MedTech News
.................... by Andrew Celentano
Merck steps up as ‘meaningful competitor’ to Gilead with HIV pill approval
The newly approved HIV drug Idvynso will also help Merck diversify as loss of exclusivity looms over its top-selling product, the mega-blockbuster cancer drug Keytruda.
Amid US ordeal, Moderna wins EU approval for flu/COVID-19 combo shot
In the U.S., Moderna withdrew its approval application for the combination vaccine in May last year and the timeline for resubmission remains uncertain.
Artera’s prostate biopsy and breast cancer assays receive CE mark
The ArteraAI prostate biopsy assay predicts the risk of prostate cancer progression.
Xeltis gains EU CE mark on positive trial data for vascular access graft
Approval for Xeltis’s aXess device was based on pivotal trial data that demonstrated 79% secondary patency and a patency related reintervention rate of 1.3 per patient year.
Johnson & Johnson wins CE mark for new Ethicon 4000 surgical stapler
Johnson & Johnson (NYSE:JNJ) announced today that it received CE mark approval for its new Ethicon 4000 surgical stapler.
Philips gets FDA green light for scanner platform
Philips (NYSE:PHG) announced today that it received FDA 510(k) clearance for its Rembra platform of scanning systems.
Sonorous Neurovascular earns FDA clearance for next-gen neurovascular catheter
Sonorous Neurovascular announced today that it received FDA 510(k) clearance for its BosCATH next-generation neurovascular catheter.
Luminoah wins FDA clearance for enteral feeding pump system
Luminoah announced today that it received FDA clearance for Luminoah Flow, an enteral feeding system for those who rely on tube feeding.