- GC Biopharma Receives FDA Approval for its U.S. Plasma Collection Center in Calexico, California
- Caliway Biopharmaceuticals Announces Successful EOP2 Meeting with the FDA for CBL-514 in Reduction of Abdominal Subcutaneous Fat
- Neogap Therapeutics Selected for EIC Soft-landing Programme in Boston
- Median Technologies Submits U.S. Application for 510(k) Clearance of eyonis® LCS
- BD Launches Landmark Cell Analyzer Featuring Breakthrough Spectral and Real-Time Cell Imaging Technologies
- CPR Therapeutics Receives Follow-on U.S. Patent for Integration of Defibrillation into an Automated CPR Device
- Piramal Pharma Ltd. Continues to Invest In USA; $90M in Expansions of Two US Sites
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Medical Device Industry News: Latest Developments, Breakthroughs, and Future Outlook

1st International Harmony SHR® Robotic Rehabilitation System Installed at Prestigious Chinese University of Hong Kong Medical Centre
“This is a major milestone for our company as we work to expand our footprint and bring Harmony SHR to more providers and patients,” said Harmonic Bionics CEO Mark Hunter. “There is tremendous opportunity for growth in Asia and this installation at CUHK Medical Centre is a great starting point to our intended success in the market.”

Aerobiotix Supports Updates to AORN’s Sterile Technique Guidelines
Aerobiotix is committed to helping healthcare facilities meet these new guidelines: “The latest recommendations from AORN reinforce the essential role of advanced air decontamination systems in today’s operating rooms. Aerobiotix is dedicated to providing technologies like the Illuvia Sense, which meet and exceed these new standards, ensuring safer surgical environments for patients and healthcare professionals

ŌURA Announces Two New Heart Health Features, Moving Deeper into Preventative Health
New Cardiovascular Age and Cardio Capacity capabilities further establish ŌURA as a personal health companion for improving healthspan and longevity

Epione Advises: 100th Patient Milestone with Epione® Achieved at US Hospital
A minimally invasive procedure, Epione uses CT-guided navigation for the percutaneous ablation of tumors in the abdomen.
Clinical Trials
Exact Sciences Presents Multiple Studies at San Antonio Breast Cancer Symposium Supporting Optimization and Individualization of Therapy for Breast Cancer Patients
“Exact Sciences is looking forward to presenting new evidence at SABCS that adds important perspectives to treating breast cancer patients and showing that some patients may be able to de-escalate treatments and still have positive outcomes,” said Dr. Rick Baehner, Chief Medical Officer, Precision Oncology, Exact Sciences. “Every year, we build upon the precedent set by the Oncotype DX Breast Recurrence Score® test and its prognostic and predictive abilities to determine the chemotherapy benefit for specific breast cancer patients. We are pleased to see authorities expanding access to this test as we continue to develop key evidence in collaboration with some of the world’s most prestigious, breast cancer-focused organizations.”
Research Team at UNC Validates PixCell Medical’s HemoScreen as Game-Changer for Clozapine Monitoring in Psychiatry
Clozapine has been established as the most effective antipsychotic medication for treatment-resistant schizophrenia. However, it is significantly underutilized mainly due to the risk of developing agranulocytosis and the need to frequently monitor the absolute neutrophil count (ANC).
Clinical Validation Data Published in CHEST Demonstrate that Veracyte’s Percepta Nasal Swab Test Improves Lung Cancer Risk Assessment for Patients with Lung Nodules
The findings suggest that the novel, non-invasive genomic test can help physicians guide next steps for these patients, enabling them to potentially avoid unnecessary invasive procedures or accelerate time to appropriate treatment.
Biotechnology News

Thermo Fisher Scientific Launches New Ion Chromatography Instrument to Improve Reliability, Efficiency, and Functional Adaptability for Labs
The Thermo Scientific™ Dionex™ Inuvion™ Ion Chromatography (IC) system, helping to make ion analysis simpler and more intuitive for labs of all sizes. The new analytical instrument is designed to be easily reconfigurable, providing those who require determination of ionic and small polar compounds with a one stop shop for consistent, reliable ion analysis.
Blacksmith Medicines and Zoetis Announce Research Collaboration for Novel Animal Health Antibiotics
This new collaboration is another example of Blacksmith’s creative deal-making with top tier partners that bring expertise to the table which helps de-risk and accelerate scientific discoveries for the development of valuable products.
B. Braun Launches Heparin Sodium 2,000 Units in 0.9% Sodium Chloride Injection, 1,000 mL (2 units/mL)
Heparin Sodium 2,000 units in 0.9% Sodium Chloride Injection 1,000 mL (2 units/mL), is indicated as an anticoagulant to maintain catheter patency.
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

Theranica Secures $45 Million Series C Funding Round
Theranica advises the proceeds will fund the U.S. commercial expansion of migraine treatment device , Nerivio®
Avenda Health Raises $10M in Series B
Avenda Health notes the capital will be used to accelerate the use of iQuest, an AI-enabled patient management software that identifies and visualizes a patient’s prostate cancer. The funding will also be used to continue clinical evidence development.

Levee Medical Reports Closing of $6.6 Series A Financing
Levee Medical notes the funds will be used to advance product development, scale infrastructure, and expand the team to support the development of the company’s Voro Urologic Scaffold, a bioresorbable post-prostatectomy implant.
NeuroOne Announces $3.5 Million Accelerated Milestone Payment from Zimmer Biomet for Evo® sEEG Electrode
NeuroOne notes the amendment provides Zimmer Biomet with 350,000 warrants with exercise price of $3.00 per share.
Market Reports
Advancements in Imaging

Philips and Prisma Health Sign Multi-year, Long-term Strategic Partnership
South Carolina’s largest health system adopts Philips software solutions for patient monitoring and enterprise imaging, helping to drive interoperability and data analytics, and deliver on Quadruple Aim
Dyad Medical, Inc. Joins the Japan External Trade Organization
With its association with JETRO, Dyad Medical aims to connect with potential investors and other partners in Japan and other countries in Asia.

Esaote S.p.A. Celebrates 40 Years of Activity
Esaote S.p.A., a leading biomedical company in the diagnostic imaging sector – in the fields of ultrasound, magnetic resonance and Information Technology for health –
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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