Dexcom (NSDQ:DXCM) shares jumped yesterday after the company scored a unique FDA approval for its G6 continuous glucose monitor, marking the first time the U.S. regulatory agency has cleared a CGM as “fully interoperable” with other medical devices. The company’s latest CGM also eliminates the need for patients to calibrate the device by pricking their fingers. […]
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Meet the insulin-makers and device companies developing smart insulin pens
The global market for connected insulin pens could be worth up to $123 million by 2023, according to a report published this year by Research & Markets. Insulin pens, designed for people who control their diabetes with multiple daily injections instead of a pump or wearable patch, are portable devices that were first introduced in 1985 with […]
Patent board upholds AgaMatrix’s CGM patents in Dexcom IP spat
The legal back and forth between Dexcom (NSDQ:DXCM) and AgaMatrix over the companies’ continuous glucose monitoring IP dates back to March of 2016, when AgaMatrix launched a patent infringement lawsuit against the San Diego, Calif.-based manufacturer in the U.S. District Court of Oregon. Later that year, Dexcom filed for inter parters review with the Patent Trial and Appeal Board, […]
Dexcom beats The Street with Q4 sales, earnings
Dexcom (NSDQ:DXCM) beat expectations on Wall Street with its fourth quarter and full year financial results, growing its quarterly revenue 29% compared to the same period last year. The San Diego, Calif.-based company posted a net loss of -$9.4 million, or -11¢ per share, on sales of $221 million for the 3 months ended Dec. 31. […]
Insulet’s closed-loop insulin delivery algorithm succeeds in feasibility study
The algorithm used in Insulet‘s (NSDQ:PODD) closed-loop insulin delivery system performed well in a 58-patient safety and feasibility study, according to a study published today in Diabetes Technology & Therapeutics. Insulet’s device, which is still in development, combines an insulin dosing algorithm, the OmniPod insulin patch pump and Dexcom‘s (NSDQ:DXCM) continuous glucose monitor into one system that automates insulin delivery […]
Dexcom takes on Abbott in head-to-head glucose monitoring trial
Updated to include a statement from Abbott. Dexcom (NSDQ:DXCM) touted data today from a head-to-head trial comparing its G5 mobile continuous glucose monitoring system with Abbott‘s (NYSE:ABT) recently-approved FreeStyle Libre Flash glucose monitoring system. The I-Hart study, which enrolled 40 people with Type I diabetes, found that Dexcom’s device reduced patients’ time spent in hypoglycemia by 43 […]
WaveForm touts clinical trial data for continuous glucose monitor
WaveForm Technologies said today that it has finished four clinical trials of its continuous glucose monitoring system and that it expects to win CE Mark clearance for the device this year. The WaveForm CGM system is designed to be worn for 14 days and includes a sensor insertion tool, a small sensor wire, a polymer coating […]
Dexcom, UnitedHealth team up for wearable glucose management pilot program
UnitedHealth (NYSE:UNH) and Dexcom (NSDQ:DXCM) are joining forces to launch an individualized glucose management pilot program to help people with Type II diabetes manage their condition in real-time using wearable tech. People using UnitedHealth’s Medicare Advantage plan are eligible to use Dexcom’s mobile continuous glucose monitoring system to track their blood sugar levels. Participating in the program also gives […]
Dexcom posts cautious 2018 forecast despite Street-beating Q4, FY17 prelims
Dexcom (NSDQ:DXCM) shares fell today after the company issued conservative guidance for its expected revenue in 2018. The company also posted Street-beating preliminary results for its fourth quarter and full-year 2017 revenues. The company is facing competition in the new year after the FDA approval of Abbott‘s (NYSE:ABT) continuous glucose monitor, the FreeStyle Libre. But chief executive Kevin Sayer […]
Abbott nabs CMS reimbursement for FreeStyle Libre continuous glucose monitor
Abbott (NYSE:ABT) said today that its FreeStyle Libre continuous glucose monitor is now available to Medicare patients, after the Centers for Medicare & Medicaid Services determined that the device can be classified as a therapeutic CGM. The FreeStyle Libre is designed to read glucose levels through a sensor worn on the back of a person’s upper […]
These 10 medtech companies care a lot about research
Among the world’s largest medtech companies, these 10 spent the largest portion of their budgets on research and development. So what have they produced? Every year, Medical Design & Outsourcing pulls financial regulatory filings and reaches out to major, companies in some cases to create a list of the 100 largest medical device companies in […]