The U.S. FDA’s effort to compile a guidance for prescription, point-of-care (POC) blood glucose meter (BGM) test systems seems to show that guidances can be as iterative as the devices they govern. The FDA announcement for the Sept. 28, 2020, final guidance said that the differences between the 2020 final and the 2018 draft include “a minor edit” regarding user accessibility and a technical correction for hemoglobin testing concentration, yielding a document that is finally ready for prime time after four tries over six years.
With only days left before Inovio Pharmaceuticals Inc. planned to initiate a phase II/III trial of its COVID-19 DNA vaccine candidate, INO-4800, and its accompanying delivery device, the FDA placed a partial clinical hold on the company’s study. This is the study’s second delay as the company originally planned to begin in July or August. November is now the earliest potential start date. Inovio told BioWorld that the company and its partners are continuing to prepare for the phase II/III trial “following resolution of the FDA’s partial clinical hold.”
The U.S. FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program is intended to foster med-tech regulatory harmonization, but stakeholders saw a number of issues with the September 2019 ASCA draft guidance.
Children with autism spectrum disorder (ASD) can face a lifetime of frustration because of challenges with communication, social behaviors and flexibility of thought. Early intervention can improve outcomes, but nailing a diagnosis of ASD often takes years. Cognoa Inc. wants to change that with its digital ASD Diagnostic and is on track to apply for U.S. FDA clearance before the end of the year.
The U.S. Centers for Medicare & Medicaid Services (CMS) has posted a proposed rule for coverage of FDA-designated breakthrough devices, a programmatic objective that has been front and center for the agency for several years. However, Tamara Syrek Jensen, director of the Coverage and Analysis Group (CAG) at CMS, said the proposal to redefine the term “reasonable and necessary” may be the more critical piece of the proposed rule because it would give the agency unprecedented flexibility in covering a broad swath of medical technologies.
The U.S. FDA has granted breakthrough device designation status to Medtronic plc’s Tyrx absorbable antibacterial driveline wrap, a medical device aimed at reducing driveline complications in patients receiving a ventricular assist device (VAD).
Before authorizing or licensing any COVID-19 vaccine, the U.S. FDA will hold a public advisory committee meeting on that vaccine, FDA Commissioner Stephen Hahn said at a Sept. 23 hearing before the Senate Health, Education, Labor and Pensions Committee.
The U.S. FDA has posted another draft version of the intended use rule, this time with a fix for the so-called knowledge problem. This latest draft would eliminate mere knowledge of off-label use as a trigger for amendments to the product label, a provision the agency said in a Sept. 22 statement will “provide greater certainty and predictability for regulated parties.”
While the ultimate goal is increased diversity in clinical trials so as to improve health equity, a great start is making diversity a priority and a part of the research plan, Luther Clark, deputy chief patient officer at Merck & Co. Inc., said during an FDA Office of Minority Health and Health Equity webinar Sept. 22.
TORONTO – Ka Imaging Inc. has received U.S. FDA 510(k) clearance for a portable, dual-energy X-ray detector that distinguishes itself from others in this class by delivering regular digital radiography, bone and tissue images in a single X-ray exposure. Designed for early detection of pneumonia, including COVID-19, the Reveal detection system also differentiates bone and soft-tissue.
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