MedTech News Briefs | November 6th, 2023

Monday October 30th

Medtronic has entered into a five-year partnership with the University of Galway, marking the first signature partnership between the university and the industry. Medtronic’s investment will enable the expansion of the university’s medtech ecosystem, support the establishment of two new research institutes (the Institute for Clinical Trials and a research center focusing on medical technologies and advanced therapeutics), and offer early-stage seed funding for new collaborative research projects, positioning Galway as a global medtech hub and enhancing research and development in the region.
The FDA’s updated guidance on medical device cybersecurity emphasizes a “security by design” approach, necessitating manufacturers to integrate security measures into the core design of devices. Manufacturers should consider implementing holistic security practices, utilizing application security testing technologies, automating security checks through continuous integration pipelines, and fostering collaboration with stakeholders to ensure medical devices remain secure and resilient to evolving cyber threats.
The FDA has granted clearance to Neurovalens’ Modius Sleep device for treating chronic insomnia. The non-invasive device delivers electrical stimulation to the brain and nervous system, eliminating the need for surgically implanted electrodes, and can be used for 30 minutes before bedtime while users perform other activities.

Tuesday October 31st

Researchers at Columbia University have developed a technique to enhance chimeric antigen receptor (CAR) T cell therapy for solid tumors by engineering E. coli bacteria to interact with tumor cells and deposit a synthetic antigen that can be targeted by CAR T cells. This innovative approach has the potential to expand the variety of cancers that can be treated with T cell therapy, particularly solid tumors that have been challenging to target effectively in the past.
DuPont has launched Liveo Soft Skin Conductive Tape technology, which combines silicone technology with electrically conductive properties. The technology is designed for use as a skin dry electrode in biosignal monitoring applications, enabling long-term patient monitoring with stable data quality and high comfort, making it suitable for medical wearable patches for long-term monitoring lasting seven or more days.
Minnesota-based Surmodics has launched its advanced hydrophilic medical device coating technology called Preside coatings. The Preside coatings are designed to improve distal access for neurovascular applications and enhance crossing for coronary lesions or chronic total occlusions, setting a new performance standard for the industry, according to Charlie Olson, SVP and president of Surmodics’ medical device coatings business.

Wednesday November 1st

Cardio Diagnostics Holdings has secured a contract from healthcare performance improvement company Vizient, enabling Vizient’s customer base, which includes hospitals and academic medical centers in the US, to access AI-driven precision heart disease tests. The tests, such as the Epi+Gen CHD and PrecisionCHD tests, utilize AI to analyze epigenetic and genetic biomarkers from patients’ blood samples to identify individuals at risk of coronary heart disease.
The White House has issued an executive order instructing the Department of Health and Human Services (HHS) to establish an AI safety program. The program will develop a common framework for identifying clinical errors from AI, establish a central tracking repository for incidents causing harm, and collaborate with the Secretary of Defense and the Secretary of Veterans Affairs to create an AI Task Force and a strategic plan for responsible AI deployment and use.
Belgium-based iStar Medical has expanded its commercial rollout of Miniject, a minimally invasive glaucoma surgery (MIGS) implant, to Ireland. The Miniject device, designed to target the supraciliary space as a natural outflow pathway, reduces intraocular pressure (IOP) and the need for medication while integrating with surrounding tissue to limit inflammation and complications, benefiting glaucoma patients by preserving their vision.

Thursday November 2nd

Roche and Ibex Medical Analytics have partnered to integrate Ibex’s artificial intelligence (AI) algorithms for cancer diagnosis into Roche’s navify Digital Pathology platform. The collaboration aims to improve pathology workflows, allowing pathologists to securely access third-party AI-powered technology alongside Roche’s AI-based image analysis tools, enhancing clinical decision support and improving productivity in pathology laboratories.
Inari Medical has agreed to acquire medical device company LimFlow in a deal worth up to $415 million. The transaction will provide LimFlow with $250 million in cash at closing, with the potential for an additional $165 million in commercial and reimbursement milestone payments, helping to expand patient access to its LimFlow System for Transcatheter Arterialization of the Deep Veins (TADV), designed to restore blood flow in deep veins for “no-option” chronic limb-threatening ischemia patients.
Tandem Diabetes saw its stock drop nearly 20% after announcing capacity constraints and sales disruptions outside the US due to a distribution partner focusing on software updates. The disruptions affected the company’s sales in Europe, leading to an updated baseline expectation of $190 million for international sales in 2023, with potential financial impact up to $10 million related to a reimbursement change in France.

Friday November 3rd

The US FDA has approved Abbott’s molecular human papillomavirus (HPV) screening solution, designed to detect high-risk HPV infections, some of which can cause cervical cancer. The Alinity m HR HPV assay, which will be available for use on Abbott’s Alinity m laboratory instrument, provides data on five risk categories, helping physicians detect the presence of an HPV infection and determine whether it might lead to cancer.
Stryker, the Michigan-based orthopedic giant, reported Q3 profits of $692 million, equaling $1.80 per share, and recorded sales of $4.91 billion for the three months ended Sept. 30, 2023. The company’s CEO, Kevin A. Lobo, addressed concerns over GLP-1 weight loss drugs impacting joint replacement business, stating that the knee business is not at risk for a slowdown, and these drugs may actually lead to more surgery as people increase their activity levels.
Biosense Webster, a subsidiary of Johnson & Johnson MedTech, revealed positive outcomes from its Q-FFICIENCY 12-month study, indicating the efficacy of the QDOT MICRO Catheter in managing atrial fibrillation (AFib) symptom relief and improving the overall quality of life for patients. The study showed a 99% improvement in AFib control and a 93.1% reduction in AFib symptoms, culminating in an 87.9% enhancement in overall quality of life for patients

Sources

ThinkMedTek