Abbott (NYSE:ABT) won CE Mark approval for its FreeStyle InsuLinx blood glucose monitor, its first to include a mealtime (bolus) insulin calculator.
The Abbott Park, Ill.-based health care leviathan said it plans to have the system on the 55.4-million-patient market in Europe this month, beginning with Belgium, France, Germany, Netherlands, and the United Kingdom.
Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies:
- Boston Scientific launches Expect aspiration needle:
Boston Scientific (NYSE:BSX) announced the worldwide launch of its Expect endoscopic ultrasound aspiration needle.The device is used to collect biopsy samples to diagnose tumors in the gastrointestinal tract. It won FDA clearance and CE Mark approval earlier this year.
- Codman & Shurtleff wins CE Mark for stroke device:
The Codman & Shurtleff subsidiary of Johnson & Johnson (NYSE:JNJ) won CE Mark approval for its Revive SE ischemic stroke treatment in February.The Raynham, Mass.-based neurovascular products maker said the device is designed to “remove blood clots and restore blood flow to the brain in patients having a stroke.”
The approval means the device can be sold in all member states of the European Union, the European Economic Area and in Switzerland. The Revive SE, which J&J acquired in its $480 million buyout of Micrus Endovascular last September, hasn’t won a nod from the FDA yet. It resembles a tiny folding basket and is inserted into a blood vessel in the brain via microcatheter. The basket is threaded beyond the clot, deployed, collapsed around the clot and retrieved by the operating team.
