All articles by Sdebbarma Sdebbarma
MHRA secures $4.8m to expand AI medical device programme
AI Airlock is jointly run by the MHRA, DHSC, NHS AI Team, and Team AB, the consortium of UK Approved Bodies.
Route 92 Medical raises $50m to support growth strategy
The proceeds will support Route 92’s growth strategy through expediting worldwide commercial expansion.
J&J advances PFA portfolio with Varipulse Pro launch in Europe
Varipulse Pro introduces a new pulse sequence with lower temperature and five times faster ablation.
Egg Medical unveils new radiation protection system for clinical use
Barnes-Jewish Hospital is set to conduct the initial live case using the EggNest Complete Flex system.
Stereotaxis launches Synchrony system for cath labs
Synchrony is offered with SynX, a cloud-based app compliant with HIPAA and GDPR standards.
FDA grants 510(k) clearance for Allevion Medical’s Vantage system
Vantage’s intuitive three-step workflow, locate, dilate, decompress, enables physicians to perform procedures with consistency.
Zeto receives FDA clearance for New Wave EEG system
Zeto New Wave supports short-term EEG recordings up to 2.5 hours and allows clinics to deliver timely care.
Merit Medical Systems acquires View Point Medical through merger
The total transaction value is approximately $140m, including assumed liabilities, with $90m paid in cash at closing.
Distalmotion seeks FDA clearance for DEXTER use
The FDA has authorised the company to begin a US myomectomy trial through an investigational device exemption.
Applied Medical broadens MiniSPC Button with new size options
The expansion is intended for use by interventional radiologists, home healthcare providers, urologists and nurses.