Stratipath AB gained CE-IVD mark for its artificial intelligence (AI)-based software for prognostic risk stratification of breast cancers, clearing the path for introduction of the solution in the EU. Stratipath Breast analyzes digital histopathology whole slide images generated from surgically resected breast cancer tissue to identify patients with increased risk of disease progression. The system provides clearer guidance on the best treatment path for the 50% of women whose breast cancer is categorized as intermediate risk.
For a non-invasive cancer, ductal carcinoma in situ (DCIS) has spread rapidly—at least in research studies. Multiple companies presented results of diagnostic tests and genomic analysis that offer guidance for selecting treatment options for stage 0 breast cancer at the 2022 American Society of Clinical Oncology (ASCO) annual meeting, which concluded in Chicago on June 7. Several of these studies reliably predicted which patients can safely be selected for active surveillance without surgery, who would benefit from endocrine or radiotherapy following surgery and who would be best served by risk-reducing surgery such as double mastectomy.
Several companies showed promising results for automated insulin delivery (AID) systems at the American Diabetes Association (ADA) annual meeting in New Orleans. Studies of the systems, also known as artificial pancreas systems, indicate that integration with continuous glucose monitoring (CGM) systems enables substantially improved glycemic control, with more time in range (TIR) and less hypoglycemia than seen with multiple daily injection (MDI) therapy or insulin-pump therapy.
Abbott Laboratories received FDA clearance for its Freestyle Libre 3 continuous glucose monitoring system (CGM) just before the kickoff of the American Diabetes Association (ADA) annual meeting June 3 followed by breakthrough device designation for a combined CGM and continuous ketone monitoring system.
Even as new waves of COVID-19 cause less direct disruption in the delivery of health care, the ongoing pandemic leaves a dramatically altered landscape for medical devices in its wake. The RBC Global Healthcare Conference revealed trends that will continue to reshape the utilization of medical technology and delivery of health care, while industry leaders drilled down into the details in a focused panel discussion. All agreed: the pandemic catapulted telemedicine and remote monitoring ahead five or more years, a hybrid delivery system with greater fluctuations in volume will emerge, devices that facilitate the movement of care out of the hospital to home or outpatient settings will remain in high demand and patient-centered control of health care will continue to attract additional industries into health care markets.
Based on an evaluation of 10 artificial intelligence algorithms for diabetic retinopathy screening, the U.K. National Screening Committee (NSC) recommended Eyenuk Inc.’s Eyeart system as the only one ready for live clinical implementation. The system will be rolled out first in the North East London National Health Service (NHS) Diabetes Eye Screening Program (DESP).
More than 1.6 million spinal procedures are performed in the U.S. each year and between 10% and 30% of them fail to achieve their objective, indicating that the field has abundant room for improvement. Both equipment manufacturers and the FDA hope to improve spinal surgery success rates as seen in two clearances granted on May 31.
Healthquest Capital Management Co. LLC closed its oversubscribed fourth fund at its hard cap of $675 million, positioning the equity firm to ramp up its investment at the “convergent points between medical technologies, diagnostics/tools, digital health and innovative services,” the company said.
Retispec Inc. and the Toronto Memory Program launched a community screening program for Alzheimer’s disease (AD) funded by the Davos Alzheimer’s Collaborative (DAC). The program will provide two points of entry for screening—optometry clinics and the Alzheimer Society of Toronto. The project is one of 12 early detection efforts worldwide that received a total of $4.5 million in funding this week from DAC.
The transformation of cardiology continues with two U.S. FDA actions to promote the use of artificial intelligence (AI): a 510(k) clearance for Rapidai Inc.’s pulmonary embolism (PE) triage and notification product and breakthrough device designation for Anumana Inc.’s pulmonary hypertension (PH) early detection algorithm.
