Keyword: laws & regulations

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Personalized medicine

FDA approves first targeted therapy for metastatic bladder cancer

The U.S. Food and Drug Administration (FDA) granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy. Patients should be selected for therapy with Balversa…

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Breast healthcare

FDA advances landmark policy changes to modernize mammography services

The U.S. Food and Drug Administration (FDA) announced important new steps to modernize breast cancer screening and help empower patients with more information when they are considering important decisions regarding their breast health care. For the first time in more than 20 years of regulating mammography facilities, the agency is proposing amendments to key regulations that would help improve…

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Questioning the Genetic Diagnostics Act

Self-help healthcare or face a penalty?

The fact that genetic research can reveal hereditary diseases has been transferred to medical practice for some time and, since 2010, the Gene Diagnostics Act (GenDG) has regulated permissible DNA tests in medical diagnostics and pedigree in Germany. The procedure has great potential, says Professor Jochen Taupitz - but also great risks are associated with it.

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Surgical implant for damaged eyes

FDA approves first artificial iris

The U.S. Food and Drug Administration approved the first stand-alone prosthetic iris in the United States, a surgically implanted device to treat adults and children whose iris is completely missing or damaged due to a congenital condition called aniridia or other damage to the eye. The iris is made of thin, foldable medical-grade silicone and is custom-sized and colored for each individual…

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Profession

Swiss radiographers face many challenges

The radiographer in Switzerland faces many issues, from having the right education to positioning themselves both professionally and legally in the healthcare continuum. Before a large audience at ECR 2018, Yves Jaermann, head of the radiographers service Riviera-Chablais Hospital in Vaud Valay, reviewed the situation in his country. The profession of radiographer was born in 1896, when the first…

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New regulation

GDPR: Healthcare sector must be ready for data shake-up

Healthcare organisations across Europe are being warned to be ready for new laws which mark the biggest shake-up in data protection legislation in decades. The General Data Protection Regulation (GDPR) comes into effect across Europe on May 25, and despite the vote to leave the European Union the British Government has confirmed that it will be enshrined in UK law on that date. To help NHS and…

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Defibrillator use

Italian law must change to improve survival from cardiac arrest

An Italian law requiring citizens to hold a certificate to use a defibrillator must change to improve survival from cardiac arrest, researchers argued today at Acute Cardiovascular Care 2018, a European Society of Cardiology congress. “Automated external defibrillator (AED) use before the arrival of the emergency medical services (EMS) plays a key role in improving victim survival from…

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Regulation

Implementing MDR is complex and expensive and holds little reality

By 2020 medical devices manufacturers must document the clinical effectiveness of their devices more extensively. The Medical Device Regulation (MDR) presents a fundamental impact on innovation and price calculation for medical devices. Since the faulty PIP breast implants scandal in France (March 2010), there have been frequent calls for tighter licensing regulations for medical devices within…

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Manufacturers vs. bureaucracy

‘We will master this problem’

Manufacturers are required to prevent so-called anomalous use. This includes, for instance, the use of cuvettes that are not licensed in products like Teco’s Coatron-X. Norms and directives are the backbone of medical devices manufacture. Frequent updates keep them current, but also often create unforeseen problems, especially for smaller and medium-size companies, because the bureaucracy is…

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European diploma

Levelling EU qualifications for radiographers

Radiographers are increasingly central to patient care, but the heterogeneous education and skills across Europe remain challenging. Dr Jonathan McNulty and Håkon Hjemly, of the European Federation of Radiographers Societies (EFRS), explained how they plan to improve radiographers’ visibility and work towards homogenising training across Europe, notably by launching a European Diploma in…

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Accountable care organisations

“Grave concern” over plans to allow US-style bodies to operate in the NHS

It is of grave concern that there has been no public consultation on government plans to enable accountable care organisations (ACOs) to operate in England, say experts in The BMJ. ACOs were conceived in the US in an effort to improve care and reduce growing health care costs. They involve government and private insurers awarding large contracts to commercial providers to run and provide…

National security

Counterterrorism strategy is having little impact in the NHS

British NHS organisations are obliged by law to report people it fears at risk of becoming terrorists under the Prevent strategy - part of the UK government’s counterterrorism plan aimed at stopping people becoming terrorists. But new data collected by The BMJ has uncovered low levels of referrals to Prevent since the duty took hold, suggesting that it is having little impact in the NHS.

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Legislation

IVDs under the microscope

European regulators have turned the world of in vitro diagnostics (IVDs) upside down with new legislation that will come into effect at the end of this year. The new EU legislation gives manufacturers five years to meet strict standards. That may not be enough time.

Contrast agents

MultiHance receives approval for use in MRI of the whole body

Bracco Imaging S.p.A., a global leading company in the diagnostic imaging business, today announced the approval of the use of MultiHance® (gadobenate dimeglumine) in Magnetic Resonance Imaging (MRI) of the whole body in adults and paediatric patients (> 2 years). The approval was obtained through a Mutual Recognition Procedure, with the Medicines and Healthcare products Regulatory Agency…

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Infection

Siemens Zika test receives FDA emergency use authorization

The U.S. Food and Drug Administration (FDA) has granted Siemens Healthcare Diagnostics Inc. (Siemens) an Emergency Use Authorization (EUA) for its real-time PCR Zika Virus assay, the VERSANT® Zika RNA 1.0 Assay (kPCR) Kit. With respect to Zika in vitro diagnostic tests, FDA has been authorized to issue EUAs to allow for use of unapproved medical products or unapproved uses of approved medical…

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Fraud

Fighting against counterfeit medicine

Around the world, especially in developing nations, counterfeit medicines are a real problem. Until now, in many countries there hasn't been a standard protocol to conduct investigations and pursue prosecution. New research, led by Michigan State University, is providing the foundation to apply criminology theory to preventing the production and sale of fake and substandard medicines.

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