-- Including Liver, Pancreas, Kidney and Spleen Surgical Procedures –

 

REDWOOD CITY, Calif. --  Dextera Surgical Inc. (Nasdaq: DXTR), a company developing and commercializing the MicroCutter 5/80™ stapler, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to use its MicroCutter 5/80 Stapler and MicroCutter 30 White and Curved Tip White Reloads in conjunction with open solid organ parenchymal dissection techniques including organs such as the liver, kidney, pancreas and spleen.

 

“The small size and large degree of articulation provided by the MicroCutter 5/80 is especially beneficial in maneuvering within the confined spaces around solid internal organs,” said Brendan C. Visser, M.D., associate professor of surgery at Stanford University Medical Center. “In addition, with the small footprint of the MicroCutter’s jaws, I’m able to successfully operate with less dissection.”

SYLMAR, Calif. -- Second Sight Medical Products, Inc. (NASDAQ:EYES) ("Second Sight" or "the Company"), a developer, manufacturer and marketer of implantable visual prosthetics to provide useful vision to blind patients, today announced that the Company has received conditional approval from the U.S. Food and Drug Administration (FDA) to begin the Orion™ Cortical Visual Prosthesis System (Orion) feasibility clinical study. The conditional approval allows two U.S. sites to enroll up to five total patients. The FDA has also requested that the Company conduct additional device testing and address outstanding questions. Second Sight has 45 days to respond to FDA’s requests.

‒ Software Update Available for Current t:slim X2 Pump Users Via Personal Computer ‒

 

Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, today announced U.S. Food and Drug Administration (FDA) approval and commercial launch of the t:slim X2™ Insulin Pump with Dexcom G5® Mobile continuous glucose monitoring (CGM) integration, the first sensor-augmented insulin pump approved to let users make treatment decisions without pricking their finger1. The software featured on this pump will also be available to current t:slim X2 Pump users at no cost via remote software update, allowing them to add CGM integration to their existing pumps from home using a personal computer. Individual emails are being sent directly to t:slim X2 Pump customers with instructions on how to perform the update. The t:slim X2 Pump with Dexcom G5 Mobile CGM integration is approved for ages 6 and older.

Nationwide Roster of Top O&P Practices Supports MyoPro® Powered Orthosis

 

Myomo®, Inc. (NYSE MKT: MYO) (“Myomo” or the “Company”), a commercial stage medical robotics company, today announced the launch of its Center of Excellence (CoE) program, which recognizes top orthotics and prosthetics (“O&P”) practices in the U.S. that support its MyoPro® line of powered orthoses. MyoPro is the only lightweight wearable device that can restore function in the paralyzed or weakened arms and hands of individuals who have suffered a stroke, spinal cord or nerve injury, or other neuromuscular disability. With the orthosis, a paralyzed individual can perform activities of daily living including feeding themselves, carrying objects and doing household tasks, and many are able to return to work.