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Medical Device News Magazine

Our digital publication offers the latest updates on medical devices. We cover a wide range of topics, including news on clinical trials, product launches, FDA announcements, profiles of device companies, acquisitions, executive movements, non-profit and medical society updates, and more. Our main goal is to provide timely industry information to healthcare professionals, such as medical specialists, executives in the medical device industry, investors, and other allied health professionals. We achieve this objective through various social media platforms and targeted email communications to our subscribers. We invite you to regularly visit our website and explore the advertising opportunities available with us. The publication is a division of PTM Healthcare Marketing, Inc.

Empowering Healthcare Professionals and Investors: The Rise of Next-Generation Medical Devices

RayStation Used for First-Ever Radiotherapy Treatment with Hitachi’s OXRAY System

Johan Löf, Founder and CEO of RaySearch, remarked, "The OXRAY system represents a remarkable convergence of advanced radiotherapy technologies. By combining non-coplanar treatments, superior imaging capabilities, a conventional MLC, and real-time tracking, OXRAY delivers a new level of precision and flexibility. The integration with RayStation underscores our commitment to pioneering solutions that enhance cancer treatments.”

ColdVentures Unveils First-of-its-Kind, Class 1 FDA Medical Device ColdVest to Prevent Heat-Related Deaths

ColdVest has the potential to save thousands of lives around the globe each year.” Heat stroke poses a particularly deadly threat to military personnel performing strenuous activities and wearing heavy gear in scorching environments; outdoor workers including construction crews, farmers and landscapers who are exposed to direct sunlight and high temperatures for long hours; firefighters battling blazes; and athletes training and competing in hot weather conditions. Heat stroke is especially dangerous for young athletes or those unaccustomed to extreme temperatures.

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Featuring industry experts in the healthcare field who have come together to share their invaluable insights, perspectives, and opinions. With their wealth of knowledge and experience, these esteemed professionals provide a comprehensive understanding of the latest trends and developments in the healthcare industry.

5 Cardiovascular SaMD Cleared in 2023 | By Randy Horton, Chief Solutions Officer, Orthogonal

Mr. Horton advises this article takes a quick look at five interesting SaMD from the Cardiovascular panel that were cleared by the FDA in 2023. The common thread among these recently cleared SaMD is a focus on remotely monitoring patients and alerting them or their clinicians when irregular heart rhythms or dangerous heart events occur.

Revolutionizing Healthcare: Latest Biotechnology Innovations

SOPHiA GENETICS Launches New Residual Acute Myeloid (RAM) Application

Philippe Menu, M.D., PhD., Chief Medical Officer and Chief Product Officer, SOPHiA GENETICS. "We are proud to contribute to the fight against AML through our SOPHiA DDM™ RAM Solution. In particular we feel that the capability to seamlessly track longitudinally the evolution of individual mutations over time through a dedicated add-on module of our SOPHiA DDM™ Platform has the potential to be a game-changer for clinical researchers."

Aurion Biotech Receives Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation for Its Drug Candidate AURN001

Sterling Chung, Vice President of Regulatory Affairs and Quality at Aurion Biotech. “These designations underscore the importance of developing a potential solution for millions of patients around the world who suffer from corneal endothelial diseases. We look forward to working closely with the FDA to expedite the development of our cell therapy.”

Golidocitinib Approved in China as First-in-class JAK1 Only Inhibitor for Treatment of Relapsed or Refractory Peripheral T-Cell Lymphoma

Golidocitinib is a first-in-class Janus kinase 1 (JAK1) only inhibitor approved for the treatment of r/r PTCL based on results from the multinational pivotal JACKPOT8B study.

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Unveiling the Latest FDA Regulations: What Healthcare Professionals Need to Know

Endotronix Receives FDA Premarket Approval of the Cordella PA Sensor System for the Treatment of Heart Failure

Cordella, which consists of the now PMA-approved Cordella PA Sensor and commercial Cordella™ HF System, enables comprehensive heart failure management in the home using pulmonary artery (PA) pressure, a leading indicator of congestion, and non-invasive vital sign data to improve care decisions. Backed by definitive clinical evidence from the PROACTIVE-HF pivotal trial, the company is planning a U.S. launch of Cordella this year.

Acquisitions: Unveiling the Future: Medical M&A Insights

Lunit Completes Acquisition of Volpara: Pioneering Next-Level of AI-Driven Cancer Care

"We are thrilled to welcome Volpara into the Lunit family. Today, we take a monumental step towards revolutionizing our approach to cancer care. By combining our strengths, we are creating a formidable alliance in the industry, particularly in the US market. This merger enables us to develop and deliver innovative, life-saving solutions that meet critical needs in cancer diagnostics," said Brandon Suh, CEO of Lunit.

Groundbreaking Developments Shaping Modern Hospitals

Morton Plant Hospital First in Tampa Bay to Use New Treatment for Restenosis

The new drug-coated balloon, AGENT™ from Boston Scientific, was approved by the U.S. Food and Drug Administration (FDA) for commercial use in March. The balloon catheter, the first drug-coated coronary balloon in the United States, reopens the narrowed stent and releases the high concentration of drugs to prevent scar tissue from forming and blocking the artery wall again.

Top Expert Bylines

5 Cardiovascular SaMD Cleared in 2023 | By Randy Horton, Chief Solutions Officer, Orthogonal

Mr. Horton advises this article takes a quick look at five interesting SaMD from the Cardiovascular panel that were cleared by the FDA in 2023. The common thread among these recently cleared SaMD is a focus on remotely monitoring patients and alerting them or their clinicians when irregular heart rhythms or dangerous heart events occur.

How Applied Research is Transforming Medical Device Startups | By Hannah Eherenfeldt, Co-founder & CEO of ReSuture

Medical device startups face numerous barriers when trying to penetrate the crowded startup landscape. Fundraising is highly competitive, and many products fail to reach the market due to insufficient funding for research, validation, and testing. The applied research model provides a solution.This industry expert notes this is where the applied research model comes in.

Medical Associations

CMT Research Foundation Invests in ReviR Therapeutics Research to Pioneer Small Molecule Therapeutics for CMT1A

"Collaborating with ReviR Therapeutics aligns perfectly with CMTRF's mission to accelerate the development of therapies that can halt or even reverse the progression of CMT," says Cleary Simpson, CEO of the CMT Research Foundation. "Their cutting-edge technology has the potential to transform the lives of those living with this chronic condition by providing a non-invasive, potent, and easily administrable treatment option."

Brain Connectivity on MRI Predicts Parkinson’s Disease Progression

The findings support the theory that functional and structural connections between brain regions may significantly contribute to Parkinson’s disease progression.

Key Clinical Trials Unveiled: Insights for Healthcare Professionals and Savvy Investors

Micro Medical Solutions | Achieves Milestone with 200th Enrollment in HEAL Registry

reg Sullivan, CEO of Micro Medical Solutions. "This milestone is a testament to our commitment to providing innovative solutions for those suffering from CLI/CLTI. We are optimistic about the encouraging data that has emerged from the registry and look forward to utilizing this information to continue providing effective treatment options."

Venus Medtech VenusP-Valve Completed First Implantation in IDE Pivotal Clinical Study in U.S.

The VenusP-Valve PROTEUS STUDY, abbreviated from Evaluation of the PerfoRmance Of The VEnUsP-Valve System in Patients with Native Right Ventricular Outflow Tract (RVOT) Dysfunction, is a prospective multi-center non-randomized interventional study in patients with RVOT disorders comorbid with moderate or greater pulmonary regurgitation. With a target enrollment of 60 subjects, data from this trial will support VenusP-Valve's registration with the U.S. FDA and Japanese Pharmaceuticals and Medical Devices Agency (PMDA).

Pfizer Reports | ELREXFIO ™ Shows Median Overall Survival of More Than Two Years in People with Relapsed or Refractory Multiple Myeloma

“These compelling overall survival data support the clinical benefit ELREXFIO has already demonstrated and its potential to be a transformative treatment option for people with multiple myeloma,” said Roger Dansey, M.D., Chief Development Officer, Oncology, Pfizer. “The latest results from MagnetisMM-3 reinforce the very promising efficacy observed with ELREXFIO in a relapsed or refractory setting, with deep and durable responses and although definitive conclusions cannot be drawn across studies, the longest reported median progression-free survival among B-cell maturation antigen bispecific antibodies.”

Updated Phase 2 CAPTIVATE Study Results

“After more than five years, the CAPTIVATE study findings confirm the sustained benefit of the fixed duration combination of ibrutinib and venetoclax as a first-line treatment for patients living with CLL, including in those with higher risk genomic features,” said Paolo Ghia MD, Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milan, Italy, study investigator.‡ “This all-oral, chemotherapy-free, fixed-duration regimen offers eligible patients the advantage of an extended, treatment-free interval while effectively keeping their disease under control.”

Funding: Unveiling the Latest Medtech Financial Breakthroughs: What You Need to Know

Opthea Limited Successfully Completes Placement and Institutional Component of Entitlement Offer Raising A$171.5 million (US$113.2m¹)

“We appreciate the strong support from our shareholders, and from new investors, who share our belief that sozinibercept has the potential to transform patient outcomes with superior vision gains, which continues to be a significant unmet need in wet AMD,” said Frederic Guerard, PharmD, Chief Executive Officer of Opthea Limited.

InduPro Announces $85 Million Series A Financing

InduPro notes the financing will support the advancement of the first expected clinical product candidate targeting cancer tissue based on the proximity of co-targeted pairs, from preclinical development to an expected IND filing in Q4 2025 for a Phase 1 clinical trial. It will also fuel a pipeline of novel bispecific antibodies and antibody drug conjugates (ADCs) that utilizes protein proximity for identification of novel tumor selective target pairings.

Cutting-Edge Diagnostic Imaging Techniques Revolutionize Medical Diagnostics

Philips Zenition 90 Motorized receives FDA 510(k) Clearance

“During complex procedures, it’s vital to be able to rely on surgical imaging systems. As clinicians navigate their way through challenging anatomy, the priority is to quickly visualize small anatomical details while limiting X-ray dose,” said Mark Stoffels, Business Leader Philips Image Guided Therapy Systems. “The new Zenition 90 Motorized empowers medical teams to confidently perform a wide range of interventions while achieving the best possible outcome for their patients.”

VUZE Medical Announces U.S. FDA 510(K) Clearance for Second-Generation Software-Based 3D Guidance System for Spine Surgery

VUZE 2.0 provides much-extended interoperability and functionality; like VUZE 1.0, requires only a 2D C-arm and PC in the OR -- no cameras, markers, references or tool add-ons.

Nicklaus Children’s Health System, Philips Will Provide Innovative Patient & Staff Experience, Helping to Enhance Outcomes for the Smallest of Patients

Philips AI-enabled diagnostic and experiential technologies help put patients at ease while empowering staff with faster, high-quality scans and increased diagnostic confidence.

Executives on the Move

Ronil Patel Appointed Chief Business Officer at RevOpsis Therapeutics

Ronil Patel currently serves as a strategic advisor to Collage Venture Partners and was previously the Chief Business Officer at Ocuphire Pharma, a publicly traded ophthalmology biotechnology company. Prior to Ocuphire, Patel led business development for Point Guard Partners and Oculos Clinical Research (now iuvo Bioscience). Patel has been instrumental in biotech research and development and global business expansion. He has also contributed to teams that have secured approximately $100 million in funding and finalized licensing and exit deals valued at over $500 million.

Julie Sawyer Montgomery | Appointed Executive Vice President for Diagnostics at Danaher Corporation

Julie Sawyer Montgomery currently Vice President and Group Executive of Danaher's Clinical Diagnostics businesses, will become an executive officer of Danaher reporting to the President and Chief Executive Officer, Rainer Blair.

Mark Eisner MD, M.P.H. Appointed Chief Medical Officer at Vir Biotechnology

Mark Eisner MD comes from Sonoma Biotherapeutics, Inc., where he most recently held the position of CMO. In this role, he led all development functions which included biometrics, regulatory, clinical science, clinical operations, drug safety, and pharmacology.

Market Reports

Venous Thromboembolism Treatment Market to be Worth $4.40 Billion by 2030

According to a new market research report titled 'Venous Thromboembolism Treatment Market by Device (Thrombectomy, Inferior Vena Cava Filter [Retrievable, Permanent], Stockings, Compression Pump) Application (DVT, Pulmonary Embolism) End User (Hospital, Ambulatory Care Center) – Global Forecast to 2030,' published by Meticulous Research®, the venous thromboembolism treatment market is projected to reach $4.40 billion by 2030, at a CAGR of 7.2% from 2023 to 2030.

Dental 3D Printing Materials Market to be Worth $5.4 Billion by 2031

According to a new market research report, 'Dental 3D Printing Materials Market Size, Share, Forecast, & Trends Analysis by Type [Polymers (Resins, Thermoplastics), Composites, Ceramics (Zirconia, Alumina], Application (Crowns, Bridges, Dentures, Surgical Guides, Implants)– Global Forecast to 2031,' published by Meticulous Research®, the dental 3D printing materials market is projected to reach USD 5.4 billion by 2031, at a CAGR of 27.3% from 2024 to 2031.

Surgical Suction Instruments Market to Hit USD 503 Million by 2029, Driven by 6.1% CAGR

The global surgical suction instruments market is projected to reach USD 503 million by 2029, growing at a CAGR of 6.1% from USD 375 million in 2024, driven by increasing adoption of minimally invasive surgery and rising prevalence of chronic diseases.

Nurse's Corner

Noteworthy

A Must-Have Medical Equipment List For Ambulatory Care Facilities

Ambulatory care facilities cover a broad range of outpatient services. Discover the essential pieces of medical equipment every provider must have.

Marketing for Doctors:10 Best Proven Activities for Your Practice

In today's digital world, doctors cannot rely on traditional marketing methods alone to attract and retain patients. Doctors in Houston must utilize digital marketing...

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About Medical Device News Magazine

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Unlocking Success in Medical Business

The D-Actor 100 from STORZ Medical: Revolutionizing Pressure Wave Therapy Standards

The D-Actor 100 by STORZ Medical stands out in this field and is recognized as a leading device for healthcare professionals seeking effective treatment outcomes. This technology utilizes pressure waves to stimulate the body's natural healing processes, improving circulation and cell regeneration through microtrauma in targeted tissues.

Healthcare Professionals / Career Corner

6 Tips For Mitigating Risks Associated With Running A Med Spa

Running a med spa is a lucrative way to make people look and feel better, but like everything else, it has significant risks.

9 Ways to Land Higher Roles in Healthcare

There are several ways to ensure speedy career advancements to achieve higher roles in healthcare. The following are some strategies to achieve this goal.

Health / Lifestyle

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