MedTech News Briefs | October 30th, 2023

Monday October 23rd

  1. Researchers at ETH Zurich in Switzerland have developed a suction cup inspired by octopus suckers to deliver large drugs, such as peptides, into the bloodstream through the mucosal lining inside the cheek. The suction cup creates a vacuum when pressed onto the cheek lining, making the tissue more permeable to drugs, and it also exposes the mucosal lining to a permeability enhancer, allowing peptides to traverse the lining more easily.
  2. GE Healthcare plans to showcase its latest innovations, including the Allia IGS Pulse system, at the 2023 Transcatheter Cardiovascular Therapeutics conference. Among the new developments is a partnership with Boston Scientific, introducing the Avvigo+ multi-modality guidance system that integrates with Allia and provides multimodality control in one click, improving workflows in complex intravascular imaging and physiology procedures.
  3. Medtronic has received FDA approval for its Aurora EV-ICD, an extravascular implantable cardioverter defibrillator that treats dangerously fast heart rhythms with a lead placed under the breastbone, outside of the heart and veins. The device is the first defibrillation system of its kind and reduces the risk of long-term complications associated with traditional intravascular defibrillators.

Tuesday October 24th

  1. The U.S. Food and Drug Administration (FDA) has established a new Digital Health Advisory Committee to address issues related to digital health technologies (DHTs) such as artificial intelligence/machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software. The committee, scheduled to be fully operational in 2024, will provide expertise and perspectives to enhance the FDA’s understanding of the benefits, risks, and clinical outcomes associated with DHTs, promoting the development of safe and effective digital health technologies while encouraging innovation.
  2. BeCareLink has introduced BeCare Neuro Link, a quantitative and artificial intelligence-enabled app designed for remote, objective, and comprehensive assessment of patients with neurologic conditions. The app, which generates objective measurements from activities on a mobile phone, offers game-like activities mimicking neurologic tests conducted in a neurologist’s clinic and provides written reports to assess the presence of neurologic issues, aiding both screening for undiagnosed neurologic conditions and monitoring responses to treatment for known neurologic disorders. BeCareLink plans to develop additional apps tailored to patients diagnosed with specific neurological diseases such as concussion/traumatic brain injury, Parkinson’s disease, Alzheimer’s disease, and amyotrophic lateral sclerosis.
  3. TekniPlex Healthcare has introduced antimicrobial medical compounds designed for patient-contact products, including catheters, connectors, syringes, and needle-free injectors. These compounds incorporate silver ion technology proven to significantly reduce the risk of contamination due to bacteria buildup, providing long-lasting protection throughout the product’s lifespan and addressing the challenges of healthcare facility-borne infections.

Wednesday October 25th

  1. Sheffield Hallam University’s Advanced Wellbeing Research Centre (AWRC) is launching its third annual Wellbeing Accelerator programme, supported by match-funding from Barclays Eagle Labs and Sheffield Hallam University via the UK government’s Digital Growth Grant. The programme, open to applications from start-ups across the UK and internationally, offers up to £25,000 ($32,960) of non-dilutive research and development (R&D) support and access to facilities, equipment and bespoke mentoring from industry professionals to help up to 12 firms in the medical technology sector to attract funding and drive commercial success.
  2. Data from Tandem Diabetes Care’s Control-IQ Observational (CLIO) study demonstrated the benefits of its automated insulin delivery technology, showing lower adverse events for type 1 diabetes patients. The study, the largest prospective study of the Control-IQ advanced hybrid closed-loop technology to date, revealed positive results for the company’s flagship t:slim X2 pump with Control-IQ technology, which automatically observes and manages blood glucose levels in individuals aged 6 and older with type 1 diabetes.
  3. Boston Scientific presented data from its Control-IQ Observational (CLIO) study demonstrating the effectiveness of its Agent drug-coated balloon in treating patients with repeat blockages in coronary arteries. The results showed that the Agent balloon, coated in the drug paclitaxel, had a lower rate of target lesion failure and a significant reduction in the occurrence of clotting and heart attacks compared to an uncoated balloon, offering potential benefits to patients with in-stent restenosis.

Thursday October 26th

  1. Minnesota’s medtech industry received a significant boost as the Biden Administration designated the state as one of the inaugural “Tech Hubs” in the United States. The MedTech Hub 3.0, led by the Minneapolis Saint Paul Economic Development Partnership, aims to position the state as a global center for Smart Medtech, integrating artificial intelligence, machine learning, and data science into medical technology. The initiative was authorized with $10 billion from the CHIPS and Science Act, and selected regions, including Minnesota, are eligible to receive between $40 million and $70 million each for implementation funding, totaling nearly $500 million.
  2. Venture capital firm Sofinnova has invested in two artificial intelligence (AI) companies, Betteromics and L’école AI, as part of its Digital Medicine Strategy. Betteromics has received $20 million in a series A financing round and developed an AI cloud platform integrating omics data to streamline insights. L’école AI, which received $3 million in seed funding, aims to increase accessibility to AI technology by creating a user interface tailored for medical professionals and researchers. These investments align with the FDA’s increasing interest in AI-enabled devices, with a report predicting global revenue for AI platforms in healthcare to reach $18.8 billion by 2027.
  3. Researchers at Northwestern University have developed a microfluidic system called Lattice, which can emulate up to eight different organ systems at once. This technology allows for the study of complex interactions between organs during disease and enables comprehensive drug testing to investigate the effects of drug candidates on multiple organ systems simultaneously, providing unprecedented insights for medical research.

Friday October 27th

  1. Recor Medical, a subsidiary of Otsuka Medical Devices, reported positive results from a combined analysis of six-month follow-up data from three global studies evaluating its Paradise ultrasound renal denervation (uRDN) system as a treatment for hypertension. The analysis demonstrated maintained blood pressure reduction following treatment with uRDN compared to a sham procedure, with fewer antihypertensive treatments added in the uRDN group, supporting the effectiveness of uRDN as an additional therapy option for patients with uncontrolled hypertension.
  2. Spain-based imaging data software provider Quibim has partnered with Philips to offer AI-based imaging and reporting solutions for MR prostate examinations. The collaboration aims to improve early cancer detection and enhance the accuracy of first-time diagnoses by combining Philips’ high-speed MR imaging with Quibim’s QP-Prostate software, with plans to extend the partnership to address other forms of cancer beyond prostate.
  3. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has teamed up with the US Food and Drug Administration (FDA) and Health Canada to publish five guiding principles for post-market change control plans (PCCPs) for machine learning-based medical devices (MLMDs). These principles aim to support MLMD manufacturers by reducing the regulatory burden of reassessment following certain changes and updates to their devices. PCCPs will allow manufacturers to demonstrate which changes and updates would be made to ensure safety and effectiveness without the need for regulatory intervention.

Sources

  1. https://www.medgadget.com/2023/10/suction-cup-delivers-drugs-through-cheek.html
  2. https://www.massdevice.com/ge-healthcare-cardiac-imaging-collaboration-boston-scientific/
  3. https://www.medtechdive.com/news/medtronic-fda-approval-extravascular-defibrillator/697481/
  4. https://www.medicaldesignbriefs.com/component/content/article/mdb/stories/news/49363
  5. https://www.medicaldevice-network.com/news/becarelink-ai-app-neurologic-diseases/
  6. https://www.medicaldesignandoutsourcing.com/tekniplex-antimicrobial-compound-pvc-tpe-bacteria-neutralizing/
  7. https://www.med-technews.com/news/latest-medtech-news/advanced-wellbeing-accelerator-launches-for-r-d-medtech-proj/
  8. https://www.massdevice.com/tandem-diabetes-care-positive-artificial-pancreas-data/
  9. https://www.medtechdive.com/news/boston-scientific-study-drug-coated-balloon-restenosis-tct/697811/
  10. https://www.mddionline.com/business/minnesota-designated-federal-medtech-hub
  11. https://www.medicaldevice-network.com/news/sofinnova-adds-two-ai-health-companies-to-portfolio-after-200m-fund-close/
  12. https://www.medgadget.com/2023/10/microfluidic-system-incorporates-eight-organ-tissues-for-drug-testing.html
  13. https://www.massdevice.com/recor-more-positive-data-renal-denervation/
  14. https://www.medicaldevice-network.com/news/philips-launch-ai-imaging-and-reporting-tools-to-support-prostate-cancer-care/
  15. https://www.med-technews.com/news/ai-and-vr-in-healthcare/mhra-fda-and-health-canada-publish-five-guiding-principles-f/

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