
FDA clears Masimo Stork home baby monitoring system
The FDA today published a 510(k) premarket notification granting clearance to the Stork baby monitoring system from Masimo

The FDA today published a 510(k) premarket notification granting clearance to the Stork baby monitoring system from Masimo

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

William Blair analysts said the product “should revolutionize how glaucoma is treated by addressing noncompliance with drops.”

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

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

Glaukos (NYSE:GKOS) announced today that the FDA approved a New Drug Application (NDA) for its iDose TR implant.

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

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

The clearance positions BD and partner Babson Diagnostics to support blood collection from community sites such as pharmacies.

The XO Cath microcatheter is designed to deliver new levels of trackability, torque response, and embolic compatibility for improved treatment delivery.