The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Medtronic Inc. (NYSE:MDT) launched two pacemakers that had been delayed by regulatory snafus for months, the company said today.
The Fridley, Minn.-based company resolved a Nov. 2009 warning letter that enabled the company to win FDA approval for the Consulta and Syncra cardiac resynchronization therapy-pacemaker (CRT-P) systems.
The FDA granted Boston Scientific Corp. (NYSE:BSX) approval for its anchoring device for the company’s spinal cord stimulator (SCS) implant system.
The Natick, Mass.-based medical device giant designed its new Clik Anchor with locking system to increase the speed with which surgeons place the Precision Plus SCS system’s leads — the wires through which pain-masking electrical pulses are delivered to the spine for chronic pain management.
Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
Intel Corp. (NSDQ:INTC) and General Electric Co. (NYSE:GE) joint venture Intel-GE Care Innovations LLC won 510(k) clearance from the Food & Drug Administration for a virtual care coordination platform.
The clearance for the news system, called Intel Health Guide Express, brings the companies another step closer to making the product available for off-the-shelf personal computers.
Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
ViewRay Inc. received federal regulatory clearance to begin commercializing its MRI-based technology to deliver radiation therapy to cancer patients.
The Oakwood, Ohio-based company’s imaging device received clearance under the Food & Drug Administration’s 510(k) program for medical devices in January, according to the agency.
CEO Greg Ayres declined comment through a spokeswoman.
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD January 2011DEVICE: ROUGHRIDER
WHIRLWIND WHEELCHAIR INTERNATIONAL510(k) NO: K103212(TRADITIONAL)
ATTN: MARC KRIZACK PHONE NO : 415 338 6277
1600 HOLLOWAY AVENUE SCI 251 SE DECISION MADE: 03-JAN-11
SAN FRANCISCO CA 94132 510(k) SUMMARY AVAILABLE FROM FDADEVICE: PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115
DIADEXUS, INC. 510(k) NO: K101853(TRADITIONAL)
A report in the Archives of Internal Medicine is drawing a lot of buzz from its comparison of Class I recalls for devices cleared via 510(k) or via pre-market approval.
