Dignitana has partnered with ThermoTek to develop the DigniCap Delta, a model of the 2015 FDA-cleared DigniCap Scalp Cooling System.
The new model is featuring a new single-patient use cap design and a smaller, more streamlined single-patient machine, reports the company. U.S. Food and Drug Adminstration clearance for the new device is anticipated in spring 2019.
“Precise temperature control is critical to scalp cooling success and ensuring maximum comfort for patients,” said William Cronin, Chief Executive Officer of Dignitana. “With more than 89 technological patents in its medical device portfolio, ThermoTek’s proven track record allows us to confidently offer both patients and clinicians the safest, most advanced solution to chemotherapy related hair loss in a new, simple-to-use, custom-control system. As ThermoTek is also based here in Dallas, we are able to rapidly incorporate new ideas and feedback from partner sites and patients into our product development process.”
In addition to enhanced cooling technology, the DigniCap Delta introduces new features that include device portability, a more intuitive user interface, quieter operation, and an advanced ergonomic design with faster connections to improve patient comfort and clinical staff access, states the company in its press release.