FX Shoulder obtains US FDA 510(k) clearance for glenoid baseplates
The FX Shoulder Solutions’ full-wedge augmented glenoid baseplates. Credit: PRNewswire/ FX Shoulder Solutions. FX Shoulder Solutions has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its full-wedge augmented glenoid baseplates. The newly cleared baseplates expand the company’s portfolio with six additional options. This development introduces a total of 18 glenoid baseplate […]
Teltonika’s TeltoHeart smart wristband obtains CE MDR certification
The device combines PPG technology for long-term monitoring with an integrated six-lead ECG. Credit: Kaunas University of Technology. Lithuanian company Teltonika has received European CE MDR (Class IIa) certification for its TeltoHeart smart wristband, confirming its compliance with medical device standards. The TeltoHeart smart wristband is designed to assist individuals with heart rhythm disorders and […]
Elixir’s focal stress system to treat calcified lesions hits success in trial
Elixir states that nearly one-third of percutaneous coronary intervention (PCI) patients present with calcified coronary lesions. Image credit: Shutterstock/BioMedical. Elixir Medical has reported positive data from the PINNACLE I clinical trial evaluating the safety and effectiveness of its catheter system that uses stress to treat calcified coronary artery lesions. The results, shared at the ongoing […]
British device manufacturer Entaco secures £1m investment following buyout
Private equity firm has invested £1m into device manufacturer Entaco, following a management buyout. Credit: Khosro via Shutterstock. UK-based medical device manufacturer Entaco has been acquired in a management buyout, securing a £1m ($1.26m) investment from private equity company Traditum. The buyout was led by Entaco’s managing director Steve Brown, who will now serve as […]
Axonics secures Australia’s TGA approval for F15 SNM system
The Axonics F15 SNM system is designed to treat adults with an overactive bladder. Credit: GBALLGIGGSPHOTO/Shutterstock.com. Medical technology company Axonics has announced receipt of Australia’s Therapeutic Goods Administration’s (TGA) approval for its Axonics F15 recharge-free sacral neuromodulation (SNM) system. Designed to treat adults with overactive bladder, the Axonics F15 SNM system features a relatively small […]
Claritas HealthTech’s iPETcertum device to extend Claritas iPET capability
iPETcertum offers clinicians additional capability to automatically locate lesions with specified values. Credit: zlikovec/Shutterstock.com. Claritas HealthTech has announced the completion of iPETcertum, a new software device designed to automate the detection, delineation, and quantification of isotope uptake in PET scans. The software device extends the capabilities of the existing Claritas iPET, a software as a […]
Karius wins FDA breakthrough device designation for lung infection test
Pneumonia causes more than a million hospitalisations in the US each year. Image credit: Shutterstock/Orawan Pattarawimoncha. Fresh after securing $100m in financing earlier this month, Karius has a regulatory win after the US Food and Drug Administration (FDA) granted breakthrough device designation to its DNA-based blood test for lung infections in immunocompromised patients. The genomic […]
‘Gaza was already in a coma’ before 7 October – Amnesty International
Multiple aid convoys were destroyed by Israeli protestors en route to Palestine this week, including near the Tarqumiyah military checkpoint in Hebron, West Bank (pictured). Credit: Ibrahim Hamad / Getty. As more than one million Palestinians face starvation across Gaza, reserves of food and medical supplies are even smaller than first feared due to the […]
Wondfo USA’s Covid-19/Influenza Test receives FDA EUA approval
The test’s rapid diagnostic capabilities are crucial for managing respiratory infections with similar symptoms. Credit: angellodeco/Shutterstock.com. DCN Dx, a contract research organisation for in vitro diagnostics, has announced that Wondfo USA’s WELLlife Covid-19/Influenza A&B Test received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA). Wondfo USA’s collaboration with DCN Dx through […]
NICE recommends targeted radiation therapy for liver tumours
NETs are cancers of neuroendocrine cells commonly spread from organs such as the gastrointestinal tract or pancreas to the liver. Image credit: Jose Luis Calvo / Shutterstock. New guidance from the National Institute for Health and Care Excellence (NICE) recommends that patients with neuroendocrine tumours (NETs) in the liver could benefit from a therapy that […]