Online eyewear and vision care company Visibly announced it had received FDA 510(k) clearance for its at-home vision test.
The Visibly Digital Acuity Product uses a touchscreen mobile device, like a smartphone, paired with a computer to test visual acuity, or how sharp a user's vision is at a distance.
The computer screen displays optotypes, or specifically shaped symbols or letters for vision...
In early August, the FDA issued a Class 2 Device Recall for Visibly’s Online Refraction Vision Test, stating that the company did not receive authorization from the FDA to market the product. According to the recall, Visibly has already initiated the recall.
This back and forth between the Chicago-based startup (formerly known as Opternative) and the FDA has been going on for a couple of years....
Online refractive eye exam company Visibly, formerly called Opternative, has filed a complaint in Indiana seeking to overturn a law prohibiting providers from prescribing corrective lenses via telemedicine in the state.
The suit, filed in Indiana’s Marion County Superior Court, names The Medical Licensing Board of Indiana and the Indiana Professional Licensing Agency, as well as several...
Online refractive eye exam company Opternative has announced $9 million in investment financing. Trust Ventures and Pritzker Group Venture Capital led the round, with additional support from prior backer Jump Capital.
According to the announcement, the company will put toward two major goals: doubling the size of its engineering, product, sales and marketing teams; and building awareness among...
Online refractive eye exam company Opternative has launched a voice-activated, smartphone-only version of its digital eye exam. The product is a complement to the company’s existing exam, which requires both a smartphone and a separate computer.
“To build upon our vision of making eye care available to anyone, anywhere, anytime, we built the first web-based, conversational test that can be taken...
Bankrupting docs? Patient booking platform Zocdoc is putting providers in a sticky situation, CNBC reports. The platform, which lets patients book and cancel appointments, is changing its business model. Now instead of charging providers a flat annual rate per doctor, it proposes to charge a lower annual rate as well as a booking fee for each new customer.
Not only would this dramatically...
Online refractive eye exam company Opternative has launched a new white-labeled service for eye care professionals (ECPs) called EZRx.
"The digital refraction (EZRx) and visual acuity screener are licensed to each ECP individually and [are] white-labeled to match the ECP's branding and website flow," Pete Horkan, Opternative's head of US government affairs, told MobiHealthNews in an email. "The...
Opternative, a Chicago-based purveyor of online and mobile refractive eye exams, received a warning letter from the FDA last fall. The October 30 warning letter was only recently made public by the agency.
Addressed to then-CEO Aaron Dallek (Opternative named a new CEO, Brent Rasmussen, in January), the letter makes it clear that it considers Opternative's online eye exam to be a mobile medical...
In 2016, Opternative, a Chicago-based telehealth startup offering online refractive eye exams, opened a lawsuit against South Carolina’s Board of Medical Examiners and Department of Labor, Licensing, and Regulation alleging that a newly passed law restricting online eye exams was protectionist, unconstitutional legislation.
On Friday, Judge DeAndrea Benjamin of the Fifth Judicial Circuit in...
Opternative, a Chicago-based digital health company that offers an online refractive eye exam service to help consumers get prescriptions for glasses or contacts, is suing online glasses retailer Warby Parker in New York District Court. The suit alleges that Warby Parker's Prescription Check offering (launched in May) was based on proprietary information and technology obtained from Opternative...
