Neuralink Receives FDA Breakthrough Status for Device Aiding Severely Speech-Impaired Patients
Neuralink, Elon Musk’s neurotechnology company, announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its brain-computer interface aimed at restoring communication in individuals with severe speech impairments.
According to Neuralink, the device is intended to support patients affected by amyotrophic lateral sclerosis (ALS), stroke, spinal cord injury, cerebral palsy, multiple sclerosis, and other neurological conditions that hinder speech.
The FDA Breakthrough Devices Program is designed to accelerate the development and review of medical technologies that may offer significant advancements in treating or diagnosing life-threatening or debilitating conditions. It provides manufacturers with priority review, ongoing FDA guidance, and an expedited pathway to approval.
This is the second Neuralink product to receive this designation. In September 2023, the company’s Blindsight implant—designed to restore vision even in individuals without eyes or optic nerves—was also granted breakthrough status.
Neuralink Receives FDA Breakthrough Status for Device Aiding Severely Speech-Impaired Patients
Neuralink, Elon Musk’s neurotechnology company, announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its brain-computer interface aimed at restoring communication in individuals with severe speech impairments.
According to Neuralink, the device is intended to support patients affected by amyotrophic lateral sclerosis (ALS), stroke, spinal cord injury, cerebral palsy, multiple sclerosis, and other neurological conditions that hinder speech.
The FDA Breakthrough Devices Program is designed to accelerate the development and review of medical technologies that may offer significant advancements in treating or diagnosing life-threatening or debilitating conditions. It provides manufacturers with priority review, ongoing FDA guidance, and an expedited pathway to approval.
This is the second Neuralink product to receive this designation. In September 2023, the company’s Blindsight implant—designed to restore vision even in individuals without eyes or optic nerves—was also granted breakthrough status.
Promega’s ProDx MSI Detection Kit Gains Regulatory Approval in China for Lynch Syndrome Screening
Promega has announced that its ProDx MSI Detection Kit has received an innovative medical device registration certificate from China’s National Medical Products Administration (NMPA). This significant regulatory milestone allows the advanced molecular diagnostic tool to be used in clinical laboratories across China.
The kit employs a fluorescent PCR-capillary electrophoresis method to qualitatively assess eight microsatellite loci in tumor tissue, enabling the detection of microsatellite instability (MSI)—a key biomarker in colorectal cancer. MSI status helps identify patients who may benefit from further genetic testing for Lynch syndrome, the most common inherited cause of colorectal cancer.
“This certificate is the culmination of years of dedicated effort,” said Tom Duan, General Manager of Promega Shanghai. “It brings clinicians a powerful tool to support early diagnosis, guide treatment, and improve outcomes for patients with colorectal cancer.”
MSI results from uncorrected DNA replication errors that alter microsatellite sequences, and high-frequency MSI (MSI-H) is often indicative of Lynch syndrome. The ProDx MSI Detection Kit provides vital diagnostic information, aiding in cancer risk assessment and personalized treatment planning.
Promega has over 20 years of expertise in MSI research. Its PCR-based MSI detection methods are widely used in global clinical research, with more than 225 peer-reviewed publications spanning 30+ cancer types.
The ProDx MSI Detection Kit is exclusively available in China, while Promega’s MSI technology is also part of approved in vitro diagnostic (IVD) tools in the U.S., U.K., and Europe.
Promega Corporation, a leader in life sciences for over 45 years, offers a portfolio of 4,000+ products supporting research, diagnostics, forensics, and clinical applications worldwide.
This approval marks a critical step in expanding access to precision oncology tools in China.
National Ayush Mission Conclave 2025 Commences, Sets Roadmap for Strengthening Integrative Healthcare Across India
Reinforcing its commitment to promote traditional Indian systems of medicine, the National Ayush Mission (NAM) Conclave 2025 began today at Kaivalyadhama, Lonavala, Maharashtra, with participation from Ayush and Health Ministers, senior officials from States and Union Territories, and experts from across the Ayush ecosystem. The two-day event aims to chart the future course for expanding the reach, quality, and integration of Ayush services into the national healthcare framework.
The event was inaugurated by Shri Prataprao Jadhav, Union Minister of State (Independent Charge) for Ayush and Minister of State for Health & Family Welfare. He was joined by prominent dignitaries including Dr. Prem Chand Bairwa (Deputy Chief Minister, Rajasthan), Shri Y. Satya Kumar Yadav (Andhra Pradesh), Dr. Dayashankar Mishra ‘Dayalu’ (Uttar Pradesh), Shri Shyam Bihari Jaiswal (Chhattisgarh), Shri Yadvinder Goma (Himachal Pradesh), Shri G.T. Dhungel (Sikkim), and Smt. Pi Lalrinpuii (Mizoram).
Organized by the Ministry of Ayush, Government of India, the conclave serves as a platform to share best practices, promote policy convergence, and review the implementation of the National Ayush Mission. In his address, Shri Jadhav reflected on the 2023 NAM Conclave’s success, which shaped actionable strategies for improved program execution. He highlighted that the number of beneficiaries availing services through Ayushman Arogya Mandirs surged from 1.5 crore in 2021 to over 11.5 crore in 2025, signifying enhanced accessibility through better infrastructure, trained professionals, and expanded outreach.
Vaidya Rajesh Kotecha, Secretary, Ministry of Ayush, noted the exponential growth of the Ayush Mission since its inception in 2014 with a modest budget of ₹78 crore, which has now scaled up to ₹1275 crore for 2025–26. He emphasized the increasing national trust in Ayush systems, stating that according to NSSO 2022–23, 95% of rural and 96% of urban populations are aware of Ayush, with widespread Yoga practice being a strong indicator of acceptance.
State ministers shared inspiring progress stories and reaffirmed support. Uttar Pradesh, the world’s most populous state, reported 3,959 operational Ayush hospitals. Himachal Pradesh showcased its integrated Ayush model with digital innovations and rural outreach. Mizoram and Sikkim highlighted Ayush’s growing popularity and impact, made possible by NAM's robust support.
Dr. Dayashankar Mishra praised the central government’s efforts in strengthening UP’s integrative healthcare, while Shri Shyam Bihari Jaiswal emphasized the dual benefits of combining Ayush with modern medicine. Shri Prem Chand Bairwa noted Rajasthan’s plans to introduce a holistic state Ayush policy for integrated development.
Ms. Kavita Garg, Joint Secretary, Ayush Ministry, shared milestones such as 5.6 crore beneficiaries at tertiary care centers, NABH certification of 1,372 Ayush Wellness Centres, and establishment of 189 Integrated Ayush Hospitals, reflecting quality and reach improvements.
A significant highlight was the release of Standard Treatment Guidelines (STGs) on five metabolic disorders—Diabetes, Obesity, Gout, NAFLD, and Dyslipidemia—blending traditional therapies, Yoga, and nutrition. These were developed collaboratively by Ayush Research Councils and vetted by modern medicine experts.
The day concluded with a ministerial roundtable, chaired by Shri Jadhav, focusing on state-specific strategies and collaborative governance for effective NAM implementation. A spirited Y-Break session added a wellness element to the day, showcasing NAM’s commitment to holistic health.
Element Science’s Jewel® Patch-WCD Secures FDA Approval, Redefining Wearable Cardiac Care
In a major advancement for cardiac patient care, Element Science has received U.S. Food and Drug Administration (FDA) approval for its Jewel® Patch Wearable Cardioverter Defibrillator (Patch-WCD) through a successful Premarket Approval (PMA) application. This milestone marks a transformative step in the field of wearable therapeutics, offering critical protection to U.S. patients facing a temporary elevated risk of sudden cardiac arrest (SCA). The Jewel Patch-WCD had already achieved regulatory clearance in Europe and the UK earlier this year, having received CE Mark and UK Conformity Assessed (UKCA) certification in January 2024.
Dr. Uday N. Kumar, Founder, President, and CEO of Element Science, emphasized the broader implications of this development, stating, “FDA approval is more than a regulatory win—it’s a validation of our vision to deliver a life-saving device that fits into everyday life. The Jewel Patch-WCD embodies the future of patient-centric innovation, enabling individuals to feel like people, not patients, even while managing serious health risks.”
Designed with human-centered innovation at its core, the Jewel Patch-WCD represents a paradigm shift in the management of SCA risk. Unlike traditional defibrillators, the device is discreet, water-resistant, and tailored for seamless integration into daily routines—including during activities such as showering. It features advanced machine learning algorithms and a sophisticated detection system that ensures timely and accurate response to life-threatening arrhythmias, making it a reliable companion for at-home and mobile protection.
Leading cardiologist Dr. Christine Albert, Chair in Cardiology at Cedars-Sinai’s Smidt Heart Institute, praised the innovation, saying, “The Jewel marks a significant advancement in safeguarding high-risk patients from sudden cardiac arrest. Its technology fills a critical gap in cardiac care with precision and convenience.”
Lee Smith, Jr., Head of Commercial at Element Science, highlighted the device’s life-changing potential: “The Jewel Patch-WCD empowers patients to live confidently with a powerful, wearable safety net. It’s not just an advancement in cardiac care—it’s a leap in how we support and protect lives.”
With FDA approval now secured, the Jewel Patch-WCD cements Element Science’s leadership in the next generation of wearable cardiovascular technologies, offering renewed hope, freedom, and peace of mind to patients and families facing the challenges of cardiac disease.
AIIMS Delhi Pioneers India’s First TEM-Based Diagnostic Method for Primary Ciliary Dyskinesia
In a significant advancement for rare disease diagnostics, researchers at the All India Institute of Medical Sciences (AIIMS), New Delhi have developed India’s first diagnostic method for Primary Ciliary Dyskinesia (PCD) using Transmission Electron Microscopy (TEM). This novel approach, led by Dr. Subhash Chandra Yadav from the Electron Microscope Facility, Department of Anatomy, and Prof. Kana Ram Jat from the Department of Paediatrics, marks a transformative milestone in the early and accurate detection of this rare genetic respiratory disorder.
PCD is a frequently misdiagnosed hereditary condition that impairs the function of motile cilia, leading to chronic respiratory infections, infertility, and other complications. Until now, India lacked a reliable, TEM-based diagnostic solution for the disease. "This is the first such diagnosis available in the country, with no other hospital or research laboratory currently offering electron microscopy-based diagnosis for PCD," said Dr. Yadav.
The newly developed technique, published in the prestigious Microscopy and Microanalysis journal from the University of Oxford, has gained international recognition for its innovative methodology. Titled “An Innovative TEM-Based Ultrastructural Imaging Methodology for the Diagnosis of Respiratory Ciliary Disorders,” the paper details a refined imaging workflow that has revolutionized PCD diagnostics in India.
Tested on over 200 patients with suspected ciliary disorders, the method successfully confirmed PCD in 135 cases—a diagnostic accuracy rate of nearly 70%, outperforming even advanced whole-genome sequencing in identifying structural ciliary defects. According to AIIMS, the breakthrough enables detection capabilities 640 times higher than conventional diagnostic methods.
Beyond PCD, this advanced TEM technique has broader applications in diagnosing a range of ciliary disorder-related conditions, including respiratory anomalies, renal cystic diseases, blindness, neural tube defects, infertility, situs inversus, intellectual disability, and skeletal abnormalities such as polydactyly and short limbs.
The method’s strength lies in its meticulous protocol—from precise sample collection and ultra-thin sectioning to high-resolution imaging—which together ensure the visibility of even minute ultrastructural defects.
Medical experts across the country have hailed this innovation as a game-changer. It not only improves diagnostic precision and turnaround times but also lays a strong foundation for personalized treatment approaches, improved patient outcomes, and a deeper understanding of the mechanisms driving rare ciliary diseases.
This pioneering effort by AIIMS researchers elevates India’s diagnostic capabilities on the global stage and brings renewed hope to patients and families navigating complex genetic disorders.
PGIMER Chandigarh Ranked 1st in Asia, 19th Globally in Dermatology by EduRank
The Department of Dermatology, Venereology & Leprology at PGIMER, Chandigarh, has achieved a remarkable milestone by being ranked 1st in Asia and 19th globally in Dermatology for 2025, according to EduRank, a leading data-driven academic ranking platform.
EduRank assessed 1,885 universities worldwide for their research performance in dermatology, evaluating key metrics such as the number of publications and their citation impact. This evaluation was conducted from a broader pool of 14,131 global universities, placing PGIMER firmly among the world’s elite institutions in dermatological research.
Of the top 18 institutions ranked above PGIMER, 14 are based in the United States, including globally renowned names like Harvard University, University of California, Johns Hopkins University, Mayo Clinic, and Mount Sinai. The remaining four institutions are European, such as University College London and Charité – Universitätsmedizin Berlin, highlighting PGIMER's prestigious placement on the global stage.
Commenting on the achievement, Prof. Sanjeev Handa, Head of the Department, attributed the success to the department’s unwavering academic commitment despite a heavy clinical workload. “Our consultants and residents have worked tirelessly to uphold academic excellence while managing a daily OPD footfall of nearly 450 patients,” he said.
This ranking underscores PGIMER’s dual strength in both patient care and research, reaffirming its leadership in dermatology not just in India or Asia, but on a global scale.
Redcliffe Labs Appoints Dr. Prashant Nag as Chief Operating & Medical Officer to Strengthen Clinical Leadership and Drive Diagnostic Excellence
Redcliffe Labs, India’s fastest-growing omnichannel diagnostics service provider, has ushered in a new era of clinical leadership with the appointment of Dr. Prashant Nag as its Chief Operating & Medical Officer (COMO). With a rich tapestry of over 20 years’ experience in pathology, diagnostic operations, and clinical strategy, Dr. Nag’s arrival is nothing short of a game changer—truly, the right man at the right place at the right time.
A proud alumnus of AIIMS Delhi and an MD in Pathology from Government Medical College, Surat, Dr. Nag has left an indelible mark on India’s diagnostics landscape. From steering operations at NABL and CAP-accredited labs to managing massive networks of phlebotomists, he’s done it all—his track record speaks louder than words. Known for his deep expertise in molecular biology, human genetics, and hemoglobinopathies, he’s a pathologist par excellence, with several international publications under his belt.
At Redcliffe Labs, Dr. Nag will take the reins of clinical operations, supply chain optimisation, regulatory compliance, quality governance, and medical innovation—essentially, holding the steering wheel of the lab's clinical engine. As they say, with a steady hand at the helm, even rough seas become smooth sailing.
Commenting on the milestone, Aditya Kandoi, Founder & CEO, said, “We’re thrilled to have Dr. Prashant Nag join the Redcliffe family. His knack for managing large-scale diagnostic operations and his eye for clinical detail are just what the doctor ordered. As we grow and evolve, his leadership will help cement Redcliffe’s place as a beacon of trust in diagnostics.”
Dr. Nag echoed the sentiment, stating, “Redcliffe Labs has carved out a name for itself by blending reach with reliability. Their focus on quality diagnostics across the length and breadth of India matches my own values. I’m truly honoured to join this mission. Together, we’ll raise the bar and bring trustworthy healthcare solutions to every corner of the country—no stone left unturned.”
With Dr. Nag calling the shots in clinical ops, Redcliffe Labs is all set to push the envelope and bring top-notch diagnostics to the doorstep of every Indian, making quality healthcare not just a privilege, but a right.
SPARSH Hospitals Holds Pujan Ceremony Ahead of Hennur Unit Launch, Ushering in a New Era of Advanced Healthcare
In a significant milestone, SPARSH Hospitals recently held a traditional Pujan ceremony at its upcoming 300+ bedded facility in Hennur, Bengaluru. The ceremony, led by Dr. Sharan Shivaraj Patil, Chairman of SPARSH Group, along with his family and senior leadership, sought divine blessings as the hospital enters its final phase before becoming operational in mid-May.
“SPARSH Hennur represents our vision for the future of healthcare—where premium infrastructure, advanced technology, and compassionate care converge,” said Dr. Patil. This new unit is poised to become a center of clinical excellence and a key contributor to regional healthcare and economic development, creating around 2,500 direct and indirect employment opportunities.
As one of Bengaluru’s fastest-growing healthcare providers, SPARSH Group is committed to building a holistic, patient-centric ecosystem. The Hennur facility will offer advanced specialities, high-end diagnostics, and cutting-edge technologies, including AI-driven diagnostics, real-time robotic assistance, and 3D printing. It reflects the Group’s continued focus on blending medical expertise with innovation to deliver personalized, effective treatment across specialities.
SPARSH Hennur is also designed with a strong hyperlocal focus, ensuring deeper community engagement and easier access to expert care. Ethical practices and compassionate service remain at the core of its operations. The facility will further strengthen SPARSH’s leadership in critical care, organ transplants, and minimally invasive surgeries, especially in liver and kidney procedures.
With a strong emphasis on equity in healthcare, SPARSH aims to bridge the gap between advanced medical care and those who need it most. The Hennur unit marks a transformative step in SPARSH’s journey to redefine healthcare in India—accessible, ethical, and technology-driven.
NHS Rolls Out Five-Minute Cancer Jab to Transform Treatment Delivery
In a major advancement for cancer care, the NHS is introducing a quicker, injectable form of the immunotherapy drug nivolumab. The new subcutaneous injection will allow patients to receive treatment in just 3 to 5 minutes, compared to the current 30 to 60-minute intravenous (IV) infusions delivered fortnightly or monthly. This innovation is set to significantly reduce time spent in hospital for patients while freeing up clinical capacity across NHS cancer services.
Approved by the Medicines and Healthcare products Regulatory Agency (MHRA), the rollout of the new jab marks a milestone in cancer treatment delivery. Nivolumab is used to treat 15 cancer types, including skin, bladder, kidney, and oesophageal cancers. An estimated 1,200 patients per month in England could benefit from this more convenient method of administration.
Currently, around 40% of patients receiving IV nivolumab may be eligible to switch to the injectable form. Most new patients starting on the treatment are also expected to begin with the subcutaneous option. Clinical trials have shown strong patient preference for the injection due to its speed and ease, and healthcare professionals estimate that the switch could save around 1,000 hours of treatment time every month — equivalent to more than a year’s worth of NHS staff time annually.
Professor Peter Johnson, NHS England’s National Clinical Director for Cancer, said the injectable form of immunotherapy would enhance convenience for patients while boosting hospital capacity and enabling clinicians to treat more people.
James Richardson, Clinical Pharmacist and National Specialty Adviser for Cancer Drugs, called the rollout a "significant advancement" that will improve patient outcomes and reduce pressure on oncology services.
Thanks to an agreement with the manufacturer, Bristol Myers Squibb, the faster treatment comes at no extra cost to the NHS. Elizabeth O’Mahony, NHS England’s Chief Financial Officer, highlighted the financial and operational benefits, noting the initiative builds on recent progress and saves crucial treatment time without additional expenditure.
Ashley Dalton, Minister for Public Health and Prevention, praised the UK’s leadership in medical innovation. “A new jab that fastens up cancer treatment is a prime example,” she said, adding that the National Cancer Plan aims to elevate the UK’s cancer survival rates to match the best globally.
This rollout is part of NHS England’s broader strategy to optimise value from medicines, which includes implementing life-changing treatments, using biosimilars for cost savings, and introducing innovations that improve patient experience while increasing service efficiency.
Siemens Healthineers Launches MAMMOMAT B.brilliant to Transform Breast Cancer Detection in Indonesia
Breast cancer continues to be one of the most pressing health challenges in Indonesia, ranking as the third deadliest cancer after lung and liver cancer. According to the Global Cancer Observatory, breast cancer accounts for 66,271 new cases—16.2% of the total 408,661 new cancer cases reported—and has claimed over 22,000 lives. Late-stage diagnosis and inadequate imaging quality remain major contributors to the country’s high mortality rate.
Addressing this critical issue, Siemens Healthineers has introduced the MAMMOMAT B.brilliant, a next-generation mammography system aimed at transforming breast imaging in Indonesia. Unveiled at the annual Indonesian Women Imaging Society event, the system offers a breakthrough in diagnostic accuracy with its 50-degree tomosynthesis acquisition, completed in under five seconds. This allows radiologists to detect abnormalities earlier and with greater clarity.
“MAMMOMAT B.brilliant was developed with women’s wellbeing at its core,” said Alfred Fahringer, President Director of Siemens Healthineers Indonesia. “In a country where many breast cancer cases are detected too late, this technology presents a real opportunity to shift toward early detection and better outcomes.”
The system sets a new industry benchmark in image quality for both Digital Breast Tomosynthesis and Full-Field Digital Mammography (FFDM). It features the PlatinumTomo imaging platform, which integrates a high-end detector, a 50° wide-angle tomosynthesis, flying focal spot technology, and PREMIA for image reconstruction. This combination ensures exceptional depth resolution and in-plane clarity, providing radiologists with enhanced visibility in complex cases and supporting more confident diagnoses.
Designed with both patient comfort and radiographer ergonomics in mind, MAMMOMAT B.brilliant incorporates intelligent workflow features that adapt to individual clinical scenarios. The system minimizes physical strain for radiographers while enhancing the overall experience for patients—helping reduce anxiety during breast exams and enabling a more compassionate care environment.
Prof. Dr. dr. Lina Choridah, Sp.Rad (K), Chairwoman of the Indonesian Women Imaging Society, emphasized the importance of this innovation: “The MAMMOMAT B.brilliant represents a major step forward in women’s health imaging in Indonesia. Its ability to support precise and early detection aligns with our mission to improve breast cancer outcomes through clinical innovation.”
With this launch, Siemens Healthineers strengthens its commitment to advancing healthcare in Indonesia by delivering cutting-edge diagnostic solutions that meet urgent clinical needs and improve outcomes for women nationwide.