Regulatory Approvals

Stethophone™ Receives Full Approval for Use by Patients and Their Families in Ukraine

Ukraine clears breakthrough SaaMD that enables people to usetheir smartphones as clinical-grade devices that listen for cardiovascular disease at home. Sparrow BioAcoustics  announced it has...

ICU Medical Receives FDA Clearance for Plum Duo™ Infusion Pump and LifeShield™ Infusion Safety Software

The clinician-driven design of the precision system is the foundation of ICU Medical's long-term IV systems product road map that seeks to blend ease...

FDA clears AI algorithms to gauge success of complex arrhythmia ablation

The FDA cleared two AI algorithms to evaluate the success of PVI ablation for complex arrhythmias. These tools are available on a price-per-use basis. CathVision announced...

Medtronic’s spinal cord stimulator receives CE Mark

Inceptiv is claimed to be the only SCS system in Europe that provides both full-body 1.5T and 3T MRI access. Medtronic has secured CE Mark approval for its...

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,...
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