Israeli IVF treatment developer earns CE approval for AI-based solution

The platform, EMA TM, has garnered approval from the CE certifying body to market its innovative product for use in IVF fertility clinics across Europe.

Pregnant woman, illustrative (photo credit: PIXABAY)
Pregnant woman, illustrative
(photo credit: PIXABAY)
Israeli IVF (In-Vitro Fertilization) treatment developer AViF received Europe's CE certification mark to export and sell its AI-based digital embryology management platform within the European Economic Area, the company announced on Wednesday.
The platform, EMA TM, has garnered approval from CE certifying body to market its innovative product for use in IVF fertility clinics across Europe.
EMA TM combines AI, computer vision and large data sets to improve patient success rates for IVF treatments. Its evaluation tool is stated to help determine whether a given embryo is "genetically suitable for transfer without the need for an invasive biopsy (PGT-A)," AiVF said.
“Some 30% of all IVF treatments take place in Europe, and clinics have difficulty meeting the demand for treatment,” said AiVF’s co-founder and CEO Daniella Gilboa. “AiVF’s unique solution has created an automated lab that, through its remarkable digital capabilities, is able to perform many of the embryologist's tasks rapidly, accurately and objectively.”
AViF currently houses the largest database on IVF treatments in the world. The platform itself offers "objective and automatic tools" that work off this data set, which have already been implemented in a number of European clinics. Clinical trials are currently underway in the US in hopes of earning FDA approval.
“CE approval gives us an excellent starting point to operate as one of the leading companies in the European IVF market, which is the largest in the world with more than one million treatments performed annually in 1,200 clinics, and a market estimated at $4.5 billion,” Gilboa said.  
“AiVF’s solution could dramatically improve the chances of successful IVF treatments and lower their cost in the EU, thus reducing the suffering of those going through the IVF process and enabling millions of others to fulfill their dream of having a baby,” she said.
Accompanying the CE approval, AViF also appointed an expert in the field of behavioral economics, Prof. Dan Ariely, as its new chief behavioral officer.
AViF's was established in order to create the most advanced technologies to revolutionize the field of IVF, by helping to close the gaps between the demands for these types of treatments and the clinics that can meet those demands.
IVF treatments in the US traditionally cost around $20,000, with around five rounds of treatment. The AViF platform raises the chances of success for that investment substantially, with the chances of pregnancy much higher, and fewer rounds of treatment in the process.
“Traditional embryo evaluation technique is performed manually and is not AI-data driven," said co-founder and Chief Medical Officer at AiVF Prof. Daniel Seidman. "AiVF’s studies show remarkable accuracy, proving that a digital system can outperform an embryologist in making IVF decisions. With AiVF technology now commercially available in Europe and soon in the US, we can offer the first-in-class product to improve the chances of pregnancy and of delivering a healthy baby to the world.”