- Alithea Genomics Launches MERCURIUS™ Total DRUG-seq: A Next-Generation Full-Length Transcriptome Profiling Platform for High-Throughput Compound Screening and Target Validation
- Exo Launches a New Era in Disease Diagnosis with the First FDA-cleared Ultrasound AI for Detection of Pleural Effusion and Consolidation/Atelectasis
- Backed by $2 Million, Droplet IV is Set to Launch its Revolutionary Automatic IV-Line Flushing Device in EU & US in 2026
- Expanding Innovations Receives FDA Clearance for N-GAGE™ Lumbar Plate System
- What To Look for in Virtual Medical Scribing Software
- Neuspera Medical Receives FDA Approval for First Integrated Sacral Neuromodulation (iSNM) System for Urinary Urge Incontinence
- Bioness Medical Announces Acquisition of the Assets and Business of Harmonic Bionics
Medical Device News Magazine delivers the latest updates from the medical device and biotechnology sectors.
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Medical Device Industry News: Latest Developments, Breakthroughs, and Future Outlook
First Commercial Use of Baylis Medical Technologies’ PowerWire® Pro for In-Stent Restenosis
Frank Baylis, Executive Chairman of Baylis Medical Technologies, expressed enthusiasm about the PowerWire® Pro RF Guidewire’s potential impact, stating, “This innovation aims to simplify the often challenging and time-consuming process of crossing chronic occlusions in revascularization procedures, ensuring uninterrupted patient treatment.”
Stryker Reports: 1st European Surgeries Completed Using Stryker’s Gamma4 Hip Fracture Nailing System
The Gamma4 Hip Fracture Nailing System is designed to treat hip and femur fractures. Its nail design is informed by Stryker’s SOMA database, which includes over 37,000 3D bone models generated from CT scans. The system received CE certification in November 2023 and has been utilized in over 25,000 cases in North America and Japan.
Tandem Mobi Insulin Pump Now Compatible with Dexcom G7 CGM
The Tandem Mobi Insulin pump is small enough to be worn almost anywhere, including a coin pocket, providing users with more discretion, comfort, and options for how they manage their diabetes. Powered by Control-IQ technology, which has demonstrated in real-world studies improved time in range overnight and during the day4, Tandem Mobi connects with Dexcom G7 or Dexcom G6 to predict glucose levels 30 minutes in advance and automatically adjusts insulin, if needed, to help prevent highs and lows.
Pulmatrix Announces Cross License Agreement and Transfer of Laboratory to MannKind Corporation
Ted Raad, Chief Executive Officer of Pulmatrix, commented, “MannKind’s interest in iSPERSE™ validates the enablement potential of our innovative particle engineering dry powder technology. In addition, the assumption of our lease and laboratory by MannKind helps extend our cash runway further into 2026. We are able to build upon this agreement to further support development of PUR3100 and its potential application with MannKind’s Cricket® device to develop the 1st orally inhaled DHE treatment for acute migraine.”
Clinical Trials
ChemDiv Marks a Milestone as Orionis Biosciences’ Novel Immunotherapy Enters Phase I Clinical Trials
ChemDiv CEO, Bill Farley. “This marks a significant step in harnessing intrinsic immunobiology pharmacologically, and we are excited about the potential impact it may have on revolutionizing cancer therapeutics.”
AVANT GUARD Clinical Trial to Evaluate FARAPULSE™ Pulsed Field Ablation System | Reports Boston Scientific as First-Line Treatment for Persistent Atrial Fibrillation
The AVANT GUARD clinical trial will evaluate the safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation System as a first-line treatment for persistent atrial fibrillation, the only trial to study the use of PFA as frontline therapy in patients with this form of AF.
InnoCare Announces Phase II Study Results of TYK2 Inhibitor ICP-332 Meet Primary Endpoint in Patients with Atomic Dermatitis
ICP-332 in AD patients treated for 4 weeks demonstrated excellent efficacy and safety profile. ICP-332 achieved multiple efficacy endpoints including Eczema Area and Severity Index (EASI) 50, EASI 75, EASI 90 (improvement of at least 50%, 75% and 90% in EASI score from baseline) and Investigator’s Global Assessment (IGA) 0/1 (score of 0 ‘clear’ or 1 ‘almost clear’) in 80mg and/or 120mg dosing groups respectively.
Biotechnology News
Bio-Rad Launches Validated Antibodies for Rare Cell and Circulating Tumor Cell Enumeration
The company announced the launch of validated antibodies for rare cell and circulating tumor cell (CTC) enumeration. Validated for use with Bio-Rad’s Celselect Slides Enumeration Stain Kits, the antibodies are specific to CTC surface markers to enable the sensitive and specific identification of target cell populations, enhancing the study of tumor heterogeneity and disease progression at various stages.
Proteintech Germany Triples Its Space with a New Office & Laboratory
Proteintech advises the new building houses research and development, production, logistics and administration in an area more than three times larger than its previous space.
Seegene and Springer Nature Announce Awardees for the Open Innovation Program
In September 2023, Seegene and Springer Nature opened applications to scientists and experts across the global community to conduct research for the 15 designated projects to develop Seegene’s syndromic qPCR diagnostics assay reagents for the Open Innovation Program.
Our Experts – Byline Articles
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AI & Service Intelligence Continue to Drive Improved Medical Device Service Metrics: By: Sidney Lara, Service Principle at Aquant
The newly published report relies on data collected from 44 organizations that employ more than 15,000 technicians, including analysis of more than 4.6 million work orders covering more than $3.4 billion in total service costs.
Data Empowers Medtech Manufacturers to Address Challenges: By Kyle Forcier, Senior Director of Life Sciences and Product Marketing, Model N
Kyle Forcier shares the most pressing industry challenges and what device manufacturers can do to ensure greater profitability in the near and long term. Read on.
A New Approach to Personalized Immunotherapy By Ofer Sharon, MD, CEO of OncoHost
Ofer Sharon, MD, CEO of OncoHost provides his expert views on where this all began and where things are heading. Read on.
Executives on the Move
FDA Medical Device Updates
Comprehensive Insights into Medical Device & Biotechnology Company Mergers, Acquisitions & Funding
Delphinus Raises $30 Million in Series D Funding to Transform Dense Breast Screening
The round drew participation from both new and existing investors, including Arboretum Ventures, Beringea, North Coast Technology Investors, Venture Investors, Hopen Life Science Ventures, and Waycross Ventures.
Signum Surgical Secures Additional €2.9 Mil
Funds to support ongoing regulatory submissions and clinical programs leading to the commercialization of BioHealx reports Signum Surgical.
Elevation Spine, Inc. Closes $11 Million Series B Financing
Elevation Spine plans to use the proceeds from the financing to ramp the commercial production of Saber-C® as well as support product development of future product extensions of the company’s Saber® Technology platform of products.
Tuned Raises $2.5M Seed Round to Radically Upend the Status Quo in Hearing Care
Tuned advised the funding was led by Idealab NY and Elements Health Ventures.
Market Reports
Advancements In Imaging
Siemens Shapes the future Through Integrated Automation, Robotics and Gigitalization at AUTOMATE 2022
Siemens will present its extensive product and software technology portfolio for industrial manufacturing applications.
Different Types of Medical Imaging Equipment in Use
The article describes various types of medical imaging equipment to consider and buy, including used medical equipment to avoid upfront expenses and maintenance costs. Moreover, leasing also provides access to multiple tools within budget.
EchoNavigator 4.0 by Philips – New Release
EchoNavigator 4.0 gives users of Philips’ EPIQ CVXi interventional cardiology ultrasound system greater control of live fusion-imaging on the company’s Image Guided Therapy System – Azurion – platform.
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
Email Marketing Best Practices: Building Effective Campaigns for Customer Engagement
Email marketing remains a highly effective strategy for engaging customers, nurturing leads, and driving conversions. However, with inboxes flooded with promotional messages, it’s essential to
How Custom Software Development is Revolutionizing the Healthcare Industry
Here, in this article, we explore the groundbreaking changes introduced by custom software development in the healthcare industry, and how it sets the path for future innovations.
Patient Confidentiality and Digital Transformation: Balancing the Scale in Healthcare Facilities
The digitization of healthcare has significantly changed the landscape of this industry, marking a paradigm shift in how medical professionals deliver services to their patients.
Advances in Rheumatology Research: New Discoveries and Treatment Options
Rheumatology is a medical specialty for diagnosing, treating, and preventing rheumatic diseases. In recent years, there have been tremendous advancements in the research of rheumatologic
