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CIRCA Medical

FDA clears the first single-use face mask for children | Regulatory Roundup

September 29, 2011 By MassDevice staff Leave a Comment

KCHC
FDA

The FDA granted Kimberly-Clark Health Care the first 510(k) clearance for a single-use pediatric face mask.

Designated as a Class II medical device, the colorful mask is used to protect the respiratory tracts of children ages five to 12 from various bacteria, viruses and pathogens. It’s intended for use in waiting rooms and hospitals, to protect already immuno-compromised children from further infection

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: CIRCA Medical, Eye on the FDA, Kimberly-Clark Worldwide Inc., Regulatory Roundup, Terumo, Titan Spine

FDA clears CIRCA’s temp sensing probe

September 29, 2011 By MassDevice Contributors Network Leave a Comment

FDA Clears New Rapid, Large-Area, and Radiopaque Temperature Sensing Probe and System

PARK CITY, UTAH – September 13, 2011 – CIRCA Scientific today announced that its CIRCA S-CATH™ and CIRCA Temperature Monitoring System™ have received 510(k) clearance in the U.S. by the Food and Drug Administration (FDA).

The CIRCA S-CATH and the CIRCA Temperature Monitoring System address the problems associated with slow, single sensor, and small surface area standard esophageal temperature probes and monitors.

Filed Under: Uncategorized Tagged With: CIRCA Medical, Press Release

Medtronic’s scoliosis screw gets a green light from the FDA | Regulatory Roundup

September 16, 2011 By MassDevice staff Leave a Comment

Medtronic

Medtronic Inc. (NYSE:MDT) won 510(k) clearance from the FDA for a pedicle screw designed to treat adolescent idiopathic scoliosis.

The Twin Cities medical device colossus said the FDA’s Center for Devices & Radiological Health gave the nod to its TSRH Spiral system pedicle screw. It’s the second Medtronic AIS treatment to land FDA clearance.

AIS is the most common pediatric spine condition, affecting nearly one million U.S. adolescents, according to the company.

Filed Under: News Well Tagged With: Cambridge Heart Inc., CIRCA Medical, Hansen Medical Inc., Regulatory Roundup, Siesta Medical, Zimmer Biomet

The FDA approves CIRCA’s temperature system

September 16, 2011 By MassDevice Contributors Network Leave a Comment

CIRCA Scientific Announces That FDA Clears Its New Rapid, Large-Area, and Radiopaque Temperature Sensing Probe and System

PARK CITY, Utah–(BUSINESS WIRE)–CIRCA Scientific today announced that its CIRCA S-CATH™ and CIRCA Temperature Monitoring System™ have received 510(k) clearance in the U.S. by the Food and Drug Administration (FDA).

The CIRCA S-CATH and the CIRCA Temperature Monitoring System address the problems associated with slow, single sensor, and small surface area standard esophageal temperature probes and monitors.

Filed Under: Uncategorized Tagged With: CIRCA Medical, Regulatory Roundup

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