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Insulet has released pivotal trial extension data showing that its Omnipod 5 automated insulin delivery system continued to improve glycemic outcomes in young children over 12 months of use. Read More
New York-based DarioHealth reported positive results from several clinical trials of its digital therapeutics at the American Diabetes Association’s (ADA) 82nd Scientific Sessions in New Orleans, June 3-7. Read More
The first step in Operational Qualification for medical devices is design transfer, the requirement for which can be found at 21 CFR 820.30(h): “Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.” Read More
Beckton Dickinson (BD) announced the $1.5 billion acquisition of Durham, N.C.-based Parata Systems, a purchase that will give BD access to Parata’s portfolio of pharmacy automation products, such as pouch and blister medication adherence packaging and high-speed robotic dispensing technologies. Read More
A bipartisan bill that has been referred to the Senate Committee on Health, Education, Labor and Pensions would mandate that the FDA frequently update its cybersecurity guidelines to help ensure that devices are protected against cyberattacks. Read More
The FDA said Friday that it is withdrawing guidance it issued in June 2020 — three months after the beginning of the pandemic — on formal meetings and user fee applications for devices. The withdrawal is effective July 7. Read More
3DBio Therapeutics, a New York-based regenerative medicine company, and the Microtia-Congenital Ear Deformity Institute in San Antonio, Texas, have partnered to reconstruct a human ear using the company’s AuriNovo 3D-bioprinted implant. Read More
The FDA has issued final guidance that details what information should be included in premarket submissions to show electromagnetic compatibility (EMC) for electrically powered medical devices and medical devices with electrical or electronic functions and sensors. Read More