FzioMed
FzioMed’s FDA dispute panel delayed for new data submission
FzioMed said today that a dispute resolution panel slated for next month for its Oxiplex spinal surgery gel has been postponed so the FDA can review more clinical data.
FzioMed turns to FDA’s Dispute Panel to contest Oxiplex denial
Once-scorned biomaterials maker FzioMed is getting another day with the FDA to discuss its Oxiplex spinal surgery gel, which was rejected by U.S. healthcare officials in 2008.
FzioMed will meet June 10, 2014, with the FDA’s Medical Device Dispute Resolution Panel to discuss the "approvability" of the Oxiplex gel, which has been on the European market since 2012 and is approved for sale in 70 countries. The product has already been used in more than 350,000 surgeries, FzioMed said.
FzioMed wins independent review of Oxiplex gel
FzioMed said the FDA granted an independent review of its pre-market approval application for the Oxiplex spinal surgery gel.
San Luis Obispo, Calif.-based FzioMed originally filed its PMA application for Oxiplex in October 2007. The FDA responded with a "not approvable letter" back in July 2008 after determining that FzioMed hadn’t provided sufficient evidence of the gel’s effectiveness in aiding in healing following lower back spinal surgery.
FzioMed’s post-surgical gel lands a regulatory win in Australia
Privately held medical device maker FzioMed won Australian regulatory approval for its Dynavisc post-surgical gel, an absorbable gel applied to tendons and nerves to reduce adverse events after surgery.
The San Luis Obispo, Calif.-based company said the product is similar to Medtronic’s (NYSE:MDT) Medishield, which has been on the market for more than 70 years.
FzioMed files citizen petition for reconsideration following FDA rejection of its spinal gel PMA
California device maker FzioMed filed a citizen’s petition with the commissioner of the FDA, asking the agency to re-open a rejected premarket approval application for its Oxiplex spinal surgery gel.
FzioMed had originally filed its PMA for Oxiplex in October 2007, getting a "not approvable letter" back in July 2008 after the FDA determined that FzioMed hadn’t provided sufficient evidence of the gel’s effectiveness in aiding in healing following lower back spinal surgery.
Medtronic wins 510(k) for surgical sealer | Regulatory Roundup
Medtronic (NYSE:MDT) won 510(k) clearance from the FDA for the Aquamantys surgical sealer it acquired when it paid $480 million for Salient Surgical Technologies last year.