Fujifilm invests $1.2bn ramping up North Carolina facility
The project is estimated to grow the state’s economy by $4.7bn over the next 12 years. Credit: Shutterstock / Robert Way Japanese medtech and imaging giant Fujifilm announced an investment of $1.2bn in its large-scale cell culture as it expands its North Carolina manufacturing facility adding 680 jobs to the site by 2031. The expansion […]
Getinge secures EU MDR certification for Advanta V12 stent
The Getinge’s Advanta V12 covered stent system. Credit: Getinge AB/Cision. Getinge has received the European Union (EU) Medical Device Regulation (MDR) certificate for its Advanta V12 covered stent system. This certification affirms the system’s compliance with EU standards for medical devices. It also extends the stent’s indications for use, specifically for patients with aortoiliac occlusive […]
Simpson secures FDA breakthrough device designation for Acolyte system
The Acolyte system helps with the placement and positioning of guidewires and catheters within the coronary vessels. Image credit: Shutterstock/Amel Uzunovic. The US Food and Drug and Administration (FDA) has granted breakthrough device designation to Simpson Intervention’s Acolyte Image Guided Crossing and Re-Entry Catheter System. The US-based company will now be in line for prioritised […]
FDA approves trial of system to measure baby’s oxygen during labour
Initial preclinical trials have demonstrated that the device is more accurate than foetal heart rate (FHR) monitors, increasing diagnostic accuracy by 80%, as per Raydiant’s website. Credit: christinarosepix via Shutterstock. Raydiant Oximetry has secured US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) for its Lumerah technology, allowing an early feasibility study on pregnant […]
Roche wins breakthrough designation for Tau biomarker test for Alzheimer’s
Roche’s Elecsys pTau217 assay is intended to be used to help identify amyloid pathology, a feature of Alzheimer’s disease. Image Credit: Jonathan Weiss / Shutterstock. The US Food and Drug Administration (FDA) has granted breakthrough device designation to Roche’s Elecsys pTau217 plasma biomarker assay. The pTau217 assay was developed in collaboration with Eli Lilly and […]
Springing into allergy season: the allergy IgE test landscape
The rise of IgE allergy blood tests follows the rise in the incidence of allergies globally. Credit: sdecoret via Shutterstock. With spring in full swing in much of the northern hemisphere, it is hard to ignore the sneezing and sniffles accompanying warmer weather. While most individuals pop over to their local pharmacy to pick up […]
Telehealth clinical trial cuts hospital cardiac readmissions by 76%
The study, carried out by Imperial College London and dubbed TELE-ACS, also saw a 41% drop in the likelihood of patients monitored by the technology vising an emergency department. Credit: Shutterstock / mi_viri Israel-based SHL Telemedicine has announced that a UK clinical study of its SmartHeart system aimed at monitoring patients recovering from acute coronary […]
Endosmart becomes Alleima: The future of nitinol innovation under one brand
In 2002, Endosmart was founded by CEO Dr Bernd Vogel, who initially explored nitinol as part of his mechanical engineering thesis. His project involved creating a hingeless, steerable endoscope, leading to his discovery of nitinol’s potential in medical technology due to its shape memory, biocompatibility, and super elasticity. In 2022, Endosmart was acquired by Alleima, […]
Smart diabetes management paves the way for new digital tools
Digital healthcare is playing a transformative role in the management of diabetes by providing resources to help patients monitor their blood glucose levels, track medications, make informed decisions about their diet and exercise, and receive personalised guidance and support. One of the many benefits of digital applications for healthcare providers is that they can provide […]
Signati kicks off trial investigating quicker vasectomy device
The number of vasectomies being performed has risen since imposed restrictions on abortions in the US. Image credit: Shutterstock/Fabian Montano Hernandez. Signati Medical has enrolled the first patient in a clinical trial investigating its device designed to quicken vasectomy procedures. The trial, operating under an investigative device exemption from the US Food and Drug Administration […]