- Announcing RED® 72 SILVER LABEL | Now Featuring Penumbra’s Latest Engineering Enhancements Designed for Seamless Navigation
- CereVasc’s eShunt® System Gains FDA Breakthrough Designation
- Efemoral Medical Releases Positive Long-Term Results from EFEMORAL I
- BD Launches Industry-First Bioabsorbable Mesh Designed for Umbilical Hernia Repair
- Boston Scientific Chief Financial Officer Dan Brennan to Retire | Jon Monson, SR VP, Investor Relations to succeed Brennan
- Mursla Bio Receives FDA Breakthrough Device Designation for EvoLiver Test
- Navigating the Digital World: What Doctors Are Doing About Bad Reviews Online
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Medical Device Industry News: Latest Developments, Breakthroughs, and Future Outlook

STARmed to Accelerate Global Market Entry of EUSRA & ELRA Products Through Olympus
“Taewoong Medical becoming an Olympus group company is also a major milestone in our global growth strategy,” said Henry Shin, CEO of STARmed. “We look forward to our products being made available to more patients through Olympus’ global distribution network.”
Innova Vascular Announces Successful Early Commercial Use of Laguna Thrombectomy System in Patients
Sanjay Shrivastava, Ph.D., CEO, “We are extremely pleased with the early clinical performance of the system and look forward to expanding our product launch in the period ahead. Successful use of the System marks an important milestone in our commitment to develop innovative technologies targeting large, underserved markets. We are grateful to our physician advisors, who play a key role in shaping these solutions.”
Genesis MedTech Completes Enrollment in its United States Early Feasibility Study Utilizing the J-Valve™ Transfemoral System for Patients with Severe Aortic Regurgitation
Finalizing the EFS marks another significant milestone for Genesis MedTech and its U.S.-based subsidiary JC Medical.
BDC Laboratories Introduces Software to Simplify Complex GOA Determination for Prosthetic Heart Valves
BDC Laboratories describes GOA analysis as a multi-dimensional imaging challenge because heart valve substitutes have complex geometries and perform nuanced movements.
Clinical Trials
PharmaKure Submits MHRA CTA for Phase 2a Clinical Trial of PK051 in Patients with Mild Cognitive Impairment
PK051 is a combined drug that targets disaggregates of amyloid-β proteins. There is increasing scientific acceptance that overproduction and/or deposition of amyloid-β is the initial event in Alzheimer’s Disease pathology.
Oncolytics Biotech Presents Positive Updated Pancreatic Cancer Data from GOBLET Phase 1/2 Study at ESMO
“The data from this study show a correlation between the expansion of TIL-specific clones and tumor response, which provides compelling support for the use of pelareorep-based therapies in immunologically “cold” tumors. In particular, these data, along with the impressive clinical results, support the ability of pelareorep-checkpoint inhibitor combination therapies to meaningfully improve treatment responses in diseases like pancreatic cancer that have resisted immune-based therapeutic approaches,” said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics Biotech.
New Phase 3 TREMFYA® (guselkumab) Results in Ulcerative Colitis Show a 77 Percent Overall Clinical Response Rate and Early Symptom Improvement
“Ulcerative colitis is a complex immune-mediated disease that can cause a wide range of often-debilitating symptoms,” said study author Jessica R. Allegretti, M.D., Medical Director, Crohn’s and Colitis Center at the Brigham and Women’s Hospital, Boston, MA, USA.c “Results from the QUASAR studies support the potential of TREMFYA as a durable and fast-acting treatment option.”
Biotechnology News
Leading Pharma Adopts Veeva Vault Validation Management for Digital Validation Execution and Improved Efficiency
SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals Co. Ltd., a global biotech company, is using Veeva Vault Validation Management to streamline and accelerate their validation process. By adopting a validation solution with built-in best practices, the company can execute digital validation while centralizing data and improving visibility.

Thermo Fisher Scientific Launches PangenomiX Array to Support Population-Scale Disease Studies and Pharmacogenomics Research
The PangenomiX Array is currently the only research solution that combines four assays in one test: SNP genotyping, whole genome copy number variant detection, fixed copy number discovery, blood and HLA typing. The high-throughput array is designed to advance disease risk and detection research, population-scale disease research programs, ancestry and wellness testing, drug efficacy testing, and drug development research.

HORIBA Medical Launches Next Generation HELO Fully Automated Modular Hematology Solution
HELO 2.0 offers a highly flexible and efficient modular hematology solution that is fully scalable with many possible configurations for mid to large-scale laboratories.
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
BlueWind Medical Raises $64 Million
BlueWind Medical notes the funds to be used to support the ramp in their commercial footprint in anticipation of potential FDA marketing clearance for the RENOVA iStim implantable neuromodulation device.
CognitiveCare Receives a Grant of Nearly $1 Million to Advance Maternal and Fetal Health
CognitiveCare Inc. to provide antenatal risk stratification AI Support for the Bill & Melinda Gates Foundation-funded Antenatal Research Collaborative
Ictero Medical Closes $6M Series A Financing
Ictero Medical advises funding will be used to continue product development and complete initial clinical testing.
Ceryx Medical Raises £3.8m In Seed Funding
Funding will be used to commercialize its unique cardiology technology and commence the first-in-human clinical study of the Ceryx Medical innovative cardiac rhythm management device, Cysoni, later this year.
Market Reports
Advancements in Imaging
Carestream Continues Drive to Improve Image Quality and Workflow With 45 Patents in 2021
“Carestream continuously strives to deliver cutting-edge technologies worldwide, and these patents demonstrate our commitment to meet the evolving needs of providers and patients alike,” said Eugene Shkurko, Intellectual Property Counsel at Carestream.
Aidoc Partners with Novant Health
By incorporating Aidoc’s AI platform, which includes seven FDA-cleared solutions for triage and notification of patients with acute medical conditions, Novant Health is taking proactive steps to improve patient outcomes and reduce emergency department (ED) length of stay amid resource constraints inflicted by the Omicron variant.

Philips Integrates Cloud-based AI and 3D Mapping into its Mobile C-arm System Series – Zenition
“By partnering with Philips to bring our Cydar EV Maps solution to Philips’ user-friendly Zenition platform of mobile C-arms, we are a step closer to achieving our mission to ensure every image-guided minimally-invasive surgical procedure goes exactly as planned,” said Paul Mussenden, CEO of Cydar.
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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