MedTech News
Luna Diabetes launches trial for ‘world’s smallest insulin patch pump’
Luna Diabetes says it has launched a pivotal trial for what it describes as “the world’s smallest insulin patch pump.”
iRhythm’s Zio AT design changes win FDA clearance
The agency cleared one of two 510(k) submissions iRhythm filed for the heart monitor after receiving a warning letter from the agency last year.
FDA approves IDE for Medtronic Prevail drug-coated balloon
Medtronic (NYSE: MDT)+
announced today that it received FDA investigational device exemption (IDE) for its Prevail drug-coated balloon (DCB).
Digital treatment for insomnia awaiting NHS funding secures FDA clearance
A potentially cost-saving UK digital health innovation that is awaiting NHS England funding, more than two years after NICE recommended its national adoption in the NHS, will soon be made available to patients in the US after it secured FDA clearance.
Leica Microsystems unveils SpectraPlex for Life Sciences research
Leica Microsystems has announced the release of SpectraPlex, a 3D high-multiplex solution for spatial discoveries on the STELLARIS confocal platform. The company claims that this innovation sets a new benchmark for 3D spatial phenotyping in life science research.
Asahi Kasei Medical launches PlanovaTM FG1 next-generation virus removal filter
Asahi Kasei Medical has launched the Planova FG1, a ‘next-generation’ virus removal filter featuring higher flux for the manufacture of biotherapeutics.
FDA clears Gentuity imaging system for coronary interventions
Gentuity announced today that it received FDA 510(k) clearance for its HF-OCT imaging system with the Vis-Rx micro-imaging catheter.
Peytant wins FDA de novo nod for covered stent system
Peytant Solutions announced today that the FDA granted marketing authorization for its AMStent tracheobronchial covered stent system.