From 3M’s expanded 510(k) clearance for its Tegaderm dressing to Medtronic and Acacia burying the hatchet, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. InspireMD inks Taiwanese distro deal for CGuard InspireMD announced in a June 8 press release that it has signed a distribution deal with […]
Advanced Cooling Therapy
Advanced Cooling Therapy wins FDA 510(k) for Esophageal Cooling Device
Advanced Cooling Therapy said today it won FDA 510(k) clearance for its Esophageal Cooling Device with an integrated Altrix precision temperature management system from Stryker (NYSE:SYK). The Chicago-based company said the triple lumen system is designed to be inserted into the esophagus, with 2 lumens attached to existing temperature modulation equipment while a 3rd lumen simultaneously […]
Advanced Cooling Therapy wins CE Mark for esophageal cooling device
Advanced Cooling Therapy said today that it won CE Mark approval in the European Union for use of its esophageal cooling device with Stryker‘s (NYSE:SYK) Altrix Precision Temperature Management System. The Chicago-based company’s ECD is designed to modulate and control patient temperature using a single-use triple lumen system that is inserted into the patient’s esophagus. […]
ACT wins expanded CE Mark for esophageal cooling device
Advanced Cooling Therapy said today it won expanded CE Mark approval in the European Union for its Esophageal Cooling Device, now cleared to be used for up to 120 hours in patients needing warming or cooling. The ECD is designed to modulate and control patient temperature through a triple lumen system inserted into the esophagus, with 2 […]
ACT wins another 510k for esophageal cooling device
Advanced Cooling Therapy said today it won FDA 510(k) clearance for its ECD-02 esophageal cooling device, the company’s 2nd cleared product. The ECD-02 is designed to modulate and control patient temperature through a triple lumen system inserted into the esophagus, with 2 lumens attached to temperature modulation equipment and a 3rd lumen to provide gastric […]
Fujifilm Medical Systems names new COO, CMO | Personnel Moves
Fujifilm Holdings (TSE:4901) said its Fujifilm Medical Systems U.S.A. subsidiary lured an Accuray (NSDQ:ARAY) executive and a physician from the University of Southern California to its executive roster effective Sept. 28. The Stamford, Conn.-based company said Johann Fernando, formerly Accuray’s vice president & general manager, was named to be its operations chief. Dr. Diku Mandavia, who has […]
Advanced Cooling Therapy wins FDA nod
Advanced Cooling Therapy said it won de novo clearance from the FDA for its esophageal cooling device, claiming it as the sole temperature modulation device to use the esophagus. The ECD, which won CE Mark approval in the European Union last year and is on the market in Canada and Australia, is slated to hit […]
Wearable Intelligence pursues $8.4 million in support of its hospital Google Glass platform | Medtech funding for the week of August 25, 2014
Advanced Cooling Therapy secures $1.5M for temperature management
Chicago-based Advanced Cooling Therapy is planning to break onto the market now that it’s closed a $1.5 million Series A funding round.
ACT is building up to full commercial launch of its Esophageal Cooling Device, which has approval from European and Canadian regulators. The device is not yet cleared for the U.S.
