The success of remote clinical trial oversight opens the door to hybrid approaches and creates new possibilities for the future of trials. DeviceTalks Because of the pandemic, virtually overnight, all players involved in medical device clinical trials had to pivot to virtual monitoring to keep trials going. What impact did remote trial oversight have on […]
Clinical Trials
Boston Scientific touts Watchman FLX trial data
Boston Scientific (NYSE:BSX) today touted positive 24-month results from a trial evaluating its Watchman FLX left atrial appendage closure device. Marlborough, Mass.-based Boston Scientific’s Watchman FLX LAAC device for patients with non-valvular atrial fibrillation (NVAF) had previously proven its safety and efficacy in 12-month data from the same trial presented in April. The latest data, […]
FDA grants iStar Medical IDE for glaucoma implant pivotal trial
iSTAR Medical announced today that the FDA granted investigational device exemption to start a pivotal trial with its MINIject implant. Wavre, Belgium–based iStar’s MINIject minimally invasive implant for glaucoma surgery will be investigated in the STAR-V study, which will enroll over 350 patients with primary open-angle glaucoma. Get the full story at our sister site, Drug […]
Pear Therapeutics touts 9-month data for reSET-O
Pear Therapeutics today touted results from an extended retrospective analysis of real-world data for its reSET-O prescription digital therapeutic. Boston-based Pear Therapeutics developed its reSET-O prescription digital therapeutic (PDT) for treating opioid use disorder (OUD). Get the full story at our sister site, Drug Delivery Business News.
Aerin Medical touts study of nasal airway obstruction treatment
Aerin Medical today touted results from a three-month study of its VivAer treatment for nasal airway obstruction (NAO). Sunnyvale, Calif.-based Aerin’s VivAer was studied in the VATRAC trial, with results published by the International Forum of Allergy and Rhinology. According to a news release, the study confirmed the safety and efficacy of VivAer in treating […]
Philips enters partnership for stroke tech, enrolls first patient in stroke study
Royal Philips (NYSE:PHG) announced a strategic partnership and a clinical trial milestone for its expanded stroke treatment capabilities. Amsterdam-based Philips yesterday confirmed a strategic partnership with medtech stroke care company Nico.Lab that will use Philips’ Azurion image-guided therapy system to advance stroke treatment. Additionally, the company announced the enrollment of the first patient in a […]
Abbott to sell its STARLIMS informatics product suite
Global investment firm Francisco Partners announced today that it has agreed to acquire Abbott’s STARLIMS informatics product suite for an undisclosed amount. Companies in the life sciences, pharma and biotech, chemical and refining, food and beverage, manufacturing, environmental, public health and forensics sectors have used the STARLIMS suite of products for more than 35 years. […]
Levita Magnetics announces first magnetic robot-assisted surgeries
Levita Magnetics announced today that it performed the first procedures with its robot-assisted surgical platform. Dr. Ignacio Robles used Menlo Park, Calif.–based Levita’s newest system, the Levita Robotic Platform, in a reduced-incision laparoscopic cholecystectomy (gallbladder removal). The procedure took place at Clínica INDISA in Santiago, Chile, as part of a clinical study of the platform. […]
DarioHealth touts data for diabetes management platform
DarioHealth (NSDQ:DRIO) recently presented data supporting its artificial intelligence (AI)-powered diabetes management platform. New York-based Dario’s research examined users who were given access to a new product experience designed to drive better health habits and behaviors through its AI-driven personalization engine. Get the full story at our sister site, Drug Delivery Business News.
PharmaJet begins enrollment for needle-free COVID-19 vaccine trial
PharmaJet announced today that it began enrollment for a Phase 1 clinical trial for its needle-free COVID-19 vaccine in Australia. Golden, Colo.-based PharmaJet’s needle-free injection systems will be studied with Covigen, a DNA-based vaccine developed by French-Thai pharmaceutical company BioNet-Asia in collaboration with Melbourne, Australia-based Technovalia. Get the full story at our sister site, Drug Delivery […]
United Therapeutics touts study results for inhaled Tyvaso treatment
United Therapeutics (NSDQ:UTHR) today announced positive results from an analysis of forced vital capacity (FVC) change with its Tyvaso treatment. Research Triangle Park, N.C.–based United Therapeutics developed Tyvaso (treprostinil) as an inhalation solution for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The FDA approved the treatment in April 2020. Get the full story […]
