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Medical Device Industry News: Latest Developments, Breakthroughs, and Future Outlook
ConTIPI Medical Selects EVERSANA to Support U.S. Commercialization of Non-Surgical Medical Device ProVate for Women with Pelvic Organ Prolapse
EVERSANA is a leading provider of global commercial services to the life sciences industry, to support commercialization for the ProVate device in the United States to help women experiencing pelvic organ prolapse.
Boston Scientific Obtains CE Mark for ACURATE Prime Aortic Valve System
The ACURATE Prime aortic valve system is designed with several features to build upon the clinical performance of the ACURATE neo2™ platform including an additional valve size, which expands the treatment range to patients with a larger anatomy.

Noctrix Health Announces New CMS Reimbursement Codes and Payment for Nidra Tonic Motor Activation Therapy for Restless Legs Syndrome
Nidra TOMAC Tonic Motor Activation Therapy, which was authorized for marketing in the United States last year following its designation as a “Breakthrough Device” by the US Food & Drug Administration (FDA), remains the only clinically validated, non-pharmaceutical treatment available for patients with RLS.
Haemonetics Announces Full Market Release for VASCADE MVP® XL Vascular Closure System
Haemonetics notes the VASCADE MVP XL system is now available to U.S. hospitals as the newest addition to Haemonetics’ VASCADE® portfolio of vascular closure systems featuring an innovative collapsible disc technology and a proprietary resorbable collagen patch designed to promote rapid hemostasis.
Clinical Trials
Bodyport Reports | Heart Failure Monitoring Technology Doubles Sensitivity for Predicting Events While Minimizing False Alerts Versus Standard of Care
“This should be welcome news for patient care teams because a greater prediction rate with fewer false alerts translates into more effective and efficient care,” said Corey Centen, founder, president, and chief technical officer at Bodyport. “What’s more, use of the Cardiac Scale and the Congestion Index is a seamless transition for clinicians and patients because it enhances, rather than replaces, the existing pathways built around weight monitoring. The lower alert rate should lead to workflow efficiencies because care teams—who are often feeling overly burdened by the large number of notifications and data flowing in—will spend less time responding to false alerts.”

Berlin Cures: BC 007 Targets Long COVID: Solid Phase II Trial Progress with Over 50% Patient Recruitment
The potential of BC 007 extends beyond treating a single disease, making it a so-called platform technology. By neutralizing fAABs, BC 007 could potentially act against many fAAB-associated diseases.

BD Initiates International Study to Expand Treatment Options for Patients with Peripheral Arterial Disease
Dr. Sean Lyden, Chairman of the Department of Vascular Surgery at Cleveland Clinic and National Principal Investigator of the AGILITY Study said, “When we’re addressing advanced peripheral arterial disease, a self-expanding covered stent can play an important role. We need a stent that can track to the lesion, apposes the vessel wall and ultimately provides long-term durability. We’re excited to see how this technology performs.”
Biotechnology News
CERo Therapeutics Successfully Completes IND-Enabling Toxicology Studies for Lead Compound CER-1236
CERo Therapeutics is continuing IND-enabling activities in preparation for submission of Investigational New Drug Application to FDA

New US Headquarters Opened By Mass Photometry Pioneers Refeyn
Serving as Refeyn’s US Customer Interaction Center, alongside offices, meeting and training rooms, the leading-edge laboratory space in the new HQ now enables customers across North America to visit to run samples and test applications. Refeyn is working to achieve sustainability certification for this laboratory space, which includes a BSL-2 lab, service center, R&D center and applications lab. The new site also facilitates instrument maintenance, customer training sessions, and workshops that all serve to ensure excellence in support for Refeyn’s customers across North America and beyond.

Tianlong Promotes Environmental Sustainability and Hygiene Monitoring with its Biolum Portable ATP Hygiene Monitoring System Series
Tianlong’s Biolum Portable ATP Hygiene Monitoring System, a powerful tool for implementing and overseeing hygiene monitoring programs, has achieved outstanding performance, earning certification from the prestigious AOAC Research Institute’s Performance Tested Methods (PTM) Program
Our Experts – Byline Articles
Read Their Views & Share With a Colleague or Two!

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

Hyperfine, Inc. Receives Grant for an Additional Three Years to Utilize Innovative Swoop® Portable MR Imaging® System in Low and Middle-Income Countries
Dr. Khan Siddiqui, Chief Medical Officer at Hyperfine, Inc. “This investment will fill a critical role in providing an affordable, scalable method for directly evaluating the efficacy of interventions to improve infant and child health and neurodevelopment.”
Singaporean Telehealth Platform ORA Raises $10 Million USD Series A to Modernise Healthcare in the Region
ORA is the fastest-growing and biggest vertically-integrated telehealth platform in South East Asia delivering over 250,000 consultations and has experienced uninterrupted monthly growth since its 2021 launch.
MSKai Releases Innovative Lumbar Spine MRI Segmentation and Measurement Artificial Intelligence Technology
“Artificial Intelligence is rapidly integrating into healthcare,” said Adam Bruggeman, MD, chief medical officer of MSKai. “The ability to accurately and consistently identify and measure spine anatomy will lead to further efficiencies for patients and providers in the practice of spine surgery.”
Surgical Safety Technologies Furthers its Mission of Improving Operating Room Safety and Efficiency With $15 Million in Series A Funding
Surgical Safety Technologies notes the investment will fuel adoption of the company’s signature OR Black Box® technology, which is already used by leading academic healthcare centers across North America and Europe.
Market Reports
Advancements in Imaging
Lung Cancer Awareness Month Highlights Importance of Preventive Screenings
During Lung Cancer Awareness Month, Olympus Corp. of the Americas and the American Lung Association are spotlighting potentially lifesaving lung cancer screening and the diagnostic tools available to help guide treatment.
KA IMAGING to Introduce Its 1st Mobile X-ray Unit at RSNA
The Reveal Mobi Lite provides 3 images from one exposure in a seamless experience notes KA Imaging.
KA Imaging Receives CE Mark for their Reveal 35C Flat Panel Detector
“Thanks to SpectralDR™, the Reveal 35C takes general X-ray to the next level because you can simultaneously get true bone and soft tissue subtracted images for any X-ray clinical task plus a high-quality DR image in one exposure at the lowest dose,” said Dr. Karim S. Karim, CTO at KA 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

Precision Medicine Implications: An Analysis for Executive Management
Precision medicine has heralded a new era in healthcare, marking a shift from a one-size-fits-all approach to personalized, patient-specific care. At its core, precision medicine

6 Ways to Streamline Lab Processes
Laboratories are increasingly focusing on efficiency and automation. The American Association for Clinical Chemistry (AACC) notes that over 4,000 labs globally have adopted automated systems,

The Importance of Accurate Medical Coding Services in Healthcare
Healthcare systems in industries rely on various significant activities, including medical coding. It is the translation of various healthcare procedures, and software providers use to

Choosing A Phone System for Your Medical Practice
If you run a medical practice, you want to be sure that your phone system is fully in order. Any missed calls could result in
Healthcare Careers
Nurses Corner

Earning A DNP Degree: Is It Worth It?
A DNP degree isn’t for everyone – the average cost of a four-year DNP program can be upwards of $100,000, which can take decades to pay off. Learn more

Things To Consider If You Want To Become Medical Nurse
Medical nurses play a vital role in the healthcare system, and they are responsible for providing patients with quality care. Becoming a medical nurse is

How to Prepare for a Second Career in Nursing
Second-career professionals are incredibly brave. It takes a lot of gumption to shrug off the progress you have made in an existing career to get