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.
Eyenuk is well-versed in EU medtech regulations, having received a CE mark in 2015 under the medical devices directives (MDD) for its autonomous EyeArt artificial intelligence (AI) eye screening system to detect diabetic retinopathy.
More recently, the Californian digital health firm has had to grapple with the transition to the EU’s stricter Medical Device...
Agent drug coated balloon, Watchman product sales, and electrophysiology (EP) business unit growth offset Acurate discontinuation and tariff headwinds. CEO Michael Mahoney shouted out coronary therapies business and answered questions on CMS proposed Ambulatory Surgical Center codes.
The Cancer Research Horizons Innovation Awards took place on July 10. Medtech Insight spoke to nominees for the women’s entrepreneur of the year award: Mireia Crispin-Ortuzar, CEO of 52 North Health; Anita Grigoriadis, CEO of PharosAI; and Maria Giovanna Lizio, Founder of WILD-Imaging Technology.
A deep-learning AI-based retinal image scanning tool can predict the risk of cardiovascular events over a 10-year period with 70% accuracy. The test is comparable to routine GP health checks, researchers from the University of Dundee have shown.
The Milner Institute, the on-campus hub for start-up acceleration at Cambridge University, hosted its annual Pitch Day on July 1. Start-ups Panakeia, PathwayBio and Sentinal4D presented diagnostic technologies.
A deep-learning AI-based retinal image scanning tool can predict the risk of cardiovascular events over a 10-year period with 70% accuracy. The test is comparable to routine GP health checks, researchers from the University of Dundee have shown.
A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.
Waters Corp. will acquire Becton Dickinson’s Biosciences and Diagnostics business for $17.5bn, doubling its TAM to $40B. Analysts praise the flow cytometry addition but see weaker growth in diagnostics.
