Cardiology FDA Approved

Spry Health Continuous Wrist-Worn Pulse Oximeter, Heart and Lung Meter FDA Cleared

Released on April 16, 2019

Spry Health, a Silicon Valley company, won FDA clearance to introduce its…

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Cardiology FDA Approved

LIFEPAK CR2 Defibrillator Reads ECG During Chest Compressions, FDA Approved

Released on April 15, 2019

Stryker won FDA approval to introduce its LIFEPAK CR2 defibrillator with LIFELINKcentral program manager…

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FDA Approved Neuro

Penumbra VR device wins FDA clearance

Released on April 15, 2019

Penumbra recently announced that it has received FDA 510(k) clearance for its Real Immersive virtual reality system. The Real Immersive System […]

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FDA Approved Vascular

FDA approves Intact Vascular’s Tack dissection repair device

Released on April 15, 2019

The FDA last week granted pre-market approval to the Tack endovascular repair device developed by…

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FDA Approved Orthopedic

Stryker wins FDA PMA, launches Lifepak CR2 AED

Released on April 12, 2019

The newly launched Lifepak CR2 AED features new technology including …

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FDA Approved Spine

FDA clears moldable OssiMend bioactive bone graft from Collagen Matrix

Released on April 12, 2019

The moldable Ossimend product is designed to …

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FDA Approved Women's Health

EnVisio Surgical Navigation System for Breast Lumpectomies Cleared in U.S.

Released on April 12, 2019

Elucent Medical, a firm based in Eden Prairie, MN, won FDA clearance…

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Digital Health FDA Approved

FDA clears Spry Health’s Loop clinical-grade wearable

Released on April 10, 2019

Spry Health has received FDA clearance for its…

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Cardiology FDA Approved

Avinger wins FDA nod for Pantheris SV small vessel atherectomy device

Released on April 10, 2019

Avinger (NSDQ:AVGR) said today that it won FDA 510(k) clearance for its…

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Diagnostics FDA Approved

FDA clear’s Bio-Rad’s blood screening system

Released on April 9, 2019

Bio-Rad Laboratories (NYSE:BIO) said today it has received 510(k) clearance from the FDA for…

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Biotech FDA Approved

CoaguSense wins FDA clearance for monitoring system

Released on April 5, 2019

CoaguSense (Fremont, Calif.) recently announced that it has received FDA 510(k) clearance for…

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Cardiology FDA Approved

FDA Approves First New Therapy to Treat Heart Attacks in Years

Released on April 4, 2019

Heart attacks are typically treated by placing stents at the sites of narrowing coronary arteries…

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Cardiology FDA Approved

TherOx wins FDA approval for SuperSaturated Oxygen therapy

Released on April 4, 2019

TherOx said a pivotal trial showed a 26% relative reduction in…

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FDA Approved

RejuvenAir Cryospray for Treating COPD with Chronic Bronchitis Going on Trial

Released on April 3, 2019

The FDA has just issued a Breakthrough Device designation and an Investigational Device Exemption (IDE) to …

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FDA Approved Imaging

FluoroShield Reduces Radiation Exposure from Fluoroscopes, Gets FDA Clearance

Released on April 3, 2019

Radiation reduction continues to be an important goal in …

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FDA Approved Ophthalmology

FDA accepts second application for Ocular Therapeutix’s drug-delivering implant

Released on April 3, 2019

Ocular Therapeutix is positioning its product as a way to …

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Cardiology FDA Approved

CardioFlux Magnetocardiography System with Faraday Analytical Cloud FDA Cleared

Released on April 2, 2019

Genetesis, a company based in Mason, Ohio, won FDA clearance for its cardiac imaging offering that combines the CardioFlux magnetocardiograph with the the integrated Faraday Analytical Cloud (FAC).

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FDA Approved Neuro

NexStim wins Health Canada approval for NBS, NexSpeech

Released on March 29, 2019

Nexstim said today that it won approval from Health Canada for its NBS system and NexSpeech devices.

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FDA Approved Vascular

First U.S. patient treated with Cook Medical endovascular aortic dissection system

Released on March 29, 2019

Cook Medical has launched its Zenith dissection endovascular system, recently approved by the FDA.

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FDA Approved

AngioDynamics wins expanded FDA clearance for OARtrac radiation dose monitor

Released on March 29, 2019

AngioDynamics (NSDQ:ANGO) said late yesterday that it won expanded FDA 510(k) clearance for its OARtrac radiation dose monitoring system.

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FDA Approved Urology

InControl Medical wins FDA nod for OTC incontinence device

Released on March 28, 2019

InControl Medical (Brookfield, Wisc.) has received FDA clearance for its Attain over-the-counter, non-implantable muscle stimulator for urinary and bowel incontinence.

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Cardiology FDA Approved Imaging

FDA clears Genetesis’ CardioFlux biomagnetic cardiac imager

Released on March 25, 2019

Genetesis said last Friday it won FDA 510(k) clearance for its CardioFlux biomagnetic cardiac imaging platform.

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FDA Approved

Masimo wins FDA 510(k) for Rad-67 pulse co-oximeter

Released on March 25, 2019

Masimo (NSDQ:MASI) said today it won FDA 510(k) clearance for its Rad-67 pulse co-oximeter system.

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Cardiology FDA Approved

Omron wins FDA nod for combined blood pressure monitor, EKG

Released on March 25, 2019

Omron Healthcare (TYO:6645) has won FDA 510(k) clearance for its Blood Pressure Monitor + Echocardiogram device, according to a recently posted FDA release.

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