The Food and Drug Administration (FDA) has released guidance providing recommendations on what information should be included in a predetermined change control plan (PCCP) tailored to marketing AI-enabled medical devices.
"This final guidance is part of the FDA's broader commitment to develop and apply innovative approaches to the regulation of device software functions and contains...
A Saudi-based healthcare startup has successfully raised $1.2 million in its first round of funding, it has been confirmed.
Co-founded last year, HealTec – described as a “dedicated B2B healthcare rehabilitation manufacturing facility” – reportedly facilitates the local production of medical prosthetics and other devices “to serve long-term care and rehabilitation patients.” It secured the...
According to a recent report by international growth partnership company Frost and Sullivan, Western Europe’s medical device market is on track to recover from the COVID-19 pandemic by 2023.
The report, titled ‘Impact of COVID-19 on Elective Procedures in Western Europe, 2020–2023’, projects that the market for selective medical devices for elective procedures will reach $16.8 billion (€13.76B)...
The EU’s new regulation on medical devices finally came into full application today, following a year’s delay due to the COVID-19 pandemic.
According to the European Commission, the Medical Devices Regulation (MDR) seeks to ensure a high level of public health and patient safety taking into account scientific progress.
The regulation entered into force in May 2017, replacing the Medical Devices...
Following its recent departure from the EU, the UK has introduced a new medical device information system (MDIS) that requires all medical devices available on the UK market to be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) using official global medical device nomenclature (GMDN).
The new system came into effect on 1 January 2021, with certain devices allowed a...
The UK government has released a proposed regime on the regulation of medical devices in Great Britain, Northern Ireland and the European Union post Brexit.
Under the guidance, the Medicines and Healthcare products Regulatory Agency (MHRA) will continue to recognise CE marks and certificates issued by European Economic Area-based Notified Bodies until 30 June 2023.
From 1 July, companies will...
French digital firm Withings today announced that its latest wearable is available in Europe, after receiving the CE marking for medical devices.
Developed by cardiologists and sleep experts, Withings says that ScanWatch is the world's first clinically validated hybrid smartwatch to detect both atrial fibrillation (AFib) and overnight breathing disturbances.
The smart watch is designed to help...
