FDA AdCom votes in favour of Abbott’s tricuspid valve repair system
The US FDA advisory committee’s positive recommendation for Abbot’s TriClip TEER system was based on data from the TRILUMINATE trial in addition to expert testimony. Image Credit: Michael Vi / Shutterstock. A US Food and Drug Administration (FDA) advisory committee (AdCom) has recommended approval of Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system. The Circulatory System […]
Tandem introduces automated insulin delivery system
The new Tandem Mobi insulin delivery system. Credit: Business Wire/Tandem Diabetes Care, Inc. Tandem Diabetes Care has announced the commercial launch of the Tandem Mobi insulin delivery system in the US. Tandem Mobi is said to be the world’s smallest, automated insulin delivery system for individuals with diabetes. Tandem has started accepting orders for the […]
Bone Solutions’ Mg OSTEOCRETE gains clearance for body fusion
Mg OSTEOCRETE was approved earlier for posterolateral spine procedures. Credit: Olena Yakobchuk/shutterstock.com. Orthobiologics technology company Bone Solutions has received 510(k) clearance from the US Food and Drug Administration (FDA) for Mg OSTEOCRETE to be used in intervertebral body fusion procedures. Mg OSTEOCRETE becomes the first magnesium-based bone substitute to receive FDA clearance for use in […]
PatenSee, Fresenius collaborate to enhance dialysis care
PatenSee’s monitoring system for the vascular access stenosis detection in haemodialysis patients. Credit: PRNewswire/PatenSee. Fistula monitoring system developer for dialysis patients PatenSee has signed a clinical collaboration agreement with Fresenius Medical Care. The companies will conduct a joint, multi-centre pilot trial of PatenSee’s contactless monitoring system within Fresenius Medical Care’s dialysis clinics in Israel. This […]
Butterfly Network launches handheld ultrasound device in US
The Butterfly iQ3 device features “no focus” rubber lens. Credit: BusinessWire/ Butterfly Network, Inc. Butterfly Network has announced the commercial launch of Butterfly iQ3, its third-generation handheld point-of-care ultrasound (POCUS) system, in the US. The US Food and Drug Administration (FDA)-approved Butterfly iQ3 system is built on the P4.3 ultrasound-on-Chip technology with the world’s fastest […]
MIT develops new ultrasound sticker
The wearable sensor is approximately the size of a postage stamp. Credit: ioat via Shutterstock. The Massachusetts Institute of Technology (MIT) has created an ultrasound sticker that can determine the stiffness of internal organs for early disease detection. This wearable sensor, which is approximately the size of a postage stamp, adheres to the skin and […]
SCOPE: FDA facilitates AI and ML use for clinical trials and drug development
The FDA released draft guidance on the use of AI and ML in drug development in May 2023. Image credit: Shutterstock / grandbrothers The US Food and Drug Administration (FDA) is focusing on how artificial intelligence (AI) can be used to support clinical trials but says it will take time to get there, as per […]
Apple’s Vision Pro heralds a new world of medical XR
Neurosurgeon Dr Robert Masson using the Apple Vision Pro. Credit: eXeX. The release of Apple Vision Pro has catapulted extended reality (XR) technology back into the spotlight, following a previous cross-sector lull in conversation around augmented reality (AR) and virtual reality (VR) innovation. According to a July 2023 GlobalData report: “XR is poised to revolutionize […]
Spotlight on hearing loss prevalence as World Hearing Day nears
The WHO claims that more than 80% of ear and hearing care needs remain unmet globally. Credit: steph photographies via Shutterstock. Every year on 3 March, World Hearing Day aims to elevate awareness surrounding the prevention of deafness and hearing loss while advocating for ear and hearing care worldwide. With hearing loss becoming increasingly prevalent, […]
Pancake day injuries: the latest innovations in treating burns
England’s NHS says demand for burn treatment soars on Shrove Tuesday each year, with the burns and scalds page on its website viewed once every 16 seconds. Image credit: Shutterstock/Slatan. While Shrove Tuesday sees anything from bananas to bacon being paired with pancakes, lesser-highlighted accompaniments are the burns to budding chefs. England’s NHS says demand […]