R3 Vascular announced today that the FDA granted investigational device exemption (IDE) to evaluate its Magnitude drug-eluting bioresorbable scaffold. Mountain View, California-based R3 Vascular designed Magnitude for treating below-the-knee (BTK) peripheral arterial disease (PAD). With the FDA granting IDE, it can now initiate the ELITE-BTK pivotal trial for the next-generation bioresorbable scaffold. R3 Vascular makes […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
FDA clears Quanta home hemodialysis system
Quanta Dialysis Technologies announced today that it received FDA 510(k) clearance for the use of its dialysis system in the home. Beverly, Massachusetts–based Quanta said in a news release that the FDA nod makes it the only company offering a high dialysate flow (500 mL/min) system across the entire care continuum for end-stage renal disease […]
FDA clears Exactech porous 3D tibial implant for knee replacement
Exactech announced today that it received FDA 510(k) clearance for its Truliant porous tibial tray, a 3D tibial knee implant. Truliant leverages additive manufacturing to create a porous structure designed to mimic the structure of cancellous bone. Exactech designed it to facilitate both initial and biological fixation to accommodate patients’ active lifestyles. The laser-printed 3D […]
FDA clears second set of changes to iRhythm Zio AT to resolve warning letter
iRhythm Technologies (Nasdaq:IRTC) announced that the FDA granted 510(k) clearance for Zio AT design modifications and labeling updates. San Francisco-based iRhythm submitted two updates to the mobile cardiac telemetry device following an FDA warning letter last year. The letter, made public shortly after the company’s announcement, accused iRhythm of violations related to rules for labeling, quality […]
RFK Jr. says he’ll control FDA and Health and Human Services if Trump wins
Robert F. Kennedy Jr. says former President Donald Trump promised him “control” of the U.S. Department of Health and Human Services and its agencies — including the FDA, CDC and NIH — if Trump returns to office. In August, Trump said he would consider adding Kennedy to his administration’s second term if Kennedy ended his […]
FDA approves Abbott CGMs for use during medical imaging
Abbott (NYSE:ABT) today announced a significant regulatory milestone that could make common medical procedures easier for people with diabetes. Our sister site, Drug Delivery Business News, reports today that the FDA cleared the removal of the imaging contradiction for the FreeStyle Libre 2 and 3 continuous glucose monitors (CGMs) for procedures like X-rays, CT scans and […]
FDA says do not use Hologic’s BioZorb marker implants following recall
The FDA is advising consumers and healthcare providers not to use BioZorb Markers and BioZorb LP Markers made by Hologic following a recent recall. Hologic issued a voluntary recall on October 24 for all unused BioZorb markers following reports of serious adverse events in patients who had the devices implanted in breast tissue. The company […]
Distalmotion wins FDA de novo nod for Dexter surgical robot
Distalmotion announced today that it received FDA de novo approval for its Dexter surgical robot for adult inguinal hernia repair. Lausanne, Switzerland–based Distalmotion can now bring Dexter to the U.S. with more than 1,300 patients already treated in Europe. The company designed Dexter to deliver robotics’ benefits to more hospitals, outpatient departments and ambulatory surgical […]
Vantis Vascular wins FDA nod for integrated microcatheter guide extension system
Vantis Vascular announced today that it received FDA 510(k) clearance for its CrossFast integrated microcatheter guide extension system. San Jose, California-based Vantis develops the CrossFast system along with the CrossShock intravascular lithotripsy (IVL) system. It designed CrossFast to help physicians perform faster, easier and safer procedures. The guide extension catheter offers additional support and facilitates […]
Dexcom submits 15-day CGM to FDA, beats Street in Q3
Dexcom’s third-quarter earnings report included news of a significant submission to the FDA for the company’s latest-generation technology. Our sister site, Drug Delivery Business News, reported that San Diego-based Dexcom submitted a 15-day version of its G7 continuous glucose monitor (CGM) to the FDA. The technology previously had a wear time of 10 days. This would […]
FDA approves Medtronic’s Affera cardiac mapping and ablation system and Sphere-9 catheter
Medtronic (NYSE:MDT) today said it received FDA approval for its Affera mapping and ablation system with the Sphere-9 catheter. The all-in-one, high-density (HD) mapping, pulsed field ablation (PFA) and radiofrequency (RF) ablation system treats persistent atrial fibrillation (AFib) and offers RF ablation for cavotricuspid isthmus (CTI) dependent atrial flutter. Medtronic also recently received the FDA’s […]
