The United Kingdom issued a warning for failure in a spinal fixation system manufactured by Johnson & Johnson (NYSE:JNJ) unit DePuy Synthes. An alert sent out by the Medicines and Healthcare Products Regulatory Agency highlighted an issue with the cracking of the USS II Polyaxial 3D head rings that may result in the loosening of the spinal […]
CEO Ryan explains how Cala Health is building bioelectronic medicine business
In this week’s episode of DeviceTalks Weekly, Tom Salemi, editorial director of DeviceTalks events and content, visits with Renee Ryan, the CEO of neuromodulation startup Cala Health. Ryan came to Cala from the venerable medtech investor Johnson & Johnson Development Corp., where she made over 15 investments helping to create companies including Auris Surgical, Cala […]
J&J accelerates development of its COVID-19 vaccine candidate
Johnson & Johnson (NYSE:JNJ) announced today that its Janssen Pharmaceutical subsidiary has moved up first-in-human clinical trials of its COVID-19 vaccine candidate to late July, versus the previously planned start in September. “Based on the strength of the preclinical data we have seen so far and interactions with the regulatory authorities, we have been able to […]
MedTech 100 roundup: Stocks take a slight dip to end April
Medtech stocks remain in a stronger position than they were at the low point of the COVID-19-induced economic crisis, but they took a small dip over the last week. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 80.62 points at the end of last week […]
Johnson & Johnson pharma booms, medtech sinks in COVID-19-affected Q1
Johnson & Johnson (NYSE:JNJ) shares dipped today despite first-quarter results that topped the consensus forecast. The New Brunswick, N.J.-based company posted profits of $5.8 billion, or $2.17 per share, on sales of $20.7 billion for the three months ended March 29, 2020, for a 54.6% bottom-line gain on sales growth of 3.3%. Adjusted to exclude one-time […]
These medical devices are getting ready to launch in 2020
Despite the COVID-19 pandemic, medical device companies are still working to gain regulatory approvals and launch new devices this year. The pandemic has largely fixed the FDA’s focus on emergency use authorizations (EUAs), leaving more typical device approvals waiting. At press time, the regulatory agency had granted 84 EUAs beginning Feb. 4 and had approved […]
How Johnson & Johnson is expanding manufacturing for a potential coronavirus vaccine
Johnson & Johnson (NYSE:JNJ) recently announced that its Janssen Pharmaceutical Cos. will collaborate with Emergent BioSolutions to support the manufacturing of its lead investigational COVID-19 vaccine candidate. The New Brunswick, N.J.–based pharmaceutical and medical device giant described the deal as the first in a series of contract manufacturing agreements that it expects to ink as it seeks […]
DeviceTalks Weekly Podcast: Ep.5 — How can startups move forward during a pandemic?
Raising capital for startup is never easy. Try doing it during a pandemic. In this week’s DeviceTalks Weekly, we’ll try to help entrepreneurs by talking with two guests who are committed to helping startups find the funding they need. Paul Grand, founder and CEO of MedTech Innovator, explains how he’s working to keep startups connected […]
How is coronavirus vaccine development going in the U.S.?
Researchers in Pittsburgh and Boston are moving forward with research into two separate vaccine programs against SARS-CoV-2, the new coronavirus causing the COVID-19 pandemic. The work of the University of Pittsburgh School of Medicine researchers is detailed in a paper published recently in EBioMedicine, which is published by the Lancet. Delivery of the vaccine involved a microneedle array to […]
DePuy Synthes wins CE Mark for hip replacement dual mobility system
Johnson & Johnson’s (NYSE:JNJ) DePuy Synthes announced that it won CE Mark approval for its Bi-Mentum dual mobility system for people with a higher risk of dislocation. Bi-Mentum is designed with a standard femoral head articulating within a large polyethylene liner that swivels within a metal shell, reducing the risk of dislocation, which can impact patient satisfaction […]
J&J’s Janssen, Thermo Fisher Scientific to collaborate on oncology diagnostic
Thermo Fisher Scientific (NYSE:TMO) announced today that it entered into an agreement with Johnson & Johnson‘s (NYSE:JNJ) Janssen Biotech to co-develop a companion diagnostic (CDx) in oncology. Under the agreement, Thermo Fisher is set to collaborate with Janssen’s R&D scientists to validate biomarkers for use with Thermo Fisher’s Oncomine DX target test in identifying variant-positive patients for […]
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