Pent-up demand could make orthopedic devices a hot space in 2021. The COVID-19 pandemic was especially brutal for the orthopedic device industry. Many of the largest companies in the space saw double-digit percentage declines in revenue in 2020. Health providers delayed or canceled elective procedures to focus on the pandemic, and patients stayed away in […]
Johnson and Johnson
FDA releases scathing inspection report regarding Emergent BioSolutions plant
An FDA report cites multiple failures in an Emergent BioSolutions plant tapped to produce vaccines for Johnson & Johnson and AstraZeneca. The vaccine plant had been forced to discard up to 15 million doses of Johnson & Johnson’s COVID-19 vaccine in a single manufacturing batch. Emergent Biosolutions recently paused production of the vaccine during the FDA inspection and […]
9 things to know as AstraZeneca and J&J COVID-19 vaccines face safety scrutiny
With COVID-19 cases surging in many parts of the world, the need is high for multiple vaccines to slow the virus. But the fate of adenovirus-vectored vaccines from AstraZeneca and Johnson & Johnson has become murky after a limited number of people receiving those vaccines have developed severe blood clot disorders. Officials in both the […]
EMA begins investigation of J&J COVID-19 vaccine’s blood clotting potential
The European Medicines Agency (EMA) announced that it is beginning a review of blood clots appearing in a handful of recipients of the Johnson & Johnson COVID-19 vaccine. EMA recently concluded that blood clots associated with low blood platelet levels were a “very rare” side effect of Vaxzevria, the vaccine from AstraZeneca. Four recipients of […]
Johnson & Johnson COVID-19 vaccine shipments plunge
Johnson & Johnson will cut COVID-19 vaccine shipments by 86% in the coming week, according to CDC projections. The week of April 5, the company shipped nearly 5 million doses. Next week, that figure could fall to approximately 700,000. The company anticipates that it can eventually deliver up to 8 million doses weekly, assuming FDA authorizes […]
Factory error ruins 15M J&J COVID-19 vaccine doses
Employees at an Emergent BioSolutions facility in Baltimore made a mistake several weeks ago when formulating the ingredients for Johnson & Johnson’s COVID-19 vaccine, requiring 15 million doses of it to be discarded. A quality control process revealed that one batch of a drug substance for the J&J COVID-19 vaccine “did not meet quality standards,” […]
J&J leader McEvoy lays out future for medtech giant; Stryker’s Murray talks 3Dprinting
In this week’s DeviceTalks Weekly podcast — the 50th of the series— J&J’s medical device chief Ashley McEvoy makes her debut. McEvoy, EVP and chair of Medical Devices at Johnson & Johnson, delivered insights on several areas of interest including: COVID-19’s impact on J&J in the past, and what changes may remain in the future; […]
DTW Podcast: Can AI, advanced imaging and robotics ‘democratize’ surgery?
A new generation of digital surgery systems will level surgeons’ playing field — giving them artificial intelligence, robotic tools, and other assistive technologies. In three interviews in this week’s DeviceTalks Weekly Podcast, leaders from Asensus, ActivSurgical and Memic explain how their systems will improve surgeon performance, reduce errors, and deliver the “democratization” of surgical robotics. […]
Is there a link between Bell’s palsy and COVID-19 vaccines?
One adverse event common to clinical trials for currently authorized COVID-19 vaccines is Bell’s palsy, an asymmetrical weakness or paralysis of the face that is often temporary. Two vaccine recipients in the Johnson & Johnson Phase 3 clinical trial developed Bell’s palsy, as did two people in the placebo group. Another patient developed facial swelling […]
Is J&J’s COVID-19 vaccine linked to tinnitus?
In Johnson & Johnson’s (NYSE:JNJ) Phase 3 trial for the Ad26.COV2.S COVID-19 vaccine, six vaccine recipients developed tinnitus or ringing in the ears. In five of those individuals, tinnitus had either resolved or was resolving. The condition was unresolved in the other trial volunteer. No placebo recipients developed the condition. Get the full story from Drug […]
12 surgical robotics companies you need to know
Surgical robotics remains a hot area in medtech — even as it faces headwinds from the COVID-19 pandemic. Intuitive Surgical (NSDQ:ISRG) pioneered robotic surgery through the early 2000s and remains the dominant player, but major companies including Medtronic (NYSE:MDT) and Johnson & Johnson (NYSE:JNJ) have big plans to enter the space and compete. Meanwhile, Stryker (NYSE:SYK) has built a […]
