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DEKA Research and Development Corp.

FDA clears automated insulin delivery system from Sequel Med Tech

March 18, 2024 By Sean Whooley

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 […]

Filed Under: 510(k), Diabetes, Drug Pumps, Drug-Device Combinations, Food & Drug Administration (FDA), Health Technology, Patient Monitoring, Regulatory/Compliance, Software / IT Tagged With: DEKA Research and Development Corp., Sequel Med Tech

United Therapeutics launches Remunity pump for Remodulin

February 10, 2021 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Drug Pumps, Drug-Device Combinations, Featured, Vascular Tagged With: DEKA Research and Development Corp., United Therapeutics

FDA clears RemUnity drug pump co-developed by Deka, United Therapeutics

May 7, 2019 By Danielle Kirsh

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 […]

Filed Under: 510(k), Regulatory/Compliance Tagged With: DEKA Research and Development Corp., United Therapeutics

Mobius Bionics touts 1st use of DEKA’s LUKE bionic prosthetic arm

July 14, 2017 By Fink Densford

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 […]

Filed Under: Business/Financial News, Prosthetics Tagged With: DEKA Research and Development Corp., Mobius Bionics

DEKA’s LUKE prosthetic robotic arm set to debut later this year

July 11, 2016 By Fink Densford

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 […]

Filed Under: Business/Financial News, Prosthetics Tagged With: DEKA Research and Development Corp., Mobius Bionics

Toyota resurrects DEKA’s iBot wheelchair

May 23, 2016 By Brad Perriello

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 […]

Filed Under: Wall Street Beat Tagged With: DEKA Research and Development Corp., Toyota

Deka wins $7m Defense Dept. contract for prosthetic arm

July 6, 2015 By Brad Perriello

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 […]

Filed Under: Business/Financial News, Prosthetics Tagged With: Defense Advanced Research Projects Agency (DARPA), defensedepartment, DEKA Research and Development Corp.

GOPers want answers on draft guidances | Medtech regulatory news for the week of May 12, 2014

May 13, 2014 By MassDevice Contributors Network Leave a Comment

Senate Republicans want answers from FDA commish Hamburg on draft guidances

May 8, 2014 by Brad Perriello

Senate Republicans want answers from FDA commish Hamburg on draft guidances

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Cook Medical, DEKA Research and Development Corp., U.S. Senate

Prosthetic arm that translates muscle signals into action wins FDA approval

May 9, 2014 By Brad Perriello Leave a Comment

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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.

Filed Under: Food & Drug Administration (FDA), News Well, Prosthetics, Regulatory/Compliance Tagged With: DEKA Research and Development Corp.

You can make a buck, but can you make a difference? | 5 questions for Dean Kamen

July 18, 2013 By Arezu Sarvestani Leave a Comment

Dean Kamen and Karen Licitra, MassDevice.com Big 100 East 2013

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.

Filed Under: News Well Tagged With: DEKA Research and Development Corp., MassDevice Big 100 Roundtable East - 2013, MassDevice Q&A

Baxter acquires hemophilia assets, wins IDE for hemodialysis system

November 20, 2010 By MassDevice staff Leave a Comment

BAX logo

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.

Filed Under: Business/Financial News, News Well Tagged With: Baxter, DEKA Research and Development Corp., Hemophilia, HHD LLC, Renal

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