Friday, June 9, 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!


Hememics Biotechnologies, Inc. and General Graphene Corporation Cement Strategic Partnership for Large-Scale Production of Graphene-Based Biosensors

In the past nine months alone, Hememics in conjunction with General Graphene has manufactured more than 100,000 graphene biosensors. Using its patented desiccation technology for detection biology, Hememics has functionalized and tested these biosensors through numerous molecular and antigen tests to detect SEB and ricin at consistent sensitivities in the low picomolar range and get results within 5 minutes.

Telix Opens European Radiopharmaceutical Production Facility

Located in the heart of Belgium’s ‘Radiopharma Valley’, the 2,800 square metre facility is one of Europe’s largest radiopharmaceutical production facilities. It will serve as the primary manufacturing site for radioisotopes and commercial and clinical products for patients in the Europe Middle East and Africa (EMEA) region and beyond advises Telix.

PathPresenter Empowers Biorepositories to Share Pathology Imaging Data for Biomedical Research

The scalable and secure cloud-based platform makes the imaging data easily available to researchers and provides smart tools to maximize collaborative research for the ultimate benefit of patients and donors. By adopting the PathPresenter platform, biorepositories and organizations have a unique opportunity to generate a return on investment for their digital pathology infrastructure.

Transgene and NEC Present New Data on TG4050, an Individualized Cancer Vaccine, Showing it Induces Specific Immune Responses Against Head and Neck Carcinoma at...

TG4050, the first individualized therapeutic vaccine based on the myvac platform, TG4001 for the treatment of HPV-positive cancers, as well as TG6002, BT-001 and TG6050, three oncolytic viruses based on the Invir.IO viral backbone.

Breaking News

Endologix Receives FDA Approval of the DETOUR System to Treat Long Complex Superficial Femoropopliteal Lesions in Patients with PAD

"We are delighted to receive FDA approval of the DETOUR System," said Matt Thompson, MD, President, and CEO of Endologix. “PTAB therapy represents a significant step forward for patients with complex PAD, they have long needed a more effective and less invasive treatment option for long lesions of the SFA. We are proud to be pioneering this novel approach and continuing to innovate on behalf of patients. We look forward to launching this new therapy in the U.S. through a targeted market release in the coming weeks."

Fairtility Expands European Market Penetration with CHLOE EQ ™, as Clinics in Five Countries Embrace Breakthrough AI Technology in IVF

“We selected CHLOE EQ because of its ability to provide quantifiable biological data on embryo development, quality and viability. This transparency and interpretability set it apart from other AI-based decision support tools available,” said Shabana Sayed, Senior Embryologist and IVF Lab Manager at Klinikk Hausken, part of Medicover. “Our embryologists see this system as a companion that helps augment and standardize decision making. It speaks to them in a language they understand –human biology.”

AliveCor Collaborates with European Market Leader in Remote Patient Monitoring Luscii to Offer World’s First ‘Virtual Heart Clinic in a Box’

Together, the companies will launch the world's first 'virtual heart clinic in a box', revolutionising cardiac care for millions of patients by making it easy for any hospital or GP to deliver high-quality, remote patient monitoring to their patients.

Magenta Medical Reports 1st Patients Treated in the US with the World’s Smallest Heart Pump

“Magenta Medical CEO Dr. David Israeli, CEO said, "Magenta is proud to partner with top cardiology centers in the United States to further the validation of its technology and provide cardiologists with a powerful tool to support their high-risk patients during complex procedures. We are looking forward to a speedy recruitment process and favorable study outcomes that would allow us to take the next step in the clinical program towards ultimate market approval.”

Laird Thermal Systems Unveils Micro Multistage Thermoelectric Cooler & Optical TEAs Integration Capability

“Advanced process automation has enabled a new level of miniaturization for our MSX multistage series to support next-generation imaging solutions that require smaller optical packages,” said Andrew Dereka, Thermoelectrics Product Director at Laird Thermal Systems

Clinical Trials

Graphene Sensors May Help to Detect Sepsis Earlier in Critically Ill Patients

A new study from the University of Bath has shown that graphene-based biosensors, designed by Integrated Graphene, have the potential to play a major role in detecting increased levels of lactate, an important biomarker for the treatment of critically ill patients.

Gore announces First U.S. Enrollment for the GORE® VIAFORT Vascular Stent iliofemoral Study

The first U.S. patient was enrolled by David J. Dexter II, M.D. at Sentara Vascular Specialists, Norfolk, Virginia. "With several FDA-approved stents on the market, there was a concern that enrollment in another iliac vein stent trial would be difficult. Designed with the unique qualities for flexibility and radial force, the VIAFORT Device is compelling to use in a clinical trial," he said.

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.

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

Top Tips for Maintaining and Cleaning Your Medical Scrubs | Steven John Cumper, B.App.Sc. (Osteo.)

In this article, Cumper notes In hospitals and other healthcare settings, scrubs mark you out as a professional. And for this reason alone, he provides some important and top tips for keeping your medical scrubs clean and looking fresh for longer.

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.

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 Clears CorNeat EverPatch, World’s First Non-degradable, Synthetic Tissue Substitute for Ophthalmic Surgery

CorNeat Vision's EverPatch utilizes EverMatrix™, a novel material technology able to integrate with surrounding tissue.

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.


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.”


Study: Heart Attack Outcomes Far Worse for Those With COVID-19

The study published in the peer-reviewed journal Current Problems in Cardiology-also found that the Black, Hispanic, Asian, and Pacific Islander patients who had both COVID-19 and acute myocardial infarction (AMI)-the medical term for a heart attack-fared worse than their white counterparts.

Northwell Health Walk Raises Record-setting $1.06M to Advance Health Care in Our Communities

“Every year, thousands of people across the region join the Northwell Health Walk to affirm their belief in Northwell’s commitment to raise health in our communities,” said Brian Lally, senior vice president and chief development officer for Northwell Health. “It’s extraordinary to see the outpouring of support that grows each and every year.”

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.

Executives on the Move

Mark Alley Appointed as President of Cipher Surgical Inc.

Mark Alley is a proven global executive leader with extensive experience building and developing teams that consistently exceed revenue goals.

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.

Market Reports


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.


Articles of Interest

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