


Healthcare News Roundup: FDA
HSMN NewsFeed - 18 Mar 2013
Lantos Technologies Receives FDA Clearance for its 3D Ear Scanning System
Lantos Technologies Receives FDA Clearance for its 3D Ear Scanning System
HSMN NewsFeed - 28 Feb 2013
FDA Grants QIDP and Fast Track Designations for Cubist’s Late-Stage Antibiotic Candidates
FDA Grants QIDP and Fast Track Designations for Cubist’s Late-Stage Antibiotic Candidates
HSMN NewsFeed - 28 Feb 2013
ArthroCare(R) Receives FDA Clearance for SpeedLock(R) HIP Knotless Fixation Implant
ArthroCare(R) Receives FDA Clearance for SpeedLock(R) HIP Knotless Fixation Implant
HSMN NewsFeed - 28 Feb 2013
CSL Behring Receives FDA Approval to Expand the Indication for Corifact(R)
CSL Behring Receives FDA Approval to Expand the Indication for Corifact(R)
HSMN NewsFeed - 28 Feb 2013
InVivo Therapeutics Submits Updated IDE to FDA to Begin Spinal Cord Injury Human Study
InVivo Therapeutics Submits Updated IDE to FDA to Begin Spinal Cord Injury Human Study
HSMN NewsFeed - 27 Feb 2013
Surgical Theater, LLC(TM) Receives FDA Clearance for Surgery Rehearsal Platform(TM)
Surgical Theater, LLC(TM) Receives FDA Clearance for Surgery Rehearsal Platform(TM)
HSMN NewsFeed - 26 Feb 2013
On-X LTI Receives FDA Approval for On-X Heart Valve With Anatomic Shaped Sewing Ring
On-X LTI Receives FDA Approval for On-X Heart Valve With Anatomic Shaped Sewing Ring
HSMN NewsFeed - 26 Feb 2013
FDA Advisory Panel Recommends Approval of the NeuroPace RNS(R) System for Medically Refractory Epilepsy
FDA Advisory Panel Recommends Approval of the NeuroPace RNS(R) System for Medically Refractory Epilepsy
HSMN NewsFeed - 25 Feb 2013
Dynavax Receives FDA Complete Response Letter on HEPLISAV(TM) Biologic License Application
Dynavax Receives FDA Complete Response Letter on HEPLISAV(TM) Biologic License Application
HSMN NewsFeed - 22 Feb 2013
Lupin Receives FDA Approval for New Drug Application for SUPRAX(R) Oral Suspension, 500 mg/5mL
Lupin Receives FDA Approval for New Drug Application for SUPRAX(R) Oral Suspension, 500 mg/5mL
HSMN NewsFeed - 21 Feb 2013
FDA Approves Natrelle(R) 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
FDA Approves Natrelle(R) 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
HSMN NewsFeed - 19 Feb 2013
Dallen Medical Receives FDA Clearance for New Compressyn(TM) Staple for Rigid Small Bone Fixation
Dallen Medical Receives FDA Clearance for New Compressyn(TM) Staple for Rigid Small Bone Fixation
HSMN NewsFeed - 7 Feb 2013
Fully Automatic AED Plus from ZOLL Granted 510(k) Clearance by U.S. Food and Drug Administration
Fully Automatic AED Plus from ZOLL Granted 510(k) Clearance by U.S. Food and Drug Administration
HSMN NewsFeed - 6 Feb 2013
Smiths Medical Receives FDA Clearance for CADD-Solis VIP Ambulatory Infusion System
Smiths Medical Receives FDA Clearance for CADD-Solis VIP Ambulatory Infusion System
HSMN NewsFeed - 6 Feb 2013
Elite Pharmaceuticals Announces FDA Approval of Supplemental Application for Naltrexone
Elite Pharmaceuticals Announces FDA Approval of Supplemental Application for Naltrexone
HSMN NewsFeed - 5 Feb 2013
FDA Clears Sculptor Robotic Guidance Arm(TM) for Unicompartmental Knee Replacement Surgery
FDA Clears Sculptor Robotic Guidance Arm(TM) for Unicompartmental Knee Replacement Surgery
HSMN NewsFeed - 4 Feb 2013
Ethicon Receives 510(k) Clearance for ENSEAL(R) G2 Articulating Tissue Sealer
Ethicon Receives 510(k) Clearance for ENSEAL(R) G2 Articulating Tissue Sealer
HSMN NewsFeed - 31 Jan 2013
Digirad Corporation Receives U.S. FDA 510(k) Market Clearance for Expanded Uses of ergo(TM) Imaging System
Digirad Corporation Receives U.S. FDA 510(k) Market Clearance for Expanded Uses of ergo(TM) Imaging System
HSMN NewsFeed - 28 Jan 2013
Genzyme’s LEMTRADA(TM) (alemtuzumab) Application for MS Accepted for Review by the FDA
Genzyme’s LEMTRADA(TM) (alemtuzumab) Application for MS Accepted for Review by the FDA
HSMN NewsFeed - 25 Jan 2013
FDA Approves OXYTROL(R) FOR WOMEN, the First Over-the-Counter Treatment for Overactive Bladder in Women
FDA Approves OXYTROL(R) FOR WOMEN, the First Over-the-Counter Treatment for Overactive Bladder in Women
HSMN NewsFeed - 24 Jan 2013
myoscience Device Receives FDA Clearance for Pain Management in Peripheral Nerve Tissue
myoscience Device Receives FDA Clearance for Pain Management in Peripheral Nerve Tissue
HSMN NewsFeed - 22 Jan 2013
ARROW(R) UltraQuik(TM) Peripheral Nerve Block Needles Receive FDA 510(k) Clearance
ARROW(R) UltraQuik(TM) Peripheral Nerve Block Needles Receive FDA 510(k) Clearance
