Sequel Med Tech announced today that its partner, DEKA R&D, won FDA 510(k) clearance for its automated insulin delivery (AID) system. The twist system, powered by Tidepool, directly measures the volume and flow of insulin delivered with every microdose. It offers the capability and flexibility to address each patient’s individual dosing needs. Sequel will market […]
DEKA Research and Development Corp.
United Therapeutics launches Remunity pump for Remodulin
United Therapeutics (NSDQ:UTHR) announced today that it launched its Remunity pump for Remodulin in patients with pulmonary arterial hypertension (PAH). Research Triangle Park, N.C.-based United Therapeutics’ Remunity pump initially received FDA clearance in May 2019 for patient filling, adding another 510(k) clearance in February 2020 to enable cassettes to be prefilled with Remodulin by contracted specialty […]
FDA clears RemUnity drug pump co-developed by Deka, United Therapeutics
United Therapeutics and Deka Research and Development have received FDA 510(k) clearance for the co-developed RemUnity system. The RemUnity system is a subcutaneous delivery system for Remodulin injections. The two companies have co-developed the device that is indicated to treat pulmonary arterial hypertension. “We developed the RemUnity system to address safety and patient convenience problems […]
Mobius Bionics touts 1st use of DEKA’s LUKE bionic prosthetic arm
Mobius Bionics, the company commercializing the robotic LUKE arm developed by Dean Kamen’s DEKA research and development, said last week the 1st 2 LUKE prosthetic arms were provided to the US Dept. of Veterans Affairs. The LUKE arm is designed as a robotic prosthetic arm for patients with forearm through shoulder-level amputations, and allows for a […]
DEKA’s LUKE prosthetic robotic arm set to debut later this year
The robotic LUKE arm developed by Dean Kamen’s DEKA research and development company is looking to hit the market later this year, being commercialized by Mobius Bionics. The LUKE arm is designed as a robotic prosthetic arm for patients with forearm through shoulder-level amputations, and allows for a range of different motion, including overhead, behind […]
Toyota resurrects DEKA’s iBot wheelchair
Toyota Motor North America said last week that it’s planning to resurrect the iBot stair-climbing wheelchair developed by famed investor Dean Kamen’s DEKA Research & Development company. The deal calls for DEKA to complete the development and launch of a new version of the iBot, the Japanese auto maker said. Toyota said it will also license the […]
Deka wins $7m Defense Dept. contract for prosthetic arm
The U.S. Defense Dept. awarded a 57-month contract worth nearly $7 million to Dean Kamen’s Deka Innovative Solutions for the sensorized prosthetic arm Deka developed. The Deka arm is the 1st prosthetic arm to translate muscle signals into action that’s approved for the U.S. market. The device won de novo approval from the FDA in May […]
GOPers want answers on draft guidances | Medtech regulatory news for the week of May 12, 2014
Prosthetic arm that translates muscle signals into action wins FDA approval
The FDA today said it will allow the 1st prosthetic arm to translate muscle signals into action onto the U.S. market under its de novo protocol for innovative devices. The prosthesis, called the DEKA arm system, was developed by inventor Dean Kamen’s DEKA Integrated Solutions.
You can make a buck, but can you make a difference? | 5 questions for Dean Kamen
Dean Kamen poses with Johnson & Johnson Global Medical Solutions Group worldwide chairman Karen Licitra.
Photograph by Carolyn Bick
Dean Kamen is perhaps most commonly known for having invented the Segway, but he’s also invented a prosthetic robotic arm, a portable dialysis system and a robotic wheelchair that can climb stairs.
Baxter acquires hemophilia assets, wins IDE for hemodialysis system
Baxter International Inc. (NYSE:BAX) notched a pair of wins over the past 24 hours, acquiring Archemix Corp.’s hemophilia assets and winning an investigational device exemption for a home hemodialysis system from the Food & Drug Administration.
