- 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
- 4 Key Criteria for High-Precision Medical Materials
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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
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Steps to take to draw customers in
Prinses Máxima Center for Pediatric Oncology Implements Callisto™ from Volta Labs to Streamline Clinical Genomics Workflows
The Prinses Máxima Center is the largest pediatric cancer center in Europe, dedicated to integrating care and research to improve outcomes for children with cancer
‘CART BP pro’ Opens a New Paradigm in Blood Pressure Management, Maintaining Accuracy Across Arm Positions
The device demonstrated consistent accuracy even when the arm was positioned below heart level, meeting the rigorous validation requirements set by the European Society of Hypertension (ESH).
MDI Health and Stanford Medicine’s Healthcare AI Applied Research Team (HEA₃RT) Launch Research Collaboration on AI-Powered Medication Management Intelligence
Pioneering study aims to demonstrate the robustness of personalized medication analysis and recommendations for polypharmacy patients generated by MDI Health’s novel Artificial Pharmacology Intelligence (API).
Clinical Trials
Phenomix and Mayo Clinic Publish Research Demonstrating Utility of MyPhenome Test for Personalized GLP-1 and Phen-Top Treatment
Published in Cell Metabolism, the Phenomix and Mayo Clinic research shows the MyPhenomeTM test can help providers guide obesity treatment by matching patients to GLP-1s or phentermine/topiramate based on their unique biology.
FastWave Medical Announces Successful First-in-Human Procedures in Study of Sola, Its Next-Generation Coronary Laser IVL System
Initial FIH procedures launch FastWave’s multi-center feasibility study evaluating the safety and performance of its laser-based coronary IVL platform.
GC Biopharma’s Phase 3 Clinical Trial Results for Hunterase Published in SCIE-Indexed Journal
Conducted at Samsung Medical Center, the Phase 3 clinical trial enrolled 24 newly diagnosed Hunter Syndrome patients with no prior treatment. It evaluated the efficacy and safety of Hunterase over a one-year treatment period.
Biotechnology News
Alithea Genomics Launches MERCURIUS™ Total DRUG-seq: A Next-Generation Full-Length Transcriptome Profiling Platform for High-Throughput Compound Screening and Target Validation
“MERCURIUS™ Total DRUG-seq represents a new frontier in transcriptome-scale compound screening,” said Riccardo Dainese, CEO and Co-founder of Alithea Genomics. “We are empowering scientists to capture the full complexity of transcriptional responses—at a massive scale and with minimal cost. This product opens the door to discovering new biology, new targets, and new drugs faster than ever before.”
1Elevan Biopharmaceuticals Announces the Development of Its Next-Generation Peptide Therapeutics Headquarters in Fishers, Indiana
The new 133,500-square-foot headquarters at 12001 Exit 5 Parkway will house an advanced pharmacy featuring category III, 503A/503B compounding capabilities alongside integrated telemedicine services for peptide therapy management and prescription fulfillment.
Pimicotinib Demonstrates Best-in-Class Potential with Significant Efficacy and Clinically Meaningful Improvements in Patients with Tenosynovial Giant Cell Tumor
Merck KGaA, Darmstadt, Germany, today announced the presentation of detailed positive results from Part 1 of the global Phase 3 MANEUVER trial evaluating pimicotinib in TGCT.
Our Experts – Byline Articles
Read Their Views & Share With a Colleague or Two!
Digital Pathology Reaches an Inflection Point as AI Targets Workflow Gaps | By Yair Rivenson, PhD Founder and CEO, Pictor Labs
Laboratories face mounting pressure to modernize imaging, preserve tissue, and reduce sequencing failures as adoption continues to move at a glacial pace
FIZE Medical Launches 5,000-Patient Retrospective Study to Further Establish the benefits of using FIZE kUO in managing ICU patients’ Hemodynamic status
By continuously capturing renal function patterns, the study aims to demonstrate how FIZE kUO® can provide data for early signs of instability that are often missed by intermittent measurements
Skin May Become the First Organ to Fulfill the Promise of Regenerative Medicine | By Dr. Ned Swanson – President & Chief Medical Officer of PolarityBio
The field of regenerative medicine may be on the cusp of an evolution, and due to the unique attributes of skin and wounds, the largest organ in the body may be emerging as a leader
FDA Medical Device Updates
Terumo Neuro Receives FDA Approval for Carotid Stent System
This milestone marks the first dual-layer micromesh carotid stent approved in the United States, offering physicians a clinically proven option to improve patient outcomes in carotid artery disease treatment reports Terumo Neuro.
U.S. FDA Grants Paige Breakthrough Device Designation for AI Application that Detects Cancer Across Different Anatomic Sites
Paige PanCancer Detect recognized by FDA as a Breakthrough Device intended to assist pathologists in the detection of cancer across multiple tissue and organ types.
restor3d Receives FDA Clearance for iTotal IdentityTM CR 3DP Porous Fully Personalized Total Knee Replacement System
This milestone marks a significant achievement in expanding restor3d’s knee replacement technology since the acquisition of Conformis, introducing the first cementless offering to the patient-specific implant portfolio. The company plans a limited market release in Q3 of 2025.
Comprehensive Insights into Medical Device & Biotechnology Company Mergers, Acquisitions & Funding
Oramed Pharmaceuticals Announces $36.9 Million Investment and Strategic Collaboration with Alpha Tau Medical
Oramed leverages its strategic capital markets expertise to support Alpha Tau’s breakthrough cancer therapy technology
Gestalt Diagnostics Raises $7.5 Million Series A Funding | to Expand AI-Powered Pathology Platform
The round was led by Cowles Ventures, TVF Funds, Inland Imaging Investments, KickStart Funds, and prominent angel investors from the Pacific Northwest.
Intensity Therapeutics, Inc. Announces $2.35 Million Public Offering
The Series B-1 warrants will have an exercise price of $0.85 per share, will be immediately exercisable and will expire 5 years from issuance. The Series B-2 warrants will have an exercise price of $0.85 per share, will be immediately exercisable and will expire 18 months from issuance.
Overture Life Secures $57M in Total Funding | Earns U.S. CLIA License to Deliver Reliable, Scalable IVF Automation
Overwater Ventures, GV, and Khosla Ventures invest in a rigorous clinical approach that raises throughput for fertility clinics, expands access, and empowers women to plan on their own terms.
Market Reports
Advancements in Imaging
Philips and AWS Expand Strategic Collaboration to Advance HealthSuite Cloud Services and Power Generative AI Workflows
“The collaboration between Philips and AWS gives healthcare providers scalable, secure-by-design cloud-enabled solutions to accelerate healthcare innovation,” said Matt Garman, CEO of AWS. “Combining Philips’ healthcare informatics portfolio with AWS generative AI capabilities gives clinicians access to imaging insights so they can deliver more effective and efficient care to patients anywhere, anytime, with best-in-class security and privacy.”
Elucid Announces Fifth Medicare Administrative Contractor to Cover AI Coronary Plaque Analysis
“This latest expansion of coverage by Noridian means that even more patients could be positively impacted by PlaqueIQ, which offers the only non-invasive measurement of lipid-rich necrotic core, a vulnerable, high-risk component of plaque that can lead to heart attack and stroke,”4 said Kelly Huang, CEO of Elucid. “These recent decisions from five of the seven MACs recognize the importance of new technologies like ours that can help quantify and classify coronary artery plaque to help physicians reduce the clinical and economic burden of cardiovascular disease.”
Mediso Introduces True Theranostic TheraMAX SPECT/CT
The TheraMAX is equipped with three, large surface detectors (up to 5x larger than 12-detector CZT systems) surrounding the patients completely (360°). The 15.9mm thick NaI crystals ensure improved sensitivity for high energy photons, while the high-density sensor arrangement (123 PMT per detector head) allows high spatial resolution leading to PET-like image quality in all NM applications.
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
How Local SEO Helps Private Practices Compete With Big Healthcare Chains
Local SEO is no longer a “nice to have.” It’s a necessity for any private clinic that wants to grow in 2025 and beyond..
What To Look for in Virtual Medical Scribing Software
Virtual Medical Scribing Software: The healthcare industry is constantly changing, and the introduction of medical scribing software is revolutionizing how healthcare professionals operate. With the
IoT in Healthcare: 5 Revolutionary Devices
IoT in Healthcare: The healthcare industry is rapidly adopting IoT technology. According to a report by MarketsandMarkets, the global market for IoT in healthcare will grow from $127.7 billion in 2023 to $289.2 billion by 2028.
How Individual Coverage Health Reimbursement Arrangements Are Changing Health Benefits
Many employers researching innovative ways to redesign their benefits programs are now looking into ADP’s plans and similar offerings to see how they can deliver a personalized experience without sacrificing business stability.
Healthcare Careers
Top Healthcare Careers You Should Consider in 2023
The healthcare industry is constantly expanding and evolving, providing various career opportunities for those passionate about helping others. There are many choices for people who
Medical Device Jobs a Recruiter Could Help Your Business Find
Medical devices are used every day to treat everyday people suffering from various health conditions, including the use of defibrillators, cochlear implants, insulin pumps, pacemakers,
Steps to Start Your Career as an EKG Technician
Working as an EKG technician is a rewarding profession that allows you to help others, but to obtain this position, there are certain steps and
Nurses Corner
New Opportunities for Aspiring Nurses in Idaho with Joyce University Expansion
Joyce University offers two post-licensure programs for those looking to further their nursing careers: the 4-semester online RN to BSN program and the 3-semester online MSN in Leadership program.
Wolters Kluwer Health Launches ClinicalPulse™ | A Simplified Continuing Education Solution for Nurse Practitioners
Rafael Sidi, Senior Vice President & General Manager of Health Research, Wolters Kluwer Health. “In the current healthcare landscape, NPs are facing demanding workloads paired with staying current on the latest medical evidence to ensure care is meeting the needs of their patients. ClinicalPulse provides critical, high-quality learning tailor-made for NPs in a format that is convenient and easy to use.”
Dana-Farber Cancer Institute Nurses Have Voted to Ratify New MNA Contract | Featuring Significant Investment in Nursing and Patient Care
Registered nurses and nurse practitioners voted overwhelmingly to finalize an agreement reached in June to help DFCI recruit and retain the nurses needed to provide world-class cancer care .