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"Medical Device and Biotechnology Sector News: Essential Key Insights and Noteworthy Developments that are Shaping the Future"

Medtronic Announces FDA Approval of Newest-generation Evolut TAVR System for Treatment of Symptomatic Severe Aortic Stenosis
The Evolut ™ FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access
Bio-Rad Launches Validated Antibodies for Rare Cell and Circulating Tumor Cell Enumeration
The company announced the launch of validated antibodies for rare cell and circulating tumor cell (CTC) enumeration. Validated for use with Bio-Rad’s Celselect Slides Enumeration Stain Kits, the antibodies are specific to CTC surface markers to enable the sensitive and specific identification of target cell populations, enhancing the study of tumor heterogeneity and disease progression at various stages.

Inkwell Medicine: Crafting Effective Medical Content
“Inkwell Medicine,” requires a blend of scientific knowledge, linguistic skill, and a deep understanding of the target audience’s needs and expectations.
eGenesis Announces World’s First Successful Transplant of Genetically Engineered Porcine Kidney in a Living Patient
This is the first ever transplantation of a genetically engineered porcine kidney into a living human recipient.
Comprehensive Insights into Medical Device & Biotechnology Company Mergers, Acquisitions & Funding
Delphinus Medical Technologies Raises $12 Million as Footprint Continues to Expand
Mark J. Forchette, president and CEO of Delphinus Medical Technologies. “SoftVue provides a comprehensive solution that enables providers to transform their patients’ clinical experience. Our relationship with Trinity Capital helps us make impactful investments in execution, to help our clinical partners embrace this innovation, and serve the unmet needs of patients with dense breast tissue that SoftVue was designed to address.”
Theken Companies Acquires VisionAir Solutions
Randy Theken, Founder of Theken Companies, said of the acquisition, “I was truly overwhelmed by the technology created by the VisionAir team at Cleveland Clinic. The VisionAir 3D Patient-Specific Stents provide significantly improved stent life and an improved patient quality of life. This is exciting not only for the pulmonary field, but for the potential to apply this technology to other medical devices.”
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

Modulim Announces CE Mark of Clarifi Imaging System for Microvascular Assessment
Modulim can now expand its marketing and distribution throughout Europe and apply for registration in other international markets that recognize the CE Mark.

Samsung Electronics Co., Ltd. will showcase its premium diagnostic imaging solutions in ultrasound, digital radiography and mobile computed tomography at the Radiological RSNA from November 29 to December 5.
“This year has been a pivotal year for Samsung in moving forwards new solutions across a variety of areas. We are looking forward to putting on display our advancements within ultrasound, digital radiography and mobile CT modalities,” stated Yongkwan Kim, Head of Health & Medical Equipment Business at Samsung Electronics and CEO of Samsung Medison. “Our innovative solutions demonstrate Samsung’s commitment to leveraging our innovation engine to better address the needs of healthcare providers and their patients.”
3M and Rad AI Team Up to Offer Rad AI’s Advanced Technology for Generating Customized Radiology Reporting. More on this and details at RSNA 2020
“Rad AI and 3M share a common goal of helping radiology teams become stronger and more resilient in the face of growing demand, complex regulations and increased competition,” said Dr. Jeff Chang, ER radiologist and Rad AI co-founder.