Intel Corp. (NSDQ:INTC) and General Electric Co. (NYSE:GE) joint venture Intel-GE Care Innovations LLC won 510(k) clearance from the Food & Drug Administration for a virtual care coordination platform.
The clearance for the news system, called Intel Health Guide Express, brings the companies another step closer to making the product available for off-the-shelf personal computers.
The system is designed to help healthcare professionals and patients manage chronic care by making vital signs collection, interactive patient health sessions, video conferencing capabilities, and multimedia educational content available on consumer PCs, according to the companies.
"With this new platform, Intel-GE Care Innovations facilitates greater care coordination that gives healthcare organizations the ability to innovate and provide customized care," Intel-GE Care Innovations CEO Louis Burns said in prepared remarks.
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.
- Ventus lands CE Mark for Provent sleep apnea therapy
Belmont, Calif.-based Ventus Medical Inc. received CE Mark for its Provent sleep apnea therapy. "We are pleased to accomplish this important regulatory milestone. Receiving CE Mark for Provent Therapy will facilitate our international commercialization strategy and allow us to launch this product in selected countries over the next several months," CEO Peter Wyles said in prepared remarks. "There is a clear need for therapeutic options other than [continuous positive airway pressure] and Provent Therapy represents an attractive new alternative," he said.
- Meridian Bioscience gets FDA clearance for its illumigene C. difficile test for pediatrics
Cincinnati, Ohio-based Meridian Bioscience Inc. (NSDQ:VIVO) won FDA 510(k) clearance for a new pediatric claim for its illumigene C. difficile (Clostridium difficile) molecular amplification test. C. difficile is a bacterium that is frequently associated with antibiotic therapy often causing diarrhea and, in severe cases, a life-threatening inflammation of the colon. The illumigene molecular test is designed to target the region of the C. difficile DNA that is presented in all toxin A and/or toxin B producing strains. The illumigene test provides highly accurate results in under an hour. Meridian Bioscience’s illumigene test is the only C. difficile test that is cleared by the FDA for use on children under the age of two.
- Vasomedical positioned to seek increased reimbursement for EECP therapy
Westbury, N.Y.-based Vasomedical Inc. (OTC:VASO) announced the execution of a definitive agreement with Edgary Consultants LLC to facilitate its effort to broaden reimbursement coverage of EECP therapy, a proprietary technology for the treatment of certain cardiovascular diseases, with commercial third-party payers as well as Centers for Medicare and Medicaid Services (CMS). EECP therapy received initial coverage by Medicare in 1999.
- MP Biomedicals wins approval for HIV test in Brazil
MP Biomedicals Asia Pacific PTE LTD, a subsidiary of MP Biomedicals LLC, received approval from The National Health Surveillance Agency (ANVISA) to market its HIV Blot 2.2, HIV Blot 1.3, HCV Blot 3.0 and HTLV – I/II ELISA 4.0 diagnostic tests in Brazil. This is MP Biomedicals second approval from ANVISA, with the first coming in August of 2010 when the company’s Assure Dengue IgA rapid test was cleared for marketing. MP Biomedicals said it will work closely with its distributors and with the blood centers in Brazil to introduce these diagnostic products.