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.
Vuno Inc. received approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for Vuno Med Deepcars, its artificial intelligence (AI) medical device for cardiac arrest prediction. Approval in hand, Seoul-based Vuno will push for wider adoption of its biosignal-based AI technology. Vuno Med Deepcars predicts the probability of cardiac arrest occurring within a 24-hour period by analyzing a patient’s pulse, respiratory rate, diastolic and systolic blood pressure as well as body temperature. The data is collected from the electronic medical record of hospitalized patients.
The use of voice recognition systems based on artificial intelligence (AI) in health care is emerging in India, which offers a potentially enormous market, according to Scribetech Healthcare (India) Pvt. Ltd., one of the leading voice recognition companies in the country.
Fujifilm Holdings Corp. has bagged the Japanese Pharmaceuticals and Medical Devices Agency (PMDA)’s approval for CXR-AID, its artificial intelligence (AI) powered chest X-ray analysis system developed in collaboration with Lunit Inc.
Verily Life Sciences LLC, a division of Alphabet Inc., took its first major step to fulfill its goal of transforming clinical trials with the announcement of an agreement to buy Signalpath LLC for an undisclosed sum. The deal is Verily’s first major acquisition since the company spun out of Google Inc. in 2015. It’s likely not the last deal for the company in the short-term, however, as it raised $700 million in December 2020 to fund its aggressive expansion plans.
Using a minimally invasive brain implant, Feinstein Institutes for Medical Research scientists produced tingling sensations in the fingers of patients who lacked the sense of touch as a result of nerve damage, according to a study published in Brain Stimulation. A second study by the team, which appeared in Frontiers in Neuroscience, used stereoelectroencephalography (SEEG) electrodes to decode neural signals to improve the hand control algorithms in brain-computer interfaces.
Scientists at Cleveland-based Case Western Reserve University have used artificial intelligence (AI) to identify biomarkers contained in naturally occurring collagen that could predict whether breast cancer will return after treatment. Identified from standard tissue biopsy slides of early-stage breast cancer, collagen-based assays could also be less expensive than gene expression-based assays typically conducted at highly specialized labs in California.
PARIS – Screenpoint Medical BV has just closed $28 million in series C funding to scale its latest generation of the Transpara system, which uses fusion AI for 2D and 3D mammography.
Nihon Kohden Corp. has acquired Advanced Medical Predictive Devices, Diagnostics and Displays Inc. (AMP3D) for an undisclosed sum. The company provides data analytics and artificial intelligence solutions for proactive clinical care. Charlottesville, Va.-based AMP3D owns a large library of clinical predictive algorithms, as well as the Continuous Monitoring of Event Trajectories predictive analytics platform. The latter, a software-as-a-service platform, leverages patients’ continuous monitoring data, vita signs, medical records and laboratory tests to display patients’ risk trajectories, both in current and continuous time.