Regulatory Approvals

Levita® Magnetics Wins FDA Clearance for Pioneering MARS™ System

Levita Magnetics, whose mission is to help more patients get access to better surgery, announced today it has received U.S. Food and Drug Administration...

Nurami receives US FDA approval for resorbable repair graft

ArtiFascia integrates two layers of electrospun nanofibres to create biomimetic scaffolds and a non-porous barrier layer. Nurami Medical has received the US Food and Drug...

Exactech Announces FDA 510(k) Clearance for Advanced Activit-E™ Knee Replacement Polyethylene

Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, announced 510(k) clearance from the U.S. Food and...

GE HealthCare Portrait Mobile patient monitoring device receives FDA clearance

The smartphone-sized device offers continuous monitoring of respiration rate while allowing patient mobility. GE HealthCare announced its smartphone-sized Portrait Mobile wireless monitoring solution has received FDA...

Heart Failure start-up, Acorai, embarks on the next vital stage towards regulatory approval

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 Receives FDA 510(k) Clearance for its VitalHold™ on the Radixact® System

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...

FDA approves POLARx cryoablation system from Boston Scientific

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...

FDA approves J&J’s Afib ablation devices for use without fluoroscopy

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 Starts FDA and CE Regulatory Approval Processes for SSi Mantra Surgical Robot

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...
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