In a fireside chat at the Advanced Medical Technology Association (Advamed)-sponsored Virtual Medtech Conference on Oct. 5, U.S. FDA Commissioner Stephen Hahn addressed questions that have been circulating for months about the political pressure that the agency is facing to quickly approve a vaccine for COVID-19 by reiterating that any decisions will be “completely dependent on when data is mature” from phase III trials.

Medtronic plc’s winning streak continued this week with the announcement that the U.S. FDA had given its nod for new one-month of dual-antiplatelet therapy (DAPT) labeling with an expanded indication for high bleeding risk (HBR) patients implanted with the Resolute Onyx drug-eluting stent (DES). The approval is based on results from the Onyx ONE Clear Study that evaluated about 1,500 complex HBR patients on one-month DAPT treated with Resolute Onyx.

Genetron Holdings Ltd., a Beijing-based precision oncology company, has gained breakthrough device designation status from the U.S. FDA for its blood-based, next-generation sequencing test for the early detection of hepatocellular carcinoma (HCC). The test, called HCCscreen, is intended for individuals at high risk for HCC due to chronic hepatitis B virus infection or liver cirrhosis.

FDA enforcement of clinical research regulations has often been "light-handed, slow-moving, and secretive," a new look at the agency's enforcement track record concludes. Published today in the journal Science, the analysis said the shortcomings may be harming both patients and trial integrity.

The COVID-19 pandemic has not run its course, but the U.S. FDA is already working on a plan for handling devices in the period after the public health emergency ends. Bill Maisel, chief medical officer at the FDA’s Center for Device and Radiological Health (CDRH), said the agency is thinking through what would have to appear in a guidance for a transition that may span a number of months, providing industry with some much-needed breathing room.

Sentiar Inc. received U.S. FDA clearance for its holographic guidance system, known as Commandep, for use in cardiac ablation procedures. The system allows electrophysiologists (EPs) to visualize 3D electroanatomic models in real-time, using augmented reality (AR), to seamlessly navigate invasive procedures. “The Commandep is intended for use as a medical imaging system that allows the review, analysis, communication and media interchange of multidimensional digital images,” Berk Tas, Sentiar’s CEO, told BioWorld.

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.