Know Labs Inc. has received approval from an independent institutional review board for an internal clinical study of its noninvasive glucose monitoring technology. The aim is to further validate the Bio-RFID (radio frequency identification) platform’s ability to accurately measure and detect changes in blood glucose levels. The study will be conducted at the Seattle-based company’s new research and development laboratory and include 200 subjects.
Johnson & Johnson business Cerenovus Inc. is launching a balloon guide catheter for the U.S. and Canada stroke market. The Irvine, Calif.-based company’s Emboguard device is designed to remove blood clots by controlling blood flow during mechanical thrombectomy procedures. It is the latest addition to the Cerenovus stroke portfolio, which includes the Embotrap III revascularization device, the Prowler EX microcatheter, the Cerenovus large bore catheter and Cerebase guide sheath.
The Feb. 10 meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) is about far more than one biologic license application (BLA), as the single question the agency will put to the committee is whether data from a trial in one foreign country are sufficient to support approval in the U.S.
The U.S. House of Representatives passed the COMPETES Act of 2022 in a narrow Feb. 4 vote that may help restore U.S. manufacturing of pharmaceuticals and the semiconductors that are critical for medical devices. However, the House bill also includes unrelated provisions such as a section dealing with health insurance costs, just one of several elements that are not seen in a similar Senate bill and which foreshadow a drag-inducing showdown between the two bills.
The FDA’s device center reported the addition of four device types to the ranks of class II devices, including one each for de novo petitions by Apple Inc., of Cupertino, Calif., and Roche Molecular Systems Inc., of Pleasanton, Calif.
As the U.S. FDA struggles to meet a massive court-ordered release of documents related to its approval of the Pfizer Inc.-Biontech SE COVID-19 vaccine, it could help itself by being more proactive in publicly releasing documents related to the approval and labeling of prescription drugs, according to a U.S. regulatory expert.
The U.S. FDA has approved Sanofi SA’s treatment for cold agglutinin disease (CAD), sutimlimab, after the drug was initially rejected by the regulator for technical reasons in 2020. Paris-based Sanofi’s drug will be branded as Enjaymo.
The CDC’s Advisory Committee on Immunization Practices (ACIP) has unanimously recommended the agency endorse administering Moderna Inc.'s COVID-19 vaccine, Spikevax (elasomeran), to adults. The vote was a strong echo of the FDA’s full approval of the vaccine for adults only a few days earlier, on Jan. 31. After hearing safety and efficacy data from Moderna and an internal analysis of that data from the CDC, ACIP recommended by a vote of 13-0 that the CDC endorse the vaccine’s use for people 18 years and older.
The FDA’s device center has repeatedly asserted that its goal is to ensure that patients in the U.S. will always have first access to the latest and greatest in med tech, and a new priority document resurrects that goal in principle. However, the latest strategic plan qualifies that metric as half of manufacturers of novel technologies bringing their devices to the U.S. market “first, or in parallel with other major markets” by the end of 2025.
Despite mandating earlier this year that private health insurance plans make over-the-counter COVID tests free to their subscribers, the U.S. CMS took until Feb. 3 to make the same benefit available to Medicare beneficiaries. The problem is that these tests will not be available to Medicare beneficiaries free of charge until “early spring,” the agency said, a point in time by which the latest surge of the pandemic is likely to have dissipated.
RSS
