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.
- FDA: Aethlon can sell unapproved blood filter in India
Aethlon Medical Inc. (OTC:AEMD) announced that the Food & Drug Administration granted the company’s request to export its Hemopurifier medical device to India. The FDA’s approval was given under Section 801 (e) of the Federal Food, Drug and Cosmetic Act, which covers class III medical devices, such as the Hemopurifier, that have not yet received an approval in the U.S. by the FDA. Section 801 (e) applies to medical devices that are acceptable to the importing country and that are manufactured under the FDA’s Good Manufacturing Practices. San Diego-based Aethlon is currently conducting a clinical study for the Hemopurifier for treating chronic HCV infection at the Medicity Institute near Delhi, India.
- Wright Medical launch hammertoe fixation device
Arlington, Tenn.-based Wright Medical Group Inc. (NSDQ:WMGI) launched its PRO-TOE VO hammertoe fixation system. The device won 510(k) clearance from FDA last July. This system was designed in cooperation with world-renowned foot and ankle surgeons to offer a simple and efficient means to surgically repair the lesser toes following correction of a hammertoe deformity. A hammertoe is a contracture of the tissues surrounding the joints of the lesser toes, causing significant pain and discomfort in addition to an altered physical appearance. It is estimated that 10 to 20 percent of the U.S. population will suffer from hammertoes at some point in their life.
- Guided predicts delay in FDA approval for cervical cancer test
The FDA has inspected two clinical trial sites as part of its review process for Norcross, Ga.-based Guided Therapeutics Inc. (OTC:GTHP)’s LightTouch non-invasive test for the early detection of cervical pre-cancer and raised no formal compliance issues. Advanced Scientifics Inc., the manufacturer of the company’s single-patient-use disposable patient interface, also reported a successful FDA inspection. "Given the timing of the FDA’s inspections and questions, though, it now appears less likely we will be part of the next Obstetrics and Gynecology Devices Panel meeting, tentatively scheduled for May 19-20," CEO Mark Faupel said in prepared remarks. "Still, we believe it is possible to meet our target for a year end 2011 or early 2012 launch in the U.S. with the next currently scheduled panel meeting date in September, 2011," he said. The PMA was accepted for filing as on Sept. 23, 2010.
- Spacelabs Healthcare wins FDA clearance for anesthesia system
OSI Systems Inc. (NSDQ:OSIS) division Spacelabs Healthcare of Issaquah, Wash. received FDA 510(k) clearance for "Enhanced Flow Meter" visualization on its BleaseSirius anesthesia system. With the EFM, patient data becomes immediately available for export to patient monitoring and hospital information systems.
- Henry Schein wins ONC certification for EHR system
Melville, N.Y.-based Henry Schein Inc. (NSDQ:HSIC) announced that its MicroMD EMR Version 7.5 achieved ONC-ATCB 2011/2012 Complete EHR (Electronic Health Record) Certification, and can help health care providers using electronic health record technology meet the requirements needed to receive financial incentives earmarked under President Obama’s American Recovery and Reinvestment Act (ARRA) of 2009. MicroMD EMR Version 7.5 attained ONC-ATCB 2011/2012 Complete EHR certification status through the Certification Commission for Health Information Technology (CCHIT), a U.S. Office of the National Coordinator – Authorized Testing and Certification Body (ONC-ATCB).