- Sensorion Announces Preliminary Positive Data from the First Cohort of the Audiogene Phase 1/2 Gene Therapy Clinical Trial
- MedEdge Innovations Unveils New ePTFE Platform and CDMO Services for Medical Implant Applications
- Expertise United Around Augmented SBRT – Enhanced Prostate Cancer Treatment with Minimal Side Effects
- Portal Biotech Raises $35 Million Series A | Leveraging AI to Deliver the World’s First Full-Length Single-Molecule Protein Sequencer
- JLL Partners Announces Investment in Vascular Technology, Incorporated
- The Importance of Relationship Mapping in Salesforce for Sales Success
- Merck KGaA, Darmstadt, Germany, Honors Alán Aspuru-Guzik with the Heinrich Emanuel Merck Award for Computational Sciences
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
Shoulder Innovations Further Strengthens IP Portfolio in Key Areas with Recent Patent Grants
“These recent grants further strengthen key patent families that are foundational to our technology, and we are pleased the USPTO continues to recognize our meaningful innovation in the shoulder arthroplasty segment,” said Rob Ball, CEO of Shoulder Innovations. “This noteworthy expansion of our IP position represents the culmination of over 10 years of research and development, and we are proud of our team for their continued dedication to creating practical solutions for shoulder surgeons and advancing patient outcomes.”
Radical Catheter Technologies Presents Analysis of Disruptive, Recently FDA-Cleared Endovascular Technology at the Society of NeuroInterventional Surgery 21st Annual Meeting
This new catheter, the first product commercialized from this novel technology platform, is designed to enable access to the blood vessels in the brain for both femoral and radial access. A multi-center analysis of this disruptive technology is being presented today at Society of NeuroInterventional Surgery 21st annual meeting. In addition, the Company confirmed the closing of a $20 million financing round led by NeuroTechnology Investors, which will be used to scale the company and expand the Radical platform notes Radical Catheter Technologies.
Rapid Medical™ Completes Initial Neurovascular Cases in the USA Following FDA Clearance of Its Active Access Solution
“With DRIVEWIRE, our design goal was to bring new levels of access and control to the interventional suite while improving best-in-class guidewires,” comments Giora Kornblau, Chief Technology Officer at Rapid Medical. “When physicians are looking for technologies that increase the clinical possibilities and safety for the patient, we want Rapid to be the first place they look.”
HeartFlow Introduces Next Generation Interactive Plaque Analysis Platform to Assess Patient Risk in Suspected Coronary Artery Disease
The HeartFlow Plaque Analysis uses proprietary algorithms to analyze coronary CT angiogram (CCTA) scans, creating a personalized 3D model that quantifies and characterizes plaque volume in the coronary arteries, aiding risk assessment of coronary artery disease. The technology was introduced at the Society of Cardiovascular Computed Tomography (SCCT) Annual Scientific Meeting in Washington, D.C.
Clinical Trials
Invizius Treats First Patients in First-In-Human Phase 1 Clinical Study of Lead Dialysis Product H-Guard ®
First patients treated with H-Guard at the National Institute for Health and Care Research Manchester Clinical Research Facility. MHRA approves continuation of Invizius’s first-in-human clinical study following a prearranged two-patient safety and performance review. Study is investigating safety and tolerability of H-Guard®, a second generation complement regulator, to address serious immune system-driven complications of dialysis.
Dilon Technologies Announces the Beginning of Enrollment in its Pivotal Trial of the Next Generation MarginProbe™ 2 Used in Real-Time Margin Assessment
Dilon Technologies looks to continue building evidence around its MarginProbe™ platform that already has over 12 peer-reviewed publications demonstrating reduction in re-excision rates. “We remain committed to being a leader in women’s healthcare by providing technology for patients that will improve their outcomes. MarginProbe™ is beginning to become an integral component of breast surgery for more surgeons across the United States each month,” stated George Makhoul, CEO of Dilon Technologies.
Randomized Controlled Trial for the EkoSonic™ Endovascular System Commences
“Optimal treatment of PE is still poorly understood and there is a need for a coordinated institutional approach to this complex, life-threatening problem,” said Kenneth Rosenfield, M.D., study co-lead principal investigator and section head, Vascular Medicine and Intervention, Division of Cardiology, Massachusetts General Hospital, Boston. “The lead investigators of the trial are pleased to collaborate with the PERT Consortium, which is committed to evidence-driven therapy and is proud to take part in the HI-PEITHO study, aiming to advance the care of patients with PE.”
Biotechnology News
AbbVie and Gilgamesh Pharmaceuticals | Announce Collaboration and Option-to-License Agreement to Develop Next-Generation Therapies for Psychiatric Disorders
Under terms of the agreement, AbbVie and Gilgamesh Pharmaceuticals have agreed to research and develop a portfolio of next-generation therapeutics for psychiatric disorders.
PharmaLogic Announces Opening of Radiopharmaceutical Production Facility in New York City
Acquired in 2022, the facility has undergone extensive renovations and boasts state-of-the-art equipment, signifying the companys significant investment in fostering the development of novel radiopharmaceuticals in the region.
Ossium Health Launches HOPE Program to Give All Patients Hope for a Cure
Through the HOPE Program, patients across the globe can receive bone marrow from Ossium’s bank free of charge.
Our Experts – Byline Articles
Read Their Views & Share With a Colleague or Two!
Securing the Promise of AI Medicine: Addressing Cybersecurity Challenges in Healthcare & Medical Devices | By James F. Jordan
The introduction of AI medicine brings an opportunity to improve both our cost and quality by reducing inefficiencies and availing prevention opportunities. AI Medicine can make it easier for medical professionals to diagnose patients earlier and deploy treatment more quickly and accurately to simultaneously reduce cost and improve quality.
Why CROs Need Access to Modern PV Operations Tools | Interview with Jung Min Lee & Emmanuel Belabe
Jung Min Lee, Pharmacovigilance Director, has been in charge of clinical and pharmacovigilance work at Korea Pharmaceutical institutions for about 20 years. Emmanuel Belabe, better known as “Manny,” has worked within ArisGlobal in a number of different roles over his 15 years with the company.
How Better Data Management Improves Patient Experience | By Ben Herzberg, Satori Chief Scientist and VP of Marketing
In this article Herzberg explains how better data management helps deliver more successful treatment, patient scheduling and much more.
Executives on the Move
FDA Medical Device Updates
Comprehensive Insights into Medical Device & Biotechnology Company Mergers, Acquisitions & Funding
Dymicron Launches Regulation A+ Equity Crowdfunding Investment Offering
Dymicron has partnered with DealMaker for its self-hosted $15.8 million raise. Regulation A+ raise. Regulation A+ is a relatively new exemption which allows private companies to sell their shares to unaccredited investors.
Miach Orthopaedics Secures $40 Million Financing
Miach Orthopaedics advises funds will enable ongoing operations and expand the U.S. commercial rollout of the BEAR Implant.
Ferronova Secures A$11 Million to Advance Nanotech Image-guided Cancer Therapy
Ferronova CEO Stewart Bartlett said raising capital in a challenging environment and winning a CRC-P grant was a credit to the strength of Ferronova’s technology.
Visura Announces Closing of Series B Financing
Funding will support the company’s rapid, full commercialization of its TEECAD® System. “These significant investments underscore the tremendous confidence in our state-of-the-art solution, experienced team, and the growth trajectory we are on to fully commercialize our TEECAD System,” says Christine Horton, president and CEO of Visura.
Market Reports
Advancements In Imaging
Philips to Spotlight Integrated, Data-driven Cardiology Solutions at ESC 2022
Philips AI-powered interventional and diagnostic smart systems and at-home solutions connect care across the cardiology care pathway to enhance diagnostic confidence, drive greater efficiency, and improve patient outcomes.
Synthetic Medical Imaging: How Deepfakes Could Improve Healthcare
This groundbreaking study for the first time demonstrates how the use of a novel Generative Adversarial Network (GAN), (U.S. Patent Numbers: US 11,217,350 B2; US 11,276,151 B2; US 11,398,013 B2), often referred to as a “Deep Fake”, improves the diagnostic accuracy of AI algorithms in identifying periodontal disease.
Carestream’s Lux 35 Detector Wins Frost & Sullivan New Product Innovation Award
“The Frost & Sullivan Award is another validation of our research and development team’s continued success at developing solutions that incorporate cutting-edge technology to improve radiology workflow and enhance patient care,” said Dharmendu Damany, Chief Technology Officer at Carestream.
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
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