Transforming Healthcare: Innovations, Collaborations, and Standards Shaping the Future

Welcome to Medcallings newsletter, where we explore ground-breaking developments in the MedTech sector, highlighting collaborations, innovations, and technologies reshaping the future of healthcare.

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BIS Focuses on Standards for Critical Medical Devices

The Bureau of Indian Standards (BIS) is prioritizing the development of standards for 214 critical medical devices, including septal closure devices, plasma sterilizers, and phototherapy machines, aligning with the National Medical Device Policy, 2023. These standards, set for phased completion by December 2025, aim to enhance the safety, efficacy, and global competitiveness of Indian medical devices. BIS is also working on innovative products like therapeutic footwear, portable ramps, braille displays, and fall detectors for individuals with disabilities. With over 1,700 published standards, including 1,200 focused on critical medical devices across specializations like cardiology and neurology, BIS is ensuring quality healthcare solutions in India.

Medtronic Launches InterStim X Sacral Neuromodulation Therapy in India

Medtronic has introduced the FDA-approved InterStim X Sacral Neuromodulation (SNM) system in India to treat overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention. The advanced therapy targets nerve signals regulating bladder and bowel functions, offering relief for patients unresponsive to non-invasive treatments. The system includes an evaluation phase to test therapeutic response before implantation and is reversible. The two-stage procedure involves lead implantation followed by connection to a subcutaneous pulse generator (IPG). The device features a fifth-generation battery with over 10 years of life, a smart programmer for discreet therapy adjustments, and SureScan technology enabling MRI scans. This innovation aims to expand access to proven SNM therapies, supported by extensive clinical research, to benefit Indian patients.

Neuralink Advances Brain Implant Trials for Quadriplegia

Neuralink, Elon Musk’s brain technology startup, has announced the launch of a new feasibility study to evaluate the safety and effectiveness of its wireless brain-computer interface and surgical robot. Part of the ongoing PRIME study, the trial focuses on enabling patients with quadriplegia to control external devices through thought. Neuralink has received approval from Health Canada to conduct a similar trial involving six participants with paralysis, complementing its work in the United States, where the device has already been implanted in two patients. These patients have used the implant to play video games, browse the internet, post on social media, and design 3D objects. The innovative technology underscores Neuralink’s mission to revolutionize assistive devices for individuals with severe mobility impairments.

Abbott Launches Leadless Pacemaker in India for Slow Heart Rhythms

Abbott has introduced the AVEIR VR leadless pacemaker in India, designed to treat patients with slow heart rhythms by delivering electrical pulses to regulate heartbeats. Approved by both India’s Central Drugs Standard Control Organization and the USFDA, the device eliminates the need for a chest incision, generator pocket, or cardiac leads, addressing complications associated with traditional pacemakers. The retrievable design allows flexibility for future therapy adjustments. Healthcare experts from Max Superspeciality and Apollo Hospitals highlighted the pacemaker's advantages, including seamless implantation, reduced complications, and enhanced patient outcomes.

IIT-BHU Develops Breakthrough Therapeutic Platform for ALS

A research team at IIT (BHU), led by Dr. Sudip Mukherjee from the Department of Biomedical Engineering, is pioneering a revolutionary cell-based therapeutic platform to address Amyotrophic Lateral Sclerosis (ALS), a fatal neurological disorder with no current cure. Combining 3D bioprinting and bio-engineered cells that release therapeutic factors, the team aims to create a medical device capable of managing and potentially reversing ALS symptoms. The device will be tested on ALS mouse models before progressing to human clinical trials. Co-researcher Dr. Deepak Kumar emphasized the innovative approach's potential to transform ALS treatment by leveraging regenerative capabilities. The project will also explore genetic and environmental contributors to ALS in collaboration with Nil Ratan Sircar Medical College and Hospital, focusing on gene mutations in patients from eastern and northern India. IIT (BHU) Director Professor Amit Patra highlighted the study's potential to provide critical insights into the genetic foundation of ALS, paving the way for future therapeutic advancements.

IIT Indore Develops Patented Technology to Enhance ECG and Pacemaker Safety

IIT Indore, led by Professor Anirban Sengupta, has developed and patented a cutting-edge technology to improve the safety and reliability of ECG machines and pacemakers. The innovation focuses on creating secure chips with a unique fingerprint hallmark to authenticate and differentiate between genuine and counterfeit ECG detector chips before integration into devices. This advancement addresses reliability challenges in cardiac devices, reducing the risk of misdiagnosis and errors that could impact patient outcomes, ensuring safer and more effective heart disease?treatments.

GRASSROOT Trial Revolutionizes Stroke Treatment in India

India's GRASSROOT clinical trial, led by AIIMS Delhi and 15 other centers, is testing an advanced stent-retriever device designed for fast and effective clot removal in stroke patients. This next-generation device, developed with input from Indian and international experts, addresses unique challenges of strokes in India, such as younger patient demographics and specific clot types. Successfully treating its first patient, the trial aims to provide affordable, cutting-edge stroke care to the 17 lakh annual stroke patients in India, only a fraction of whom currently access mechanical thrombectomy. Approved by regulatory bodies, the trial's data will guide nationwide implementation, transforming stroke treatment accessibility and outcomes.

Launch of “Anamaya”: India’s First Indigenous 1.5T MRI Scanner

3i Med-Tech, a Refex Group company, has achieved a historic milestone with the launch of “Anamaya,” the first Made-in-India 1.5T whole-body MRI scanner. Now installed at Ruby Medical Services in Sangamner, Pune, this state-of-the-art scanner is tailored to address the specific clinical needs of Indian patients. The Anamaya 1.5T MRI scanner works by using powerful magnets and radio waves to create detailed images of the body's internal structures, aiding in precise diagnosis. Its advantages include tailored features to address India's specific clinical needs, potentially offering enhanced imaging quality, faster scan times, and improved cost-effectiveness compared to traditional imported MRI systems. Esteemed guests, including Dr. Purvez Grant and Padma Shri Dr. Harsh Mahajan, shared their perspectives on advancing the Indian MedTech industry. This innovative step forward highlights India’s commitment to precision healthcare and patient-focused diagnostic technology.

NHA and IIT Kanpur Collaborate to Advance AI-Driven Healthcare

The National Health Authority (NHA) and IIT Kanpur have signed an MoU to develop digital public goods under the Ayushman Bharat Digital Mission (ABDM), aimed at transforming healthcare with AI. The collaboration will create a federated learning platform, a quality-preserving database, an open benchmarking platform for validating AI models, and a consent management system for research. This initiative seeks to address challenges like fragmented health data and the reliability of AI-based diagnosis, improving data access and fostering innovation while maintaining data privacy. The platform will empower researchers, healthcare providers, and policymakers to leverage AI for better health outcomes, enabling trustworthy AI models and enhanced statistical quality preservation. This partnership is a significant step towards strengthening India’s digital public health infrastructure.

Silver Award Winner at Medicall Healthcare Innovation Awards 2024: Ashok Chandra Plates [Distal Tibia Plating System]

Dr. Sathish Kumar Thangamani from Stanley Medical College has been recognized with the Silver Award in Medical Devices at the Medicall Healthcare Innovation Awards 2024 for developing an innovative distal tibia plating system. Designed specifically for fractures of the posterior aspect of the ankle, this unique system combines the small-fragment 3.5 system (used in distal radius plating) and the large-fragment 4.5 system (used in proximal tibia plating), ensuring anatomical alignment and superior fixation strength. Addressing the limitations of existing plates such as inadequate strength in distal radius plates and oversized proximal tibia plates this innovative solution was born from a resident's thesis exploring the posterior approach to distal tibia fractures. Crafted with biocompatible materials and featuring dynamic holes, this plating system enhances surgical outcomes and fills a critical gap in orthopedic care.

NABH Checklist made easy,?By?Reallist

Reallist is a QR code-based digital checklist application designed to enhance patient safety through quality improvement. It enables quick setup within 10 minutes, includes a curated package of 70 NABH accreditation-ready checklists, and offers features like image capture, digital signatures, auto-save drafts, and automated email reports. Reallist ensures on-time checklist execution with real-time alerts, reminders, and notifications to line managers for missed tasks, along with instant deviation reporting for corrective actions within predefined TATs. An escalation matrix addresses unresolved issues, while a real-time analytics dashboard provides managers with comprehensive monitoring of usage, deviations, and actions taken, ensuring efficient and transparent?operations. For more information, visit https://Reallist.io

The world of healthcare is evolving rapidly. Subscribe to Medcallings Newsletter to stay informed about the latest innovations, advancements in medical technology, and transformations shaping patient care and healthcare delivery. Join us as we explore the future of medicine, or connect with us via email: [email protected]

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