Regulatory Approvals

 Olive Diagnostics, an IoMT MedTech startup that uses AI for 100% passive urine analysis, announced that it has received the CE Mark in Europe for the...

Neosoma, Inc., an innovative medical technology company focused on helping clinicians advance the treatment of brain cancers, announced it has received U.S. Food...

The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that DEKRA Certification UK Ltd has now joined the three current UK Approved Bodies,...

Duramesh combines implant incorporation in mesh repair with suture placement precision for the repair of soft tissues. Mesh Suture, which does business as MSi, has...

The company’s Seer Home device allows for potential epilepsy diagnosis through at-home data collection. Australian company Seer Medical received FDA 510(k) clearance for its at-home electroencephalograph (EEG)...

Though drugs can help treat many cases of epilepsy, for the roughly 30% of patients with drug-resistant cases, it can take decades to find...

The Primary Relief neurostimulation device administers periodic low-level electrical pulses to the ear for more than 72 hours. DyAnsys has received approval from the US Food and...

The OptaBlate system allows physicians to easily customise their procedure and reduces ablation times by three minutes. Stryker has obtained 510(k) clearance from the US Food and Drug...

BIOCORP (FR0012788065 – ALCOR / Eligible PEA‐PME), a French company specialized in the design, development, and manufacturing of innovative medical devices, and SANOFI announced...