Envoy Medical has submitted the second of four planned modules for its Modular Premarket Approval (PMA) application to the FDA for the Acclaim cochlear implant, which has Breakthrough Device Designation. This submission, mainly covering engineering data, follows the first module sent in June 2026 and allows the FDA to review the device in stages while clinical trials continue. Envoy Medical aims to complete the final clinical module submission by Q2 2027, moving closer to potential market approval of this fully implanted hearing device designed for severe hearing loss. The ongoing FDA dialogue and rolling submission process help address regulatory feedback progressively.
Envoy Medical's submission of the second module for its Modular Premarket Approval application provides context for readers following medical device developments. For readers following Health-sector stocks, here is Pluang's market snapshot as of Oct 12, 2026 18:51 WIB: out of 128 priced Health-sector US stocks tradable on Pluang, 64 rose and 43 fell today. Notable movers include CTXR (Citius Pharmaceuticals Inc) at USD 0.49 with a -1.86% change and a typical hold time of 17 days, XRAY (DENTSPLY SIRONA Inc) at USD 8.67 with a -1.81% change and a typical hold time of 72 days, and DNA (Ginkgo Bioworks Holdings Inc) at USD 12.79 with a -1.62% change and a typical hold time of 7 days.
Alignment Health Plan introduced Central Health Harmony, a new Medicare Advantage plan starting January 1, 2027, targeting Asian American seniors in Los Angeles and Orange counties. The plan offers access to over 600 physicians who speak Chinese, Kor...
NVIDIA and Cisco have introduced Ultra-Dense Small Form Factor Pluggable (USFP), a new optical module supporting 400Gb/s per lane, enabling up to 12.8Tb/s capacity for AI data centers. This technology doubles bandwidth per lane and increases power ef...
Hasbro announced the fourth annual Women Innovators of Play Design Challenge, accepting submissions from October 15 to November 20, 2026. The program now includes year-round in-person networking events alongside the design competition, aiming to conn...
Micas Networks introduced three new 102.4 Tbps open Ethernet switch platforms based on Broadcom Tomahawk 6 technology, designed to enhance AI factory networks. The portfolio includes air-cooled 800G, liquid-cooled 1.6T, and co-packaged optics (CPO) s...
Ferrari N.V. has repurchased 43,000 of its common shares on Euronext Milan as part of the third tranche of its multi-year €3.5 billion share buyback program announced in 2025. The recent purchases, totaling nearly €14.8 million, are part of a broader...
