NeuroMetrix (NSDQ:NURO) announced today that it received FDA breakthrough device designation for its Quell technology. Woburn, Massachusetts-based NeuroMetrix’s Quell garnered the breakthrough nod for reducing moderate-to-severe symptoms of chemotherapy-induced peripheral neuropathy (CIPN) that have persisted for at least six months following the end of chemotherapy. Shares of NURO were up 36.6% at $6.72 per share […]
FDA
Ahead of G7 launch, Dexcom CEO plans for ‘more activity than we’ve ever seen’ in 2022
With a major product approval and launch in its sights, Dexcom prepares for a big year in 2022. Across 2021, Dexcom (NSDQ:DXCM) took several steps forward. The company touted its next-generation G7 continuous glucose monitor (CGM) and announced a major regulatory nod and partnership for real-time application programming interfaces (APIs), to list a couple. As the new year gets underway, expectations for […]
FDA grants new drug approval to Glenmark’s rhinitis-treating nasal spray
Glenmark Pharmaceuticals announced today that it received FDA approval for a new drug application (NDA) for Ryaltrais. Ryaltris, a fixed-dosed, prescription drug product nasal spray treats symptoms of seasonal allergic rhinitis in adults and pediatric patients over 12 years of age in the U.S. Glenmark’s fully owned subsidiary, Glenmark Specialty S.A. (Switzerland), received the NDA approval […]
Abbott wins FDA clearance for new cardiac mapping system
Abbott (NYSE:ABT) announced today that it received FDA clearance for its EnSite X EP with EnSite Omnipolar technology (OT). The company designed the new cardiac mapping platform, now available in the U.S. and across Europe, to help physicians treat abnormal heart rhythms (cardiac arrhythmias) better. EnSite X EP creates highly detailed, three-dimensional maps of the […]
Lazurite submits wireless arthroscopic camera system for FDA 510(k) clearance
Lazurite (formerly Indago) announced today that it submitted a 510(k) premarket notification to the FDA for its ArthroFree system. Cleveland-based Lazurite designed its ArthroFree wireless camera system for minimally invasive surgery and expects it to become the first FDA-cleared, fully wireless, minimally invasive camera system for the operating room. The ArthoFree platform incorporates Lazurite’s proprietary […]
Abiomed picks up regulatory wins in U.S., Asia
Abiomed (NSDQ:ABMD) announced today that regulators in three different countries granted new approvals to Impella surgical products. Danvers, Massachusetts-based Abiomed won FDA early feasibility study (EFS) investigational device exemption (IDE) for the Impella BTR (bridge-to-recovery), while the Impella 5.5 with SmartAssist won approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and Hong Kong’s Medical […]
Dexcom CEO touts unprecedented performance of G7 in clinical trial, awaits FDA decision
Exciting new data for the next-generation Dexcom (NSDQ:DXCM) G7 continuous glucose monitor (CGM) surprised even the company’s leadership. Dexcom Chair, President & CEO Kevin Sayer — presenting clinical study results for the G7 at the 40th Annual J.P. Morgan Healthcare Conference — has previously lauded the expected impact of the wearable glucose monitor, and the new data […]
Medtronic recall of cranial software for neurosurgical procedures is Class I
The FDA confirmed that a recall of cranial software from Medtronic (NYSE:MDT) has been designated as Class I, the most serious kind of recall. Both the Synergy Cranial and StealthStation S7 Cranial software are included in the recall, which affects 943 devices distributed between May 1, 2019, and Oct. 29, 2021, in the U.S. Medtronic […]
FDA postpones some inspectional activities amid omicron surge
The FDA announced earlier this week that it made some temporary changes to its inspectional activities due to COVID-19. With the omicron variant of the virus causing surges across the world, the FDA implemented the changes in the U.S. on Dec. 29, 2021, to ensure the safety of its employees and the firms it regulates, […]
BD wins FDA clearance for microbiology bacterial identification testing automation platform
BD (NYSE:BDX) announced today that it received FDA 510(k) clearance for its Kiestra IdentifA system for testing automation. Franklin Lakes, N.J.-based BD designed its Kiestra IdentifA system to automate sample preparation for microbiology bacterial identification testing, using BD Synapsys informatics to select discrete bacterial colonies from a digital plate image. According to a news release, […]
FDA clears Glaukos’ iPrime
Glaukos (NYSE:GKOS) announced that it received FDA 510(k) clearance for its iPrime viscodelivery system. San Clemente, California-based Glaukos designed the Prime viscodelivery system as a sterile, single-use, minimally invasive device for delivering viscoelastic fluid during ophthalmic surgery. Get the full story at our sister site, Drug Delivery Business News.