Regulatory Approvals

Acorai, a start-up medical device manufacturer from Sweden, has announced the initiation of a global clinical trial with the enrollment of its first patient in London,...

Accuray Incorporated has announced that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its VitalHold™* breast package on the Radixact® System. The...

Boston Scientific announced that it received FDA approval for its POLARx cryoablation system. The new system received an indication for the treatment of patients with paroxysmal...

The devices can now be guided with ultrasound which reduces radiation exposure to patients and medical staff. Medical staff will no longer need to wear...

SS Innovations International, Inc. has announced that it is beginning the process of applying for FDA and CE regulatory approval for its flagship surgical robotic...

Advanced Neuro Diagnostic Imaging (ANDI) software extracts features from medical images to map and analyze microstructural properties of white matter Provides adjunctive information for use...

UltraSight receives FDA approval for AI-based cardiac ultrasound technology. UltraSight has secured approval from the US Food and Drug Administration (FDA) for its artificial intelligence (AI)-based cardiac...

Microbot Medical Inc. has announced the first steps towards its planned European market clearance, by engaging with a leading Notified Body. The Notified Body will audit...

Imperative Care, a medical technology company developing connected innovations to elevate care for people affected by stroke and other ischemic diseases, announced U.S. Food...