- The Essential Role Of Chemicals In Scientific Inquiry
- How Medical Device Distributors Accelerate Sales Growth
- Akumin Reports: First 2 Innovative Akumin AXIS™ Expandable Patient Units Deployed at Hospital Partner Locations
- Dr Jared Auclair, Co-Lead of BioConnects New England, Named 2025 Champion Public Advocate by MassBioEd
- Recor Medical Announces Paradise Ultrasound Renal Denervation System Receives Manufacturing and Marketing Approval in Japan for the Treatment of Resistant Hypertension
- Sethera Therapeutics Announces Newly Published Paper Unveils Breakthrough Enzyme That Expands Possibilities for Peptide Drug Discovery
- Spotlight Medical Announces Publication in Journal of Clinical Oncology Validating AI Pathology Assay That Identifies Low-Risk Subgroup Within Clinically High-Risk Early ER+/HER2- Breast Cancer
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Medical Device Industry News: Latest Developments, Breakthroughs, and Future Outlook
CPR Therapeutics Receives Follow-on U.S. Patent for Integration of Defibrillation into an Automated CPR Device
CPR Therapeutics Inc. is an early-stage start-up supported by funding from the NSF and NIH
Thirona and COPD Foundation Partner to Advance AI-Driven Phenotyping of COPD Patients
This collaboration aims to extract and validate a range of AI-based quantitative CT (QCT) measures, identifying imaging biomarkers that hold the greatest potential for improving COPD phenotyping and advancing precision care.
Guided Spinal Navigation Landmark Surgery Opens the Door to Cost-Effective 3D Augmented Reality
A groundbreaking surgical procedure was successfully performed on a small island in the Mediterranean, marking a significant advancement in spinal surgery.
Nihon Kohden Payment Solutions Launches to Help Healthcare Facilities Acquire Critical Tech
With customizable plans and flexible payment structures, NK Payment Solutions empowers hospitals to invest in advanced patient monitoring and diagnostics technologies while preserving cash flow, existing credit lines and long-term financial flexibility.
Clinical Trials
New Data Presented at ESMO 2024 Show that Veracyte’s Decipher Prostate Test Predicts Chemotherapy Benefit in Patients with Metastatic Prostate Cancer
“The Decipher Prostate test’s ability to help guide treatment for patients with localized prostate cancer is already proven in dozens of peer-reviewed publications and is the only molecular test to achieve ‘Level 1B’ evidence status in the most recent NCCN® Guidelines* for prostate cancer,” said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. “These new phase 3 data from the STAMPEDE trial now further prove the performance and utility of our test in patients with metastatic prostate cancer. We believe our test can have a tremendous positive impact on care for these patients.”
Delcath Systems Reports Positive Outcomes from Independent Study on Hepatic Perfusion for Uveal Melanoma Patients
The 30-patient study reported that the Delcath Systems HEPZATO KIT™ (melphalan/Hepatic Delivery System (HDS)) provided better disease control in the liver and improved progression-free survival in patients with hepatic metastases from uveal melanoma, compared to both immunotherapy and other liver-directed therapies.
Lucid Diagnostics Announces Publication of Analytical Validation Study of EsoGuard® for Early Detection of Esophageal Precancer and Cancer
“This analytical validation study strongly complements EsoGuard’s extensive peer-reviewed, published clinical validity and clinical utility evidence base,” said Suman Verma, M.D., PhD, Chief Scientific Officer at Lucid Diagnostics. “The results demonstrate very robust analytical performance of the EsoGuard assay performed in our CLIA-certified, CAP-accredited, NY State-approved commercial laboratory.”
Biotechnology News
Capricor Therapeutics Completes Submission of Biologics License Application to the U.S. FDA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy
“The submission of the BLA marks a pivotal step for Capricor Therapeutics and those impacted by DMD. This BLA is the culmination of a body of work that has been focused on bringing this potentially transformational therapy to those patients in need,” said Linda Marbán, Ph.D., Chief Executive Officer of Capricor. “We believe that the strength of this application is that deramiocel has shown in multiple clinical trials attenuation of the cardiac implications of DMD. We look forward to working with the FDA throughout the review process to support this potential approval.”
PharmaEssentia Reaffirms its Commitment to Robust and Reliable Access to Interferon Therapies Amid Global Supply Challenges
“Our longstanding commitment to operational resilience has positioned us to navigate these challenges effectively,” said Dr. Ko Chung Lin, CEO of PharmaEssentia. “We recognize that dependable medication supply is essential, and we are working closely with our partners around the world to ensure the continuity of these important therapies. We have made substantial investment to ensure that all of our supply chain elements are strong, of the highest quality, and reliable.”
YolTech Therapeutics Granted FDA Orphan Drug and Rare Pediatric Disease Designations for YOLT-203 to Treat Primary Hyperoxaluria Type 1
After reviewing YolTech Therapeutics submission, the FDA determined that the therapy is not only appropriate for primary hyperoxaluria type 1 (PH1), but also applicable to the broader category of primary hyperoxaluria (PH). As a result, the designations were granted for PH, reflecting the expanded scope of the therapy’s potential impact. These dual designations underscore the transformative potential of YOLT-203 to address this rare and life-threatening genetic disorder.
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
ExpressionEdits Raises $13M in Seed Funding to Advance Protein Expression Using AI-Driven Intronization Technology
The funding will accelerate candidate selection for preclinical studies and develop a pipeline of protein-based therapeutics. The primary focus for the pipeline will be recombinant proteins that have historically faced production and manufacturing challenges based on current technology notes ExpressionEdits.
Matter Bio Successfully Closes $7M Seed Funding Round
“Genomic integrity is a cornerstone of longevity and healthspan extension,” said George Church, Professor of Genetics at Harvard Medical School. “Matter Bio is pioneering a crucial approach in the fight against aging by focusing on the preservation of our genetic blueprint. I am excited to see the impact of their work on enhancing human health.”
Enifer Secures €36M In Funding
Enifer, a biotech scaleup is gearing up the production of its PEKILO® mycoprotein with a new €33M factory located in Kirkkonummi, Finland. With already existing collaborations with the world’s leading food and feed companies, Enifer is prepared to annually upcycle food industry side streams into up to 3,000 tons of its sustainable fungi-based protein
Phenomix Sciences Raises $7.8M in Funding to Accelerate Adoption of Obesity Precision Medicine
Funding will accelerate the commercialization and adoption of the MyPhenome™ test in the obesity specialist market and the wider industry. The MyPhenome test equips physicians with essential tools to develop effective treatment plans including lifestyle and diet intervention as well as medication and/or procedure recommendations reports Phenomix Sciences.
Market Reports
Advancements in Imaging
Vieworks Showcases X-ray Imaging Excellence: RSNA 2023 Spotligh
Vieworks will present its comprehensive range of DR flat panel detectors (FPDs) catering to general radiography, dynamic applications, and mammography. The focal point remains on the latest VIVIX-S F series, accompanied by the revolutionary VIVIX-S 1751S—a long-format detector tailored for imaging larger body parts and long bones.
Samsung Ushers in a New Era of Diagnostic Solutions at RSNA 2023
The clinical launch of the OmniTom Elite with PCD, the first US FDA 510(k) cleared single-source photon counting computed tomography scanner with a single detector on a mobile system, will be featured at this year’s meeting. Photon counting is a next-generation CT technology that sorts the different energies of X-rays after they have passed through the scan field, capturing the X-ray photons directly at the detector and converting the energy to electrical signals.
Olympus Announces Market Launch of EVIS X1 Endoscopy System
The EVIS X1 endoscopy system received clearance earlier this year along with two compatible endoscopes: the GIF-1100 gastrointestinal videoscope indicated for use within the upper digestive tract and the CF-HQ1100DL/I colonovideoscope indicated for use within the lower digestive tract.
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
Streamlining Private Practice Management in the Digital Age
The healthcare field is changing fast. Many hospitals and companies are buying up about 14,000 independent practices in 2021. To compete as a private practice, it’s crucial to use technology. Things like virtual care platforms can make medical tasks easier. By using these, private practices can focus on providing excellent patient care.
Unleashing Efficiency in Healthcare Practices with Document Scanners for Medical Records
Efficient healthcare practices are essential for the smooth functioning of any medical institution. In today’s fast-paced world, where technology is advancing at a rapid pace,
Launching a Medical Startup: Navigating the Path to Innovation and Success
This article courtesy of infomeddnews.com delves into the critical steps for launching a successful medical startup, while also highlighting the importance of a strong visual identity, achievable through tools like online logo makers.
10 Key Vulnerabilities in the Global Pharmaceutical Supply Chain
The global pharmaceutical supply chain, while essential for modern commerce and interconnected economies, is riddled with vulnerabilities that can disrupt the flow of goods and services, leading to economic instability and potential crises. These vulnerabilities have been highlighted by various events in recent years, such as the COVID-19 pandemic and cyberattacks on critical infrastructure. Here are 10 key vulnerabilities of the global supply chain
Healthcare Careers
What Are Some Medical Careers You Can Pursue Without Finishing College
There are many medical careers that you can pursue without having to finish college. In fact, many of these careers only require a high school
Interesting Ways to Make an Inspiring Career in the Medical Field
There are many interesting ways to have a career in the medical field. You could be a doctor, nurse, or even a medical researcher. All
How Long Does It Take To Become A Medical Assistant?
Medical assistants play a significant role in today’s healthcare industry. Medical assistants work alongside treating physicians as their assistants. They do a little bit of
Nurses Corner
The Different Settings Where Certified Nursing Assistants Work
Certified Nursing Assistants (CNAs) are integral to the healthcare industry, providing essential services to patients across diverse settings. As unsung heroes of patient care, CNAs
Dozee Partners with Association of Nurse Executives in India (ANEI) for Revolutionizing Patient Care
By joining forces with ANEI, we will be able to further their mission and enable India’s collective nursing community to reach its full potential.
Business Tips for Starting Your Own Practice as a Nurse Practitioner
Starting your own business is exciting and challenging. All the responsibility rests on your shoulders, but you have the freedom to run your business exactly