Tag Archives: Food and Drug Administration

16Oct/23

FDA Roundup: October 13, 2023

October 16, 2023HealthCompanies based in Bangalore, Food and Drug Administration, Glance, u.s. food and drug administrationadmin

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Continue reading

18Aug/23

Heart Failure start-up, Acorai, embarks on the next vital stage towards regulatory approval

August 18, 2023ReasearchClinical research, Clinical trial, Food and Drug Administration, London, Medical device, Patient recruitment, Pharmaceutical industry, Sweden, United Kingdom, Ventricular assist deviceadmin

Today, Acorai, a start-up medical device manufacturer from Sweden, has announced the initiation of a global clinical trial with the enrollment of its first patient in London, UK. Acorai was designated as a breakthrough device by the US FDA in August 2023 and they aim to submit their heart monitor for regulatory approval to the FDA and CE-marking in 2024. Continue reading

14Apr/23

Medaica Announces Free Telehealth Stethoscope for Rural and Underserved Patients

April 14, 2023HealthcareArticles, Assistive technology, Food and Drug Administration, Health, Health informatics, Stethoscope, Technology, Telehealth, u.s. food and drug administrationadmin

Medaica, a digital health company extending the capability of home diagnostics, today announced that the U.S. Food and Drug Administration (FDA)-cleared1 Medaica M1 Telehealth Stethoscope (M1) will be free of charge, starting with qualifying strategic partners supporting rural or underserved patients with chronic heart and/or lung conditions. Continue reading

Tag: Food and Drug Administration