ThinkMedTek

Monday October 2nd

1. MGS, a global leader in end-to-end manufacturing solutions for healthcare innovators, has acquired Winther Mould Technology A/S, a healthcare tooling manufacturer based in Denmark. This strategic move strengthens MGS’ capacity in complex, premium-quality tooling and moldmaking, enhancing its ability to provide best-in-class speed-to-market solutions for Pharma, Diagnostic, and MedTech applications, and reinforcing its position as a leading provider of high-precision plastic solutions for the healthcare industry.
2. Pulse Biosciences has entered into a collaboration with CardioNXT to support its planned first-in-human study of its pulsed-field ablation technology for treating atrial fibrillation (AFib). The partnership aims to integrate Pulse Biosciences’ proprietary nanosecond pulsed-field ablation cardiac catheter with CardioNXT’s iMap navigation and mapping system, allowing electrophysiologists to visualize individual cardiac structures and perform circumferential ablations of targeted pulmonary veins for AFib treatment, potentially offering a fast, effective, and safe zero-fluoro ablation of cardiac tissue.
3. The FDA’s proposed amendments to 21 CFR 4 and 820 aim to align its medical device quality management system requirements with ISO 13485:2016, the international consensus standard for devices. The changes, expected to go into effect before 2025, emphasize the incorporation of risk management, monitoring, and measurement of quality management systems (QMS) effectiveness. Manufacturers should actively work on systems that incorporate these elements, focusing on risk management, feedback, and quality planning, and participation in programs like the Medical Device Single Audit Program (MDSAP) can help prepare for the upcoming requirements.

Tuesday October 3rd

4. Zeiss Medical Technology has formed a long-term strategic collaboration with Boehringer Ingelheim to develop predictive analytics for eye diseases. The partnership aims to facilitate early detection of eye diseases and offer personalized treatments to prevent vision loss for patients with serious eye conditions. By combining their expertise in ophthalmological technology, algorithms, data analytics, and treatment development, the companies will focus on detecting markers of early stages of retinal diseases and developing accurate treatments for chronic retinal diseases through new treatment pathways.
5. A group of investors, including Innova Partnerships and the existing Novarum CEO and chairman, has acquired Novarum DX, the mobile development firm specializing in reading lateral flow tests with smartphones. The buyout will allow Novarum to expand the range and type of tests it supports, enabling the company to deliver its technology differently and explore alternative business models. The new owners, NDX Holdings, plan to provide app development services, software-as-a-service solutions, and modular software capabilities to support scalability, with a vision to enable anyone, anywhere, anytime, to run a test and understand its result.
6. Anumana, a Massachusetts-based company backed by Nference, has received FDA 510(k) clearance for its AI-powered ECG-AI LEF medical device. Developed in collaboration with Mayo Clinic, the breakthrough medical device detects low ejection fraction (LEF) in patients at risk of heart failure. The software-as-a-medical-device (SaMD) algorithm uses data from routine 12-lead electrocardiograms (ECGs) and has demonstrated high sensitivity and specificity, improving LEF diagnosis without increasing the overall rate of echocardiogram usage.

Wednesday October 4th

7. Medasense Biometrics, a pain management technology company, has developed AI-powered patient monitoring solutions to help clinicians manage physiological pain more effectively. The company’s technology provides a more objective and real-time assessment of pain levels during surgery when patients cannot convey their pain level, offering actionable data to inform perioperative pain management decisions. Medasense’s algorithms analyze the non-linear relationship between physiological parameters using AI, creating a unique pain signature for each patient. The company’s flagship device, the PMD-200, monitors physiological responses to pain and provides real-time data for precise anesthesia and pain medication adjustments. Medasense is currently used in Europe, Canada, Australia, Israel, Turkey, the United Arab Emirates, and Latin America, with plans to expand its commercial use globally.
8. Researchers at Duke University have developed SenseToKnow, an AI-powered app designed to screen for autism in toddlers. The app displays short movies and records the child’s behavioral responses using the tablet’s front-facing camera and computer vision to detect signs of autism, such as differences in social attention, facial expressions, and head movements. Machine learning analyzes the data to screen for autism, potentially improving the accuracy of autism screening in real-world settings. The app, when combined with the Modified Checklist for Autism in Toddlers-Revised with Follow-Up (M-CHAT-R/F), increased the positive predictive value to 63.4%, suggesting a role for screening apps like SenseToKnow in autism detection.
9. Dutch medical robotics firm Microsure has secured $40m in a series B2 funding round led by the European Innovation Council Fund. The financing will be used to advance the development of its MUSA-3 microsurgical robot through clinical studies and regulatory clearances. Microsure aims to improve the accuracy and efficiency of microsurgery by using robotic assistance, with its MUSA-3 robot enhancing dexterity and reducing tremors for surgeons. The funding round included participation from kineo and invest-NL, as well as existing investor Innovation Industries. Microsure has also entered into an asset financing agreement with kineo to lease its robot to hospitals.

Thursday October 5th

10. Canon Medical Systems UK has built the Canon Medical Arena in Sheffield, combining community sports facilities with the South Yorkshire Medical Diagnostic Centre. The new arena provides healthcare services closer to the community and helps reduce inequalities in healthcare outcomes in Sheffield. The Medical Diagnostic Centre offers advanced medical imaging services, including AI-assisted CT and MRI scanners, ultrasound, digital X-ray, and consulting rooms, among others. The initiative aims to bring healthcare and wellbeing services closer to the community, supporting a preventative approach to healthcare and aiding faster rehabilitation. The construction of the arena has been carbon offset with support from CO2Balance and the delivery of wind turbines in India, creating carbon credits.
11. The U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) for Nissha Medical Technologies’ HeartSync defibrillation electrodes. These electrodes offer enhanced patient comfort due to their smaller pad size, greater efficiency with flexible lead-wire length options up to 60 inches, improved energy distribution through a new conductor plate shape, and superior adhesiveness with advanced hydrogel material. The approval highlights the product’s clinical success and reinforces Nissha Medical Technologies’ reputation for excellence in the medical device industry.
12. Biotronik has reported positive results from the BENEFIT-02 clinical trial for its Neuro Prospera spinal cord stimulation (SCS) system. The trial evaluated the Resonance multiphase stimulating paradigm used in the Neuro Prospera system for treating patients with chronic pain. The Resonance system uses a proprietary integrated circuit design and delivers a continuous, spatially and temporally distributed therapeutic pulse pattern across the spinal cord. In the trial, 63.9% of participants reported greater pain relief with multiphase therapy compared to commercial SCS, and they also reported an increase in average sleep quality and physical activity. The findings support the effectiveness and safety of the Biotronik Prospera SCS system.

Friday October 6th

13. A retrospective study funded by Johnson & Johnson (J&J) compared the effectiveness of catheter ablation and antiarrhythmic drugs in atrial fibrillation (AFib) patients. The study, using the Optum Clinformatics database, found that catheter ablation was linked to a significant 57% reduction in the risk of heart failure compared to antiarrhythmic drugs in matched cohorts of more than 9,000 patients. The study provides decision-making evidence for effective AFib treatment options, although it has limitations, including being retrospective and excluding certain patient groups.
14. Neway has entered into a strategic lab services arrangement with Quest Diagnostics to expedite dialysis laboratory testing and reduce costs for end-stage renal disease (ESRD) patients. Under the agreement, Neway will utilize Quest’s lab network to provide local dialysis laboratory testing services with next-day results after arrival. This decentralized approach aims to offer faster and more cost-effective testing options compared to the traditional centralized lab model, where specimens are transported to a single laboratory for processing. The partnership aims to benefit dialysis patients, programs, insurance payers, and the entire dialysis industry.
15. Artivion presented data from a post-market study of the On-X aortic heart valve at the 37th European Association for Cardio-Thoracic Surgery Annual Meeting. The study demonstrated that the valve was safe and effective when used with low-dose warfarin. On-X is a significant product for Artivion, generating $35.6 million in sales in the first half of 2023. The study analyzed follow-up data ranging from 1 to 5 years, with a follow-up time of 3.4 years, indicating positive outcomes for patients undergoing heart valve replacement therapy.

Sources

1. https://www.medicaldesignandoutsourcing.com/mgs-acquires-medical-toolmaker-winther-mould-technology/ 
2. https://www.massdevice.com/pulse-biosciences-cardionxt-collab-pulsed-field-ablation/
3. https://www.mddionline.com/qaqc/changes-cfrs-will-focus-how-manufacturers-use-risk-management 
4. https://www.medicaldevice-network.com/news/zeiss-boehringer-predictive-analytics-eye-diseases/
5. https://www.med-technews.com/news/medtech-business-merger-acquisition-finance-and-investment-news/novarum-dx-to-expand-into-new-markets-and-technologies-after/ 
6. https://www.massdevice.com/anumana-fda-clearance-ecg-ai-algorithm/ 
7. https://www.medicaldesignandoutsourcing.com/medasenses-finger-probe-makes-pain-management-easier-for-anesthesiologists/ 
8. https://www.medtechdive.com/news/duke-app-autism-screening-machine-learning/695560/ 
9. https://www.medicaldevice-network.com/news/microsure-raises-40m-for-microsurgical-robot/ 
10. https://www.med-technews.com/news/latest-medtech-news/sheffield-opens-new-medical-diagnostics-centre-within-canon-/
11. https://www.medicaldesignandoutsourcing.com/nissha-medical-technologies-fda-approval-heartsync-defibrillation-electrodes/
12. https://www.massdevice.com/biotronik-positive-data-spinal-cord-stimulation/
13. https://www.medtechdive.com/news/catheter-ablation-jj-study-afib/695819/
14. https://www.medicaldevice-network.com/news/neway-quest-diagnostics-esrd-testing/?cf-view 
15. https://www.medicaldevice-network.com/news/artivion-strengthens-on-x-heart-valve-data-with-real-world-study/?cf-view