Medical device
Fresh off its $13-billion acquisition of medical devices developer Shockwave Medical, Johnson & Johnson is expecting greater business growth in the future.
Following the regulatory victory of Balversa in urothelial carcinoma, Johnson & Johnson on Friday continued its bladder cancer winning streak with an 82.8% complete response rate forTAR-200 in high-risk non-muscle invasive bladder cancer.
Fresh from its IPO, Fractyl Health got an Investigational Device Exemption from the FDA, clearing a pivotal study of its Revita system to help maintain weight loss following the discontinuation of GLP-1 drugs.
Both the White House and Congress have proposed legislation for the appropriate use of AI while the FDA continues to serve as the gatekeeper for patient privacy and safety.
Thursday’s FDA advisory committee rejection is the latest regulatory defeat for the company’s drug-device combo. The panel found that the benefits of the treatment did not outweigh its risks.
Nearly three-quarters of the highest-revenue U.S. patient advocacy organizations have board members or senior leadership with ties to the pharma or medical device industries, finds study.
Following a nearly decade-long effort, Delcath Systems finally won the FDA’s greenlight for its Hepzato Kit for the liver-directed treatment of adult patients with metastatic uveal melanoma.
In 2022, Elon Musk’s Neuralink tried – and failed – to secure permission from the FDA to run a human trial of its implantable brain-computer interface, according to a report published Thursday.
The partners will combine Miromatrix’s single-use bioengineered liver with Baxter’s PrisMax system, which is designed to provide individualized therapies to patients.
Shockwave Medical bolsters medical device portfolio with acquisition of Neovasc.
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