Edwards Lifesciences announced today that the FDA granted approval for its Evoque tricuspid valve replacement system. The company says this makes Evoque the first transcatheter therapy to receive an FDA nod to treat tricuspid regurgitation (TR). Irvine, California-based Edwards won CE mark for the Evoque system in October 2023. That approval also marked a first […]
FDA
FDA clears latest Philips TEE transducer for cardiac care
Philips announced today that the FDA granted 510(k) clearance to its latest TEE transducer technology. The Dutch medtech giant designed its transesophageal echocardiography (TEE) ultrasound transducer to help in the early diagnosis of structural heart disease. TEE helps cardiologists by providing highly detailed images of the heart and its internal structures. Additionally, TEE can help […]
FDA approves Farapulse pulsed field ablation tech from Boston Scientific
Boston Scientific announced today that it received FDA approval for its Farapulse pulsed field ablation (PFA) system. Shares of BSX were up more than 2% at $62.79 in morning trading on the back of the news, as the company also posted strong fourth-quarter earnings results. MassDevice‘s MedTech 100 Index was up nearly 1%. The much-anticipated […]
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 […]
Philips discontinues certain CPAP product lines after recall saga, stock sinks on Q4 results
Philips has discontinued the U.S. sales of several respiratory device product lines, including one from its much-maligned CPAP portfolio. The company says it agreed with the FDA and the DOJ on the terms of a consent decree focused on the Respironics business. Philips says it provides “clarity and a roadmap” for compliance and the restoration […]
CroíValve wins FDA IDE for tricuspid heart valve
CroíValve announced today that it began an early feasibility study for its Duo tricuspid coaptation valve system. The beginning of the study follows FDA investigational device (IDE) approval. Tandem II, a prospective, multi-center, non-randomized, single-arm study looks at the safety and performance of Duo in patients with severe or greater symptomatic tricuspid regurgitation (TR). Duo […]
Abbott wins FDA nod for world’s smallest rechargeable DBS system with remote programming
Abbott announced today that it received approval from the FDA for the launch of its Liberta RC DBS system. Liberta RC DBS (rechargeable deep brain stimulation) features remote programming for treating people with movement disorders. Abbott says it requires the fewest recharges of any FDA-approved DBS system, needing just 10 recharge sessions a year for […]
FDA clears Syngo Virtual Cockpit tech from Siemens Healthineers
Siemens Healthineers announced that the FDA cleared its Syngo Virtual Cockpit, a private, secure communication platform. The platform enables real-time image visualization, acquisition and collaboration between healthcare professionals across multiple sites. Siemens Healthineers designed the software so users can connect to CT, MR, PET and a number of other scanners. Scanners include those made by […]
FDA grants breakthrough nod for Pi-Cardia leaflet modification device for TAVR
Pi-Cardia announced today that the FDA granted breakthrough device designation for its ShortCut leaflet modification device. ShortCut facilitates valve-in-valve transcatheter aortic valve replacement (TAVR) procedures in patients at risk of coronary obstruction. Rehovot, Israel–based Pi-Carda earned the breakthrough nod after completing enrollment in a U.S. and European pivotal study last September. The leaflet modification system […]
Modular Medical submits next-gen insulin pump for FDA clearance
Modular Medical (Nasdaq:MODD) announced today that it submitted its next-generation MODD1 insulin pump to the FDA for 510(k) clearance. San Diego-based Modular Medical develops patented insulin delivery technologies, aiming to improve access to glycemic control. Its founder, Paul DiPerna, previously founded leading insulin pump maker Tandem Diabetes Care. DiPerna invented and designed Tandem’s t:slim pump. […]
FDA approves expanded MRI labeling for Abbott Proclaim neurostim
Abbott announced today that the FDA approved expanded MRI labeling for its Proclaim DRG neurostimulation system. Proclaim DRG provides targeted relief for people with complex regional pain syndrome (CRPS) types I and II of the lower limbs. It stimulates the dorsal root ganglion (DRG) clusters of nerve cells found along the spine. Abbott says four […]