FDA Cleared Archives - Page 10 of 10 - TMG Pulse

FDA clears Cochlear piezoelectric hearing implant

The FDA has cleared a second-generation pioezoelectric bone-conduction hearing implant from Cochlear (ASX:COH), the company announced today. […]

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FDA Cleared Orthopedic

FDA clears augmented glenoids for Shoulder Innovations system

Shoulder Innovations announced today that it won FDA clearance for its InSet Plus augmented glenoids for […]

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FDA Cleared Surgery

MolecuLight FDA Cleared to Detect Bacteria Infected Wounds

Knowing whether a wound is infected by a bacterial colony is important for monitoring patients […]

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FDA Cleared Imaging

MolecuLight wins FDA clearance for handheld imaging device

MolecuLight announced that it won FDA 510(k) clearance for its i:X handheld fluorescence imaging device for […]

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Diagnostics FDA Cleared

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

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

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Biotech FDA Cleared

Israeli fingerprick blood testing company gets FDA clearance for CBC analyzer

The opportunity presented in fingerprick blood testing is one that many companies are chasing. Among […]

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FDA Cleared Robotics

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

Dive Brief: FDA has cleared two Intuitive technologies for use in sealing procedures, the Sunnyvale, California-based […]

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FDA Cleared Gastroenterology Surgery

PENTAX Medical’s DEC HD Partially Disposable Duodenoscope FDA Cleared

PENTAX Medical is releasing its DEC HD duodenoscope, a high-definition device that uses disposable distal […]

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Diagnostics FDA Cleared Imaging

Siemens Healthineers Unveil SOMATOM X.cite Premium CT Scanner

Siemens Healthineers won FDA clearance and is releasing its brand new SOMATOM X.cite premium single-source […]

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FDA Cleared Ophthalmology

MiSight Contacts FDA Cleared to Slow Myopia in Kids

Myopia is a very common condition in children, often progressing rapidly and triggering earlier onset […]

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FDA Cleared Orthopedic

OrthoPediatrics launches PediFoot system

OrthoPediatrics (NSDQ:KIDS) announced the U.S. launch of its PediFoot deformity correction system for feet after it […]

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FDA Cleared Imaging Orthopedic

Conformis launches next-generation hip system

Conformis (NSDQ:CFMS) has won FDA clearance for its latest 3D-designed Conformis hip system for hip surgeries. […]

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FDA Cleared Robotics

Hands-free robotic system given FDA clearance

XACT Robotics’ first robotic system has been cleared by the Food and Drug Administration (FDA) for […]

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FDA Cleared Radiology

Omega FluoroShield FDA Cleared to Reduce Radiation Exposure

Omega Medical Imaging, a firm based in Sanford, Florida, has won FDA clearance for its […]

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FDA Cleared Neuro

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

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

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FDA Cleared Radiology Robotics

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

– Hands-free robotic system combines image-based planning and navigation with instrument insertion and steering to deliver […]

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FDA Cleared Vascular

Medtronic thoracic stent graft system approved in Japan

Dive Brief: Medtronic received clearance to sell its Valiant Navion thoracic stent graft system in […]

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FDA Cleared Imaging Robotics

XACT Robotic Needle Navigation System Cleared in U.S.

XACT Robotics, an Israeli company, just announced winning FDA clearance for its robotic needle steering […]

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Drug-delivery FDA Cleared

Insulet wins FDA nod for Omnipod with Novo Nordisk’s Fiasp insulin

Insulet (NSDQ:PODD) said last week that it won FDA clearance for the use of Novo Nordisk‘s […]

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FDA Cleared Gastroenterology

Gastrointestinal innovator has endoscopic shield cleared by FDA

GI Scientific, a developer of innovations for gastrointestinal disease, has had its ScopeSeal Duodenoscope Protective Device, […]

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FDA Cleared Surgery

FDA clears GI Scientific’s duodenoscope ScopeSeal

GI Scientific said today that the FDA cleared its ScopeSeal duodenoscope protective device for protecting the […]

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FDA Cleared Neuro

NICO Myriad NOVUS Provides Xenon Lighting for Brain Resections

NICO Corporation, a company based in Indianapolis, Indiana, is releasing its new NICO Myriad NOVUS […]

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FDA Cleared Imaging

Canon Ultra High-Res Aquilion Precision CT Now Boosted by Artificial Intelligence

Canon has announced that its new Advanced Intelligent Clear-IQ Engine (AiCE) has been cleared by […]

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FDA Cleared Neuro

Nico wins FDA nod for Myriad Novus resection tool

Nico Corp. said it won 501(k) clearance from the FDA for its Myriad Novus resection […]

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FDA Cleared Wearables

FDA Clears geko Muscle Pump Activator to Prevent VTE

Venous thromboembolism (VTE) too often strikes bedridden patients in the hospital, and this is one […]

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FDA Cleared

HairBoom Air Helmet FDA Cleared to Treat Hair Loss

WONTECH, a Korean company, won FDA clearance for its HairBoom Air hair loss treatment helmet. […]

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FDA Cleared

Sky Medical Technology Nabs FDA Clearance for VTE Device

Sky Medical Technology Ltd. won FDA clearance for a device that stimulates calf muscles to […]

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FDA Cleared Vascular

FDA Clears GEKO DEVICE for Use in Non-surgical Patients at Risk for Deep Vein Thrombosis Based on Study Demonstrating a Zero Percent DVT Rate in Patients After a Stroke

Sky Medical Technology furthers presence in 3.5bn1 dollar US market for VTE prevention DARESBURY, England, Oct. 10, […]

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FDA Cleared Imaging

Epica International, Inc. Announces U.S. FDA 510(k) Clearance for its Multi-modality, Mobile Computed Tomography Imaging Platform, SeeFactorCT3™

Wednesday, October 2, 2019 – 9:00 am Pacific San Clemente, California. Epica International Inc. (Epica), […]

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FDA Cleared Radiology Surgery

Epica SeeFactorCT3 Multi-Modality System Wins FDA Clearance

Epica, a company based in San Clemente, California, won FDA clearance for its SeeFactorCT3 system […]

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FDA Cleared

FDA clears Exogenesis nano-modified hernia mesh

Exogenesis said yesterday that it won FDA 510(k) clearance for its hernia mesh implant for soft […]

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Biotech FDA Cleared

FDA clears Insulet’s OmniPod Dash as insulin pump alternative

Insulet (NSDQ:PODD) said today that it won FDA clearance to market its Omnipod Dash alternate controller-enabled […]

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FDA Cleared Imaging Orthopedic

FDA clears Viseon’s Voyant spine surgery imaging device

Viseon said today that it won FDA clearance for its Voyant system for integrating minimally invasive […]

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FDA Cleared Orthopedic Robotics

OrthoSpin Receives FDA Regulatory Clearance

MISGAV, Israel, Sept. 18, 2019 /PRNewswire/ — OrthoSpin Ltd. a portfolio company of The Trendlines Group Ltd. (“Trendlines”) (SGX: 42T) […]

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FDA Cleared Vascular

FDA clears Rex Medical’s Revolution peripheral atherectomy device

Rex Medical said last week that it received FDA 510(k) clearance for its Revolution peripheral atherectomy […]

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CE Mark FDA Cleared Neuro

Wallaby Medical wins FDA nod, CE Mark for Avenir neurovascular coil

Wallaby Medical announced yesterday that it won FDA 510(k) clearance and CE Mark approval in the […]

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FDA Cleared Orthopedic

Zimmer Biomet Receives FDA Clearance of JuggerStitch™ Meniscal Repair Device

WARSAW, Ind., Sept. 16, 2019 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global […]

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Digital Health FDA Cleared

Healthy.io Brings Home FDA Nod for Smartphone-Based Test

Healthy.io has developed an interesting use for smartphones. The Tel Aviv, Israel-based Company is turning […]

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FDA Cleared

Masimo wins expanded clearance for O3 oximetry device

Masimo (NSDQ:MASI) said today that its O3 regional oximetry device has been cleared for three additional […]

Topic: FDA Cleared

FDA clears Cochlear piezoelectric hearing implant

FDA clears augmented glenoids for Shoulder Innovations system

MolecuLight FDA Cleared to Detect Bacteria Infected Wounds

MolecuLight wins FDA clearance for handheld imaging device

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

Israeli fingerprick blood testing company gets FDA clearance for CBC analyzer

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

PENTAX Medical’s DEC HD Partially Disposable Duodenoscope FDA Cleared

Siemens Healthineers Unveil SOMATOM X.cite Premium CT Scanner

MiSight Contacts FDA Cleared to Slow Myopia in Kids

OrthoPediatrics launches PediFoot system

Conformis launches next-generation hip system

Hands-free robotic system given FDA clearance

Omega FluoroShield FDA Cleared to Reduce Radiation Exposure

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

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

Medtronic thoracic stent graft system approved in Japan

XACT Robotic Needle Navigation System Cleared in U.S.

Insulet wins FDA nod for Omnipod with Novo Nordisk’s Fiasp insulin

Gastrointestinal innovator has endoscopic shield cleared by FDA

FDA clears GI Scientific’s duodenoscope ScopeSeal

NICO Myriad NOVUS Provides Xenon Lighting for Brain Resections

Canon Ultra High-Res Aquilion Precision CT Now Boosted by Artificial Intelligence

Nico wins FDA nod for Myriad Novus resection tool

FDA Clears geko Muscle Pump Activator to Prevent VTE

HairBoom Air Helmet FDA Cleared to Treat Hair Loss

Sky Medical Technology Nabs FDA Clearance for VTE Device

FDA Clears GEKO DEVICE for Use in Non-surgical Patients at Risk for Deep Vein Thrombosis Based on Study Demonstrating a Zero Percent DVT Rate in Patients After a Stroke

Epica International, Inc. Announces U.S. FDA 510(k) Clearance for its Multi-modality, Mobile Computed Tomography Imaging Platform, SeeFactorCT3™

Epica SeeFactorCT3 Multi-Modality System Wins FDA Clearance

FDA clears Exogenesis nano-modified hernia mesh

FDA clears Insulet’s OmniPod Dash as insulin pump alternative

FDA clears Viseon’s Voyant spine surgery imaging device

OrthoSpin Receives FDA Regulatory Clearance

FDA clears Rex Medical’s Revolution peripheral atherectomy device

Wallaby Medical wins FDA nod, CE Mark for Avenir neurovascular coil

Zimmer Biomet Receives FDA Clearance of JuggerStitch™ Meniscal Repair Device

Healthy.io Brings Home FDA Nod for Smartphone-Based Test

Masimo wins expanded clearance for O3 oximetry device