Here’s a roundup of companies announcing regulatory clearances from the Food & Drug Administration and foreign regulatory agencies:
- ArthroCare win 510(k) for SpeedFix labrum anchor
ArthroCare Corp. (NSDQ:ARTC) received clearance from the Food & Drug Administration for its SpeedFix suture anchor system, a push-in anchor made of PEEK (polyether-etherketone) polymer designed for the repair of certain tears of the labrum in the shoulder.
- Carestream Health lands FDA approval letter for CR mammography system
Carestream Health received an approval letter from the Food & Drug Administration for its high-resolution computed radiography system for mammography. Once the FDA approves the final product labeling, Carestream Health can immediately begin commercial distribution of this innovative CR system for mammography in the U.S.
- Covidien get 510(k) nod for compression comfort sleeve and controller
Covidien (NYSE:COV) announced 510(k) clearance from the Food & Drug Administration for the Kendall SCD sequential compression comfort sleeve and Kendall SCD 700 Series controller.
- Bovie Medical asks for 510(k) review of J-Plasma handpiece
Bovie Medical Corp. (NYSE:BVX) announced its applciation for 510(k) clearance from the Food & Drug Administration for its J-Plasma handpiece with retractable cutting features in both laparoscopic and open configurations.
- Varian Medical Systems receives 510(k) clearance for Acuros XB advanced dose calculation algorithm
Varian Medical Systems (NYSE:VAR) received FDA 510(k) clearance for the Acuros XB advanced dose calculation algorithm which can complete a RapidArc treatment plan two to three times faster than conventional planning algorithms. Varian incorporated the Acuros algorithm for external beam radiotherapy treatment planning into its market-leading Eclipse treatment planning system.
- BSD Medical wins CE Mark for MicroThermX microwave ablation system
BSD Medical Corp. (NSDQ:BSDM) received CE Mark approval for its MicroThermX microwave ablation system (MTX-180) in Europe.
- GE Healthcare wins 510(k)s for cardiovascular ultrasound, patient monitor
GE Healthcare announced 510(k) clearance for the latest iteration of its Vivid E9 cardiovascular ultrasound system and its Carescape Monitor B650 patient monitoring solution.
- Ortho Clinical Diagnostics receives FDA clearance for intact parathyroid hormone assay
Ortho Clinical Diagnostics announced Food & Drug Administration 510(k) clearance of the VITROS intact parathyroid hormone assay.
- MiCardia wins CE Mark approval for enCor mitral valve repair system
MiCardia Corp. received CE Mark approval to begin marketing its enCor mitral valve repair system in the European Union.
- IDEV Technologies announces 510(k) clearance for Supera Veritas
IDEV Technologies Inc. announced Food & Drug Administration 510(k) clearance to market the Supera Veritas transhepatic biliary system.
- Idaho Technology submits FilmArray respiratory panel for 510(k) clearance
Idaho Technology Inc. announced that it filed a submission with the Food & Drug Administration for 510(k) clearance to market its FilmArray respiratory panel as an in vitro diagnostic for patients with symptoms of upper respiratory tract infection.