- Catalyst OrthoScience announces $15M in financing
- Qure.ai continues pace of US growth with 19th FDA clearance
- Crystal Clinic Hand and Wrist Surgeon, Dr Mollie Manley Develops Innovative, Surgical Procedures For the Minimally-Invasive Repair of Common Wrist Injuries
- Journal of Clinical Microbiology Publishes Article on ARUP’s Validation of AI for Parasite Detection
- Preceptis Medical Selects AcuityMD for Expansion of Breakthrough In-Office Pediatric Ear Tube Device
- Archetype Launches ‘Expertise for Equity’ Approach to Accelerate Early-Stage Innovation First Investment Partnership Agreed with LumipenPro™
- AESOP Technology announces DxPrime is now a qualified solution on Mayo Clinic Platform
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Medical Device News Magazine delivers the latest updates from the medical device and biotechnology sectors. We take pride in offering high-quality, in-depth content, crafted by a team of experienced professionals. Our goal is to provide a unique perspective on the trends and innovations driving the future of medical technology. By reading our articles, you’re not only gaining exclusive industry insights but also becoming part of a community committed to advancing healthcare through groundbreaking technologies. Explore our content and consider partnering with us for advertising opportunities!
Medical Device Industry News: Latest Developments, Breakthroughs, and Future Outlook
Spinal Elements Awarded Vizient Innovative Technology Contract for Karma® Fixation System
The contract was awarded based on the recommendation of the Karma Fixation System by hospital experts who serve on one of Vizient’s client-led councils, and it signifies to Vizient provider clients unique qualities that potentially bring improvement to the healthcare industry
Ellipsis Health Selected as Key Partner in CMS Health Tech Ecosystem to Drive National Healthcare AI Transformation
The company, represented by CEO Mainul Mondal, joined CMS Administrator Dr. Mehmet Oz, federal leadership, and a select group of leading health systems, payors, and innovators, in Washington, D.C. to tackle developments in healthcare that serve the benefit of all patients.
Norwalt Automation Group Partners with ei3 to Launch Nexus: A Smarter, Data-Driven Future for Manufacturing Automation
Manufacturers can now achieve 24/7 operational intelligence and predictive maintenance without additional IT staff through this AI-powered IIoT integration
Hohenstein Medical Earns GLP Certification for Medical Device Testing
Good Laboratory Practice certification expands company’s ability to support medical device manufacturers in meeting the complex demands of international regulatory frameworks.
Clinical Trials
CorWave Completes 6-Month In Vivo Study for Clinical Trials Initiation
In vivo studies demonstrated the pump’s successful operation for a period of up to six months. Additionally, nine chronic ovine implants were conducted for 60 days with no device failure or sign of thrombosis at explant. These significant milestones mark the final stage of CorWave’s preclinical development, paving the way for its First-In-Human study.
Vektor Medical Announces Post-Market Study Evaluating Benefit of AI-Powered Analysis to Identify and Ablate Non-Pulmonary Vein AF Targets
vMap is the only FDA-cleared non-invasive AI-powered arrhythmia analysis technology designed to improve, enhance, and accelerate ablation procedures, utilizing data from a standard 12-lead ECG.
Efemoral Medical Releases Positive Long-Term Results from EFEMORAL I
“The EVSS represents a new paradigm in peripheral interventions,” said Christopher Haig, Co-Founder and CEO of Efemoral Medical. “It’s easy to deploy, has high radial strength, can be made in longer lengths, and offers the promise of durable outcomes without the need for a permanent implant.”
Biotechnology News
Seegene’s CURECA(TM) Emerges as a Potential Game Changer in End-to-End PCR Automation
With a fully modular design, CURECA introduces a bold vision for automating pre-treatment across diverse PCR specimen types
VERAXA Biotech Enters Co-discovery Alliance with OmniAb for a Novel Bispecific Antibody Drug Conjugate Program
Partnership Combines VERAXA’s Proprietary ADC Technology with OmniAb’s Antibody Discovery Technology for Novel Therapies Targeting Solid Tumors.
Nanobiotix Announces Full Results From Completed Phase 1 Study Evaluating JNJ-1900 (NBTXR3) in Pancreatic Cancer
Results demonstrated favorable safety, injection feasibility, and encouraging oncologic outcomes in patients (n=22) with locally advanced or borderline resectable pancreatic cancer.
Our Experts – Byline Articles
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FDA Medical Device Updates
U.S. FDA Grants Orphan Drug Designation to Ariceum Therapeutics’ Proprietary Radiopharmaceutical Cancer Therapy
Manfred Rüdiger, Chief Executive Officer at Ariceum Therapeutics, said: “Receiving ODD for 225Ac-satoreotide is a recognition of its potential as a treatment option for patients with SCLC and an important regulatory milestone for Ariceum. The FDA’s ODD will support our objective to accelerate the development of 225Ac-satoreotide through human trials to provide a potentially life-saving therapy to patients with limited alternatives.”
Huxley Medical’s SANSA Home Sleep Apnea Test Gets FDA Nod
In a clinical trial involving 340 patients across seven institutions, SANSA obtained its initial FDA clearance in 2024, demonstrating its accuracy in comparison to the gold-standard polysomnography. This innovative test incorporates nine distinct physiological channels, such as oximetry, respiratory effort, sleep/wake staging, and a reference electrocardiogram (ECG), into a single patch worn on the chest. This integration allows for a comprehensive understanding of cardiopulmonary health and provides valuable insights.
RapidAI Secures FDA 510(k) Clearance for Groundbreaking AI 3D Head and Neck CTA Imaging: Lumina 3D™
RapidAI continues to pioneer AI advances by revolutionizing 3D imaging with no-click, AI-powered reconstruction.
Comprehensive Insights into Medical Device & Biotechnology Company Mergers, Acquisitions & Funding
OrganOx Completes $142 Million Equity Financing Led by HealthQuest Capital
The oversubscribed round was led by new investor HealthQuest Capital with support from existing OrganOx investors BGF and Lauxera Capital Partners, along with additional new investors Sofina, Soleus Capital, and Avidity Partners.
Advancing Eye Health: Perceive Pharma Secures $15M Investment Boost
In addition, Perceive Pharma announced that Carol Gallagher, Pharm.D. has joined the company’s Board of Directors as an independent director.
Exero Medical Closes on $12.7M Preferred Seed Financing
This financing includes investments from new investors Longevity Venture Partners, Tech Council Ventures, and Edge Medical Ventures, alongside participation from existing investors notes Exero Medical.
REEV Raises $9.2M | To Revolutionize Mobility Assistance for Patients with Gait Disorders
“With the support of our world-class partners, we are thrilled to enter the next phase of clinical and industrial development,” said Amaury Ciurana, Co-Founder and CEO of REEV. “Our innovative technologies, like the DREEVEN motorized orthosis, aim to redefine mobility assistance, transforming lives and reshaping the orthotics industry.”
Market Reports
Advancements in Imaging
LG Electronics Launches 5MP Diagnostic Monitor for Breast Imaging
LG Electronics reports: Intended for digital mammography and digital breast tomosynthesis, the 21HQ613D-B is a 21.3-inch 5-megapixel (MP) IPS diagnostic monitor designed to deliver high-definition radiological images and maintains consistent image quality through its internal front calibration sensor and calibration software.
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.
Hospitals In the News
Medical Device and Biotechnology Executives: Innovative Professionals on the Move and Making Waves in the Industry
Non-Profit News
Healthcare - Understanding the Business Side of the Industry and Its Implications
Telemedicine: Bridging the Gap in Healthcare Access and Delivery
The healthcare industry has seen significant changes and transformations in the rapidly advancing world of technology. One of the most groundbreaking developments in recent times
Top 10 Must-Have EMS Vehicle Equipment for Emergency Responders
Modern EMS vehicles require comprehensive medical equipment and supplies, with costs averaging around $19,000 per vehicle to ensure readiness for any emergency scenario.
How to Ensure Your Business Meets FDA Compliance Standards
Business Meets FDA Compliance Standards:
MHPAEA Act & NQTL Analysis And Rules
The U.S. Departments of Treasury, Labor, and Health and Human Services have recently released final regulations regarding nonquantitative treatment limitations (NQTL) under the Mental Health Parity and Addiction Equity Act (MHPAEA Act).
Healthcare Careers
Career Opportunities for Dental Professionals: 7 Pathways
There are numerous career opportunities for dental professionals out there. Typically, there are three directions people in this medical field can focus their efforts on:
Exploring Dental Hygiene As A Career
Dental hygienists are oral healthcare professionals responsible for cleaning teeth, educating patients on proper oral hygiene, and assisting dentists during various procedures. You might consider
A Small Guide On How To Become A Medical Assistant
When most people think of healthcare workers, their minds go to doctors, nurses, and surgeons. However, there are many other positions and jobs that are
Nurses Corner
Collette Health Appoints Christine Gall as Chief Nursing Officer
Christine Gall will oversee all clinical operations and innovation initiatives to further enhance Collette Health’s commitment to helping hospitals integrate virtual patient safety solutions to prevent falls and adverse events and improve patient outcomes.
Symtech Systems Announces Nurse Call Systems Expected to Surge in Market Growth in 2024
By partnering with Symtech Solutions, healthcare facilities can benefit from cutting-edge nurse call systems that enhance patient care and increase staff productivity. The company’s commitment to delivering the best solutions combined with its industry expertise positions them as a trusted and reliable provider in the market
How Postgraduate Nursing Education Improves Patient Outcomes
In this article, we’ll examine the advantages of postgraduate education for nurses so that you can decide whether it’s the right path to take for your career.