Kheiron Medical Technologies (Kheiron) has received CE certification for its new artificial intelligence (AI)-based breast screening software, making it the first U.K. company to receive such a designation for deep learning software in radiology.
The software, now approved for use across Europe, will serve as a second reader of mammographic images. Clinicians, the company claims, will receive results “within seconds,” directly into their existing workflows. The software will also allow radiologists to triage imaging studies before review, so they can prioritize studies based on the findings.
“With the approval of Kheiron’s software for use as a second reader, the screening workload of overstretched clinical staff in all screening settings is potentially reduced, allowing them to focus on other more complex modalities and tasks,” read a prepared statement issued by the company. “For the National Health Service (NHS), Kheiron’s software presents a new technology tool that could benefit the global ongoing radiology workforce shortage, starting with the NHS Breast Screening Program.”
Through a clinical study, Kheiron’s software demonstrated performance above the current national benchmarks for breast screening radiologists. Kheiron is also launching additional clinical evaluations in Europe and the US to assess and improve performance measures and to better determine the potential impact on breast screening outcomes.
“Regulatory approval for Kheiron comes just as the new Health Secretary announces his vision for a more technologically driven NHS,” said Kheiron’s CEO, Peter Kecskemethy, PhD, in the statement. “As a UK [small- and medium-sized enterprise] we welcome the forward-thinking of our healthcare leadership and are excited to be working closely with both clinicians and service providers to ensure that patients receive the benefits of this new wave of technology.”
Kheiron is now in the process of applying for FDA approval.
As a senior news writer for TriMed, Subrata covers cardiology, clinical innovation and healthcare business. She has a master’s degree in communication management and 12 years of experience in journalism and public relations.