Regulatory Approvals

LEM Surgical wins new FDA clearance for humanoid surgical robot

LEM Surgical has received a new FDA 510(k) clearance for its Dynamis robotic surgical system, expanding the platform’s capabilities in spine surgery and marking...

Masimo gets FDA nod for AI-enabled opioid-induced respiratory depression detection tech

Masimo has received FDA clearance for an AI-enabled opioid-induced respiratory depression (OIRD) detection capability designed for its Radius VSM wearable continuous monitoring system. The technology...

FiberSense to bring new CGM to European market with CE mark

FiberSense has received CE mark approval for its continuous glucose monitoring (CGM) system, allowing the company to move toward commercialization in selected European markets. The...

AngioDynamics wins FDA IDE for feasibility study of NanoKnife in BPH

AngioDynamics has received FDA investigational device exemption (IDE) approval to begin the RELIEF feasibility study, evaluating its NanoKnife system for treating lower urinary tract...

Distalmotion gets FDA nod to expand Dexter surgical robot indications to gynecology

Distalmotion has received FDA 510(k) clearance to expand the use of its Dexter surgical robot across additional gynecologic procedures, including sacrocolpopexy, sacrocervicopexy, sacrohysteropexy, and...

SurGenTec gets FDA nod for lumbar facet fixation system

SurGenTec has received FDA clearance for its ION-L lumbar facet fixation system for patients with degenerative disc disease (DDD) affecting the L3 to S1...

Medtronic secures CE mark for Stealth AXiS system for ENT surgery

Medtronic has received CE mark approval for its Stealth AXiS surgical system, allowing hospitals and surgeons across Europe to use the technology in ear,...

Karl Storz gets FDA nod for exoscope for open surgery

Karl Storz has received FDA clearance for its Rubina Lens exoscope, expanding the company’s near-infrared (NIR) imaging technology into open surgical procedures in the...

Xenix Medical announces FDA clearance and full commercial launch of the Lux System

Xenix Medical announced FDA 510(k) clearance and full commercial launch for its Lux Expandable Lumbar Interbody Fusion System. Lux is the result of strong market...
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