- Bionical Emas and Pharma Resources Announce Exclusive Global Clinical Trial Supply Partnership
- Isotopia and Cardirad Announce Launch of Isoprotrace ® in Sweden and Denmark, Expanding Access to Advanced Prostate Cancer Imaging
- Precision Medicine – Closing the Loop: Why a Test Alone Isn’t Enough | By Dr Tom Stubbs – CEO Hurdle
- MellingMedical Adds the joimax® Suite of Full-Endoscopic, Minimally Invasive Spinal Surgery Products to Its Federal Health Portfolio
- Olympus Announces Launch of New Endoscope Drying Cabinet
- Hyperfine Announces FDA Clearance of Optive AI™ Software, Introducing the Most Substantial Image Quality Improvement Ever for the Swoop® System
- AVNA INC. Appoints David Bonvenuto and Aaron Mambrino to Board of Directors
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Medical Device Industry News: Latest Developments, Breakthroughs, and Future Outlook
Applied Medical Technology Launches IntelAir™, a Nasopharyngeal Airway
“We designed the IntelAir™ to fulfill a market need; while some devices focused on patient needs and others on clinician needs, none appropriately served both. With this all-in-one device, users can benefit from the streamlined approach paired with AMT’s commitment to excellence,” reflected Dr. George Picha M.D., Ph.D., F.A.C.S., Founder & CEO of Applied Medical Technology, Inc.
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.
Clinical Trials
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.
First Patient Dosed in Clinical Trial of YOLT-201 for the Treatment of Hereditary ATTR-CM
YOLT-201 Injection utilizes several lipid components including ionizable lipids as primary excipients to encapsulate mRNA and sgRNA raw materials, forming lipid nanoparticles (LNP). Upon intravenous injection into the body, plasma ApoE protein binds to the surface of LNP particles.
Thubrikar Aortic Valve Announces Authorization to Expand the TAVI-1 CE Mark Trial with the Precision 2 Delivery Catheter
The Precision 2 Catheter is engineered to provide operators with significant control. It allows the Optimum TAV to be repositioned and recaptured for retrieval, if necessary, during the TAVI procedure. Due to the innovative catheter design, the Optimum TAV’s short frame reorients as it is deployed in the diseased valve which results in automatic axial alignment of the valve. The Company’s Medical Advisors, Dr. Susheel Kodali, Director of the Structural Heart & Valve Center at New York-Presbyterian/Columbia University Medical Center, and Dr. Mathew Williams, Director of the Heart Valve Center at NYU Langone Health, provided guidance on the development of the new catheter.
Biotechnology News
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.
Lindus Health Launches “All-In-One Metabolic CRO” Offering to Accelerate and Enhance Metabolic Clinical Trials
Lindus Health has taken learnings from this experience to build a bespoke “All-in-One Metabolic CRO” offering that combines the expertise of a seasoned full service CRO and internal site/PI expertise with a distinctive technology driven approach on its proprietary Citrus™ platform. This unique marriage of technology and services sets metabolic sponsors up to run faster, more patient-centric clinical trials.
Our Experts – Byline Articles
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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
Comprehensive Insights into Medical Device & Biotechnology Company Mergers, Acquisitions & Funding
FEMSelect Secures US$9M Series B Financing
Debbie Garner, Co-CEO of FEMSelect, commented, “This investment is a testament to our team and the EnPlace® system. It enables us to expand the medical and patient communities and to serve many more women who are seeking a minimally invasive treatment option. This is a tremendous step forward for the company.”
Garvis Raises €3.5 Mil Euros for a Bionic AI Platform to Optimize Supply Chain Management
Garvis notes investors include British investment funds Superseed and Scalebridge Capital, and the German group Bosch Ventures.
Axis Spine Technologies Raises £10.8m After Successful Product Release in US
The funding, which follows the successful release of its first product in the US, will enable Axis Spine Technologies to expand to new hospitals, broaden its product portfolio, and position itself as a leader in anterior lumbar surgery.
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.
Market Reports
Advancements in Imaging
Carestream Shares Path to Accelerated Delivery of AI Features at HPE Discover 2022 Conference
Carestream leverages HPE GreenLake’s enterprise-grade cloud service for machine learning (ML Ops platform) to accelerate development of its AI applications for medical imaging.
Atik Cameras launches ChemiMOS
This 9-megapixel camera, with a set point cooling of -20°C, has been optimized for long exposures notes Atik Cameras.
MinXray Affirms Quality of Its Medical Devices with ISO Certification
Moving forward, MinXray’s certification will help its business stand out and grow in the industries that require ISO compliance.
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
Improving Academic Writing: Enhance Your Vocabulary with Merriam-Webster’s Word of the Day
Did you know that you can access simple online and easily accessible tools to improve your academic writing skills? You are at the right place,
The Importance of Signage In Medical Settings
Have you ever been lost in a hospital corridor? Your pulse raises as your eyes are darting about looking for the correct department. Thinking ‘I’m
4 Mistakes Phlebotomy Technicians Should Avoid
Phlebotomists draw blood from patients for various blood tests. These medical professionals work in hospitals, doctor’s offices, and surgical centers, among many other medical facilities.
Healthcare Data Compliance: What You Need to Know in 2023
It’s important to understand what keeping patient information safe and secure means. Especially in this era of data. This is where healthcare data compliance comes