Neurolief secures equity investment from Japan’s Sawai Group
Neurolief had recently secured approval for Relivion in Japan. Credit: Neurolief. Neurotechnology developer Neurolief has secured a strategic equity investment from Japan’s Sawai Group. The investment will strengthen the partnership between Neurolief and Sawai, following an exclusive agreement signed by the companies for the development and marketing of Sawai’s therapy Relivion in Japan. Relivion is […]
Roche acquires LumiraDx’s point of care technology for $295m
Following the Roche acquisition news, the stock price of LumiraDx group dropped by more than 21% in pre-market trading on 2 January, compared to the market close on 29 December 2023. Image Credit: Michael Vi / Shutterstock. Roche has entered a definitive agreement to acquire LumiraDx’s point of care (POC) technology in a deal worth […]
Carmat launches software enhancement for artificial heart Aeson
Carmat’s research teams have developed and tested the changes. Credit: T. Schneider/Shutterstock.com. French medical technology company Carmat has launched a new software enhancement for its artificial heart Aeson. The enhancement is claimed to have been designed to significantly improve Aeson’s safety profile. With this update, the prosthesis software can be enabled to detect potential malfunctions […]
PharmaSens seeks FDA approval for new insulin pump
The insulin pump system has a 3ml reservoir for extended usage period. Credit: Hdc Photo/Shutterstock.com. Switzerland-based medical devices maker PharmaSens has submitted an application to obtain approval from the US Food and Drug Administration (FDA) for its ‘niia essential’ insulin patch pump system. For PharmaSens, the move is considered to be a significant milestone in […]
SeaStar Medical builds enrolment in pivotal trial for AKI device
SeaStar’s SCD device was granted breakthrough device designation by the US Food and Drug Administration (FDA) in October 2023. Image credit: Shutterstock/Oleksandr Drypsiak. SeaStar Medical is progressing its pivotal trial evaluating the use of its Selective Cytopheretic Device (SCD) in patients with acute kidney injury (AKI), with the company announcing that 12 patients have now […]
Boston Scientific begins trial of persistent atrial fibrillation system
The FARAPULSE PFA System works by delivering electric fields for selective ablation of heart tissue. Credit: Boston Scientific Corporation or its affiliates. Boston Scientific has commenced the AVANT GUARD clinical trial of the FARAPULSE Pulsed Field Ablation (PFA) System as a first-line treatment for persistent atrial fibrillation. The first trial subject was enrolled at the […]
Co-Dx seeks FDA emergency use authorization for Covid-19 test
The test kit demonstrated the capability to detect Covid-19 from anterior nasal swab samples in clinical evaluations. Credit: Drazen Zigic / Shutterstock.com. Molecular diagnostics company Co-Diagnostics (Co-Dx) has sought emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its Co-Dx PCR Covid-19 test with Co-Dx PCR Pro instrument. Co-Dx’s submission for […]
Sequana Medical’s alfapump set for FDA review
Alfapump automatically collects the fluid and moves it to the bladder to be eliminated through urination. Image credit: Sequana Medical. Sequana Medical has submitted a premarket approval (PMA) application to the US Food and Drug Administration (FDA) for its implantable alfapump device. The pending approval is for use in patients with recurrent or refractory ascites […]
Inspira’s blood sensor shows high accuracy against gas analysers
The new sensor technology could provide continuous and real-time data collection and analysis of blood samples. Credit: Photoroyalty / Shutterstock.com. Inspira Technologies has reported that its HYLA blood sensor line (blood sensor) attained 95% accuracy versus conventional blood gas analysers. This is claimed to aid in offering sustained and real-time blood monitoring expertise as against […]
Sofwave Medical secures FDA clearance for skin laxity improvement device
Sagging or loose skin is most often caused by ageing, but it can also be a result of weight loss, genetics, and external factors such as ultraviolet radiation. Image credit: Shutterstock/EdwardsMediaOnline, The US Food and Drug Administration (FDA) has expanded clearance to Sofwave Medical’s technology to improve the appearance of skin laxity on the upper […]