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Canary Wharf’s bid to become a new hub for the lifesciences sector in the UK has been given a boost following the decision by Genomics England to relocate to the development. facility dedicated to a combination of wet lab and office space, revealed in March, intended as a focal point for lifesciences companies in London.
Jeffrey Shuren, MD, JD, director of the Center for Devices and Radiological Health (CDHR) at the Food and Drug Administration (FDA), and Dr. Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research (CBER) at the … Continue reading →
GE HealthCare’s newly US Food and Drug Administration (FDA)- approved flurpiridaz F 18 positron emission tomography (PET) radiotracer, Flyrcado, could offer a new approach to diagnosing coronary artery disease (CAD).
In the European hospital setting, the first to digitise were the picture archiving systems (PACS) in radiology departments then electronic medical records (EMRs), patient administration systems and departmental IT flow work solutions (eg, laboratory information systems and radiology information systems). About the author.
It can mean everything from patient-facing disease management apps and wearables to background AI dramatically altering drug discovery or radiological imaging. I believe the lifesciences industry ecosystem is getting to be more familiar with digital health overall as a concept. About the interviewee.
This week, Magnus Medical’s SAINT Neuromodulation System received 510(k) clearance from the US Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD) in adults who did not have satisfactory improvement from past antidepressant medications in their current episode. The SAINT Neuromodulation Trial.
On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criteria for regulation.
We are taking bold steps into the future of drug development, investing strongly in areas at the forefront of the biomedical and technological revolution. Re-imagining Radiology. In particular, AI bears vast potential for advancing radiology.
Cidara Therapeutics and Melinta Therapeutics recently announced that Rezzayo (rezafungin for injection) has been approved by the US Food and Drug Administration (FDA). Echinocandins offer a number of advantages to other antifungal medications including fewer drug-drug interactions, unique mechanism of action and fewer AEs.
The US Food and Drug Administration (FDA) has granted marketing authorization to Cepheid for its groundbreaking Xpert HCV test and GeneXpert Xpress System, marking a significant advancement in the diagnosis and treatment of hepatitis C virus (HCV). billion in 2018 and is projected to reach $9.84 percent.
Overcoming drug resistance: A major challenge in cancer treatment is the development of resistance to chemotherapy drugs. CRISPR/Cas9 offers a pathway to potentially overcome this, by modifying genes that are responsible for drug resistance in cancer cells.
Clinical Trials Day is an opportunity to acknowledge the contributions of clinical researchers and participants and the advancements in medical science that improve patient outcomes worldwide. The FDA’s message emphasized the crucial advancements in science and technology that are propelling medicine forward.
Bayer, a renowned German pharmaceutical company, has recently announced that its Ultravist 300 and 370 (iopromide) injection has won approval from the US Food and Drug Administration (FDA) for use in contrast-enhanced mammography (CEM).
According to an analysis of the 2013 Medical Expenditure Panel Survey, one in six US adults reported taking a psychiatric drug at least once in 2013. CNS drugs treat a range of neurologic and psychiatric disorders, such as psychosis, depression, Parkinson’s disease, multiple sclerosis and epilepsy.
As the COVID-19 pandemic shifts with new case surges largely owing to new variants of SARS-CoV-2, the US Food and Drug Administration (FDA) continues to offer up emergency use authorizations (EUA) for tests for the detection of COVID-19 infection, with the latest being antibody and antigen tests from Symbiotic and Quidel, respectively.
Dr. Olaf Weber, Head of Radiology Research and Development at Bayer. there have been three patients (1.9%) with drug-related TEAEs – one on gadobutrol (paresthesia) and two on gadoterate (pruritus, urticaria). About Radiology at Bayer Everyone deserves clear answers about their health, starting with an early and accurate diagnosis.
The Minuteful Kidney test is Healthy.io’s most recent innovation that has acquired 510(k) clearance from the US Food and Drug Administration (FDA). It has become the first-ever digital home kidney test to enable early warning of kidney disease. “Healthy.io in the company’s press release.
Hojvat served as the director of the Division of Microbiology Devices at the Center for Devices and Radiological Health at the Food and Drug Administration for 12 years. Additionally, the company appointed Sally Hojvat, as a regulatory strategy advisor. Source link.
In the US, the Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) offer guidance for the development, application and use of appropriate container closure systems through the integration of analytical tests that ensure product integrity and compatibility. USP <1207.1>:
Along with COVID-19 vaccine authorizations, the US Food and Drug Administration (FDA) remains committed to increasing access to COVID-19 tests and supporting their development, having authorized three new tests recently for emergency use. The products encompass molecular, antigen and T cell-based testing approaches.
On August 18, 2021, Abiomed received breakthrough device designation from the United States Food and Drug Administration (FDA) for its Impella ECP expandable percutaneous heart pump , the world’s smallest heart pump and the first to be compatible with small-bore access and closure techniques. Helius Medical Technologies, Inc.
Over the last year, there have been new acquisitions, launches and deals for novel radiotherapeutics and newly created peptide-radioisotope drug conjugates. Advantages of Alpha Emitter Therapy Over the past two decades, the radiological and chemical properties of alpha emitting isotopes have regained prominence in medical physics.
Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Bahassi emphasized that each one of those methods has its own challenges that limit its clinical implementation. percent show less reliability).
With the theme “Shaping the Future of Anticancer Therapies,” ESMO 2024 saw record crowds and focused on advancements across immuno-oncology, antibody drug conjugates (ADCs) and numerous malignancies. We heard about monoclonal antibodies, bispecifics and antibody-drug conjugates, and many of these are being used in combination.
The US Food and Drug Administration (FDA) granted approval to four of Medtronic’s cardiovascular product offerings, further expanding the company’s foothold in this sector. Numerous partnerships with hospitals and other medtech companies were also announced.
By using AI we can extract all the information – including symptoms, signs and drug prescription outcomes throughout the patient journey.”. There are a good number of use cases as to why pretty much every big lifescience company is choosing us these days,” says Medrano. AI use in the pandemic.
Several factors contribute to this under-representation: Historical Exclusion: The thalidomide tragedy of the 1950s and 60s, where a drug used to treat nausea in pregnancy caused severe birth defects, prompted the US Food and Drug Administration (FDA) to implement strict policies.
Drugs and Vaccines. The most promising news about any drug thus far in the pandemic just came out of the UK where Southampton researchers together with Synairgen showed that an inhaled form of interferon-? production and that treatment with this new drug may boost the lung’s antiviral defenses against the virus. percent in 2021.
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