MedTech News

Align Technology wins FDA nod for Invisalign palatal expander system
Align Technology (Nasdaq:ALGN) announced today that the FDA granted 510(k) clearance for its Invisalign palatal expander system.

Glaukos wins FDA approval for drug-releasing eye implant to treat glaucoma
William Blair analysts said the product “should revolutionize how glaucoma is treated by addressing noncompliance with drops.”

B. Braun launches luer device for IV infusions
B. Braun Medical announced that it launched its new CareSite Micro luer access device designed to make IV access safer.

JVC launches FDA-cleared over-the-counter hearing aids
JVC today announced the commercial availability of its FDA-cleared, self-fitting, over-the-counter (OTC) hearing aids.

NuEyes wins FDA approval for augmented reality surgical visualization tech
NuEyes announced today that the FDA granted approval to its patent-pending NuLoupes augmented reality smart glasses technology.

FDA approves Glaukos iDose TR glaucoma-treating drug delivery implant
Glaukos (NYSE:GKOS) announced today that the FDA approved a New Drug Application (NDA) for its iDose TR implant.

Xpan secures FDA 510(k) clearance and announces successful completion of initial human clinical cases in the United States
The XpanTM Universal Trocar System is a first of its kind, radially expanding trocar that can be tailored by surgeons during laparoscopic procedures to accommodate 3 mm up to 12 mm instruments

Medtronic PulseSelect pulsed field ablation wins FDA approval
The FDA has approved the Medtronic (NYSE: MDT)+
PulseSelect pulsed field ablation (PFA) system, the device developer said today.