Dexcom generated 42% higher year-over-year sales in the second quarter after the June launch of its G6 integrated continuous glucose monitoring system. The company is conducting validation and verification of the first-generation Verily miniature CGM device, in partnership with Verily, and is looking to release a second-generation version in 2021.
Israel-based Itamar Medical has filed a request with the Securities and Exchange Commission to be listed for trading on Nasdaq. The company, which makes home devices for sleep apnea diagnosis, is looking to secure regulatory approval for the next generation of its WatchPAT device by mid-2019.
An agreement has been reached by EKF Diagnostics with McKesson Medical-Surgical for the US distribution of the DiaSpect Tm reagent-free hemoglobin analyzer, a hand-held device that provides hemoglobin measurements using a broad-spectrum photometric method. The device will be offered by McKesson Medical-Surgical in the US as the McKesson Consult Hb analyzer, with a product launch scheduled this year.
A Research and Markets report predicts the worldwide interbody fusion cage market will hit $2.31 billion by 2023 with a 3.4% compound annual growth rate. Key market players include Medtronic, Zimmer Biomet, DePuy Synthes, NuVasive, B. Braun Melsungen and Orthofix International.
A Meddevicetracker report predicts the global liquid biopsy market will reach $2 billion by 2022 at a compound annual growth rate of 27.2%, driven by the increasing cancer incidence. Liquid biopsies are used most often for lung cancer, followed by breast, colorectal, stomach and prostate malignancies.
A pilot study of Medtronic's Extravascular Implantable cardioverter defibrillator system has begun, with the first implantation performed in New Zealand. The study will enroll 20 patients across four centers in Australia and New Zealand.
The FDA has granted NaturalCycles Nordic permission to market its Natural Cycles app, a contraception method designed for premenopausal women age 18 and older. The app uses menstrual cycle data and daily body temperature measurements to predict which days the user is expected to be fertile.
The cyclospora outbreak that is linked to Fresh Express salads from McDonald's has sickened 436 people and caused 20 to be hospitalized across 15 states. Lawsuits have been filed in connection to the outbreak.
Medtronic announced the US launch of its Inner Circle patient engagement program, which uses gamification to motivate patients with diabetes to do activities that help control blood glucose levels and engage in a community where they can challenge other users and monitor their own progress. The company will invite users to enroll in the program once they are on the Guardian Connect smart continuous glucose monitoring system or the MiniMed 670G automated insulin delivery system.
Krystal Biotech's KB105, which is being developed to treat patients with transglutaminase 1-deficient autosomal recessive congenital ichthyosis, received orphan drug status from the FDA.