1. Dextera seeks expanded indications for MicroCutter 5/80 stapler
Dextera Surgical announced in a June 1 press release that it has filed a 510(k) with the FDA for its MicroCutter 5/80 stapler. The company wants to expand the indications of the MicroCutter 5/80 for use in liver, pancreas, kidney and spleen surgeries. Currently, the staplers are used for transection and resection in multiple open minimally-invasive urologic, thoracic and pediatric surgical procedures. It is also used for transection, resection and creation of anastomoses in the small and large intestines and for the transection of the appendix.
2. EndoGastric Solutions launches new EsophyX Z GERD device
EndoGastric Solutions has launched its EsophyX Z device outside of the U.S., according to a June 1 press release. The Esophy X Z device is used in the transoral incisionless fundoplication 2.0 procedure and is the 3rd generation of EsophyX devices from EndoGastric Solutions.
3. Inolife, eyeing up-listing, taps investment bank
Inolife Technologies announced in a June 1 press release that it has signed an agreement with Maxim Group to receive strategic corporate planning and investment banking services. Maxim Group will also help Inolife Technologies become fully reporting under SEC guidelines and hopes to finish an uplisting to the Nasdaq Capital Market within the next year.
4. Implandata wins CE Mark for Eyemate
Implandata received CE certification for its Eyemate system, according to a May 31 press release. The Eyemate system is used for enhanced monitoring and care of glaucoma patients. The Eyemate system uses a permanent implantable micro-sensor more directly measure eye pressure. A hand-held device powers sensors and reads data to communicate real-time through the Internet with eyecare doctors. The system received CE mark for use with primary open angle glaucoma patients.
5. MicroTransponder touts neurostim data
MicroTransponder announced in a May 30 press release that it had positive results Vivistim Stroke Rehabilitation clinical trial. The purpose of the trial was to improve upper limb mobility in stroke survivors who were suffering chronic disability. The data showed that 75% of patients had a clinically meaningful response on the Fugl-Meyer Upper Extremity Scale by the end of physical therapy after 6 weeks compared to 33% for the control group.
6. C2 Therapeutics touts cryoballoon data in Barret’s esophagus
C2 Therapeutics is touting data from its C2 CryoBalloon Ablation System clinical trial, according to a May 9 press release. The C2 CryoBalloon Ablation System is used for ablation of Barrett’s esophagus. The study suggested physicians had a shorter learning curve with CbAS than for radiofrequency ablation therapy and patients had less pain 2 days post-procedure than with RFA. It also showed that the ablation system had potential for CbAS in ablation of gastric antral vascular ectasia and esophageal squamous cell neoplasia.
7. DreaMed Diabetes, Harvard & Schneider Children’s Hospital to study Type I diabetes
DreaMed Diabetes, Harvard and Schneider Children’s Hospital announced in a May 9 press release that they have collaborated in an effort to improve insulin management for people who have Type 1 diabetes. The group plans to optimize therapy options for Type 1 diabetics who have multiple daily injections of insulin and use point-of-care capillary glucose measurements.