Abbott (NYSE:ABT) announced today that it started the LIFE-BTK clinical trial for its Espirit BTK everolimus-eluting resorbable scaffold system. According to a news release, Abbott’s Espirit system is the first to begin an investigational device exemption (IDE) trial in the U.S. for a fully resorbable device for treating below-the-knee blocked arteries or critical limb ischemia (CLI) […]
Clinical Trials
Large study of rapid COVID-19 tests concludes with plea for more studies
A large review of the results from rapid point-of-care COVID-19 tests found inconclusive evidence of their accuracy and led to a plea for more studies. The researchers at Cochrane sought to determine if rapid point-of-care antigen and molecular tests for COVID-19 are accurate enough to replace RT-PCR tests, which require laboratory analysis to diagnose infection. […]
Concept Medical begins DCB trial for peripheral artery disease
Concept Medical announced today that it enrolled the first patient in its Future BTK trial for its peripheral artery disease (PAD) treatment. The first patient was enrolled in Singapore yesterday for the randomized, double-blind, placebo-controlled, multi-center trial for determining the effectiveness of the MagicTouch sirolimus coated balloon compared to standard balloon angioplasty in treating below […]
Feds’ convalescent plasma claim questioned
Scientists are questioning the Trump administration’s claim for the effectiveness of convalescent plasma in preventing deaths from COVID-19, according to published reports. President Trump and the heads of the FDA and the Department of Health and Human Services all said on Sunday that plasma donated by former coronavirus patients has reduced deaths by 35%. Their […]
Report: Top FDA official vows to quit if vaccine approved prematurely
A top FDA official has threatened to resign if the Trump administration moves too quickly to approve a vaccine for COVID-19, according to a published report. Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER), made the threat over concerns a vaccine would be approved without being proven safe and effective, […]
NIH puts $4.3M into convalescent plasma trial for COVID-19 treatment
The National Institutes of Health today awarded the Albert Einstein College of Medicine and Montefiore a $4.3 million grant to test plasma in treating COVID-19. Einstein and Montefiore launched a Phase 2 clinical trial to evaluate the efficacy of convalescent plasma in treating COVID-19 in April. The $4.3 million will support the randomized, double-blind, placebo-controlled […]
Cala cites positive data in Trio tremor trial
Bioelectronic company Cala Health released positive data from its ongoing PROSPECT trial demonstrating that a majority of patients using its FDA-cleared Cala Trio device reported a reduction in hand tremors. The study — published in Tremor and Other Hyperkinetic Movements — enrolled 263 patients with essential tremor across 26 sites. Patients wore the Trio on […]
Thrive raises $257m for CancerSeek
Investors once again lined up behind Thrive Earlier Detection and its potentially revolutionary cancer diagnostic The one-year-old start raised a $257 million Series B round from a syndicate of venture and crossover investors, including round leaders Casdin Capital and Section 32 and new investors Bain Capital Life Sciences, Brown Advisory, Driehaus Capital Management, Intermountain Ventures, […]
Moderna touts preclinical study results for COVID-19 vaccine candidate
Moderna (NSDQ:MRNA) announced today that the preclinical study of its COVID-19 vaccine candidate observed immune response and protection against the virus in non-human primates. Cambridge, Mass.-based Moderna’s study, published in The New England Journal of Medicine, showed that a two-dose vaccination schedule of the mRNA-1273 vaccine candidate led to a “robust immune response and protection” against SARS-CoV-2 infection […]
Moderna launches Phase 3 study of its COVID-19 vaccine candidate
Moderna (NSDQ:MRNA) announced today that it began dosing participants in the Phase 3 clinical study of its mRNA-1273 COVID-19 vaccine candidate. Cambridge, Mass.-based Moderna’s COVE (coronavirus efficacy) study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research […]
DTWeekly Podcast: Can Drawbridge, Edwards bring disruptive innovation to blood drawing, heart surgery industries?
In this week’s podcast, we talk with Holly Logue, general counsel at Drawbridge Health, about the OneDraw, an innovative new tool that might upend the collecting, storage and testing of blood. Logue, a panelist in the upcoming DeviceTalks Tuesdays sponsored by Finnegan, will explain how her past work on Capitol Hill is helping this Silicon […]