The FDA issued a notice updating instructions for a number of ventilators made by Philips (NYSE:PHG) Respironics. This recall involves updating instructions for devices, not removing them from use or sale. The FDA identified the recall as the most serious kind, as it may cause serious injury or death. It relates to an October warning […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Medtronic wins FDA nod for new InPen app to support launch with Simplera CGM
Medtronic (NYSE:MDT) today announced a regulatory milestone that supports the rollout of its next-generation CGM. Our sister site, Drug Delivery Business News, reports today that the FDA cleared the medtech giant’s new InPen insulin delivery system application. Clearance paves the way for the launch of the company’s smart multiple daily injection (MDI) system. That system includes […]
Augmedics picks up FDA nod for new CT-Fluoro registration
Augmedics announced today that the FDA cleared the CT-to-fluoroscopy (CT-Fluoro) registration method for its Xvision Spine System. The Xvision Spine System uses augmented reality to give surgeons “X-ray vision” during surgery. It launched new, FDA-cleared features and indications for the system in March. This latest addition enables surgeons to navigate off a preoperative CT scan and […]
Breaking: Medtronic expects to submit Hugo surgical robot to FDA in 2025
Medtronic (NYSE:MDT) said today that it expects to submit its Hugo surgical robot to the FDA for urology indications in early 2025. Chair and CEO Geoff Martha said on the company’s second-quarter earnings call that the medtech giant expects a submission in the first quarter of calendar year 2025. On the call, Martha said the […]
Think Surgical wins another FDA clearance for its surgical robot
Think Surgical announced today that it received FDA 510(k) clearance to use its TMINI surgical robot with the LinkSymphoKnee. The clearance enables a collaboration agreement with Waldemar Link GmbH & Co. KG, to progress. It adds the LinkSymphoKnee from Waldemar Link to the Think Surgical ID-Hub, a proprietary data bank of implant modules. They work […]
BrightHeart earns FDA clearance for AI-powered prenatal heart ultrasound tech
BrightHeart announced today that it received FDA 510(k) clearance for its first AI software for prenatal ultrasound evaluations of the fetal heart. Paris-based BrightHeart designed its AI to address the challenges of detecting congenital heart defects (CHDs) in newborns. The company says misdetection or delayed diagnosis often leads to severe consequences, including missed opportunities for […]
Zimmer Biomet wins CE mark for Persona Knee
Zimmer Biomet (NYSE:ZBH) announced today that it received CE mark approval in Europe for its Persona Revision Knee system. Warsaw, Indiana-based Zimmer Biomet said the addition to its Persona portfolio builds on its commitment to personalized solutions. Persona Revision Knee provides advanced tools for revision knee arthroplasty. The system offers a personalized fit and optimized […]
Trump taps RFK Jr. to run HHS — but two groups could block him
President-elect Donald Trump says he wants Robert F. Kennedy Jr. to serve as secretary of the U.S. Department of Health and Human Services (HHS), giving him oversight of the FDA, CMS, CDC, NIH and other critical health agencies and functions. It’s not clear yet whether Republicans in the U.S. Senate would confirm Kennedy’s appointment given […]
FDA clears outpatient cardiac telemetry for SmartCardia ECG patch
SmartCardia announced today that it received FDA clearance for mobile outpatient cardiac telemetry (OCT/MCT) for its ECG platform. The clearance comes for the company’s seven-lead live ECG montoring patch and cloud platform. SmartCardia designed its easy-to-wear, cable-free, waterproof patch for up to 14 days of continuous monitoring. The Lausanne, Switzerland-based company already has FDA clearance […]
GE HealthCare wins FDA nod for new head-only MRI system
GE HealthCare (Nasdaq:GEHC) announced today that it received FDA 510(k) clearance for its Signa Magnus MRI scanner. The 3.0T high-performance, head-only scanner offers new capabilities for both clinical imaging and neuroscience. It has the potential to aid in the detection of neurological, oncological and psychiatric conditions, according to a news release. Signa Magnus features what […]
FDA Commissioner Dr. Robert Califf weighs in on Trump’s election as he plans his own exit: ‘Stand by the people’
FDA Commissioner Dr. Robert Califf said industry support will be the biggest factor in keeping talented employees at his agency under President-elect Donald Trump’s administration. In an interview today at the Friends of Cancer Research annual meeting, Califf said he was personally disappointed by the election results but wouldn’t engage in hypotheticals about potential changes […]
