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The US Food and Drug Administration (FDA) has classified the recall of Vyaire’s respiratory support devices as Class I – the most serious type of recall. 

The US company initiated the recall of its AirLife manual resuscitator devices on 6 December 2023. The FDA tagged the recall as Class I – meaning continued device use could result in serious injury or death – on 21 March 2024. 

The recall covers more than six and a half million devices and includes nine products from Vyaire’s AirLife range. The devices are single patient-use resuscitators intended for respiratory support.

Vyaire initiated the recall following reports of patients not receiving enough ventilation, potentially resulting in hypoventilation or hypoxia. A total of 37 incidents were reported, including two injuries and two deaths.  

Siemens Healthineers has announced plans to shut down its Fast Track Diagnostics unit, affecting 90 jobs in a move the company blames on a post-Covid-19 decline in diagnostics demand. 

The Germany-headquartered healthcare firm will now no longer be producing some of the polymerase chain reaction (PCR) testing products previously bound for the general European market and intends to shut the unit down by the end of September 2024. Whilst the company has confirmed that 90 jobs will be affected, mostly based out of facilities in Luxembourg, it has not announced lay-offs. The move comes as part of a wider company-wide restructuring effort.

Medtech giant Medtronic has successfully seen two patents for its sacral neuromodulation (SNM) upheld before US courts, opening the way for a lawsuit against bladder and bowel company Axonics. 

The Patent Trial and Appeal Board (PTAB), part of US Patent and Trademark Office (PTO) has upheld the two Medtronic patents as part of a patent infringement lawsuit brought by the company against the California-based Axonics, who sought to invalidate Medtronic’s claim over the technology. As a result, a full infringement lawsuit against Axonics can now continue. 

Bayer and Thermo Fisher Scientific have entered a collaboration to develop next-generation sequencing (NGS)-based companion diagnostic assays (CDx). 

The assays, which will make use of Thermo Fisher’s NGS platform, will be used to help identify patients eligible for Bayer’s precision cancer therapies. Thermo Fisher’s Oncomine Dx Express Test, which is on the company’s Ion Torrent Genexus Dx System, will be offered up for the collaboration.

Laboratory services provider Labcorp has launched its standalone phosphorylated tau 217 (pTau217) blood biomarker test, for the diagnosis of Alzheimer’s disease.  

The test is designed to identify the presence or absence of biomarker pTau217. Elevated levels of pTau217 in cerebrospinal fluid have been associated with the presence of Alzheimer’s pathology, including the accumulation of tau protein tangles in the brain.