Resapp Health Ltd. saw its stock shoot up 35% on the heels of positive clinical results for its new smartphone-based COVID-19 screening test. In a pilot clinical trial of 741 patients recruited in the U.S. and India, digital health company Resapp’s screening test, which uses machine learning to analyze the sound of a patient’s cough, correctly detected COVID-19 in 92% of people with the infection. Read More
Eko Devices Inc. launched a redesigned app and smart stethoscope system to detect heart disease during a regular physical, potentially reducing the time to diagnosis and treatment for America’s number one killer. The system incorporates artificial intelligence (AI) to identify heart murmurs and atrial fibrillation with performance the company says is on par with cardiologists. Read More
Diagnostic imaging group Bracco Imaging SpA signed a licensing and collaboration agreement with Philochem AG. The companies will focus on developing and commercializing a small molecule for diagnostic imaging applications that can detect metastatic solid tumors in cancer patients. Read More
Much of the question of FDA regulation of artificial intelligence (AI) and machine learning (ML) is seen as revolving around changes to the statute, but that does not mean the FDA and other agencies are in wait-and-see mode. Representatives of both the FDA and Health Canada said on a March 22 webinar that guidances related to these algorithms will be posted later this year, thus opening the door to a more predictable premarket path for these products. Read More
Murrysville, Pa.-based Philips Respironics Inc. has had its share of troubles with its devices for respiratory use, including several CPAP machines. The FDA reported March 21 that the company’s V60 and V60 Plus respirators are now the subjects of a class I recall due to the use of an expired adhesive that could ultimately lead to a shut-down of the devices, including instances in which the shut-down would not be accompanied by an alarm. Read More
The tides have turned for med-tech financings as private companies are now raising the largest proportion of money. In the early months of 2021, 2020 and 2019, public companies took the greatest share. However, amounts raised overall are down by 50% over the same period of 2021 and the number of transactions has fallen 17%. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Appliedvr, Lumithera, Perspectum, Resapp Health. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arthrex, Bimini Health, Biocardia, Biocomposites, NIBIOHN, Nuvo, Royal Philips, Suneva, Viveon, Zimmer Biomet. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Catalyst Orthoscience. Read More
