Merit Medical Systems (Nasdaq:MMSI) announced today that it received FDA 510(k) clearance for the Scout MD surgical guidance system. Scout MD broadens the South Jordan, Utah–based company’s oncology portfolio. Merit designed the system to enhance the diagnosis and treatment of breast cancer, as well as other soft tissue cancers. The system includes the Scout radar […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
FDA clears first over-the-counter fingertip pulse oximeter from Masimo
Masimo announced today that it received FDA clearance for its MightySat Medical over-the-counter fingertip pulse oximeter. The company says that the regulatory nod makes MightySat Medical the first and only FDA-cleared medical fingertip pulse oximeter available over the counter (OTC), direct to consumers without a prescription. Irvine, California-based Masimo powers its OTC pulse oximeter with […]
Wandercraft wins FDA clearance for exoskeleton for people with spinal cord injuries
Wandercraft announced today that it received FDA clearance for its Atalante X exoskeleton for individuals with spinal cord injuries (SCIs). The FDA granted clearance for people with SCIs at levels T5 to L5 to utilize the self-balancing robotic exoskeleton technology. The system enables those with limited mobility to stand up and walk again. Wandercraft says […]
FDA approves MRI labeling on Mainstay Medical’s ReActiv8 restorative neurostimulation system
Mainstay Medical this week announced it received FDA approval for MRI labeling on its ReActiv8 restorative neurostimulation system. The approval allows patients implanted with the 45 cm ReActiv8 leads to be eligible for full-body MRI scans. Patients will be able to undergo 1.5T full-body MRI scans. Specific scan conditions and safety information are provided in […]
FDA clears 5008X hemodialysis system from Fresenius Medical Care
Fresenius Medical Care announced today that it received FDA clearance for its 5008X hemodialysis system. The company said this marks a step toward bringing a new standard of care in dialysis therapy to the U.S. Bad Homburg, Germany-based Fresenius can now begin U.S.-based clinical evaluations and user studies ahead of a broad launch in 2025. […]
Philips wins FDA nod for latest IntelliVue patient monitor software including Sounds alarm package
Philips announced today that it received FDA 510(k) clearance for its latest IntelliVue patient monitor software. The latest IntelliVue technology includes several new solutions, including the Philips Sounds alarm package. This clearance means the alarm package now has availability in the U.S. and more than 200 countries worldwide. Philips worked with clinicians and sound experts […]
Philips has a serious BrightView recall due to potential falling component
Philips issued a recall notification deemed Class I — the most serious kind — for its BrightView SPECT imaging systems. In December 2023, Philips notified customers about a potential issue with BrightView systems (including BrightView, BrightView X and BrightView XCT). Under specific circumstances, the detector may move downward due to a potential component (lead screw) […]
Microbot Medical submits surgical robot for FDA IDE
Microbot Medical (Nasdaq:MBOT) announced today that it filed an FDA investigational device exemption (IDE) application for its surgical robot. Braintree, Massachusetts-based Microbot designed the Liberty surgical robot for potential use in neurovascular, cardiovascular and peripheral vascular procedures. The system includes a compact design and remote operating capabilities to reduce radiation exposure and physical strain on […]
InspireMD wins CE mark for carotid stent system
InspireMD (Nasdaq:NSPR) announced today that it received CE mark approval for its CGuard embolic prevention carotid stent system (EPS). The Tel Aviv, Israel-based company designed CGuard for the prevention of stroke. It utilizes the company’s MicroNet technology for strong acute results and durable, stroke-free, long-term outcomes. InspireMD highlighted the importance of the transition to the […]
Magstim wins FDA nod for latest transcranial magnetic stim tech
Magstim announced today that it received FDA clearance for its Horizon 3.0 transcranial magnetic stimulation (TMS) system with StimGuide Pro. The latest platform builds on the previous H 3.0 system for treating patients with depressive or obsessive-compulsive conditions. Horizon 3.0 with StimGuide Pro is the first integrated TMS system with navigation, Magstim said in a […]
FDA to reassess cryoablation tech for destroying tumors from IceCure Medical
IceCure Medical (Nadsaq:ICCM) announced today that the FDA responded affirmatively to a request for supervisory review. This follows the agency’s 2022 denial of IceCure’s de novo classification request for its ProSense cryoablation system. The Caesarea, Israel-based company sought clearance for ProSense to treat patients with early-stage, low-risk breast cancer. FDA’s affirmative response reopens the de […]