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.
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.
The company has just two quarters’ of cash remaining, but has also achieved major milestones towards the development and commercialization of its implant that hopes to restore vision in patients with age-related macular degeneration.
The new EU Medical Device Regulation sets a high bar for medtech companies. Kaushal Solanki, founder of US-based Eyenuk, tells Medtech Insight how the firm navigated the new regulation and gained two extra indication approvals for its class IIb eye screening device.
The US Food and Drug Administration published three device-related warning letters in January – two that went to divisions of endoscope vendor Olympus, and one to a Maryland vision treatment firm.
A recent webinar ranking last year’s best and worst legal verdicts said that product liability cases involving pelvic mesh and artificial lenses were the very worst.
This new Medtech Insight feature compiles news briefs on a range of US regulatory and legal happenings. This week: Congressional criticism of ClinicalTrials.gov, new radiation device performance standards, clearance of a new sepsis test and two new device classifications.
The FDA sent a warning letter to Arbor Center for EyeCare for failing to submit an IND before beginning a trial of a novel drug-device combination product.
The FDA’s Ophthalmic Devices Panel approved a Class I designation for ophthalmic dispensers, which were reclassified from drugs to devices after the Genus v. FDA decision.
The comment period for a draft guidance document on labeling for LASIK surgery equipment has been extended for another month. Ninety people have already filed comments, representing a wide range of views about the procedure.
In his recent report on Alcon, BTIG analyst Ryan Zimmerman estimated that its pharmaceutical portfolio could generate close to $900m in fiscal year 2022.
Essilor International is paying more than $16m to the US government and an additional $5m to the states to resolve allegations the company offered financial incentives to eye-care providers in exchange for sales.
The document would ask manufacturers to include additional plain-language labeling to ensure people considering LASIK have additional information about potential side effects and contraindications.
ForSight Robotics said after applying its robotic technology successfully in animals, it will use the new funding to test the technology in clinical trials.