The med-tech regulatory picture is already in a state of flux thanks to changes imposed by the EU, but device makers and those in the digital health space might soon be facing yet another series of profound changes in Europe. The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) has proposed to revamp its regulatory framework for both traditional medical device and for software/artificial intelligence, adding yet more uncertainty to an already turbulent European regulatory environment.
Prophet, Oncohost Ltd.’s artificial intelligence-driven proteomics profiling platform, predicted response to immune checkpoint inhibitor (ICI) therapy in non-small-cell lung carcinoma (NSCLC) patients in a study presented at the European Society for Medical Oncology Virtual Congress 2021. While ICI can generate a significant positive response in some patients with advanced NSCLC, in others the therapy promotes tumor growth, making identification of likely responders prior to treatment critical.
Startup company Medial Earlysign Ltd. and Roche Diagnostics International Ltd. are teaming up to bring to market artificial intelligence (AI) solutions for early detection of cancer. Founded in 2013, Tel Aviv-based Medial Earlysign uses machine learning tools to flag patients with a high probability of developing specific illnesses. The partnership with Roche will initially focus on gastric cancer.
Lunit Inc. won an innovative medical device designation from South Korea’s Ministry of Food and Drug Safety (MFDS). The designation was for Lunit Insight MMG, its commercial artificial intelligence (AI) solution for breast cancer detection from mammography images. The company said that Lunit Insight MMG is now the first medical device of its type to receive the designation, and the company now has its second innovative medical device designation. “All of our commercialized products are now designated innovative medical devices by the MFDS. We will ensure that our Lunit Insight AI products allow medical staff to rapidly and accurately diagnose patients,” said Beomseok Suh, CEO at Lunit.
There are few guidelines of any sort that are specific to artificial intelligence (AI) for medical devices, but that doesn’t mean there are no signposts for developers. There are existing product marketing authorizations that offer some insights, but the FDA’s Bakul Patel said a risk stratification guidance by the International Medical Device Regulators Forum (IMDF) is an example of a non-AI blueprint for how the FDA will ultimately approach regulation of AI.
LONDON – Health data specialist Sensyne Health plc is opening up broader access to its U.S./U.K. patient information system with the launch of a subscription service giving accredited users the ability to interrogate more than 2 million longitudinal electronic health records. At an annual cost of £25,000 (US$34,602) per head, the company will provide “industrial scale” access to anonymized hospital records “to the smallest company or to a single researcher working in academe,” through the new Sensight service, said Paul Drayson, CEO.
Stryker Corp. has made its second acquisition of the year, picking up Gauss Surgical Inc. – the developer of an artificial intelligence (AI) platform for real-time monitoring of blood loss during surgery. Financial terms of the deal were not disclosed. Kalamazoo, Mich.-based Stryker’s shares (NASDAQ:SYK) were trading 5% higher following the acquisition. Menlo Park, Calif.-based Gauss Surgical’s Triton AI technology aims to fill a void in maternal health by enabling early detection of hemorrhage.
Centaur Diagnostics Inc. herded up interest in its gamified system for labeling medical data for use in artificial intelligence (AI) applications. The Boston-based company raised $12 million in a series A round that will help Centaur build out its crowdsourced system for labeling medical images, videos, text and audio recordings. The round brings the company’s funds raised to date to $15 million. Matrix Partners led the charge along with Accel Partners, Global Founders Capital, Susa Ventures, and Y Combinator.
The Medical Device Innovation Consortium (MDIC) has launched a digital health initiative that will aid the FDA in its efforts to devise a workable regulatory system for these products, which includes a work stream for change control. This work stream promises to be a massive effort, but Joe Sapiente, MDIC's vice president for clinical science and technology, told BioWorld that MDIC needs subject matter experts in this and several other areas to sustain the group’s momentum and thus aid the FDA’s efforts to produce guidance for digital health products.
LONDON – Ibex Medical Analytics Ltd. has claimed a further advance in applying artificial intelligence (AI) to the interpretation of digitized pathology slides, reporting that the first commercial system in the world using AI to detect gastric cancers has gone live. The Galen Gastric system has been deployed at the pathology lab of Maccabi Healthcare Services, one of Israel’s leading HMOs, where it is now operational alongside Ibex’s breast and prostate cancer AI systems.