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Illumina, the embattled diagnostics company at the heart of a years-long antitrust battle over its acquisition of cancer test manufacturer Grail, has finally put an end to the saga by announcing that it will divest the company in 2024.

The announcement follows the company’s filing of a Form 10 with the Securities and Exchange Commission on 11 December, the first official step the company had taken to move towards divestiture.

Illumina’s issues began in 2021 when it pursued the acquisition of its old subsidiary Grail during a waiting period imposed by the European Commission (EC), which subsequently levelled its largest-ever fine against the company and ordered the deal be undone. 

Things only worsened when the Federal Trade Commission (FTC) in the US came to the same conclusion, fearing that as one of the only companies equipped to process the tests Grail manufactures Illumina would use the acquisition to prevent competition in the space. 

Alveo Technologies, a provider of molecular sensing and diagnostics services, has established 19 new distributor partnerships across Europe, Africa, and the Middle East (EMEA) in a bid to expane its global presence for upcoming product releases and meeting the demand for its existing be.well Covid-19 product in the market.

In Europe, the company has signed new distribution partnerships with Biosan (Hungary), Farmas (North Macedonia, Albania, and Kosovo), Hydrox (Lithuania, Latvia, Estonia), InterPharm (Montenegro), and MD Solutions (Serbia). It has also established partnerships with OK SERVIS Biopro (Czech Republic and Slovakia), Synmed Bulgaria, Synmedom (Romania), Syntec Scientific (Ireland), and Techtum Lab (Sweden). 

To cover the Middle East, the company formed partnerships with Al Hayat Pharmaceutical (UAE), Al Suwaidi (Qatar), Genetics Code (Jordan), Bioteck (Lebanon), Ideal Medical (Saudi Arabia), and Ultra Diagnostic (Egypt). In Africa, the company has established partnerships with MMCD (Algeria), Cyclopharma (Morocco), and Maghreb Medical Maintenance (Tunisia). 

LUMA Vision has raised $22m in Series A3 financing to fund the FDA clearance and commercialisation of Verafeye in the country.

The financiers included EQT Lifesciences, ABV Uni Fund, imec.xpand, Atlantic Bridge Growth Fund and Bayern Kapital. It builds on previous funding from the Irish Government’s Disruptive Technologies Innovation Fund and the European Union’s EIC Accelerator grants of $6m and $3m, respectively.

Verafeye is a four-dimensional (4D) cardiac imaging and navigation platform that uses a proprietary catheter sensor combined with advanced digital imaging and deep learning to provide real-time guidance during cardiac surgery. Thereby, eliminating the need for external systems such as X-ray or CT scan.

The use of artificial intelligence (AI) such as deep learning has been increasing in the medical device sector. GlobalData forecasts the AI market to reach sales of $93bn in 2023, a 12% increase from 2022. Many companies have invested in using AI in cardiac imaging. 

Boomerang Medical has completed stage two enrolment of a pilot study investigating the use of its bioelectronic technology to treat inflammatory bowel disease (IBD).

Boomerang Medical said the BOOM-IBD clinical trial (NCT05414955) has successfully enrolled patients with Crohn’s disease or ulcerative colitis – the two most common forms of IBD. The trial is recruiting across eight clinical sites in the US.

As per a ClinicalTrials.gov entry, Boomerang has not outlined the therapy regimen in stage two of the study. Patients with IBD will be “treated with neuromodulation at various intervals”.

The single-group, open-label clinical trial is estimated to enrol 40 adult patients with diagnosed Crohn’s disease or ulcerative colitis. Boomerang stated that, unlike typical IBD studies, BOOM-IBD is open to patients who may not have already tried biologic therapy. The trial enrolled its first patient in April 2023. 

Boomerang’s device was granted breakthrough device designation by the US Food and Drug Administration (FDA) in March 2023. 

Neuronetics has received US Food and Drug Administration (FDA) clearance for its NeuroSite Coil placement accessory, a tool that helps users with accurate coil placement.

US-based Neuronetics was the first company to receive FDA approval for its transcranial magnetic stimulation (TMS) devices called NeuroStar for treatment-resistant depression. The devices use a coil to deliver magnetic pulses that stimulate nerve cells in the brain in regions responsible for mood regulation.

The add-on will help with coil positioning and placement and reduce patient setup time, with Neuronetics stating the device is compatible with both legacy and new NeuroStar systems.

It will become available to NeuroStar providers in Q1 2024.

NeuroStar, which is also CE-marked, is a non-drug, non-invasive therapy for patients with major depressive disorder. It provides a valuable option for patients with the condition who do not respond to antidepressant medications. Neuronetics states its technology has been used to deliver more than 5.9 million treatments in 145,000 patients.