Merit Medical Systems (Nasdaq:MMSI) announced today that it received FDA premarket approval for its Wrapsody cell-impermeable endoprosthesis. With approval, the company can begin commercializing the device in the U.S. in 2025. South Jordan, Utah–based Merit Medical designed Wrapsody to extend long-term vessel patency in dialysis patients. It consists of a proprietary covering that features a […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Roivios wins FDA IDE for renal assist device
Roivios announced that it received FDA investigational device exemption (IDE) approval to conduct a trial for its renal assist device (RAD). The company can now move forward with a pivotal trial for the JuxtaFlow RAD for treating cardiac surgery patients with renal insufficiency. This IDE follows FDA breakthrough device designation for JuxtaFlow in April. Bahamas-based […]
Onward wins FDA nod for non-invasive spinal cord stim
Onward Medical announced today that it received FDA de novo clearance for its ARC-EX spinal cord stimulation (SCS) system. ARC-EX SCS therapy delivers targeted, programmed electrical stimulation transcutaneously to the spinal cord. The technology uses electrodes placed on the back of the neck for non-invasive therapy without the need for surgery. It enables increased strength, […]
Smith+Nephew adds pre-op planning feature for Cori surgical robot
Smith+Nephew announced today that it received FDA clearance for its Coriograph pre-op planning and modeling services. The London-based orthopedic giant picked up clearance for the use of Coriograph in total hip arthroplasty (THA), exclusively with the Cori surgical robotic system. Its planning software allows for the use of either X-rays or CT scans for planning […]
Boston Scientific updates instructions for cryoablation catheters after reported deaths
The FDA issued a notice alerting customers to updates made by Boston Scientific to its PolarX cryoablation catheters. This recall involves updating instructions for use (IFU), not removing devices from the market. The FDA identified it as the most serious type of recall, though, as it may cause serious injury or death. Boston Scientific updated […]
FDA greenlights expansion of BiVacor artificial heart study
BiVacor announced today that it completed the first phase of an FDA early feasibility study (EFS) for its Total Artificial Heart (TAH). Five patients received the BiVacor TAH between July and November 2024 in the study looking at the TAH as a bridge to donor heart transplant. The initial phase supported patients with the TAH […]
FDA clears new stemless anatomical total shoulder implant from Smith+Nephew
Smith+Nephew announced that it received FDA clearance for its stemless anatomic total shoulder for the Aetos system. The company said Aetos Stemless addresses the growing demand for anatomical total shoulder replacement with a small operating room footprint, enabling an efficient procedure. Smith+Nephew designed it to maximize metaphyseal fixation and stability. It has an inlay collar, […]
BD to pay SEC $175M to settle Alaris investigation
BD announced that it reached an agreement with the SEC to resolve an investigation related to its Alaris system. The investigation relates to prior public disclosures and SEC reporting regarding Alaris, an infusion pump system. BD neither admits nor denies the findings of an SEC order related to those matters occurring more than four years […]
Boston Scientific warns on potential need to replace Accolade pacemaker devices early
The FDA today issued an alert after Boston Scientific warned of the potential need for the early replacement of certain pacemaker devices. This month, Boston Scientific issued a notice to customers saying that it identified issues with a subpopulation of Accolade, Proponent, Essentio and Altrua 2 dual-chamber standard life and dual-chamber extended life pacemakers and […]
HeartBeam wins FDA nod for at-home ECG tech
HeartBeam (Nasdaq:BEAT) announced today that it received FDA 510(k) clearance for its comprehensive arrhythmia assessment system. Santa Clara, California–based HeartBeam said its device — a high-fidelity electrocardiogram (ECG) system — is the first of its kind to receive FDA clearance. It features a credit card-sized form factor and cable-free design. The device captures heart signals […]
FDA clears Mindset Medical’s contactless pulse measurement app
Mindset Medical announced that it received FDA 510(k) clearance for its contactless pulse rate measurement device, the IVC app. This marks Mindset Medical’s first clearance and follows a Series A financing round earlier this year for the Phoenix-based company. The IVC (Informed Vital Core) app allows healthcare professionals to collect pulse rate physiological measurements in […]
