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【EXPERT Q&A】When exporting Class I medical devices, should they be declared for non-medical or medical use?

Drugdu.com expert’s response: The declaration of Class I medical devices as non-medical or medical depends on the specific use of the device and the regulations of the target market. Typically, Class I medical devices refer to low-risk medical equipment, such as surgical instruments and some diagnostic devices. In most cases, these devices are categorized as medical because they are used directly or indirectly for the diagnosis, prevention, monitoring, treatment, or alleviation of diseases. However, if the same type of device is intended for non-medical purposes (for example, solely for cosmetic or personal care), it may be classified as non-medical. In such cases, the classification should be determined based on the actual use of the device and the regulations of the target market. Therefore, when declaring, you should consider the following factors: Purpose of the Device: Is the main use of the medical device for medical or non-medical purposes (such ...
- Source: drugdu
- 194
- February 15, 2024
Electrochemical Sensors with Next-Generation Coating Advances Precision Diagnostics at POC

Current point-of-care (POC) diagnostic technologies are typically limited to measuring a single disease biomarker or several biomarkers from the same class of molecules, such as various RNAs, proteins, or antibodies. However, the ability to measure multiple biomarkers from different molecular classes could provide a more comprehensive understanding of a disease’s state, severity, progression, and individual variations in its development. Electrochemical biosensors, which convert the chemical signal of a biomarker found in a small biofluid sample (like blood, saliva, or urine) into an electrical signal proportional to the biomarker’s amount, could potentially address many diagnostic challenges at the point of care. These sensors can be assembled into multiplexed arrays to detect different biomarkers, and recent advances have overcome the challenge of “biofouling” – the degradation of electrode surfaces by nonspecific biological molecules in samples – through the development of thin antifouling coatings. Now, researchers at Wyss Institute at Harvard University (Boston, ...
- Source: https://www.labmedica.com/clinical-chemistry/articles/294800220/electrochemical-sensors-with-next-generation-coating-advances-precision-diagnostics-at-poc.html
- 140
- February 14, 2024
FDA grants breakthrough status to J&J’s nipocalimab for HDFN

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to Johnson & Johnson’s (J&J) nipocalimab for alloimmunised pregnant people at increased risk of increased severe haemolytic disease of the foetus and newborn (HDFN), which can cause life-threatening anaemia. This investigational therapy is the only one in the clinics for the condition, which occurs when the blood types of the pregnant individual and the foetus are incompatible. Nipocalimab is a fully human, aglycosylated, effectorless, monoclonal antibody designed to hinder the neonatal fragment crystallisable receptor (FcRn) and reduce levels of circulating immunoglobulin G antibodies. The regulator granted BTD based on findings from the proof-of-concept, open-label Phase II UNITY clinical trial of the therapy. The multicentre, international, non-blinded trial assessed nipocalimab’s efficacy, safety, pharmacodynamics and pharmacokinetics. The study met this primary endpoint with 54% of pregnant subjects. A small number of severe adverse events were reported in the study. ...
- Source: https://www.pharmaceutical-technology.com/news/fda-breakthrough-jj-nipocalimab/?cf-view
- 134
- February 14, 2024
Innovate UK grants funds for breast cancer therapy project

Innovate UK has awarded a £1m ($1.26m) grant for a collaborative initiative called AI-VISION to aid treatment decisions for breast cancer patients. The project involves the Institute of Cancer Research (ICR), Durham University, the Royal Marsden Hospital and techbio company Concr. It will support clinical decision-making, including directing breast cancer patients on the use of immunotherapy. AI-VISION is a 24-month observational clinical study to assess tissue samples from early triple-negative breast cancer (TNBC) patients. These subjects will be analysed to define and establish chemotherapy response biomarkers, irrespective of immunotherapy status. The study aims to validate the safety and performance of new computational methods to offer precision therapies for patients. Concr will apply Bayesian computational frameworks, inspired by astrophysics, to interconnect diverse oncology data, enabling researchers to detect and develop biomarkers indicative of drug response. The ICR will contribute genomic data from its genomics facility, which will be integrated with clinical ...
- Source: https://www.pharmaceutical-technology.com/news/innovate-uk-funds-breast-cancer/?cf-view
- 127
- February 14, 2024
NHS launches Pharmacy First to treat seven common conditions

Over 10,000 pharmacies in England will be offering the new advanced service The NHS has announced the launch of Pharmacy First, which allows patients in England to receive treatment for seven common conditions without needing to see a GP. Approximately 10,265 community pharmacies in England will be offering the new advanced service. From today, patients in England will be able to receive treatment for sinusitis, sore throat, earache, infected insect bite, impetigo, shingles and uncomplicated urinary tract infections in women under the age of 65 without needing a GP appointment or prescription. Community pharmacies play a vital role in keeping local communities in England healthy. The NHS has said that the new service will free up to ten million GP appointments by this winter. “This is all part of [a] major transformation in the way the NHS delivers care, [which will give] people more choice in how they can access ...
- Source: https://healthmedia.blog.gov.uk/2024/02/01/pharmacy-first-what-you-need-to-know/
- 134
- February 14, 2024
MRC Laboratory of Medical Sciences worth £120m opens on ICL campus

The institute is one of two UK laboratories wholly funded by the MRC The Medical Research Council (MRC) has opened a new Laboratory of Medical Sciences (LMS), worth £120m, at Imperial College Healthcare NHS Trust’s Hammersmith hospital. The institute is one of two laboratories in the UK that is wholly funded by the MRC. Commissioned by the LMS with investment from Imperial College London, the new eight-story building houses 400 scientists who work across themes including genes and the environment, heart and metabolic diseases and sex-based differences in diseases. It was designed to amplify the institute’s ability to bridge the gap between scientists exploring fundamental biological mechanisms as well as those translating that work into clinical applications. Professor Wiebke Arlt, LMS director, takes a new approach to research with a challenge-led team science approach, designed to build dynamic collaborations around specific biomedical challenges, co-designed with a variety of stakeholders such ...
- Source: https://pharmatimes.com/news/mrc-laboratory-of-medical-sciences-worth-120m-opens-on-icl-campus/
- 121
- February 14, 2024
Everly Health Partners With National Kidney Foundation, Expands Kidney Health Testing Suite

Everly Health is teaming up with the National Kidney Foundation to improve education around chronic kidney disease, the company announced Monday. In addition, Everly Health is also expanding its diabetes monitoring and kidney health testing suite for health plans and employers. Austin, Texas-based Everly Health is a digital health company for remote diagnostics and managing health conditions. It has three brands: Everlywell, which offers direct-to-consumer at-home health tests; Natalist, which offers fertility and pregnancy products; and Everly Health Solutions, which works with health plans and employers by providing at-home lab tests and virtual care to members and employees. Through the partnership between Everly Health and the National Kidney Foundation, the two organizations will have co-branded educational information about the importance of kidney health screening. Everly’s health plan customers will identify the patients who are at risk of chronic kidney disease, such as being diagnosed with diabetes. Everly Health will ship ...
- Source: https://medcitynews.com/2024/02/kidney-disease-home-testing/
- 122
- February 13, 2024
Why One Google Cloud Exec Thinks HHS’ New Cybersecurity Guidelines Are A Step In The Right Direction

Cyberattacks remain a formidable threat to healthcare providers, with hackers’ tactics getting more sophisticated by the day. Policymakers are trying to combat this. For example, New York Governor Kathy Hochul released a proposed set of cybersecurity regulations in November that require hospitals to establish new policies and procedures to protect themselves from ever-intensifying cyber threats. And a couple weeks ago, HHS published guidance outlining voluntary cybersecurity performance goals for the healthcare sector. While this initial guidance is voluntary, these goals will likely be used to inform upcoming HHS rulemaking. In its guidance, HHS outlined 10 key goals for strengthening providers’ cybersecurity: mandating basic cybersecurity training, mitigating known vulnerabilities, boosting email security, using multifactor authentication, ensuring strong encryption, requiring unique credentials, revoking credentials for departing workforce members, separating user and privileged accounts, establishing incident response plans, and vetting vendors’ cybersecurity. These guidelines are a starting point toward a more secure and ...
- Source: https://medcitynews.com/2024/02/google-cloud-hhs-cybersecurity/
- 122
- February 13, 2024
MHRA agrees licence change for Pfizer-BioNTech’s Comirnaty vaccine

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for a variation in licence for Pfizer-BioNTech’s 30 micrograms dose of Comirnaty XBB.1.5, a Covid-19 vaccine targeting the Omicron variant. The decision follows the vaccine’s fulfilment of the UK regulator’s safety, quality and effectiveness standards. The latest approval for the single-dose vials allows for the vaccine’s thawing and re-labelling by an authorised manufacturer outside of the UK’s National Health Service (NHS), adhering to good manufacturing practice standards. The NHS previously managed the thawing and distribution of the Comirnaty Omicron XBB.1.5 vaccine centrally. The vaccine requires ultra-low temperature storage at -80°C before it is thawed for usage. MHRA noted that the formulation of the Comirnaty vaccine, approved in September 2023, remains unchanged. The new authorisation by the MHRA is applicable only in Great Britain. The UK regulator also approved Novavax’s Nuvaxovid, an adapted vaccine targeting the Omicron XBB 1.5 ...
- Source: https://www.pharmaceutical-technology.com/news/mhra-licence-pfizer-biontech-vaccine/?cf-view
- 130
- February 13, 2024
Alys Pharmaceuticals announces launch with $100m funding

Alys Pharmaceuticals has announced its launch with a research and development (R&D) immuno-dermatology focused pipeline backed by a $100m financing from Medicxi. Co-founded by Medicxi and a team of dermatology and scientific specialists, Alys Pharmaceuticals is led by co-founder and COO Thibaud Portal, with Medicxi’s Francesco De Rubertis serving as board chairman. The company’s pipeline is powered by multiple platform technologies, targeting a range of dermatological ailments. Its goal is to transform the dermatological treatment landscape, focusing on conditions such as atopic dermatitis, vitiligo, alopecia areata and chronic spontaneous urticaria. Alys Pharmaceuticals’ pipeline also includes programmes for less common ailments such as mastocytosis and cutaneous T-cell lymphoma, and therapies to prevent skin side effects from cancer treatments. The company is partnering with establishments including the Institut Gustave Roussy and UMass Chan Medical School to advance its collaborative R&D. Alys Pharmaceuticals integrates the platforms and assets from six Medicxi companies: Aldena ...
- Source: https://www.pharmaceutical-technology.com/news/alys-pharmaceuticals-announces-launch/?cf-view
- 89
- February 13, 2024

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