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Diagnostics giant Illumina could seek an outright sale of Grail, a cancer detection test manufacturer. 

Illumina’s CFO Joydeep Goswami revealed that the company plans to file a Form 10 by the end of this year, which will allow Illumina to “engage with others who have an interest in Grail either through a sponsorship and a spend solution or an outright sale”. 

Grail has been a thorn in Illumina’s side since the latter acquired it in 2021 in contravention of the Federal Trade Commission (FTC) and European Commission, which has since required the company to be divested. The news that there is outside interest could help the firm recover some of the credibility that has been lost through a series of legal battles over the past two years. 

If Illumina is not able to successfully appeal the divesture order, it will have to get rid of Grail by October 2024. 

The US Food and Drug Administration (FDA) has issued a safety warning regarding the risk of overheating for the Philips Respironics’ DreamStation 2 continuous positive airway pressure (CPAP) machines. 

Some of the DreamStation 2 CPAP machines were distributed as replacements for recalled DreamStation 1 CPAP machines. In 2021, Philips recalled multiple ventilators, bilevel positive airway pressure and CPAP machines due to health risks.

The Utah University-based ARUP Laboratories is calling on the US Food and Drug Administration (FDA) to reverse its decision to regulate Laboratory-Developed Tests (LDTs) as medical devices. 

Previously, the FDA introduced a proposed rule change that would see LDTs regulated as medical devices, proposing to alter regulations to make explicit that In Vitro Diagnostic Products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act. Specifically, when the manufacturer of the IVD is a laboratory.

GE HealthCare exhibited more than 40 new innovations during the Radiological Society of North America’s (RSNA) Annual Meeting in Chicago, 26-30 November 2023.The range of innovations aim to address radiologist shortages, mounting workloads and lack of access to (MRI)s. 

Devices demonstrated at the event included the SIGNA Champion, a 1.5T scanner which has AI supported workflows and technologies like, Sonic DL, AIR Coils and AIR Recon DL which GE HealthCare claims can reduce scan times by 50%. 

The US Food and Drug Administration (FDA) has cleared BrainSpec’s magnetic resonance spectroscopy (MRS) platform, meaning clinicians will now have access to the artificial intelligence (AI)-powered software that measures brain chemistry. 

BrainSpec’s Core platform uses non-invasive imaging to gather data on chemical concentrations in the brain. The US company says its software gathers signals and feeds them into AI models for insights.