The FDA issued new guidance governing premarket notification submissions for pulse oximeters. The new guidelines apply to all 510(k) submissions for the non-invasive blood oxygen level and pulse rate measuring devices.
510(k)
ArthroCare lands FDA win for SpeedLock HIP implant
Surgical devices maker ArthroCare (NSDQ:ARTC) won FDA clearance for its SpeedLock HIP implant, a soft-tissue-to-bone fixation implant for hip repair surgeries.
The device’s primary use is in acetabular labral reattachment and hip capsular repair, according to a press release.
FDA clears Philips’ MicroDose SI mammography system
FDA OKs Wellaho mobile patient health monitoring system
California mobile health services company Sanitas won FDA clearance for its Wellaho system, a proprietary mobile and online platform providing a link between patients and healthcare providers.
The Wellaho platform is "an outpatient management system for chronically ill patients," according to the company’s website.
FDA clears Smiths Medical’s at-home ambulatory care unit
St. Paul, Minn,-based device maker Smiths Medical got the green-light from the FDA for its newest ambulatory infusion system, which has been approved for at-home use.
The Cadd-Solis VIP ambulatory infusion system integrates some of Smith Medical’s other products, including its infusion pump, medication-level monitoring system and medication reservoirs
Biolase expands soft-tissue laser to new markets
Biolase (NSDQ:BIOL) won FDA approval for the use of its 940nm Diolase 10 laser in a range of different markets. The federal watchdog agency also cleared 80 new procedures for the device.
The Irvine, Ca-based dental laser company said it can now sell into more than 20 new markets, including ear, nose and throat, arthroscopy, dermatology, plastic surgery and ophthalmology.
Zoll lands FDA clearance for automated external defibrillator
Asahi Kasei (TYO:3407) subsidiary Zoll Medical won 510(k) clearance from the FDA for its fully-automated AED Plus device, which improves on the former semi-automatic model.
The new automated external defibrillator allows emergency responders to pre-program a shock instead of pushing the “shock” button.
Knee replacement: Stanmore nabs FDA clearance for robotic guidance system
U.K.-based orthopedic device maker Stanmore Implants says it has received FDA clearance for its Sculptor Robotic Guidance Arm system for partial knee resurfacing procedures.
The system uses a robotic guidance arm to assist surgeons’ operation of cutting tools, and "limiting the removal of bone to a pre-defined safe area," according to a prepared release. It is part of a suite of devices and software systems the company produces for personalized orthopedic implants.
FDA green-lights Ethicon’s surgical assist device
The FDA gave the green light to Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon’s Enseal G2 surgical sealer.
Ethicon touts the device, the Enseal G2 Articulating, as a "first-of-its-kind articulating advanced energy device." It’s the 2nd in the Enseal product line, improving on the 1st iteration with the ability to bend around structures in the body.
FDA releases January 510(k) clearances
January 2013 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD January 2013
Conventus Orthopaedics wins FDA nod for wrist fracture implant
Conventus Orthopaedics said the FDA granted 510(k) clearance for its Conventus DRS minimally invasive implant for wrist fractures.
The device is designed to replace traditional volar plate implants used to correct distal radius fractures, requiring a 2-3cm incision on the forearm and "a few tiny incisions at the wrist," according to a press release.