Shanx Medtech BV raised €15 million (US$17.5 million) in a seed funding round for its in vitro diagnostic platform for ultra-rapid antimicrobial susceptibility testing. The financing came from a range of sources including equity, grants and a loan, and will be used to accelerate the development, clinical validation, regulatory approval, and commercial launch of the diagnostic platform.

Genedx delivers WGS prenatal testing

Genedx Inc. launched Genomedx Prenatal, its whole genome sequencing test, to enable more definitive diagnoses of the causes of fetal abnormalities identified by ultrasound. By combining the company’s decade of experience in prenatal exome testing and its massive Genedx Infinity rare disease dataset, the test can determine not just whether a pregnancy is at risk of a genetic disorder, but whether the fetus has a genetic disorder.

FDA reissues controversial CDS final guidance

The U.S. FDA’s September 2022 final guidance for clinical decision support (CDS) systems set a dismal record for pushback, registering not one but two citizen petitions in opposition. The new administration at the agency has reissued the CDS guidance in a move that reinforces an existing message that digital health is on tap at the FDA’s device center.

NICE offers conditional endorsement for 8 apps for asthma

The U.K. National Institute for Health and Care Excellence (NICE) has offered a thumbs-up for eight digital technologies to help patients with asthma manage their conditions. The sponsors of these products have three years to turn out enough evidence to persuade NICE to fully endorse those products, after which these platforms could have access to a market of more than five million patients.

BioWorld MedTech 2025 Year in Review

BioWorld MedTech looks back at the year’s biggest news. View our 2025 Year in Review articles.

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Alpha Aesthetics Partners, Andera Partners, Archeus Technologies, Cairn Surgical, Capstan, Cordical Medical, Corsera Health, CSA Medical, Dexcom, Forj Medical, Imdx, Imvaria, J&J, MD Anderson, Next Gen Diagnostics, Radnet, Sensus Healthcare, Sera Prognostics, Sophia Genetics, Spiro Medical, Surgibox, Team Technologies, Thurston Group Portfolio Co., Tolion Health AI, Truvian, Viz.ai, Vizient, Vygon