Carthera receives EMA endorsement for orphan medical device status of SonoCloud
Ella Day | July 2, 2025 | News story | Medical Communications, Research and Development | Brain disorders, Breakthough Device Designation, CE marking, Carthera, Devices, European Medicines Agency (EMA), Food and Drug Administration, Forfait Innovation Status, Neurology, Orphan Medical Device Status, ultrasound imaging
French biotech company Carthera has announced that its SonoCloud system has been granted orphan medical device status by the European Medicines Agency (EMA) expert panel, becoming one of the first technologies to benefit from the EU’s new pilot programme supporting early access to new medical devices for rare diseases.
SonoCloud, an ultrasound-based implant developed to temporarily open the blood-brain barrier, is being explored as a new therapeutic approach for patients with recurrent glioblastoma and other brain disorders. The expert panel’s endorsement recognises its potential clinical benefits and applicability in treating life-threatening conditions with no current effective alternatives.
“This is a very important step for the company since it creates a unique forum for dialogue with the expert panel prior to submitting the technical documentation for conformity assessment,” said Sandra Thiollière, Carthera’s director of regulatory affairs. A CE marking submission is anticipated to follow, with early advice from the expert panel expected later this year.
The EMA’s new pilot initiative prioritises devices addressing serious or life-threatening rare diseases, such as those with potential major clinical benefits. Carthera’s recognition under the scheme follows earlier regulatory milestones, including Breakthrough Device Designation from the US Food and Drug Administration in 2022 and France’s Forfait Innovation status in 2024.
“Receiving this endorsement positions us to accelerate access to our promising technology for European patients,” said Carthera CEO Frédéric Sottilini.
SonoCloud remains investigational and is currently under clinical evaluation in Europe and the US.
Ella Day
2/7/25
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