July 16, 2020 Brief: The final guidance issued in March hews closely to the partly disputed draft, with the most common change being the adoption of 3P510k, rather than 3P, as the abbreviation for the program. FDA did acquiesce to the pushback in some areas, for example by clarifying that review organizations should do assessments … Read more
July 14, 2020 The move comes as the Commission works to realign the various components of its regulatory framework for medical devices to accommodate the one-year MDR delay necessitated by the coronavirus disease (COVID-19) pandemic and the two-year Eudamed delay announced last year. The Commission also released guidelines on in May explaining the process and … Read more
July 10, 2020 The hand-held product, which is around the size of a mobile phone, is part of a new class of antigen testing technology that promises to bring faster, cheaper testing to doctors’ offices, urgent-care centers and other medical facilities. The first such test, from Quidel Corp., was cleared for U.S. use in May. … Read more
July 07, 2020 In an interview on the Device Talks Weekly podcast, Whitaker laid out steps he believes the federal government and med-tech industry must take, including addressing medical device and supply stockpiles and strengthening supply chains. Above all, Whitaker said, any response is strongest when government and industry work together, a lesson learned early … Read more
July 02, 2020 LambdaVision, with a lift from its partner Space Tango, scored $5 million from NASA to test how microgravity could affect the production of its artificial retinas. The company aims to tackle retinitis pigmentosa, a rare genetic disorder that damages the light-sensing cells lining the back of the eye. It has been developing … Read more
July 01, 2020 In 2018, researchers in the bioengineering laboratory of Harvard’s Samir Mitragotri published their methods for turning liquid drugs into a newly encapsulated and easy-to-swallow form, and demonstrated early success with insulin in animal models. Now, i2O Therapeutics is starting out with $4 million in seed money — from Sanofi Ventures and the … Read more
June 26, 2020 Dubbed Durysta, the 10 mcg implant is designed to rest as a small polymer plug on the edge of the iris, underneath the cornea, to help regulate fluid pressure within the eye in people with open-angle glaucoma or ocular hypertension. In phase 3 clinical studies, the sustained-release prostaglandin analog lowered intraocular pressure … Read more
June 24, 2020 The researchers engineered a piece of the vaccinia virus, which is part of the poxvirus family, so it can deliver two cytokines that stimulate anti-cancer responses from immune cells: interleukin-7 (IL-7) and IL-12. When they injected the virus directly into tumors in mice, the cancers regressed, they reported in the journal Science … Read more
June 18, 2020 So why are not we, in 2020, growing replacement lungs, livers and kidneys to fill the gap that donor organs cannot address? “People asked that question back when tissue engineering was being defined in the ‘90s,” said Jordan Miller, Ph.D., an Assistant Professor of Bioengineering at Rice University. “They said: ‘We’ve got … Read more
June 16, 2020 The Strasbourg-based Dianosic plans to eventually make its bloodstopping balloon available in hospitals throughout Europe, the U.S., Japan and China. After being inserted into the nostril, the company’s CAVI-T device expands to conform to the shape of the cavity and provide light amounts of compression to help stop the bleeding, including at … Read more