Latest News

1 August

Baxter recalls nearly 23,000 infusion pumps in Class I recall 

Credit: Shutterstock/Jeniffer Fontan

Baxter Healthcare has recalled two of its infusion pump products after software issues meant the devices were issuing false alarms. The US Food and Drug Administration (FDA) tagged this as a Class I recall, indicating risk of injury or death with continued use of the devices.  

On 15 June, Baxter Healthcare sent affected customers an urgent device correction letter after receiving 131 complaints about the false alarms.

The two products recalled – the SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) – are software-controlled pumps that deliver therapies like pharmaceutical drugs or blood products in controlled amounts into veins. 

There have been reported false alarms for upstream occlusion after recent software upgrades to the devices. These alarms can interrupt therapy and are particularly serious for patients receiving life-sustaining medications.  The FDA said in a recall alert that “use of these products may lead to serious injury or death.” 

3 August

UK keeps medical device regulation timeline despite Brexit concessions

CE marking on toys, radios, and pyrotechnics will now be indefinitely recognised on the UK market, but medical devices or in vitro diagnostics will remain on their UK-based regulatory trajectory beyond 2030.

On Tuesday, the UK Government announced plans to indefinitely extend the use of CE marking for the majority of goods in what is being seen as the latest Brexit concession. However, the Medicines and Healthcare Regulatory Agency (MHRA) was quick to state that medical devices and in vitro diagnostics are already under amended legislation and will not be included in the extension plans. 

Brexit meant medical device regulation in the UK moved away from European legislation, the government pivoted to make transition for the industry easier – giving extended timeframes in which CE-marked devices could be placed on the British market. In a statement, the MHRA was keen to remind companies of the deadlines which are unaffected by the blanket CE mark extension. 

3 August

FDA greenlights light-activated device for use in vascular disease trial

A drug-coated balloon that helps restore blood vessels via light activation has been approved for use in US clinical trials, following an investigational device exemption (IDE) by the US Food and Drug Administration (FDA). 

Alucent Biomedical’s light-activated, drug-coated balloon catheter technology creates a natural, stent-like scaffold that harnesses structures and processes already present in the vessel wall to treat peripheral artery disease and help haemodialysis patients with arteriovenous fistula maturation. 

The intravascular system, called Alucent Natural Vessel Scaffolding (NVS), combines traditional angioplasty techniques with a photoactivated small molecule compound. The drug diffuses into the vessel wall from the balloon and then is photoactivated by a light fibre form within the balloon. The small molecule compound helps create extracellular matrix protein linking in the vessel walls.

31 July

MIT researchers develop new early breast cancer detection device

Researchers from the Massachusetts Institute of Technology (MIT) in the US have developed a new wearable ultrasound device for the earlier detection of breast cancer. 

Designed to improve the overall survival rate for breast cancer patients, the new scanner is intended to identify patients at high risk of developing breast cancer in between routine mammograms. 

It’s a flexible patch that attaches to a bra, enabling the wearer to use an ultrasound tracker to image the breast tissue from different angles. In the latest study, the researchers demonstrated that they could achieve ultrasound images with a resolution like the ultrasound probes utilised in medical imaging centres. 

The researchers collaborated with the MIT Center for Clinical and Translational Research and evaluated the device with a 71-year-old woman who had a medical background of breast cysts.

27 July

UK designers team up with Lebanese biotech to develop ‘human-on-chip’ system     

The advent of organ-on-chips transformed disease research, and now DLOC Biosystems is looking to go one step further. The American University of Beirut spin-out wants to connect multiple chips to form an automated human-on-chip system, and it has enlisted the help of 42 Technology to help develop the platform. 

Organ-on-chips themselves aren’t that new – the first was successfully created in 2010 at Harvard University – but a lesser-known frontier is the combination of multiple organ models onto a single system. Over the past decade, organ-on-chips have been used to model a wide range of human diseases and disorders to facilitate research in drug development and explore potential therapies. 

There has also been discussion around the technology’s potential to put an end to pre-clinical animal testing. DLOC and 42 Technology – a Cambridge, UK-based design consultancy – have already been working together in a pre-planning phase over the past year and a half.