FDA Approves Edwards EVOQUE® Tricuspid Valve Replacement System
The U.S. Food and Drug Administration (“FDA”) recently approved the Edwards EVOQUE® Tricuspid Valve Replacement System (the “EVOQUE® system”) for use in treating Tricuspid Regurgitation (“TR”). The EVOQUE® system is...
Deep Brain Simulation Devices Market Expected to Reach USD 3.5 Billion by 2033
A recent paper published by market.us projects that the Deep Brain Stimulation (DBS) devices market is expected to reach around $3.5 Billion by 2033, compared to the projected $1.5 Billion...
First At-Home Artificial Insemination Kit Receives FDA Clearance
Mosie Baby, a Texas-based fertility care company, has received clearance from the U.S. Food and Drug Administration for its over-the-counter intravaginal insemination kit. The kit was developed for those who...
FDA Clears ABK Biomedical’s Eye90 Microspheres for Hepatocellular Carcinoma Treatment
ABK Biomedical successfully secured Breakthrough Device Designation from the FDA on December 5, 2023, for its Eye90 microspheres device, which is indicated for the treatment of unresectable Hepatocellular Carcinoma (HCC)....
FDA on pace for a Record Number of Breakthrough Devices in 2023
The FDA implemented the breakthrough device program in 2015. The program was designed to expedite review of premarket approval (PMA), 510(k) clearance, and De Novo marketing authorizations. Applicants can seek...
Patent on Controlling Access to Drug Delisted from Orange Book
On February 24, 2023, in Jazz Pharms., Inc., v. Avadel CNS Pharms., LLC, the U.S. Court of Appeals for the Federal Circuit affirmed the United States District Court for the District of Delaware’s...
BIOCORP Receives FDA 510(k) Clearance for Smart Injection Sensor
French medical device company BIOCORP announced in a press release that it received FDA 510(k) clearance for Mallya, a device that according to the company allows insulin pen injectors to...
