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 clears Teleflex’s VasaNova catheter locator
Limerick, Pa.-based Teleflex Inc. (NYSE:TFX) subsidiary VasoNova Inc. landed 510(k) clearance from the Food & Drug Administration to market the company’s VPS peripherally inserted central catheter tip location technology as an alternative to chest x-ray or fluoroscopy in adult patients when the guidance indicator shows a blue bullseye. Currently, after most central venous catheters are placed, the correct location of the implanted catheter needs to be confirmed by chest x-ray, a process that is costly, time consuming, often repeated because of inaccuracy and which exposes the patient to radiation.
- Cardica wins CE Mark approval for Microcutter
Redwood City, Calif.-based Cardica Inc. (NSDQ:CRDC) announced that an initial Microcutter surgical cutting and stapling device the company developed received CE Mark approval for European sale. As an integral part of the multi-step CE marking process, Cardica has obtained a Full Quality Assurance certification for its Microcutter design and manufacturing processes. With this certification, after successful completion of development, Cardica can apply the CE Mark to the first Microcutter product that Cardica expects to commercialize, the Microcutter XPRESS 30, and will be able to apply the CE Mark to future devices within the Microcutter product line that comply with the certified design and manufacturing processes in the same manner.
- Caliper microfluidic technologies wins 510(k) clearance for liver cancer assessment
Hopkinton, Mass.-based Caliper Life Sciences Inc. (NSDQ:CALP) announced that its licensee Wako Pure Chemical Industries, through its Wako Diagnostics division, has obtained 510(k) clearance from the FDA for its uTASWako i30 Immunoanalyzer and AFP-L3 and DCP Assays, which are used to assess liver cancer risk in patients with chronic liver disease. The i30 Immunoanalyzer, which incorporates Caliper’s microfluidic LabChip technologies, utilizes microfluidics to integrate sampling, mixing, separation and detection of up to six analytes. The system is currently marketed in Japan by Wako as an in vitro diagnostic (IVD) platform.
- TearLab fails to get FDA CLIA waiver
San Diego-based TearLab Corp. (NSDQ:TEAR; TSX:TLB) announced that it is in receipt of a communication from the FDA indicating that the data submitted by the company was not sufficient to gain approval of its CLIA Waiver categorization application for the TearLab Osmolarity System. "While we are evaluating the FDA’s letter to determine a clear path towards CLIA waiver, we believe that the success of our recently announced Laboratory Director for Moderate Complexity Program gives us the flexibility and time to consider all of our regulatory options," TearLab CEO Elias Vamvakas said in prepared remarks. The TearLab Osmolarity System uses a novel lab-on-a-chip approach that requires less than 50 nL of tear fluid in order to measure tear Osmolarity.