Cardiology FDA Cleared

FDA Clears geko Muscle Pump Activator to Prevent VTE

Released on October 15, 2019

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

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FDA Cleared

Sky Medical Technology Nabs FDA Clearance for VTE Device

Released on October 11, 2019

Sky Medical Technology Ltd. won FDA clearance for a device that stimulates calf muscles to prevent venous thrombosis in non-surgical patients […]

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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

Released on October 10, 2019

Sky Medical Technology furthers presence in 3.5bn1 dollar US market for VTE prevention DARESBURY, England, Oct. 10, 2019 /PRNewswire/ — UK-based medical devices company, […]

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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™

Released on October 9, 2019

Wednesday, October 2, 2019 – 9:00 am Pacific San Clemente, California. Epica International Inc. (Epica), received 510(k) clearance from the U.S. […]

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FDA Cleared Radiology Surgery

Epica SeeFactorCT3 Multi-Modality System Wins FDA Clearance

Released on October 8, 2019

Epica, a company based in San Clemente, California, won FDA clearance for its SeeFactorCT3 system that combines computed tomography (CT), fluoroscopy, […]

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FDA Cleared

FDA clears Exogenesis nano-modified hernia mesh

Released on October 4, 2019

Exogenesis said yesterday that it won FDA 510(k) clearance for its hernia mesh implant for soft tissue repair in abdominal wall hernias […]

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Biotech FDA Cleared

FDA clears Insulet’s OmniPod Dash as insulin pump alternative

Released on September 24, 2019

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

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FDA Cleared Imaging Orthopedic

FDA clears Viseon’s Voyant spine surgery imaging device

Released on September 20, 2019

Viseon said today that it won FDA clearance for its Voyant system for integrating minimally invasive surgical access with high-definition imaging technology. […]

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FDA Cleared Orthopedic Robotics

OrthoSpin Receives FDA Regulatory Clearance

Released on September 18, 2019

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

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FDA Cleared Vascular

FDA clears Rex Medical’s Revolution peripheral atherectomy device

Released on September 17, 2019

Rex Medical said last week that it received FDA 510(k) clearance for its Revolution peripheral atherectomy system. The Conshohocken, Pa.-based company’s Revolution […]

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CE Mark FDA Cleared Neuro

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

Released on September 16, 2019

Wallaby Medical announced yesterday that it won FDA 510(k) clearance and CE Mark approval in the European Union for its Avenir coil […]

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FDA Cleared Orthopedic

Zimmer Biomet Receives FDA Clearance of JuggerStitch™ Meniscal Repair Device

Released on September 16, 2019

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

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