FDA

Merit Medical Systems (Nasdaq:MMSI) announced today that it has obtained FDA premarket approval for the Wrapsody cell-impermeable endoprosthesis. With this approval, the company plans to commence U.S. commercialization in 2025.\n\nBased in South Jordan, Utah, Merit Medical created Wrapsody to enhance […]

Andromeda Surgical recently reported a groundbreaking event as a surgeon in Chile successfully performed a robotic-assisted holmium laser enucleation of the prostate (HoLEP) using their cutting-edge platform. This is recognized as the world’s inaugural robotic-assisted HoLEP procedure. Dr. Cristián Trucco

Roivios has announced receipt of the FDA’s investigational device exemption (IDE), allowing them to conduct trials for their renal assist device (RAD). The IDE approval paves the way for pivotal trials with the JuxtaFlow RAD, targeting patients with kidney issues

The landscape of the leading orthopedic device manufacturers has undergone significant shifts since last year. A modified method of evaluation has resulted in a new leader in this year’s rankings by MassDevice and Medical Design & Outsourcing. Additionally, mergers and

Onward Medical has successfully obtained FDA de novo clearance for its groundbreaking ARC-EX spinal cord stimulation (SCS) system, the company announced recently. The ARC-EX SCS therapy utilizes programmed electrical pulses delivered transcutaneously to the spinal cord via electrodes positioned on

Oura disclosed today its successful closing of a $200 million Series D funding round, featuring investment from Dexcom (Nasdaq:DXCM). Participants in this round included Dexcom and Fidelity Management & Research Company. This financial boost marks a fresh alliance in health

Smith+Nephew has announced that it has secured FDA approval for its new Coriograph pre-surgical planning and modeling services. This London-based orthopedic leader now brings this innovation to total hip arthroplasty (THA), designed exclusively for use with the Cori robotic surgical

CMR Surgical has unveiled its latest innovation, the Ultrasonic Dissector, which advances the capabilities of the Versius robotic surgical system. The new instrument utilizes ultrasonic energy for proficient tissue cutting and coagulation, enhancing the Versius Plus offerings. Versius is renowned

The FDA has communicated a notification informing users about the revisions made by Boston Scientific (NYSE: BSX) to the instructions for their PolarX cryoablation catheters. This measure involves updating the instructions for use (IFU), rather than withdrawing the product from

Medline has revealed today that it discreetly filed a preliminary registration with the U.S. Securities and Exchange Commission (SEC) for a potential initial public offering (IPO). The company, headquartered in Northfield, Illinois, has submitted its Form S-1 to the SEC