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 […]
Food & Drug Administration (FDA)
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 […]
FDA approves IDE for Medtronic Prevail drug-coated balloon
Medtronic announced today that it received FDA investigational device exemption (IDE) for its Prevail drug-coated balloon (DCB). The medtech giant can now begin a pivotal clinical trial for the coronary paclitaxel DCB for in-stent restenosis (ISR) and de novo small vessel disease. It plans to use data from its Prevail Global Clinical Program to support […]
Allurion submits weight loss balloon modules to the FDA for premarket approval
Allurion Technologies (NYSE:ALUR) announced today that it submitted three modules for its weight loss balloon to the FDA for premarket approval (PMA). Natick, Massachusetts-based Allurion expects to file the fourth and final module of the PMA early next year. That module contains clinical data from the company’s AUDACITY trial. AUDACITY evaluates the balloon in 550 […]
FDA’s Dr. Michelle Tarver officially becomes new CDRH director
The FDA has removed the “acting” from Dr. Michelle Tarver’s title as head of the Center for Devices and Radiological Health (CDRH). The FDA announcement comes about three months after Dr. Jeff Shuren stepped down as head of CDRH after 15 years as medtech’s top regulator — with plans to retire by the end of […]
Peytant wins FDA de novo nod for covered stent system
Peytant Solutions announced today that the FDA granted marketing authorization for its AMStent tracheobronchial covered stent system. Plymouth, Minnesota-based Peytant designed its AMStent to treat pulmonary obstructions caused by cancer. The novel, proprietary therapy platform is indicated for treating tracheobronchial strictures produced by malignant neoplasms in adult patients. The company developed AMStent as the first […]
Boston Scientific wins FDA nods for nav-enabled Farapulse catheter, software
Boston Scientific announced today that it received FDA approval for its navigation-enabled Farawave Nav ablation catheter and clearance for new Faraview software. The two technologies comprise part of the company’s Farapulse pulsed field ablation (PFA) system. Boston Scientific initially won FDA approval for Farapulse in January. In doing so, it became second company to earn […]
Novocure wins FDA nod for lung cancer treatment wearable
Novocure announced on Tuesday that the FDA treated its Optune Lua wearable device for treating metastatic non-small cell lung cancer. Optune Lua uses tumor-treating fields (TTFields) to exert physical forces on the electrically charged components of dividing cancer cells. This results in cell death. The FDA approved the device for concurrent use with PD-1/PD-L1 inhibitors […]
FDA revokes EUA for Cue Health COVID-19 tests
The FDA today issued a notice classifying the recall of Cue Health COVID-19 tests as Class II and revoking the tests’ EUA. Earlier this year, the FDA said an inspection found that the company made changes to tests that previously garnered emergency use authorization (EUA) in 2020 and 2021. Cue Health also won FDA de novo clearance for its […]