News

NDS receives FDA 510(k) clearance for embedded wireless video receiver in Radiance Ultra displays

by PR Newswire

SAN JOSE, Calif., June 27, 2016 /PRNewswire/-- NDS today announced it has received FDA 510(k) clearance for an embedded wireless HD-video receiver to be integrated into an endoscopy display. The ZeroWire® G2 wireless technology solution from NDS, also available as an external unit, will now be design engineered into the new Radiance® Ultra series of premium endoscopy displays as an option within the display enclosure.

By embedding the...

kBLASTER update June 2016: 510(k) search for predicates and successful 510(k) clearance strategy

The kBLASTER database has been updated today with FDA 510(k) clearances from May 2016 and FDA 510(k) splash pages for 510(k)s clearances in June 2016. If you have Saved Searches in your kBLASTER account that meet the parameters of today's imports into the kBLASTER database, you will see blue notification flags in your active kBLASTER account on those Saved Searches, as well as Alert email(s).  

Leverage ...

Masimo Announces 510(k) Clearance for O3™ Regional Oximetry

by Business Wire

IRVINE, Calif.--()--Masimo (NASDAQ: MASI) announced today FDA 510(k) clearance for O3™ regional oximetry. Regional oximetry, also referred to as tissue or cerebral oximetry, may help clinicians monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain due to various factors, such as the type of clinical procedure...

Noxilizer wins 510(k) clearance for NO2 sterilization of medical device

by Fink Densford for Medical Design and Outsourcing

Novel sterilization firm Noxilizer on Wednesday touted the FDA 510(k) clearance of a device which is terminally sterilized using the company’s nitrogen dioxide sterilization process.

The Baltimore, Md.-based company touts NO2 sterilization as “unique” as it sterilizes at low temperatures, between 10-30°C, and functions without a vacuum or humidity. Noxilizer says those aspects of the NO2 based sterilization make it ideal for temperature sensitive medical devices and biotech drugs.

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Bone Index Receives FDA 510(k) Clearance for the Bindex® Point-of-care Instrument to Help Physicians in Diagnosing Osteoporosis

by PR Newswire

Bone Index Ltd., one of Europe's top new manufacturers of medical devices, has received 510(k) clearance from the Food and Drug Administration (FDA) for the Bindex® point-of-care instrument to help in osteoporosis diagnosis.

Osteoporosis, a very underdiagnosed disease, is responsible for two million broken bones every year in the USA. These fractures translate into costs totaling about 19 billion dollars. Experts forecast that by 2025, the costs due to fractures will rise to 25.3 billion...

kBLASTER update May 2016: 510(k) search for predicates and successful 510(k) clearance strategy

The kBLASTER database has been updated today with FDA 510(k) clearances from April 2016 and FDA 510(k) splash pages for 510(k)s clearances in May 2016. If you have Saved Searches in your kBLASTER account that meet the parameters of today's imports into the kBLASTER database, you will see blue notification flags in your active kBLASTER account on those Saved Searches, as well as Alert email(s).  

Leverage ...

Another FDA 510(k) clearance for Synaptive Medical with its ImageDrive Pro

by Fink Densford for Massdevice.com

Synaptive Medical said it won FDA 510(k) clearance for its ImageDrive Pro informatics system designed to integrate its existing BrightMatter technology into multiple platforms.

The company said the new platform will allow for interoperability across all of BrightMatter’s solutions, including imaging, surgical planning, navigation and automated positioning of high definition optics.

BrightMatter gives 3D visuals of the brain in the operating room, which help guide surgeons as they...

FDA 510(k) Clears Next-Generation Version of EndoGastric Solutions’ EsophyX® Device

by Business Wire

REDMOND, Wash.--()--EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the EsophyX® Z device.

Designed for compatibility with the company’s existing 7.5 mm SerosaFuse...

FDA 510(k) Clears CareTaker® Wireless Remote Patient Monitor For Continuous Non-Invasive Blood Pressure (“cNIBP”) and Heart Rate Monitoring using patented Finger Cuff Technology

by Caretaker Medical

Charlottesville, VA April 2016 — CareTaker Medical, a pioneer in wireless remote patient monitoring devices, announced that the U.S. Food and Drug Administration has issued 510(k) clearance for the company’s Wireless Continuous Non-Invasive “Beat-by-Beat” Blood Pressure (“cNIBP”) and Heart Rate Monitor, based on patented Finger Cuff technology.

The wearable CareTaker® monitor enables uninterrupted wire-free and...

Potrero Medical, Inc. Receives FDA 510(k) Clearance for the Accuryn™ Monitoring System

by PR Newswire

SAN FRANCISCO, April 26, 2016 /PRNewswire/ -- Potrero Medical, Inc. announced today that it received 510 (k) clearance through the Food and Drug Administration (FDA) for the company's Accuryn™ Monitoring System, which transforms the traditional urinary catheter into a next-generation diagnostic tool for patients requiring tight fluid management, including patients at risk of sepsis and acute kidney injury.  

Accuryn™ provides accurate, real-time...

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