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.
- Entellus wins FDA clearance for sinus endoscope
Entellus Medical Inc. won 510(k) clearance from the Food & Drug Administration for the company’s new FinESS Endoscope. The endoscope is used with the FinESS Sinus Treatment, which employs minimally-invasive balloon dilation to open narrowed sinus drainage paths and relieve symptoms in patients with recurrent or chronic sinusitis. The new Entellus endoscope enables treatment of sinusitis patients in the doctor’s office by delivering enhanced image quality and visualization of the sinus thereby potentially reducing procedure time. The Entellus FinESS system treats the two most commonly inflamed sinuses, the maxillary and anterior ethmoid sinuses.
- Mindray lands 510(k) clearance for its A5 anesthesia system
Mindray Medical International Limited (NYSE:MR) announced that its A5 Anesthesia System has received 510(k) clearance from the FDA. The A5 anesthesia device, part of the all new A Series portfolio, is an anesthesia delivery platform that will complement Mindray’s broad range of existing ultrasound and patient monitoring systems.
- Agendia nets fifth FDA clearance for MammaPrint assay
Agendia received its fifth FDA clearance for MammaPrint(R), its widely used breast cancer recurrence assay. The new clearance is comprised of two additional Agilent Microarray scanners and two Agilent Bioanalyzers, expanding laboratory capacity to handle the increasing number of MammaPrint, TargetPrint(R) and BluePrint(R) test requests. The company said that the presence of FDA cleared equipment in both of its locations will further mitigate risk posed by a potential interruption to its business in the event of an equipment breakdown at either location. MammaPrint previously received several FDA clearances for clinical use in the U.S. and remains the first FDA cleared IVDMIA (In Vitro Diagnostic Multivariate Index Assay) on the market and the only FDA cleared breast cancer recurrence test.
- OraSure Technologies wins FDA approval for HCV rapid test
OraSure Technologies Inc. (NSDQ:OSUR) announced today that its OraQuick HCV Rapid Antibody Test has now been approved by the FDA for use in detecting HCV antibodies with a fingerstick whole blood sample. The fingerstick whole blood claim is the second application to be approved by the FDA for the OraQuick HCV test. The product received an initial approval for use in persons at risk for HCV infection with venous whole blood specimens in June 2010. The OraQuick HCV Rapid Antibody Test is the only rapid, point-of-care test for the detection of antibodies to the hepatitis C virus that is approved by the FDA. The test, which utilizes the OraQuick technology platform, provides results in 20 minutes.
- Nfocus wins CE Mark approval for Luna aneurysm embolization device
Nfocus Neuromedical Inc.’s Luna Aneurysm Embolization System (AES) received CE Mark approval for the treatment of patients with brain aneurysms. The Luna AES is designed to be a single-deployment, easy-to use system for the treatment of brain aneurysms both pre- and post-rupture. The Luna AES treats brain aneurysms by blocking (embolizing) blood flow while providing a scaffold to encourage tissue growth across an aneurysm opening and create a plug. The Luna uses a self-expandable, multi-layer oval implant made from Nitinol, a nickel-titanium alloy. The properties of the device allow it to easily compress within a conventional catheter, and then rapidly and easily open to full size once deployed within an aneurysm.
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