SUNNYVALE, Calif., May 17, 2011 – Asante Solutions, Inc. (Asante), a medical device company focused on diabetes care, announced that the U.S. Food and Drug Administration has granted 510(k) clearance for the company's Pearl Insulin Pump. Last month, the Pearl also received the CE Mark, a European proof of conformity that certifies the product meets EU safety, health and environmental requirements.
Diabetes technology section
The Swiss medical device company, Solianis, is developing products for physiological glucose monitoring, including a non-invasive, continuous glucose monitoring device. Based on impedance spectroscopy, their device uses radio waves and changes in skin resistance to monitor changes in blood composition. Solianis employs a multi-sensor approach to monitor various factors, including body temperature, microcirculation, sweat, moisture in the skin and the thickness of different skin layers as often as once a minute.
Good news for all the Medtronic pump users on the Mac. On April 4, 2011, CareLink Personal was updated to be compatible with Mac computers running 10.5 or 10.6 operating systems. The CareLink 5.4 software works with more than 35 blood-glucose meters.One less hurdle to jump.
From the full press release:
GlySens Incorporated is a privately held corporation located in San Diego, California that's been around since 1998. Their focus is on an implantable long term continuous glucose monitoring sensor that will help people with diabetes monitor their glucose levels accurately without the usual fingersticks. The system will include 2 parts: the implanted sensor and an external monitor with a display.
UPDATE #1: Recent improved performance of this device can be attributed to a new shell design and a proprietary filling material for their quality control device called the phantom finger. A new algorithm development process is being tested for effectiveness in the transfer of algorithms to other instruments. This update comes from the Chief Scientific Officer, Thomas G. Scecina
This small R&D company, based in Dortmund, Germany, claims it is close to production of what is believed to be a near IR device, although it's operational range of 80% humidity or less may indicate a middle IR device. It has been developed in conjunction with a Korean company, Samsung Fine Chemicals Co., Ltd. Called the GluControl® GC300 and measuring 17.6 x 11.6 x 6 cm, with a weight of 500 grams (18 oz.), it is designed for home use.