Category: 510(k)Syndicate content

FDA clears Covidien's Nellcor pulse oximeter for pediatric care

May 28, 2013 by Sony Salzman

The FDA clears Covidien's Nellcor pulse oximeter for diagnosing congenital heart disease in infants.


Covidien (NYSE:COV) landed a 510(k) for its Nellcor pulse oximeter, which the federal watchdog agency OK'd for diagnosis of infant critical congenital heart disease (CCHD).

The Mansfield, Mass.-based med-tech titan already sells other devices in the Nellcor patient monitoring line, and is touting the pulse oximeter as the first ISO 8601-2-61 compliant oximeter in the U.S. market.

FDA gives Arcos a nod for its burn therapy device

May 27, 2013 by Sony Salzman

Arcos Medical celebrates an FDA green-light for its fluid treatment therapy device for serious burn victims

Arcos Medical won FDA clearance for its Burn Navigator, a medical device that monitors fluid therapy in burn victims.

This device is designed for serious burn victims who need fluid resuscitation, and it has already been successfully used on hundreds of patients, according to the company. The Burn Navigator works by measuring both fluid input and urine output to gauge the patient's need for more or less fluid treatment.

Signostics wins FDA go-ahead for handheld ultrasound device

May 27, 2013 by Sony Salzman

Signostics launches U.S. sales of its portable and handheld ultrasound device, the Sonimage P3

Australian medical device company Signostics won 510(k) approval for its handheld ultrasound device.

The device will be sold as the Sonimage P3 through the its partnership with Konica Minolata (TYO:4902). This device already is on the market in Europe and Australia, where it is sold as Signos RT.

FDA clears new smartphone health monitoring technologies

May 27, 2013 by Sony Salzman

New mobile phone devices win 510(k) clearance, adding to the growing market for patient self-monitoring devices

A growing demand for mobile health monitoring devices led to a boom in mobile devices that allow patients to manage chronic illnesses and measure body metrics at home. Now, several companies have won FDA clearance for next-generation health monitoring devices that connect wirelessly to mobile apps and software.

Palo Alto, Calif.-based Glooko will begin selling its second glucose monitoring app and cable device. This product comes with enhanced software that allows patients to program health goals and enhanced data security through advanced encryption.

FDA clears 21-inch medical monitors from NEC Display Solutions

May 24, 2013 by Sony Salzman

NEC Display Solutions wins 510(k) clearance for its 21-inch medical monitor systems.


NEC Display Solutions got the go-ahead from the FDA to begin selling its 21-inch medical monitor, the company announced this month. NEC's MultiSync MD211C2 and MD211C3 monitors are designed for clinical viewing of imaging for diagnostic purposes.

The monitor is designed to work with Picture Archiving & Communication System technology, and features software that automatically adjusts display brightness based on ambient light conditions.

Biolase gets FDA nod for new tissue laser

May 13, 2013 by Sony Salzman

The FDA clears Biolase's WaterLase iPlus tissue laser in the U.S.


Biolase (NSDQ:BIOL) won 510(k) clearance from the FDA for its WaterLase iPlus, a laser used for soft-tissue orthopedic procedures.

The clearance opens up a $2.6 billion market opportunity for the WaterLase device, according to a company statement.

Masimo lands FDA win for pediatric acoustic sensor

May 8, 2013 by Sony Salzman

FDA regulators give Masimo a nod for its Rainbow acoustic monitoring sensor for pediatric use.


The FDA granted 510(k) clearance to Masimo (NSDQ:MASI) for its Rainbow acoustic monitoring sensor for use in children.

Previously cleared for adults, the device can now be used in the U.S. to monitor the respiration rate of pediatric patients.