Monday, June 5, 2023

Medical Device News Magazine provides readers with breaking industry news, clinical trials, mergers and acquisitions, funding, medical device executives on the move, non-profit, hospital news, and more. Medical Device News Magazine is a Fast 1, 2, 3 easy read!

Biotechnology

Blueprint Medicines Highlights Clinical Progress Across Precision Oncology Pipeline at 2023 ASCO Annual Meeting

"At ASCO, we are reporting early clinical data for three therapeutic candidates highlighting the breadth of our pipeline, which lays the foundation for our next wave of precision therapy programs to tackle significant medical challenges," said Becker Hewes, M.D., Chief Medical Officer at Blueprint Medicines. "Together, these presentations reflect how we are developing differentiated, highly selective therapies against promising disease targets, and demonstrate strong execution in advancing potential treatment options for large patient populations, including HR+/HER2- breast cancer and EGFR-mutant lung cancer. The datasets represent a diversity of fundamental value drivers in our clinical portfolio, which create opportunities to substantially expand our patient impact and highlight our ambition to deliver many more transformational medicines to patients in the future."

Innovent Updates Phase 1b Data of IBI939 (Anti-TIGIT Monoclonal Antibody) Combined with Sintilimab in Previously Untreated PD-L1-selected NSCLC at the 2023 ASCO Annual Meeting

The company updated the Phase 1b efficacy and safety results of IBI939 (anti-TIGIT antibody) combined with sintilimab (anti-PD-1 antibody) in previously untreated PD-L1-selected NSCLC without sensitizing mutations at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.

Pangaea Data Awarded Strategic Partnership by Mersey Care NHS Foundation Trust and the University of Liverpool’s Mental Health Research for Innovation Centre (M-RIC)

Dr. Vibhor Gupta, Founder and Director at Pangaea, said: “We are excited to partner with Mersey Care NHS Foundation Trusts and the University of Liverpool’s Mental Health Research for Innovation Centre (M-RIC). The application of Pangaea’s product in the context of mental health conditions is critical, for both patients and clinicians, to support preventative health and precision medicine.”

Neogap Secures EU Patent for Innovative Personalized Immunotherapy Technology

Neogap has now obtained final approval from the European Patent Office for their pioneering approach to multiplying T-cells outside the body using their EpiTCer® technology and the production of tumor-specific T-cells.

Breaking News

IoT in Healthcare: 5 Revolutionary Devices

The healthcare industry is rapidly adopting IoT technology. According to a report by MarketsandMarkets, the global market for IoT in healthcare will grow from $127.7 billion in 2023 to $289.2 billion by 2028. The majority of IoT devices used in healthcare are related to remote...

Penumbra Expands Computer-Aided Thrombectomy Offerings with Lightning Bolt 7 Technology Designed to Rapidly Remove Blood Clots with Modulated Aspiration

Lightning Bolt 7 is the most advanced arterial thrombectomy system on the market. The latest technology combines modulated aspiration with superior catheter design to maximize blood clot removal in a single session

Element Drives Better Biocompatibility In the Medical Sector As Part of IMPULSO Project

Miguel Ángel Jiménez, R&D Manager at Element Seville, said: “We are proud to have been a part of the IMPULSO project which will improve the quality of life for patients in the future and make tomorrow safer than today.

Clinical Trials

Unweaving the Microscopic Threads of Alzheimer’s Tapestry: Single-cell Dissection of Vascular Changes Across Six Brain Regions

Shining new light on the labyrinth of human brain vessels, researchers map 22,500 vascular cells from 428 donors and six brain regions, revealing key insights for Alzheimer's disease onset and potential treatment.

Hoag Hospital Clinical Study Demonstrates Luna Reduces Post-surgical Rehab Costs by 52%

The Hoag Orthopedic Institute study showed that with the Luna care model, participating surgeons reduced their home health utilization by 86%, resulting in decreased blended costs of $2,517 per case. Patient outcomes also improved as readmission rates were reduced by 28%, compared with patients that received the traditional home health option.

Know Labs’ Non-Invasive Glucose Monitoring Technology Shows Improved Accuracy

Like all previous Know Labs clinical studies, this study was designed to assess the ability of the Bio-RFID sensor to non-invasively and continuously quantify blood glucose, using the Dexcom G6® continuous glucose monitor (CGM) as a proxy for the measurement of blood glucose.

Parkinson’s AI Proves Accuracy In Clinical Studies Reports PD Neurotechnology

Nikos Moschos, Managing Director of PD Neurotechnology, comments: “Our monitoring device is a game-changer in the fight against Parkinson’s. Studies confirm that it is effective and easy to use, and we have seen time and again how it facilitates better treatment decisions for patients based on real-world data. By providing accurate and continuous data on symptoms, together with an ecosystem to collect and present effectively, we are always aiming to help improve the management of Parkinson’s and hopefully enhance patients' quality of life.”

Imaging /Ultrasound

Jun 01, 2023 Philips and Masimo Introduce New, Advanced Monitoring Capabilities to Philips High Acuity Patient Monitors

“Combining our expertise in noninvasive monitoring and signal processing technologies with Philips’ expertise in integrated patient monitoring and therapy solutions is a win-win for patients and clinicians alike," said Jon Coleman, President of Worldwide OEM Sales and Global Health, Masimo. "We are proud that Philips has chosen to make our innovative SedLine, O3, and NomoLine technologies available to their customers. We look forward to continuing our partnership with a focus on improving patient outcomes and reducing the cost of care.”

Lumicell Announces FDA Acceptance and Priority Review of New Drug Application for LUMISIGHT™ Optical Imaging Agent for Breast Cancer

The Lumicell DVS is an investigational system designed for use in patients with breast cancer to assist in the detection of residual cancerous tissue within the lumpectomy cavity following removal of the primary specimen during breast conserving surgery.

AI-powered CT System Launches Reports Philips

Philips CT 3500, is a new high-throughput CT system targeting the needs of routine radiology and high-volume screening programs. Powered by AI, the Philips CT 3500 includes a range of image-reconstruction and workflow-enhancing features that help to deliver the consistency, speed, and first-time-right image quality needed for confident diagnoses by clinicians and increased return on investment – even in the most demanding, high-volume care settings. 

Philips’ Image-guided Navigation Increases Safety During Coronary Interventions and Reduces the Use of Contrast Media by an Average of 28.8%

The results were presented today at the European Association of Percutaneous Cardiovascular Interventions (EuroPCR) 2023 course and will also be presented later this week at the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 scientific sessions.

Probo Medical Completes Acquisition of National Ultrasound

"National has a deep history for their sales and marketing prowess, selling new and pre-owned ultrasound equipment to private practices across the country," said Michael Asmer, CEO of Probo Medical. "They have leveraged that position to expand into the veterinary market.  The opportunity to connect this expertise to our world-class ultrasound sales, service, and repair services is tremendously exciting."

Industry Executives Views & Opinions

Addressing the Escalating Nursing Shortage | By Dr. Andy Nydegger Sr Director for Campus Development at Arizona College of Nursing

There is a serious shortage of nurses in the United States. Healthcare facility job sites reveal hundreds of unfilled nursing positions. Understaffing means we see nurses taking on higher patient loads and making mistakes. A tired nurse is an unsafe nurse writes Dr. Nydegger.

Awareness is Key: Educating Executives on Cybersecurity Risks in Healthcare | By Anis Trabelsi

Trabelsi comments, "As the Chief Information Officer of Palomar Health, the largest healthcare district in California, I believe it is crucial to strike a balance between technology, cybersecurity, and business needs." Read more what he has to say.

How Medical Professionals Can Solve Healthcares Medical Waste Problem | By Steven John Cumper, B.App.Sc. (Osteo.)

In this article, Cumper evaluates some of the most common causes of medical waste, the challenges of managing them, and how to reduce waste throughout the entire industry. Yes, we have a medical waste problem!

It is Time to Optimize EHR Systems and Experiences around Patient Needs | Raghid El-Yafouri, Digital Transformation Strategist at Bottle Rocket

Raghid El-Yafouri, Digital Transformation Strategist at Bottle Rocket, delves into the possibilities of optimizing EHR systems around patient preferences, transforming healthcare into a truly patient-centered experience.

AR + AI in MedTech: Innovating Healthcare and Expanding Verticals | By Michael Freeman, CEO of Ocutrx Technologies Inc

Ocutrx Technologies, Inc. is a future-forward medical device company, harnessing the power of both AI and AI for patients and surgeons. Read on to learn more.

Second Pass Reviews, New AI Technology Will Support Hospitals’ Financial Performance During Hard Times | By Michael Gao, Founder & CEO, SmarterDx

Healthcare systems have faced significant challenges in recent years. The COVID-19 pandemic accelerated the trend of medical care outside of traditional hospital settings, leading to a decrease in patient volumes. Additionally, personnel shortages and structural issues have caused a steep rise in operating expenses. According to a January 2023 report by Kaufman Hall, hospitals on average were only able to achieve one month of profitability throughout the entire year.

Mergers / Acquisitions

Olympus Announces Plan to Establish Digital Excellence Centers Following Acquisition of Cloud-AI Endoscopy Startup Odin Vision

Peter Mountney, Ph.D., CEO of Odin Vision commented, "We are excited to set the stage for future innovation development by leading Olympus' plans for the first DECs, all in the pursuit of empowering clinicians to deliver the best possible care and outcomes to patients using the latest digital and AI tools."

Stratasys And Desktop Metal To Merge: A Milestone For Consolidation In Additive Manufacturing, Reports IDTechEx

In the past decade or so, the additive manufacturing industry has been characterized by an ever-increasing number of hardware players trying to capture their own share of the market. While there were signs of consolidation in the early 2010s, given major moves by industry leaders like Stratasys and 3D Systems, AM has instead seen a consistent stream of newcomers with their own innovative takes on AM, such that IDTechEx now segments their 3D printing hardware forecast by seventeen different categories to account for such diversity.

FDA

Hologic Announces FDA Clearance of Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay runs on the fully automated, high-throughput Panther Fusion system, which provides initial results in approximately three hours and can process more than 1,000 tests in 24 hours.

FDA Approves First Topical Gene Therapy for Treatment of Wounds in Patients with Dystrophic Epidermolysis Bullosa

"Vyjuvek is the first FDA-approved gene therapy treatment for Dystrophic Epidermolysis Bullosa a rare and serious genetic skin disorder," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research. "Today's action demonstrates the FDA's ongoing commitment to supporting the development and evaluation of new treatments that address unmet needs for rare diseases or conditions."

GROWTH / DEVELOPMENT

Conformal Medical Raises $35 Million in Oversubscribed Series D Round

Conformal Medical, Inc., a medical device company developing next-generation...

PathMaker Neurosystems Receives $200,000 START Award from MassVentures

“We are grateful for the Stage 2 award from MassVentures as we work to bring MyoRegulator® to market,” said Nader Yaghoubi, M.D., Ph.D., Co-Founder and Chief Executive Officer of PathMaker. “As we continue our US multi-center pivotal trial in post-stroke spasticity and work to launch our first clinical trial in ALS this year, MassVentures support for late-stage development of our product is greatly appreciated.”

HOSPITALS

Northwell Direct to Provide Telehealth Services to U.S. Department of State

“Northwell Direct is proud to be working with the United States Department of State and doing our part to ensure that the employees and family members who serve our country have access to the highest quality health care services while serving abroad,” said Nick Stefanizzi, Chief Executive Officer of Northwell Direct.

Tianlong Helps Hospitals in Thailand Detect Hepatitis Early with Molecular Diagnostic Solution

"Tianlong can give timely responses both online and offline when we need technical support. We have great confidence in Tianlong's products, and we would welcome more cooperation in the future," said a local hospital representative in Thailand.

Northwell Health Announces Winners of 9th Annual SPARK! Challenge

The Northwell SPARK! Challenge, which took place on May 15, shows students what it’s like to work in different medical fields. Students learn about so many professions within the Northwell Health system, and then work in teams to make posters and videos about the different disciplines.

Ukraine Hospital Improving Emergency Cardiovascular Care During National Crisis

The Ukraine hospital joins the program in an effort to improve heart attack care by reducing heart attack related deaths and saving lives in their community.

Executives on the Move

Inspira Technologies Appoints Dr Adi Rizansky Nir, PhD as CMO

Dr Adi Rizansky Nir will play a critical role in overseeing and guiding Inspira's medical operations and strategic initiatives. With an unwavering commitment to patient care, innovation, and clinical excellence, the company states Dr. Nir is poised to make a transformative impact on the healthcare landscape within their organization and on the broader medical community.

Olympus Names Wenlei Yang the Newly Established Chief Diversity, Equity and Inclusion Officer

In this newly established role, Wenlei Yang will drive, oversee and implement initiatives related to Olympus' new Diversity, Equity and Inclusion (DEI) directions set as part of the company's global ESG strategy announced on May 12, 2023. The company will deepen measures to fully realize the DEI principles in all facilities worldwide to foster a healthy organizational culture.

Woebot Health Names Matt Borowiecki Chief Financial Officer

Matt Borowiecki has more than 20 years of global experience in finance, strategy and corporate development across healthcare, insurance and financial services, and has managed acquisitions, divestitures, joint ventures and debt and equity financings totaling more than $60 billion of value.

CPR-T Hires Dave Gaddy as their Chief Engineering Officer

Dave Gaddy has a background in engineering and biomedical device development.

Peter J Brown Is Appointed President of Reverba

Peter J Brown has 20-plus years of experience in life sciences, healthcare, and patient engagement, with a track record of driving growth in highly complex, competitive markets and successfully scaling organizations to support expanding service and product offerings.

Potrero Medical welcomes The Honorable David Shulkin, M.D. Former U.S. Secretary of Veterans Affairs, to their Advisory Board

David Shulkin MD s a healthcare leader and policy expert with over 20 years of experience in both private and government sectors.

Market Reports

Noteworthy

Physician / Medical Education / Marketing

Nurses Corner

Association News

High Schooler (Rakshith Srinivasan) Empowers Youth with Nonprofit “Unlimited Potential”, Raises $100,000 for Sports Medicine Research and Advocacy

Rakshith Srinivasan, a driven high school student from Eastside Preparatory School, Kirkland, WA, has founded a nonprofit organization called Unlimited Potential (UP). UP is dedicated to generating awareness and fundraising for sports medicine research, aiming to empower children with physical disabilities and chronic health conditions to participate in school sports with ease. Rakshith Srinivasan's passion for sports medicine research and STEM awareness has led him to create UP and make a difference in the lives of young athletes within the community.

City of Hope Researchers to Present New Treatments for Blood, Prostate and Other Cancers at 2023 American Society of Clinical Oncology Annual Meeting

This year's ASCO Annual Meeting highlights the exceptional work City of Hope doctors and scientists are leading with the hope of finding better treatments against a wide range of cancers," said Steven T. Rosen, M.D., City of Hope provost and chief scientific officer, Irell & Manella Cancer Center Director's Distinguished Chair.

Health

Articles of Interest

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