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OCT News
Select US FDA Approvals and Clearances in October 2024
The US FDA granted four clearances through the ophthalmic device division using the 510(k) pathway in October 2024, according to the agency’s database. Apple gained clearance for its Digital Prism ...
November 2024 Ophthalmic News Briefs
Heidelberg Engineering announced Oct. 14 that the US FDA had granted 510(k) clearance to its Flex Module for the Spectralis diagnostic imaging platform. The Flex Module mounts the Spectralis to a m...
US FDA Grants 510(k) Clearance to Flex Module for Heidelberg Spectralis OCT
Heidelberg Engineering announced Oct. 14 that the US FDA had granted 510(k) clearance to its Flex Module for the Spectralis diagnostic imaging platform. The Flex Module mounts the Spectralis to a m...
Digital Enhancements Reshape $3.7 Billion Ophthalmic Diagnostic Equipment Market
Ongoing investments in digital products designed to enhance ophthalmic diagnostic equipment and associated outputs are signaling a shift away from the fast-paced equipment releases of the early 200...
EssilorLuxottica Acquires Majority Stake in Diagnostics Maker Heidelberg
Eyewear conglomerate EssilorLuxottica announced July 17 that it had agreed to acquire an 80 percent stake in Heidelberg Engineering, a leader in ophthalmic diagnostic imaging. Financial details wer...
EssilorLuxottica Acquires Majority Stake in Diagnostics Maker Heidelberg
Eyewear conglomerate EssilorLuxottica announced July 17 that it had agreed to acquire an 80 percent stake in Heidelberg Engineering, a leader in ophthalmic diagnostic imaging. Financial details wer...
Select US FDA Approvals and Clearances in May 2024
The US FDA granted six clearances through the ophthalmic device division using the 510(k) pathway in May 2024, according to the agency’s database. Reichert gained market clearance for its new hand-...
Nidek Launches RS-1 Glauvas OCT System
Japan’s Nidek announced June 3 that it had launched the RS-1 Glauvas optical coherence tomography (OCT) system. The device is CE marked as a Class IIa device. Nidek said the RS-1 Glauvas’ streamlin...
US FDA Grants De Novo Marketing Authorization to Notal Vision’s Scanly AI-Powered Home OCT
Notal Vision announced May 16 that the US FDA had granted de novo marketing authorization for its patient-operated Scanly home optical coherence tomography (OCT) device. The Scanly uses artificial ...
Washington U. Gets up to $20M ARPA-H Grant to Create Portable OCT
Washington University in St. Louis, Missouri, announced Feb. 13 that one of its professors had been awarded a grant of up to $20 million from the Advanced Research Projects Agency for Health (ARPA-...
Washington U. Awarded up to $20 Million Federal Grant to Create Portable OCT
Washington University in St. Louis, Missouri, announced Feb. 13 that one of its professors had been awarded a grant of up to $20 million from the Advanced Research Projects Agency for Health (ARPA-...
January 2024 Ophthalmic News Briefs
Maker of Sophi Phaco Machines UK-based Rayner announced Jan. 17 that it had acquired Switzerland’s This AG, the maker of Sophi phacoemulsification machines. No financial details were disclosed. Sop...
Nidek Commercially Launches Mirante Scanning Laser Ophthalmoscope in US
Nidek announced Jan. 11 that its Mirante scanning laser ophthalmoscope had been launched in the US market. The device was commercialized outside the US in August 2019. The Mirante is a multimodal f...
Aurolab to Develop Kubota’s At-home OCT Device for South Asia Markets
Seattle-based Kubota Vision reported Dec. 6 that it agreed to provide Aurolab, of India, with an exclusive license to develop, manufacture, and distribute eyeMo, Kubota’s low-cost, home-based, self...
OCT Inventors Receive 2023 Lasker Award, Most Prestigious US Medical Prize
Three inventors of optical coherence tomography (OCT) have received the 2023 Lasker-DeBakey Clinical Medical Research Award, one of three Lasker Awards given annually. OCT uses light to probe tissu...
OCT Inventors Receive 2023 Lasker Award, Most Prestigious US Medical Prize
Three inventors of optical coherence tomography (OCT) have received the 2023 Lasker-DeBakey Clinical Medical Research Award, one of three Lasker Awards given annually. OCT uses light to probe tissu...
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