Biosensors play a crucial role in the diagnosis and monitoring of diseases as therapeutic applications that come with ease through incorporation and collaboration with wearable medical devices. Various regulatory markets are implementing development and management strategies for this emerging medical device field. This paper provides regulatory navigation of biosensors in wearable diagnostic devices across the US, EU, and Indian markets. The regulatory structure of all three countries differs from their origination and management which is discussed in this article along with the regulatory requirements applicable to such devices. The study also focuses on areas such as Good Manufacturing Practices (GMP), risk-based device classification, validation, and post-market surveillance. Key highlights include understanding regulatory authorities, guidelines, rules, regulations, and standards; comparison of regulatory perspectives between the three markets; application of biosensors in medical devices; prospects and market size. The study identifies approval pathways, regulatory challenges, and harmonization efforts across the globe. The paper explores recent advancements in biosensors for health interventions, such as personalized medicine, collaboration with the IoT, biomedical applications, and their accessibility.
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http://dx.doi.org/10.1016/j.pharma.2025.02.007 | DOI Listing |
Magn Reson Med
March 2025
New Markets, Magnetic Resonance, Siemens Healthineers AG, Erlangen, Germany.
Purpose: Dephasing gradients can be introduced within a variety of gradient-echo pulse sequences to delineate local susceptibility changes ("White-Marker" phenomenon), e.g., for the visualization of metallic interventional devices which are otherwise difficult to display.
View Article and Find Full Text PDFBone Joint Res
March 2025
Department of Orthopedics, The Affiliated Changzhou Second People's Hospital of Nanjing Medical University, Changzhou, China.
Aims: Osteoarthritis (OA) is a widespread chronic degenerative joint disease with an increasing global impact. The pathogenesis of OA involves complex interactions between genetic and environmental factors. Despite this, the specific genetic mechanisms underlying OA remain only partially understood, hindering the development of targeted therapeutic strategies.
View Article and Find Full Text PDFActa Otolaryngol
March 2025
Department of Otolaryngology, Toho University Omori Medical Centre, Tokyo, Japan.
Background: Postoperative haemorrhage following palatine tonsillectomy occurs in 5-14% of cases. Since 2021, our department has used knot suturing with 3-0 Vicryl, and from 2023, continuous suturing with the V-Loc closure device to reduce suture time. While knot suturing is reported to reduce postoperative bleeding and pain, no studies have compared outcomes between different suture methods.
View Article and Find Full Text PDFInt J Chron Obstruct Pulmon Dis
March 2025
Real World Data Analytics, Japan Development, GSK, Tokyo, Japan.
Purpose: Following the relatively recent introduction of single-inhaler triple therapies in Japan, this study compared the effectiveness of switching from multiple-inhaler triple therapy (MITT) to once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) by investigating COPD exacerbations and adherence among patients with chronic obstructive pulmonary disease (COPD) in Japan.
Methods: This retrospective, pre-post cohort study using the Medical Data Vision Co. Ltd database identified patients with ≥1 inpatient diagnosis and/or ≥2 outpatient diagnoses of COPD at age ≥40 years prior to the index date (first/earliest date of single-inhaler FF/UMEC/VI initiation from May 1, 2019-February 28, 2022, following a switch from MITT).
Front Public Health
March 2025
School of Medicine, University of California, San Francisco, San Francisco, CA, United States.
Low-income families in dry regions, including in the Southwestern United States, frequently cool their homes with evaporative ("swamp") coolers (ECs). While inexpensive and energy efficient compared to central air conditioners, ECs pull unfiltered outdoor air into the home, creating a health hazard to occupants when wildfire smoke and heat events coincide. A community-engaged research project to reduce wildfire smoke in homes was conducted in California's San Joaquin Valley in homes of Spanish-speaking agricultural workers.
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