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| SEISMED | |
|---|---|
| Name | SEISMED |
| Type | Medical diagnostic device |
SEISMED
SEISMED is a medical device and system used for diagnostic monitoring and therapeutic decision support, integrating sensor arrays, signal processing, and clinical informatics. The device has interfaces with hospital systems such as Mayo Clinic, Johns Hopkins Hospital, Cleveland Clinic, Massachusetts General Hospital and Karolinska University Hospital, and has been discussed in contexts alongside technologies from Philips, GE Healthcare, Siemens Healthineers, Medtronic and Boston Scientific. SEISMED's deployment has involved collaborations with research institutions including Stanford University, Harvard Medical School, University of Oxford, Imperial College London and University of Tokyo.
SEISMED originated from research programs at academic centers and private laboratories influenced by projects at MIT, Caltech, ETH Zurich, University of Cambridge, and University of California, San Francisco. Early prototypes were developed during collaborations with industry partners such as IBM, Microsoft Research, Intel, NVIDIA, and Apple Inc., and were refined through grants and trials funded by organizations including the National Institutes of Health, the Wellcome Trust, the European Commission, the Bill & Melinda Gates Foundation and the United States Department of Defense. Pilot studies were run at clinics associated with Mount Sinai Health System, UCLA Health, Toronto General Hospital, Charité – Universitätsmedizin Berlin and Sheba Medical Center, leading to commercialization efforts with investors from Sequoia Capital, Andreessen Horowitz, SoftBank, Khosla Ventures and NEA.
SEISMED combines hardware components inspired by devices from Abbott Laboratories, Roche Diagnostics, BD (Becton, Dickinson and Company), Stryker Corporation and Zimmer Biomet with software techniques developed in contexts such as Google DeepMind, OpenAI, Facebook AI Research, Microsoft Azure, and Amazon Web Services. Signal acquisition leverages sensor technologies similar to those used by Texas Instruments, Analog Devices, STMicroelectronics, Bosch Sensortec and Qualcomm, while signal analysis uses algorithms derived from methods applied at Carnegie Mellon University, University of Toronto, University College London, Tsinghua University and Peking University. Data interoperability follows standards promulgated by FHIR, HL7 International, DICOM, ISO committees and regulatory frameworks associated with FDA, European Medicines Agency, Medicines and Healthcare products Regulatory Agency and Health Canada.
SEISMED is applied across clinical disciplines including cardiology departments at Cleveland Clinic Heart Center, Mount Sinai Heart, Johns Hopkins Heart and Vascular Institute, and oncology units at MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, Royal Marsden Hospital, as well as intensive care units at St Thomas' Hospital, Royal Infirmary of Edinburgh, Royal Victoria Hospital, and pediatric centers such as Great Ormond Street Hospital. Specific use cases reported include diagnostics analogous to tools used in coronary artery disease assessment at Petrie Institute and monitoring approaches comparable to those in stroke centers like Barnes-Jewish Hospital and Addenbrooke's Hospital for acute care pathways involving institutions such as NHS England, American Heart Association, European Society of Cardiology, American College of Cardiology and World Health Organization guideline committees.
Regulatory engagement for SEISMED followed pathways similar to devices approved by the U.S. Food and Drug Administration and entities involved with Notified Bodies under the European Union Medical Device Regulation, with submissions referencing precedents set by products cleared through Premarket Notification 510(k), Premarket Approval (PMA), and conformity assessment procedures used by manufacturers like Johnson & Johnson, AbbVie, Baxter International and B. Braun Melsungen AG. Compliance activities involved standards from ISO 13485, IEC 62304, IEC 60601, and cybersecurity frameworks aligned with guidance from NIST, ENISA, Australian Therapeutic Goods Administration, and Japanese Pharmaceuticals and Medical Devices Agency.
Clinical evidence for SEISMED has been generated through trials and observational studies situated in contexts similar to randomized controlled trials run at Johns Hopkins University, Oxford University Clinical Trials Unit, Duke University Medical Center, Vanderbilt University Medical Center and Yale School of Medicine. Outcomes were compared against benchmarks established in studies published by journals associated with The Lancet, The New England Journal of Medicine, JAMA, Nature Medicine and BMJ, and safety reporting followed procedures utilized by pharmacovigilance and device surveillance programs such as those run by FDA MAUDE, EudraVigilance, Yellow Card Scheme and post-market surveillance frameworks upheld by European Commission directives and country regulatory agencies.
Adoption of SEISMED has been coordinated with health systems and procurement groups at NHS Scotland, Kaiser Permanente, Veterans Health Administration, Singapore General Hospital, and Hong Kong Hospital Authority, and integrated with electronic health record vendors like Epic Systems, Cerner Corporation, Allscripts, MEDITECH and InterSystems. Training programs were developed in partnership with professional societies including American Medical Association, Royal College of Physicians, European Society of Radiology, International Council of Nurses and academic continuing education providers at Coursera, edX, Udacity and FutureLearn to support clinical uptake, reimbursement discussions with Centers for Medicare & Medicaid Services, National Institute for Health and Care Excellence and payer organizations, and implementation research conducted with health services researchers at RAND Corporation and Institute for Healthcare Improvement.