In releasing its annual report card for drug manufacturing inspections in which the per-country/region grading curve peaked at 77% and bottomed at 68%, the FDA said, “All of these scores indicate an acceptable level of compliance to CGMPs [current good manufacturing practices] on average.”
Medrhythms Inc., a digital therapeutics startup based in Portland, Maine, won an FDA breakthrough device designation for its Rhythmic Auditory Stimulation (RAS) treatment platform for people with chronic walking impairments due to stroke.
While a significant number of clinical trial delays occurred during the month of April, it was business as usual from a regulatory standpoint for companies with late-stage therapies ready for the market and for those targeting underserved patient populations.
HONG KONG – Aiming to attract more active innovation to its medical device industry, South Korea updated some of its industry regulations through 2019. The ultimate goal was to make it easier for advanced medical technologies that use artificial intelligence (AI), robotics and 3D printing that have yet to penetrate the market due to inefficient approval processes.
Heart failure is a leading cause of disability and death in the U.S., but many cases are diagnosed late due to limited access to echocardiography, the primary method of detecting the condition. To address that need, the U.S. FDA has granted breakthrough device designation to Eko Devices Inc., of Berkeley, Calif., for an electrocardiogram (ECG)-based algorithm that could serve as an easily accessible screening tool for heart failure during routine physical exams.
The European Parliament this week formally agreed to delay the requirement for certain currently approved class 1 medical devices to comply with the new Medical Devices Regulation (MDR) when it comes into force on May 26, 2020. Consequently, manufacturers of reusable surgical instruments and devices that have a measuring function will have an additional four years to meet the stricter requirements of MDR.
SUZHOU, China – Under the "Healthy China" campaign, China has introduced a three-year action plan for preventing and treating cancer. The plan vows to speed up the marketing of cancer drugs in the country, even aiming for simultaneous marketing with other countries.