- Caidya Announces $165 Million Strategic Growth Investment from Rubicon Founders
- Revvity and Element Biosciences Collaboration | To Advance Sequencing-based IVD Neonatal Testing
- R3 Vascular Secures WCG IRB Approval and CMS Category B Medicare Coverage for the ELITE-BTK Pivotal Trial of its MAGNITUDEÒ Drug Eluting Next Generation Bioresorbable Scaffold for Below-the-Knee Peripheral Arterial Disease
- Vergent Bioscience Receives FDA Fast Track Designation for Abenacianine for Injection (VGT-309) to Help Surgeons Visualize Tumors in the Lung During Surgery
- Capricor Therapeutics Completes Submission of Biologics License Application to the U.S. FDA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy
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"Medical Device and Biotechnology Sector News: Essential Key Insights and Noteworthy Developments that are Shaping the Future"
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.
Luna Partners with Leading Academic Medical Center | To Expand Access to In-home, Outpatient PT Services
Luna advises the new collaboration will start taking appointments in February 2025, and patients seeking care will receive safe, high-quality PT conveniently delivered to their homes.
Eisai Signs Research Collaboration Agreement with The National Center of Neurology and Psychiatry to Initiate Apolipoprotein E Genetic Testing in the “AD-DMT Registry” in Japan
Eisai and Biogen Japan will continue to contribute to the advancement of Alzheimer’s disease treatment through ongoing collaboration with academia.
Intensity Therapeutics Presents INT230-6 Phase 1/2 Data in Sarcoma and an Overview of its Ongoing Global Randomized Phase 3 Sarcoma Trial (“INVINCIBLE-3 Study”) in a Late-Breaking Session at the 2024 Annual Connective Tissue Oncology Society Meeting (CTOS)
Phase 1/2 data showed a median overall survival (“mOS”) of 21.3 months versus a synthetic control of 6.7 months, an increase in T-cell activation, and favorable safety profile for patients receiving INT230-6 alone notes Intensity Therapeutics.
Comprehensive Insights into Medical Device & Biotechnology Company Mergers, Acquisitions & Funding
Samsung Ventures Among Top Investors Backing AI Imaging Acquisition Market Leader Subtle Medical – Bringing Total Series B to Over $30 Million
The funds will primarily support accelerating US and global sales initiatives and expediting the launch of new AI-driven products notes Subtle Medical.
Novo Holdings Leads $105 Mil Financing of Magenta Medical | To Support FDA Approval for World’s Smallest Heart Pump
Novo Holdings reports the funds will be used to advance Magenta’s US clinical programs to support the FDA’s approval of the Elevate™ System, the world’s smallest heart pump.
Industry Expert Byline
Reimagining CRM: What’s Next for Medtech Commercial Success | By Akshay Kapadia, CEO and Founder, Conexus Solutions, Inc.
Success depends on more than just choosing the right CRM platform; it requires aligning that platform with optimized business processes, a clear data strategy, and long-term commercial goals. When all of these elements work together, the CRM platform becomes a powerful tool to support growth, innovation, and sustained value.
FDA Medical Device Updates
Our Experts - Byline Articles
Advancements in Imaging
Philips and TriHealth Announce Multi-year Partnership at zheart of New TriHealth Heart & Vascular Institute On the Campus of Bethesda North Hospital
The partnership also consists of technology management plans, helping to ensure the health system can benefit from the latest technology innovations which will help them drive their strategy and deliver on their mission notes Philips.
Lunit and Agfa HealthCare Bring Breast Imaging AI Solution to Dubai Academic Health Corporation Dubai Hospital
Dubai Academic Health Corporation (DAHC) Dubai Hospital to modernize its Breast Cancer Diagnostic and Screening program with Agfa HealthCare’s RUBEE for AI framework and Lunit INSIGHT MMG algorithm.
Invenio Imaging Announces Clinical Research Collaboration Agreement
“In this important clinical study, we will develop a novel image analysis algorithm based on machine learning to provide physicians with real-time feedback determining whether a biopsy sample contains cancer”, says Chris Freudiger, PhD, Co-Founder and CTO of Invenio Imaging.
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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