Ophthalmology

The US FDA released six more device classifications in early September, including products from Edwards, Interscope, and Baxter Healthcare.

The program, which brings together innovators and device industry stakeholders, helps ease the path to market for novel devices. 

Notal Vision, a Virginia-based patient-centric ophthalmic remote monitoring services provider, has won de novo marketing authorization from the US FDA for a product that allows patients to keep tabs on their age-related macular degeneration while at home.

The Belgian start-up is developing a scleral contact lens with an inbuilt LCD screen capable of filtering light – offering a non-surgical solution to a variety of ophthalmic conditions.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights interviews with Abbott’s head of Lingo Biowearables and top executives at Twin Health. Reed Miller provides an update on J&J MedTech’s launch of the Ottava soft-tissue robotic surgery system and Barnaby Pickering talks about his recent interview with Leo Grady, former CEO of Paige AI, to talk about his new start-up Jona.

Jacqueline Henderson was appointed president, Johnson & Johnson Vision, EMEA, in April, as part of a restructuring of senior regional roles. Now overseeing this most culturally diverse of territories for both Vision Care and Surgical Vision, she explains the rationale for the internal realignment and where Johnson & Johnson Vision goes next.

Emerging Company Profile: The US biotech SpyGlass is gearing up for a Phase I/II trial in glaucoma after recently closing a $90m fundraising to help advance its intraocular delivery platform to address poor treatment adherence in chronic eye diseases.  

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb discusses how two medtech CEOs are and aren’t using ChatGPT in their businesses while Reed Miller talks about his “Cardio Conversations” podcast interviews with Quentin Blackford, CEO of iRhythm, and Rob Krummen, CEO of Vektor Medical. Washington, DC-based reporter Hannah Daniel reviews highlights from the HIMSS conference and the latest updates on FDA guidances.

Leaders of burgeoning ophthalmology companies pitched innovations for treating glaucoma, macular degeneration and corneal blindness to potential investors and partners at the LSI Emerging Medtech Summit in Dana Point, CA. Here’s what Medtech Insight heard and learned in on-site interviews with chief executives.

The US Food and Drug Administration has granted premarket approval to Bausch Health Companies StableVisc Ophthalmic Viscosurgical Device used during cataract surgery.