- Capricor Therapeutics Completes Submission of Biologics License Application to the U.S. FDA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy
- PharmaEssentia Reaffirms its Commitment to Robust and Reliable Access to Interferon Therapies Amid Global Supply Challenges
- YolTech Therapeutics Granted FDA Orphan Drug and Rare Pediatric Disease Designations for YOLT-203 to Treat Primary Hyperoxaluria Type 1
- Poseida Therapeutics Announces Agreement to be Acquired by Roche Holdings, Inc.
- 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
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"Medical Device and Biotechnology Sector News: Essential Key Insights and Noteworthy Developments that are Shaping the Future"
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.
Cartessa Aesthetics Partners with Classys to Bring EVERESSE to the U.S. Market
Classys, which is listed on the KOSDAQ, is one of South Korea’s most distinguished aesthetic technology manufacturers, with devices distributed in 80+ markets globally. This partnership marks Classys’s official entry into the American marketplace, with Cartessa Aesthetics as the exclusive distributor for EVERESSE, launched under the Volnewmer brand in current global markets.
Stryker Launches Next-Generation of SurgiCount+
Now integrated with Stryker’s Triton technology, SurgiCount+ addresses two key challenges: retained surgical sponges and blood loss assessment. Integrating these previously separate digital solutions provides the added benefit of a more efficient, streamlined workflow for hospitals notes Stryker.
Nevro Receives CE Mark In Europe for It’s HFX iQ™ Spinal Cord Stimulation System
Nevro notes HFX iQ is the first and only SCS system with artificial intelligence (AI) technology that combines high-frequency (10 kHz) therapy built on landmark evidence that uses ongoing cloud data insights to deliver personalized pain relief
Comprehensive Insights into Medical Device & Biotechnology Company Mergers, Acquisitions & Funding
Agilent Technologies to Acquire North American CDMO BIOVECTRA
BIOVECTRA and Agilent Technologies are fully integrated CDMOs with state-of-the-art facilities that follow current Good Manufacturing Practices (cGMP), a high standard for methods, facilities, and controls used in manufacturing, processing, and packaging of active pharmaceutical ingredients.
Grünenthal Acquires US-company Valinor Pharma and Becomes Global Owner of Movantik®
“As a pain specialist, Movantik is a perfect fit for Grünenthal with our existing customer base and complementary product portfolio”, says Gabriel Baertschi, CEO, Grünenthal. “The acquisition of Valinor Pharma strengthens our footprint in the United States, the most important growth market for Grünenthal.”
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
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.
Carestream Unveils Next Generation Detector in Long-Length Digital Imaging
The CARESTREAM DRX-LC Detector (Pending FDA 510(k) clearance) captures long-bone and spine images with a single exposure, making it ideal for pediatric imaging and long-bone and spine images of people with limited mobility.
Canon Medical Components U.S.A., Inc. Announces Launch of New Products in the U.S., to Be on Display at RSNA 2022
Canon Medical Components U.S.A., Inc. is displaying a number of innovative products, some that are now available for the first time in the United States.
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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