Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies:
- St. Jude Medical wins Australian, Malaysian approvals
St. Jude Medical Inc. (NYSE:STJ) won a pair of approvals from international regulatory agencies. The company’s new manufacturing facility in Penang Island, Malaysia, won European CE Mark approval for production of pacemakers and leads, with the first product already en route to a distribution center in Veddesta, Sweden. St. Jude also pulled down a nod from the Australian Therapeutic Goods Administration for its Athena programmer for deep-brain stimulation.
- Corindus Vascular Robotics wins conditional FDA nod for pivotal trial
Corindus Vascular Robotics won investigational device exemption approval from the Food & Drug Administration to evaluate for a 154-patient pivotal trial of its CorPath 200 System for percutaneous coronary interventions.
- On-X Life Technologies and Terumo’s Vascutek win FDA nod for aortic prosthesis/graft combo
On-X Life Technologies Inc. and Terumo Corp.’s Vascutek subsidiary won FDA approval to market the On-X ascending aortic prosthesis with Vascutek’s Gelweave Valsalva graft.
- Biomerix wins CE Mark for Revive soft tissue repair mesh
Biomerix Corp. received CE Mark approval for its Revive soft tissue repair mesh. The product won 510(k) clearance from the FDA in January 2009.
- Small Bone Innovations wins 510(k) for rHead extended stem
Small Bone Innovations Inc. received 510(k) pre-market clearance from the FDA for its rHead extended stem for elbow procedures.
- Cardiac Science wins U.S. military certification
Cardiac Science Corp. won Airworthiness Release from the U.S. Army’s Research, Development, and Engineering Command for its Powerheart AED G3 Pro automated external defibrillator.
- LDR files PMA for Mobi-C artificial cervical disc
LDR announced the Jan. 14 submission of its single-level Mobi-C cervical artificial disc pre-market approval application to the FDA.
- Spectranetics wins FDA approval for manufacturing site change
Spectranetics Corp. (NSDQ:SPNC) announced that the FDA approved its pre-market approval application supplement requesting a manufacturing site change for the CVX-300 laser system in Colorado Springs, Colo., as part of a broader plan to consolidate all product manufacturing into a single facility. Employees involved in the manufacturing of laser systems will move to the new manufacturing site, also in Colorado Springs, where the company has its headquarters.
- Extension Inc. files for FDA clearance and new device classification
Extension Inc. announced the submission of its HealthAlert for Nurses solution to the FDA for product clearance, seeking a new device classification because there are no equivalent, predicate devices. The software delivers critical alerts to a Cisco IP handset or other mobile device.
- IVAX Diagnostics wins FDA clearance for Mago 4S assay
IVAX Diagnostics Inc. (NYSE:IVD) received 510(k) clearance for its Mago 4S ELISA and immunofluorescence assay system for autoimmune and infectious disease testing.