Search Results for “diagnostic” – Page 43 – media

Intuitive’s venture capital arm launches second investment fund

Dive Brief Intuitive Surgical’s venture capital arm has launched a second investment fund with $150 million in new capital. The Intuitive Ventures fund will support startups focused on improving healthcare access and coordination, developing precision diagnostics and interventions, and integrating digital technology, the firm said Monday. The new fund follows the launch of Intuitive’s first venture capital fund three years ago and brings the firm’s total assets under management to $250 million. Dive Insight The robotic surgery leader is among a number of large medtech companies to establish a venture capital operation dedicated to supporting a portfolio of early-stage companies. GE HealthCare, Johnson & Johnson and Boston Scientific have also launched venture funds. The venture has since invested in more than 10 startups, supported by Intuitive Surgical’s network and corporate oversight. Those companies include Capstan Medical, Endogenex, Flywheel, KelaHealth, MedCrypt, Neocis Optellum and Surge Therapeutics. “Fund II deepens Intuitive’s commitment ...
- Source: drugdu
- 110
- December 7, 2023
UK-India research project trialling easy-to-use UTI test to support fight against AMR

The University of Edinburgh, the University of Arts London, Silchar Medical College, Assam University and the Indian Institute of Technology Delhi have collaborated on a new UK-India research project, DOSA2, to help combat antimicrobial resistance (AMR). LifeArc, UK Research and Innovation, Economic Social Science Research Council, the Newton fund and the government of India’s Department of Biotechnology will fund and support the Diagnostics for One Health and User Driven Solutions for Antimicrobial Resistance (DOSA) project. Designated as one of the top ten global public health threats facing humanity by the World Health Organization, AMR occurs when bacteria, fungi and parasites change and adapt to antibiotics over time. Globally, urinary tract infections (UTIs) are the second leading cause of antibiotic consumption, often purchased over the counter in India, one of the highest human antibiotic-using countries in the world, and taken without medical supervision, contributing to the global issue of AMR. The ...
- Source: drugdu
- 95
- December 6, 2023
Cancer Research UK and Guardant collaborate to advance cancer detection and treatment

Cancer Research UK (CRUK), its innovation unit, Cancer Research Horizons, and Guardant Health have announced a collaboration to advance the development and precision of cancer detection and treatment. The mission-focused collaboration aims to accelerate the discovery and development of cancer drugs and diagnostics for patients. Affecting 20% of people in the UK, rare cancers are forms of cancer that can occur in unusual places in the body, requiring special treatment. Challenging to treat, rare cancer types include melanoma skin cancer, kidney cancer, brain tumours, non-Hodgkin lymphoma and pancreatic cancer. As part of the agreement, the parties will be able to discuss opportunities for collaboration to support CRUK’s research and development activities. In particular, the agreement will focus primarily on the charity’s clinical trials run by its Centre for Drug Development (CDD), including the DETERMINE trial, as well as other CRUK and Cancer Research Horizon research collaborations. The DETERMINE trial is ...
- Source: drugdu
- 91
- December 6, 2023
【EXPERT Q&A】What are the differences between the MDR and IVDR regulations?

Drugdu.com expert’s response: Although the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) share a common purpose, they apply to different categories of products, with specific differences in the following aspects: Scope of Application: MDR is a regulation for medical devices: It applies to all medical devices not used for in vitro diagnostics, including surgical tools, medical equipment, implants, etc. IVDR is a regulation for in vitro diagnostic medical devices: It specifically applies to in vitro diagnostic devices, such as reagent kits and equipment used for blood analysis. Classification System: MDR: Implements a new risk-based classification system, detailing medical devices into different levels more comprehensively. IVDR: Introduces a new risk classification rule, which is a significant change for the in vitro diagnostic device industry, especially increasing the scrutiny requirements for high-risk IVD products. Clinical Requirements: MDR: Strengthens the requirements for clinical evidence, demanding manufacturers to conduct clinical assessments and ...
- Source: drugdu
- 193
- December 4, 2023
EU’s IVD guidelines continue affecting early clinical work

The implementation of the In Vitro Diagnostic Medical Devices Regulation (IVDR) by the European Union (EU) continues to be a disadvantage for companies looking to start their clinical trials in the EU, said Malte Oppermann, senior director of clinical operations at Medigene. Oppermann spoke at a session of the Clinical Trials in Oncology (CTO) Europe 2023 conference in Munich, Germany, which took place 28 – 29 November. The session focused on the impact of IVD regulation changes on early-stage clinical trials and the challenges that come with clinical trials that incorporate IVDs. In a nutshell, IVDs are tests carried out on patient samples that can be used to prevent and treat diseases. In oncology, IVDs are used to detect biomarkers, which have become increasingly important in precision medicine. Examples of established biomarkers with approved therapies include the prognostic biomarkers HER2 and BRCA1. The IVDR came into effect on 26 May ...
- Source: drugdu
- 99
- December 4, 2023
Amgen and MSD-backed start-up wins $10m for drug and device development

Culmination Bio has secured $10m in investment from the Merck Global Health Innovation Fund (venture capital arm of MSD) and Amgen Ventures to develop an intelligence platform to facilitate diagnostic and therapeutic development. The US-based company has a library of multimodal and longitudinal data along with the accompanying biospecimens, Culmination Bio’s CEO Lincoln Nadauld told Pharmaceutical Technology. The data for Culmination’s library consists of de-identified HIPPA-compliant data from Intermountain Health. This allows the company to “identify specific patient cohorts and proactively or prospective rapidly recruit them”, which can accelerate drug discovery and clinical trial recruitment. Nadauld said that having biospecimens is instrumental in validating diagnostic devices, adding: “An example would be a liquid biopsy company validating their novel technology in the liquid biopsy space, for cancer. They often need fresh samples from patients with defined diseases, and we can deliver not only the biospecimens but the accompanying multimodal data that ...
- Source: drugdu
- 141
- December 2, 2023
In Cardiology, AI Enables Me to Deploy Therapy Faster, and Can Make the Difference Between Life and Death

I work as a cardiologist for a multi-specialty group that sees patients both in capitated payer and fee-for-service environments. This diverse practice gives me the experience to know where insurance providers will find value or what they will likely pay for. As these protocols become more scientifically validated, AI is going to help the entire healthcare system to identify at-risk patients quickly and accurately. By DR. JONATHAN A. ALIOTA As a cardiologist, I see this kind of scenario play out on a daily basis. A patient comes in for a routine procedure and a heart murmur is detected. This murmur could have several different diagnoses. While they can be a sign of something more serious, many of the heart murmurs we hear on a routine basis are normal, physiologic murmurs, such as mild mitral regurgitation. In addition, a healthy heart that had too much caffeine and not enough water that ...
- Source: drugdu
- 101
- November 28, 2023
AWS, Hoppr Launch Model to Accelerate Generative AI Tools in Medical Imaging

At RSNA 2023, AI startup Hoppr announced that it teamed up with AWS to launch a new foundation model. The product, named Grace, is a B2B model designed to help application developers build better AI solutions for the medical imaging field — and to build them more quickly. By KATIE ADAMS AI startup Hoppr teamed up with AWS to launch a new foundation model to help bring more generative AI solutions into medical imaging, the companies announced on Sunday at RSNA 2023, the annual radiology and medical imaging conference in Chicago. The new product, named Grace, is a B2B model designed to help application developers build better AI solutions for medical images — and to build them more quickly. Along with the launch of Grace, Hoppr also announced that it received “a multi-million dollar investment” from Health2047, the American Medical Association’s venture studio. Chicago-based Hoppr, which was founded in 2019, ...
- Source: drugdu
- 123
- November 28, 2023
Why 1 Health System Is Embedding Genomics Into Primary Care

When people think of genomics, they typically don’t visualize the primary care setting — but Northshore–Edward Elmhurst Health is trying to change that. Genomics is a key part of the health system’s approach to personalized care delivery, said Kristen Murtos, its chief innovation and transformation officer, in a recent interview. NS-EEH, the third largest health system in Illinois, was created in January 2022 when NorthShore University HealthSystem and Edward-Elmhurst Health completed their merger. “Several years ago, NorthShore leaned heavily into the power of genomics and integrated that as part of primary care practice — unlocking the opportunity to more holistically understand predisposition to certain diseases, to tailor care plans and to be able to give proactive and preventative care versus waiting until disease manifests and just being treated after that,” she explained. At NS-EEH, all patients are offered genetic testing as part of their primary care visit, Murtos pointed out. ...
- Source: drugdu
- 108
- November 23, 2023
AstraZeneca’s AKT Inhibitor Wins FDA Approval for Combo Breast Cancer Treatment

By Tyler Patchen Pictured: AstraZeneca office in Gothenburg, Sweden AstraZeneca announced Friday that its adenosine triphosphate (ATP)-competitive inhibitor Truqap (capivasertib), in combination with its endocrine therapy Faslodex (fulvestrant), has been approved by the FDA to treat adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer. According to AstraZeneca, the first-in-class inhibitor of all three AKT isoforms (AKT1/2/3) “has potential to reshape treatment for breast cancer patients” with specific biomarker alterations (PIK3CA, AKT1 or PTEN). The company also announced that the FDA has approved a “companion” diagnostic test meant to detect the “relevant” alterations. The FDA approval was based on the CAPItello-291 Phase III trial, which showed that the combination of Faslodex and Truqap reduced the risk of disease progression or death by 50%, compared to Faslodex alone, in patients with tumors having PI3K/AKT pathway biomarker alterations. “The combination of capivasertib and fulvestrant, a first-of-its-kind combination, provides a much-needed ...
- Source: drugdu
- 130
- November 21, 2023

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