Vitestro’s robotic blood drawing device meets trial endpoints
Vitestro’s device was designed using AI, advanced imaging technology and robotics. Image Credit: Vitestro / PR Newswire. Netherland-based Vitestro has announced positive results from a trial evaluating the safety and efficacy of its autonomous blood-drawing device. The results were from the pivotal phase of the Autonomous Blood Drawing Optimization and Performance Testing (ADOPT) study (NCT05878483). […]
Cionic reports positive data from real-world MS study
Data published in the International Journal of MS Care detailed how Cionic’s Neural Sleeve was able to use the proprietary array-based stimulation approach to address neuromuscular walking challenges. Credit: Shutterstock/ CC7 California-based bionic clothing firm, Cionic, has published results from a real-world study that demonstrated its Neural Sleeve assistive technology has a positive impact on […]
FDA’s Final Rule on IVDs: a stop gap en route to the VALID Act?
The FDA first proposed its Final Rule on September 29 2023. Credit: Shutterstock / rafapress. On 29 April, the US Food and Drug Administration (FDA) published its Final Rule, making explicit that laboratory-developed tests (LDTs), defined as in vitro diagnostics (IVD) products, are medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C). Under […]
Bausch + Lomb’s enVista Envy IOL obtains Canada approval
Bausch + Lomb is also seeking regulatory approvals in other markets for the enVista Envy IOL. Credit: megaflopp / Shutterstock.com. Eye health company Bausch + Lomb has secured regulatory approval from Health Canada for its enVista Envy full visual range intraocular lens (IOL). Built on the enVista IOL platform, the new lens is designed to […]
Hyperfine partners with Radiosurgery to market MR system in India
The Swoop Portable MR Imaging system can provide images of the head’s internal structure. Credit: create jobs 51 / Shutterstock. US-based Hyperfine has signed a distribution agreement with Radiosurgery Global to bring the Swoop portable magnetic resonance (MR) brain imaging device to India, expanding its global reach. The Swoop system, which received 510(k) clearance in […]
Medical outcry over fatal Israeli airstrike on Rafah tent camp
Medical professionals on the ground near Rafah have described the situation as a “horror”. Credit: Jehad Alshrafi / Getty. Medical organisations have denounced Israel’s airstrike on Sunday (26 May) which hit an encampment for displaced Palestinians in Rafah, killing at least 45 people and overwhelming nearby hospitals. Overnight bombing by the Israel Defence Forces (IDF) […]
Dopavision sees success from early-stage Myopia app trial
The MyopiaX app was designed to help children recover from myopia treatment faster. Credit: Shutterstock / Terelyuk. German medical software company Dopavision has announced positive results from its MyopiaX-1 proof-of-concept clinical trial examining its smartphone app designed to advance the recovery of children who have had photobiomodulation treatment for myopia. The company describes the app […]
Roche and Hitachi extend partnership ahead of diagnostic analysers launch
Roche has a series of immunoassays that can be run on the Cobas in vitro diagnostic analysers developed in collaboration with Hitachi High-Tech. Image Credit: JHVEPhoto / Shutterstock. Roche and Hitachi High-Tech have signed a ten-year contract renewal to jointly develop and manufacture diagnostic solutions. The agreement follows a successful 46-year partnership that has yielded […]
Spineart wins FDA clearance for anterior cervical cage
Spineart raised $22m earlier this year. Image credit: Shutterstock / Prostock-studio. The US Food and Drug Administration (FDA) has granted clearance to Spineart for its Scarlet AC-Ti anterior cervical cage. Cages are interbody devices used in spinal fusion surgeries to act as a space holder between vertebrae to help decompress the spinal cord and nerve […]
Lifespin and Acıbadem University partner for precision medicine platform
The collaboration will help to deploy Lifespin’s products across the ACU’s network via a software as a service (SaaS) model. Credit: NicoElNino via Shutterstock. Germany-based medical technology manufacturer Lifespin has teamed up with the Istanbul-based Acıbadem University (ACU) to establish an AI-driven metabolomics precision medicine platform. Under the agreement, Lifespin and the ACU will establish a […]