The European Commission plans to begin a public consultation about the revision of the European directive on in vitro diagnostics in an effort to reach worldwide concurrence on regulations concerning IVDs. The EC plans to seek comments on the proposed revision by Sept. 19.
The FDA has granted clearance to Israel-based EarlySense for its improved EverOn Touch patient-monitoring device. The system can track and alert medical providers about a patient's vital signs and movements.
Philips plans to unveil next month a technology that allows medical providers to assess stroke using a 3-D rotational scan and an injection protocol for the contrast agent. Called VasoCT, the product can be used with the company's Allura Xper interventional X-ray system during angiography.
Piramal Healthcare has agreed to pay about $3.8 million to buy the assets of Biosyntech, a Canadian device firm that specializes in the development of hydrogels used for the treatment of chronic wounds and damaged cartilage and bones. Biosyntech filed for bankruptcy protection after failing to raise funds to support ongoing operations and pay maturing debts.
The FDA said it approved Abbott Laboratories' ARCHITECT HIV Ag/Ab Combo assay, a test that can detect HIV infections before patients develop antibodies against the virus. The diagnostic test, which could be unveiled by the end of the year, was also approved for use in pregnant women.