Diagnostics FDA Cleared

FDA clearance positions Sight Diagnostics to deliver on two-drop blood testing promise

Released on December 5, 2019

Today’s news that Sight Diagnostics secured 510(k) clearance for its Olo analyzer certainly will reduce the flow of future patient tears and fears […]

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Biotech FDA Cleared

Israeli fingerprick blood testing company gets FDA clearance for CBC analyzer

Released on December 4, 2019

The opportunity presented in fingerprick blood testing is one that many companies are chasing. Among these is Israeli diagnostics firm Sight […]

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FDA Cleared Robotics

Intuitive gets FDA go-ahead for robotic system sealing instrument, power generator

Released on December 2, 2019

Dive Brief: FDA has cleared two Intuitive technologies for use in sealing procedures, the Sunnyvale, ​California-based company said last week. The devices […]

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FDA Cleared Gastroenterology Surgery

PENTAX Medical’s DEC HD Partially Disposable Duodenoscope FDA Cleared

Released on November 21, 2019

PENTAX Medical is releasing its DEC HD duodenoscope, a high-definition device that uses disposable distal caps and elevator levers, in the […]

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Diagnostics FDA Cleared Imaging

Siemens Healthineers Unveil SOMATOM X.cite Premium CT Scanner

Released on November 21, 2019

Siemens Healthineers won FDA clearance and is releasing its brand new SOMATOM X.cite premium single-source CT scanner. The device, along with […]

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FDA Cleared Ophthalmology

MiSight Contacts FDA Cleared to Slow Myopia in Kids

Released on November 20, 2019

Myopia is a very common condition in children, often progressing rapidly and triggering earlier onset of other eye conditions, such as […]

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FDA Cleared Orthopedic

OrthoPediatrics launches PediFoot system

Released on November 19, 2019

OrthoPediatrics (NSDQ:KIDS) announced the U.S. launch of its PediFoot deformity correction system for feet after it won FDA 510(k) clearance months ago. […]

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FDA Cleared Imaging Orthopedic

Conformis launches next-generation hip system

Released on November 8, 2019

Conformis (NSDQ:CFMS) has won FDA clearance for its latest 3D-designed Conformis hip system for hip surgeries. The Billerica, Mass.–based company began hip surgeries […]

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FDA Cleared Robotics

Hands-free robotic system given FDA clearance

Released on November 7, 2019

XACT Robotics’ first robotic system has been cleared by the Food and Drug Administration (FDA) for use during computed tomography (CT) guided […]

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FDA Cleared Radiology

Omega FluoroShield FDA Cleared to Reduce Radiation Exposure

Released on November 6, 2019

Omega Medical Imaging, a firm based in Sanford, Florida, has won FDA clearance for its FluoroShield technology, as well as the […]

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FDA Cleared Neuro

Axonics announces first commercial US patient implanted with its sacral neuromodulation system

Released on November 4, 2019

Axonics has announced the first US-based implantation of the Axonics r-SNM system subsequent to its clearance by the US Food & […]

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FDA Cleared Radiology Robotics

First-of-its-Kind XACT Robotic System Cleared by FDA for Percutaneous Interventional Procedures

Released on November 1, 2019

– Hands-free robotic system combines image-based planning and navigation with instrument insertion and steering to deliver increased procedural accuracy, consistency and efficiency […]

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