Submissions and Approvals

FDA Clears Quidel’s AmpliVue Group B Handheld Strep Test

January 2, 2014

Quidel has won 510(k) clearance from the FDA for its AmpliVue Group B strep assay. Read More

Atossa Genetics Seeks 510(k) Clearance, Relaunch of ForeCYTE Breast Aspirator

December 27, 2013

Atossa Genetics has submitted a 510(k) notification for its ForeCYTE breast aspirator products. Read More

Reverse Medical Gets CE Mark for Barrel Device for Intracranial Aneurysms

December 23, 2013

Reverse Medical has won CE mark approval for its Barrel vascular reconstruction device. Read More

Baxter Wins CE Mark Approval for VIVIA Hemodialysis System

December 20, 2013

European regulators have given the CE Mark to Baxter’s VIVIA home high-dose dialysis treatment system. Read More

Solana Surgical’s CrossCHECK Plating System Gets FDA 510(k) Nod

December 20, 2013

The FDA has cleared Solana Surgical’s CrossCHECK plating system for orthopedic and podiatric surgeries of the foot and ankle. Read More

FDA Approves First Device to Treat Migraine Pain

December 20, 2013

eNeura Therapeutics has won FDA approval of its Cerena Transcranial Magnetic Stimulator, the first device approved to relieve pain from migraine headaches. Read More

BSX’s X4 CRT-D Systems Earn CE Mark

December 18, 2013

Boston Scientific’s X4 product line of defibrillators and leads has received CE Mark approval. Read More

FDA Clears Ethicon’s Harmonic Focus+ Shears

December 16, 2013

The FDA granted 510(k) clearance to Ethicon’s next generation Harmonic Focus+ surgical shears. Read More

BSX’s Watchman Gets Yes Vote, Could Affect St. Jude Trial

December 13, 2013

Boston Scientific got an overwhelmingly positive FDA panel vote Wednesday for its Watchman left atrial appendage closure device. Read More

Report: CDRH Must Improve Training, Consistency, Metrics in Review Process

December 13, 2013

The FDA’s device center needs to improve consistency in decisionmaking during premarket reviews and ensure all employees are up to speed on its review software systems, Booz Allen Hamilton says in a preliminary set of priority recommendations on the review process. Read More

Smith & Nephew Launches Durafiber AG Wound Dressing in the EU

December 12, 2013

Smith & Nephew announced Thursday the European launch of its Durafiber AG wound dressing. Read More

St. Jude Wins CE Mark for 25 mm Portico Transcatheter Aortic Heart Valve

December 12, 2013

St. Jude Medical to launch 25 mm Portico transcatheter aortic heart valve in EU, following CE mark approval. Read More

Submissions and Approvals
RSS

FDA Clears Quidel’s AmpliVue Group B Handheld Strep Test

Atossa Genetics Seeks 510(k) Clearance, Relaunch of ForeCYTE Breast Aspirator

Reverse Medical Gets CE Mark for Barrel Device for Intracranial Aneurysms

Baxter Wins CE Mark Approval for VIVIA Hemodialysis System

Solana Surgical’s CrossCHECK Plating System Gets FDA 510(k) Nod

FDA Approves First Device to Treat Migraine Pain

BSX’s X4 CRT-D Systems Earn CE Mark

FDA Clears Ethicon’s Harmonic Focus+ Shears

BSX’s Watchman Gets Yes Vote, Could Affect St. Jude Trial

Report: CDRH Must Improve Training, Consistency, Metrics in Review Process

Smith & Nephew Launches Durafiber AG Wound Dressing in the EU

St. Jude Wins CE Mark for 25 mm Portico Transcatheter Aortic Heart Valve

Upcoming Events

MAGI@home Clinical Research Conference 2024

Featured Products

From QSR to QMSR: Meeting FDA’s New Requirements

FDA Oversight of Laboratory-Developed Tests — The Impact of the Final Rule

Featured Stories

Risk of 10 Obesity-Driven Cancers Reduced by GLP-1s, Study Says

Three Device Areas Added to CDRH’s Device-Advancing TAP Program

Third Alzheimer’s Drug Gets FDA Approval, Just as Diagnostic Criteria Expand

Draft Guidance Covers Using URRAs in Combo Product Applications

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Submissions and Approvals RSS

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Submissions and Approvals
RSS