Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have submitted data to FDA indicating that their vaccine is stable at –25° C to –15°C. Currently, the vaccine can be stored in an ultra-cold freezer between –80° C and –60° C, according to current CDC guidelines. Updating the companies’ emergency use authorization prescribing information would be simplify logistics. It would […]
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DTW Podcast – Tale of Two CEOs – How Tim Herbert led Inspire to an IPO; Where Rob Bodor wants to take Protolabs
Inspire Medical CEO Tim Herbert never set out to be a CEO. Yet, he spun a promising sleep apnea technology out of Medtronic. He then assembled a team that helps hard-to-treat apnea patients live healthier lives through better sleep. Oh, and the electrical-engineer-turned-startup-CEO took the medtech public in 2018. Listen to this episode to hear […]
Fifth round of medtech user fee talks set to begin soon
Every five years, the FDA, the medtech industry and the public sit down and hammer out how the agency should spend the money it collects in fees from medical device developers seeking approvals and clearances. The agency also uses the Medical Device User Fee Amendment (MDUFA) to set fees for biologics license applications, 513(g) requests for information and de […]
The worst catheter-based device recalls of 2020
The U.S. saw nine serious medical device recalls related to catheters in 2020 — up from four the previous year, according to the FDA. FDA in 2020 reported a total 33 medical device recalls at its most serious Class I level, down from 49 in 2019. The list of the most serious catheter-based device recalls […]
Could artificial intelligence boost surgical robotics to new heights?
Ken Goldberg thinks artificial intelligence will enable surgical robots to achieve their best function — not replacing surgeons but augmenting their work by reducing the monotony of specific subtasks like suturing. The William S. Floyd Jr. Distinguished Chair in Engineering at UC Berkeley, Goldberg and his research team have continued to advance the field. The group — which includes postdoctoral […]
Biden announces $4B to support global vaccinations worldwide
President Joe Biden announced that the U.S. is set to provide $4 billion to the COVAX Facility to support access to safe and effective COVID-19 vaccines. Money appropriated by a December 2020 Congressional vote will comprise an initial $2 billion contribution to Gavi, the Vaccine Alliance for the COVAX advance market commitment (AMC) covering 92 […]
New FDA medtech cybersecurity chief: Guidance to debut in 2021
The FDA’s first medical device cybersecurity chief says he will work across private and public lines to lower the threat of cyberattacks against medical devices and the healthcare systems and patients who use them. Medical device manufacturers can expect a new FDA cybersecurity draft guidance for new medical devices sometime this year, according to the […]
J&J submits EUL application to WHO for single-shot COVID-19 vaccine
Johnson & Johnson (NYSE:JNJ) announced today that it submitted for emergency use listing (EUL) to the World Health Organization (WHO) for its COVID-19 vaccine. New Brunswick, N.J.-based J&J’s Janssen subsidiary’s single-dose COVID-19 vaccine candidate was submitted for EUL with a data package including interim efficacy and safety results from the Phase 3 Ensemble clinical trial, which […]
This vocal biomarker software can screen for COVID-19
Startup Vocalis Health today announced that its artificial intelligence-aided screening tool, VocalisCheck, screening tool, VocalisCheck, has obtained a CE mark for screening for COVID-19. VocalisCheck is designed as a screening tool that can deliver a reliable risk score to guide people who may need diagnostic testing for the coronavirus. A smartphone or other device using […]
FDA panel votes against BD Lutonix drug-coated balloon for below-the-knee
An FDA advisory panel voted against a favorable recommendation for BD‘s Lutonix catheter-based, drug-coated balloon for use below the knee. The FDA’s Circulatory System Devices Advisory Panel yesterday voted 15-to-2 in favor of the issue of safety when Lutonix is used as intended and voted 15-to-2 against the issue of a reasonable assurance of effectiveness. The […]
Google opening office near Mayo Clinic
Google announced today that it will open an office in downtown Rochester, Minn., to be close to Mayo Clinic. The tech giant plans to have an office up and running with a handful of workers as soon as possible, given the ongoing COVID-19 pandemic, according to a news release posted on the website of the […]