treating Painful Diabetic Neuropathy with 10 kHz Therapy

Findings from all three studies highlight the significant benefits of HFX™ for PDN¹ in the clinical and real-world settings.  HFX for PDN is the only spinal cord stimulation (SCS) system approved by the U.S. Food and Drug Administration with a specific on-label indication for treating PDN.

Large International Study Reveals Spectrum of COVID-19 Brain Complications

The largest multi-institutional international study to date on brain complications of COVID-19 has found that approximately one in 100 patients hospitalized with COVID-19 will likely develop complications of the central nervous system.

COVID-19 Linked to Heart Inflammation in College Athletes

For the new study, clinicians at schools in the highly competitive Big Ten athletic conference collaborated to collect data on the frequency of myocarditis in student-athletes recovering from COVID-19 infection.

Canon Medical Signals Its Support for a Multicenter Ultrasound Liver Evaluation and Assessment Study

This Multicenter study is focusing on the assessment of NASH (Non-Alcoholic SteatoHepatitis) using non-invasive innovative ultrasound liver imaging techniques against the current gold standard of liver biopsy. Researchers from China, Japan, South Korea, USA and Europe, aim to recruit over 200 patients for the study and to compare their results.

Spectral MD’s DeepView® Burn AI Clinical Study Results Presented at Southern Region Burn Conference

Spectral MD devices are in various stages of research and development including pre-clinical testing and clinical investigations. At this time, no SMD devices have received marketing authorization and therefore, are not available for sale in the U.S.A.

CE Mark

iSTAR Medical Receives European Market Approval for Glaucoma Implant MINIject

MINIject is currently being investigated in iSTAR Medical’s pivotal STAR-V study, which was approved by the United States Food and Drug Administration (FDA) in July 2021,

Medtronic Hugo™ Robotic-Assisted Surgery System Receives European CE Mark Approval

CE Mark approval comes on the heels of major milestones in the Hugo RAS system global launch, including the first urological and gynecological procedures, which took place in Latin America and India and marked the start of the Hugo RAS system global patient registry.

LSO Medical Announces CE Approval of Next-Gen LUMESEAL Laser

Designed to enhance ease-of-use and to provide greater precision and control throughout the procedure, Lumeseal is announced as the successor of the efficient and widely used ENDOTHERME 1470 platform.

Next-Gen LUMESEAL Laser for Treatment of Varicose Vein Receives CE Approval

"The integration of SnakeBack® technology on LUMESEAL® is a big step forward for the development of the technique. Beyond its direct impact on enhancing the reproducibility and comfort of laser delivery, the LUMESEAL® platform allows us to assess further improvements in the EVLT technique (new wavelengths, applicators,) "says M. Rochon, LSO Medical CEO.

CoapTech Receives CE Mark Approval and CPT Procedure Code for Its PUMA-G System

The PUMA System™ is a new category of minimally invasive devices, enabling ultrasound to be used for procedures in hollow organs of the body where previously it was impossible or unsafe to do so.

EG-UC5T Linear Array Endoscope Receives CE Mark Reports SonoScape

"SonoScape's EUS portfolio will certainly extend the company's path into more and larger hospitals. This again underpins the company's leading role in the global digestive endoscopy market." said Steven He, Sales Director of Endoscopy Division at SonoScape.

FDA

FDA In Brief: FDA Takes New Steps Aimed at Advancing Development of Individualized Medicines to Treat Genetic Diseases

This field is rapidly evolving, and antisense oligonucleotide drugs are the most advanced in this space

Revival Health Inc. Announces 9 Mil FDA EUA Authorized COVID-19 Rapid At-home Tests

Revival Health Inc. (Revival), a leading global medical device manufacturer, announced the availability of over 9 million units per month of the EUA authorized COVID-19 rapid at-home...

ImmersiveTouch Wins FDA Clearance For New Suite of Medical Diagnosis and Treatment Planning Tools

ImmersiveTouch’s COO, Jay Banerjee says, “adding this additional FDA 510(k) Clearance for medical diagnosis and treatment planning to our portfolio just strengthens what ImmersiveTouch can offer surgeons.”

Cardiologs’ AI Receives 510(k) Clearance for Pediatric Use

The new model, now supported by more than 20 million EKG recordings, was used to evaluate a global sample of 10,000 EKG readings from patients in various age groups.

FDA Expands Eligibility for COVID-19 Vaccine Boosters

"The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older," said Peter Marks, M.D., Ph.D.,

Blackrock Neurotech’s MoveAgain Brain-Computer Interface System Receives Breakthrough Device Designation from the FDA

The FDA Breakthrough Device designation aims to expedite the review of innovative technologies that can improve the lives of people with irreversibly debilitating diseases or conditions.

Funding

HypnoVR Raises €4.5 Million

The funds will allow HypnoVR to accelerate the commercial roll-out of its virtual reality-based medical hypnosis solution in France and globally. The company will also be stepping up efforts in its award-winning R&D program in order to further increase the therapeutic efficacy of its solution and broaden its scope of application to other medical and paramedical fields. 

Fluidx Medical Technology Announces Series A Led by Multinational Strategic Investor

Fluidx Medical Technology, a privately held medical device company founded to develop GPX, an innovative embolic material, and other technologies today announced the oversubscribed closing of the...

Alpheus Medical Closes $16M In Series A Financing For Novel Glioma Brain Cancer Treatment

Funds to support first-in-human (FIH) clinical trial of the company's proprietary, non-invasive sonodynamic drug-device therapy system for recurrent high-grade gliomas.

LifeVoxel.AI Raises $5 Million Seed Round for its AI Diagnostic Visualization Platform

LifeVoxel’s patented technologies empower instant and ubiquitous access to interactive imaging studies and data, with zero latency and zero client footprint, rendering them at 4K image quality.

Aohua Endoscopy, the Leading Endoscope Company Invested by Legend Capital, Successfully Listed on China’s STAR Market

Legend Capital exclusively invested in Aohua Endoscopy's Series B financing in 2014 and co-led its Series C financing in 2016, becoming its largest institutional investor.

AppliedVR Raises $36 Million Series B

The round, which included investments from F-Prime Capital, JAZZ Venture Partners, Sway Ventures and SVB Ventures, set up AppliedVR for rapid growth as it prepares for its decision from the FDA on its first de novo submission.

Acquisitions & Mergers

Trajan Group Acquires Axel Semrau GmbH

Trajan's automation business and Axel Semrau have worked in close cooperation for several years.

Pacur To Acquire CAROLEX To Expand Global Position And Customer Reach

Pacur is the leading supplier of extruded PETG sheet used principally to provide rigid, high-performance packaging for medical devices.

Clinical Ink Acquires Digital Artefacts

Digital Artefacts is a digital endpoint-based technology company with an unrivaled modular platform for complex cognitive, behavioral, & physiological data capture.

Philips to Acquire Cardiologs

Cardiologs will further strengthen Philips’ cardiac monitoring and diagnostics offering with innovative software technology, electrocardiogram (ECG) analysis and reporting services

Avantor® Completes Acquisition of Masterflex®

"The acquisition of Masterflex extends Avantor's single-use offering and gives us a complete end-to-end solution for aseptic fluid transfer throughout the bioproduction workflow," said Michael Stubblefield, President and CEO of Avantor.

ZEUS Scientific Acquires Synthetic Peptides from Sheba Medical Center’s Tech Transfer Co.

The company intends to utilize these innovative multi-epitope citrullinated peptides for the development of a new generation of immunoassays designed to measure autoantibodies as an aid in the diagnosis of Rheumatoid Arthritis.

Executives on the Move

Robotics

Movia Robotics Launches Its TheraPal Digital Health Aide with FDA Registration

MOVIA's TheraPal Progress Tracker, TheraPal Home and TheraPal Clinical Assist Aides will be the first of their kind to the market, further cementing MOVIA's mission, innovation, and dedication as an industry leader.

Robocath Successfully Performs 1st Carotid Stenting in France with R-One™ Robot

The procedure is part of a clinical study, which is the first stage of an ambitious research program launched last July by Robocath and Rennes University Hospital, in partnership with Philips France. It aims to enrich the current and future generations of robotic platforms, with the long-term view of improving the treatment of cerebrovascular incidents (CVA, stroke).

Smith+Nephew Announces Digital Surgery & Robotics Innovation Center in Europe

The center will feature a dedicated medical education facility, where surgeons can refine techniques and experience the latest technology through hands-on learning and immersive simulation technology.

Medtronic Hugo™ Robotic-Assisted Surgery System Receives European CE Mark Approval

CE Mark approval comes on the heels of major milestones in the Hugo RAS system global launch, including the first urological and gynecological procedures, which took place in Latin America and India and marked the start of the Hugo RAS system global patient registry.

Medtronic Hugo™ Robotic-Assisted Surgery System: 1st Procedure Performed In Asia

The Hugo RAS system — Medtronic's solution to historic cost and utilization barriers that have kept surgical robotics out of reach for many hospitals — is a modular, multi-quadrant platform designed for a broad range of soft-tissue procedures. It combines wristed instruments, 3D visualization, and Touch Surgery™ Enterprise, a cloud-based surgical video capture and management solution, with dedicated support teams specializing in robotics program optimization, service, and training.

St. Vincent Charity Medical Center is First Hospital in Ohio to Perform Total Knee Replacement Procedures with THINK Surgical’s Next-Generation Robot System

Bernard Stulberg, M.D., a renowned orthopedic surgeon, performed the first procedure with the new system .

Hospitals

Colgate Family Donates $1 Million Toward Purchase of Glen Cove Hospital’s First MRI

“We are so grateful for this gift from the Colgates, which will elevate the care and comfort of all our patients,” said Kerri Scanlon, RN, FAAN, executive director of Glen Cove Hospital.

Sheba and Datos Health Launch Remote Monitoring Program for Children with Complex Heart Defects

Sheba Medical Center, Israel’s largest medical center and a Newsweek top-10 ranked world’s best hospital for the last three years, today announced the inauguration of a...

Non-Profit News

American College of Radiology Association Announces Scope of Practice Fund Recipients

Four state radiological societies have been awarded grants from the American College of Radiology Association® (ACRA®) Scope of Practice (SOP) Fund. Societies receiving initial funds are Kansas, New York, Pennsylvania and Wisconsin.

AI-LAB™ Federated Learning: A Leap Forward for Radiology AI Development

This free, vendor-neutral toolset allows users to “test drive,” develop and train AI algorithms at their institutions using local patient data. With federated learning, registered sites soon can participate in multi-site algorithm creation while allowing their data to remain safely on their own servers.

Radiology Health Equity Coalition to Address Health Care Disparities

The coalition includes the American Board of Radiology, Radiology Section Council of the American Medical Association, Association of University Radiologists, Section on Radiology and Radiation Oncology for the National Medical Association, Radiological Society of North America, Society of Chairs of Academic Radiology Departments, and Society of Interventional Radiology, with specialty and state radiology organizations already joining the initiative.

House Embraces Historic Insulin Affordability Measures in Build Back Better Act

The House-passed legislation creates an out-of-pocket co-pay limit of $35 per month for insulin. In the days before the House vote, nearly 15,000 ADA advocates contacted their representatives through the ADA’s Engagement Platform to urge support for co-pay caps and for allowing the government to negotiate drug prices with manufacturers.

MedExecWomen Empowers Women in Leadership Roles in the Medical Device Diagnostics and Digital Health Industries

MedExecWomen’s third annual conference will be held June 14, 2022, in Boston, MA.

The American Academy of Orthopaedic Surgeons Named a 2021 Top Workplace by the Chicago Tribune

AAOS Chief Executive Officer, Thomas E. Arend, Jr., JD, CAE. "Together with the recognition we received from the NABR earlier this year, this award underscores our c­ommitment to creating a culture that puts the wellbeing of our people first and strengthens our competitive position in the marketplace to recruit and retain high level talent. I am proud to be part of this fantastic team dedicated to the AAOS mission and the orthopaedic surgeons we have the ability to serve."

Market Reports

United States Cardiovascular Devices Market 2021-2027

United States Cardiovascular Devices Market is projected to reach US$ 39.98 Billion by 2027 from US$ 25.34 Billion in 2020, growing with a CAGR of 6.73%

Global Cerebrospinal Fluid Drainage Catheter Market (2021 to 2027) – by Application, Type and Regional Outlook

The Global Cerebrospinal Fluid Drainage Catheter Market size is expected to reach $402.6 Million by 2027, rising at a market growth of 8.6% CAGR during the forecast period. For the treatment of hydrocephalus, placement of cerebral spinal fluid (CSF) shunt systems is becoming a common medical and life-saving procedure for the majority of the patients.

United States Insulin Delivery Devices Market Report 2021

This new report provides an in-depth assessment of the U.S insulin delivery devices market dynamics, opportunities, future road-map, competitive landscape and discusses major trends.

Global $45 Billion Endoscopy Market Insights & Forecasts to 2025

The global endoscopy market is predicted to reach US$45.28 billion in 2025, growing, at a CAGR of 7.50%, for the duration spanning 2021-2025.

Global Remote Monitoring Devices Market Research Report (2021 to 2026)

Global Remote Monitoring Devices Market size was estimated at USD 1,035.35 million in 2020, is expected to reach USD 1,170.22 million in 2021.

Research Efforts Fuel the Future of Global Obstructive Lung Disease Management Markets – ResearchAndMarkets.com

The "Global Obstructive Lung Disease Management Research Report" report has been added.

Articles of Interest

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