Here are 10 recent FDA decisions on new and updated drugs and medical devices.
1. FDA Approves Carestream's Vue Motion Medical Image Viewer. The FDA approved this HTML5 web-based viewer for use on mobile devices. The viewer doesn't require any additional software or applications and allows users to access clinical data, full report history and relevant prior exams; to integrate with other picture archiving and communication systems, DICOM archives and XDS repositories; to communicate with other users via links and sticky notes and to enable log-in to HIS and EMR portals.
2. FDA Rejects Merck & Co.'s Glaucoma Treatment. The FDA rejected Merck & Co.'s glaucoma medicine tafluprost. The drug is also known by its brand name Saflutan and is already available in some overseas markets. Merck & Co. did not release the FDA's reasoning for the rejection.
3. FDA Approves Anti-Clotting Drug Xarelto. The FDA approved Johnson & Johnson and Bayer's anti-clotting drug Xarelto for the treatment of atrial fibrillation. Xarelto will carry a safety warning stating that patients should not stop taking the drug without notifying their physicians, as discontinuing the drug can increase the risk of stroke.
4. FDA Approval for Edwards' Sapien Device is a First for U.S. Market. The FDA approved Edwards Lifesciences' Sapien transcatheter device that allows coronary valve replacement without open-heart surgery. This is the first time such a device has been approved in the U.S. market.
5. Pacira's Pain Drug Gets FDA Approval. The FDA approved Pacira's pain drug Exparel, which uses bupivacaine, a local analgesic, and is delivered through the company's DepoFoam technology. The drug extends the duration of the analgesia for up to 72 hours.
6. FDA: Medtronic Catheter Effective, But Doesn't Meet Safety Goals. The FDA rejected Medtronic's catheter system, which treats a form of atrial fibrillation by blocking abnormal electrical impulses, because it did not pass safety tests. The device was effective in 56 percent of the 138 patients receiving the treatment, but four of them suffered strokes within seven days.
7. Sagent Pharmaceuticals Announces FDA Approval of Injectable Bupivacaine. The FDA approved Sagent Pharmaceuticals' bupivacaine hydrochloride injection, a local or regional anesthetic. The bupivacaine will be available in six single-dose and two multi-dose latex-free vials.
8. Cook Medical’s GI Stent Approved by the FDA. The FDA approved Cook Medical's Evolution Duodenal Controlled-Release Stent, a gastrointestinal stent for use in patients suffering GI obstructions from cancer. A European study found that 21 of 23 patients had "significant improvement" with the stent.
9. GE's New MRI Machine Gets FDA Approval. The FDA approved GE Healthcare's new wide-bore 3-Tesla MRI machine, the Discovery MR750w 3.0T. The machine accommodates patients that are traditionally hard to scan — obese, elderly, claustrophobic and young patients — with its wide, 70-centimeter bore. The machine also includes the Geometry Embracing Method suite of coils and patient positioning table, LED accent lights, a 50-centimeter field of view and OpticalRF technology.
10. FDA Okays Mauna Kea's Updated Cellvizio Endomicroscopy System for GI Tracts. The FDA approved Mauna Kea's updated Cellvizio endomicroscopy system for the GI and pulmonary tracts. New features of the new Cellvizio 100 Series include improvements in endomicroscopic image acquisition and interpretation.
Related Articles on the FDA:
Rep. Joe Pitts: FDA Approval Process Prevents Jobs and Cures
Legislators Petition FDA for Faster, Simpler Medical Device Review Process
FDA Issues Two Draft Guidances on Medical Device Development, Studies
1. FDA Approves Carestream's Vue Motion Medical Image Viewer. The FDA approved this HTML5 web-based viewer for use on mobile devices. The viewer doesn't require any additional software or applications and allows users to access clinical data, full report history and relevant prior exams; to integrate with other picture archiving and communication systems, DICOM archives and XDS repositories; to communicate with other users via links and sticky notes and to enable log-in to HIS and EMR portals.
2. FDA Rejects Merck & Co.'s Glaucoma Treatment. The FDA rejected Merck & Co.'s glaucoma medicine tafluprost. The drug is also known by its brand name Saflutan and is already available in some overseas markets. Merck & Co. did not release the FDA's reasoning for the rejection.
3. FDA Approves Anti-Clotting Drug Xarelto. The FDA approved Johnson & Johnson and Bayer's anti-clotting drug Xarelto for the treatment of atrial fibrillation. Xarelto will carry a safety warning stating that patients should not stop taking the drug without notifying their physicians, as discontinuing the drug can increase the risk of stroke.
4. FDA Approval for Edwards' Sapien Device is a First for U.S. Market. The FDA approved Edwards Lifesciences' Sapien transcatheter device that allows coronary valve replacement without open-heart surgery. This is the first time such a device has been approved in the U.S. market.
5. Pacira's Pain Drug Gets FDA Approval. The FDA approved Pacira's pain drug Exparel, which uses bupivacaine, a local analgesic, and is delivered through the company's DepoFoam technology. The drug extends the duration of the analgesia for up to 72 hours.
6. FDA: Medtronic Catheter Effective, But Doesn't Meet Safety Goals. The FDA rejected Medtronic's catheter system, which treats a form of atrial fibrillation by blocking abnormal electrical impulses, because it did not pass safety tests. The device was effective in 56 percent of the 138 patients receiving the treatment, but four of them suffered strokes within seven days.
7. Sagent Pharmaceuticals Announces FDA Approval of Injectable Bupivacaine. The FDA approved Sagent Pharmaceuticals' bupivacaine hydrochloride injection, a local or regional anesthetic. The bupivacaine will be available in six single-dose and two multi-dose latex-free vials.
8. Cook Medical’s GI Stent Approved by the FDA. The FDA approved Cook Medical's Evolution Duodenal Controlled-Release Stent, a gastrointestinal stent for use in patients suffering GI obstructions from cancer. A European study found that 21 of 23 patients had "significant improvement" with the stent.
9. GE's New MRI Machine Gets FDA Approval. The FDA approved GE Healthcare's new wide-bore 3-Tesla MRI machine, the Discovery MR750w 3.0T. The machine accommodates patients that are traditionally hard to scan — obese, elderly, claustrophobic and young patients — with its wide, 70-centimeter bore. The machine also includes the Geometry Embracing Method suite of coils and patient positioning table, LED accent lights, a 50-centimeter field of view and OpticalRF technology.
10. FDA Okays Mauna Kea's Updated Cellvizio Endomicroscopy System for GI Tracts. The FDA approved Mauna Kea's updated Cellvizio endomicroscopy system for the GI and pulmonary tracts. New features of the new Cellvizio 100 Series include improvements in endomicroscopic image acquisition and interpretation.
Related Articles on the FDA:
Rep. Joe Pitts: FDA Approval Process Prevents Jobs and Cures
Legislators Petition FDA for Faster, Simpler Medical Device Review Process
FDA Issues Two Draft Guidances on Medical Device Development, Studies