The U.S. FDA has granted breakthrough device designation to Tempus Inc. for its ECG Analysis Platform. Developed in collaboration with Geisinger, the artificial intelligence (AI)-powered platform helps clinicians identify patients at increased risk of developing atrial fibrillation (AF) or atrial flutter.

HONG KONG – Israel and U.S.-based Rsip Vision Ltd. unveiled an advanced joint segmentation tool to assist with the planning of revision arthroplasty and other orthopedic procedures for patients with pre-existing metal implants. The detailed, noninvasive artificial intelligence (AI)-based software module enables quick and accurate segmentation of different joints from CT scans of hips, knees, shoulder and spines.

The COVID-19 pandemic has affected wide swaths of the global economy, mostly in a negative manner, but it has spurred some types of innovation at a rate that would be unimaginable in ordinary times. That seems to be the take-away for an emergency use authorization (EUA) granted to Miami-based Tiger Tech Solutions Inc. for its COVID Plus monitor, which uses plethysmography and a machine learning algorithm to provide a screening mechanism at mass gatherings, thus bringing the world one step closer to a state of normalcy.

TORONTO – Hemocath Ltd. is gearing up for a first-in-human trial of a device that addresses two critical metrics for the treatment of heart failure: pulmonary artery and central venous pressure. Hemocath’s pulmonary artery catheter (PAC) is part of a larger heart failure monitoring platform and is intended to assess fluid status in patients with severe or worsening congestive heart failure. The hope is to replace larger, more invasive catheters inserted into a patient’s neck.

COVID-19 continues to dramatically reconfigure medicine as an ever-broadening array of digital therapies rolls out and telemedicine tackles increasingly complex applications. Abbott Laboratories’ newly launched Neurosphere Virtual Clinic exploits both trends to make management of chronic pain and movement disorders easier for patients.

Inflammatix Inc. raised $102 million in series D financing to advance development and commercialization of its novel immune response diagnostics portfolio. D1 Capital Partners led the round, with additional funds provided by existing investors Northpond Ventures LLC, Khosla Ventures, Think.Health GmbH, and OSF Healthcare Ventures, among others.

Corvista Health Inc., a subsidiary of Toronto-based Analytics for Life Inc., reported closing on $65 million in series C equity financing, bringing total cash raised for a new cardiac diagnostics device to nearly $100 million. The Corvista system is described as noninvasive, point-of-care diagnostic system for coronary artery and other cardiovascular diseases.

MIT Media Labs spinoff Empatica Inc. secured the CE mark for its Aura system, a wearable solution for the monitoring and early alert of respiratory infections, including COVID-19. For use with people 14 and older, Aura is commercially available in Europe and the U.K., and for pilot purposes in the U.S. – pending FDA authorization. Aura’s algorithm analyzes vital signs from Empatica smartwatches, comparing data against the wearer’s historical baselines. In validation studies, Aura was able to detect patients with possible H1N1 influenza, rhinovirus or SARS-CoV-2 infection with 0.94 sensitivity. Detection occurred on average two days after infection.

Medi-Scan Inc. has emerged from stealth mode with cloud-based software that converts the data on ultrasound analog 2D grayscale images into a digital 3D high-definition (HD) format in less than two minutes. The company is currently focusing its efforts on the heart and lungs, with the aim of providing quick, point-of-service evaluation and triaging of patients with heart disease and other conditions, including COVID-19.

HONG KONG – The Korea Advanced Institute of Science and Technology (KAIST) is making headway with its 3D holotomography technology, which enables a more accurate and systematic way to view cell-to-cell interactions. This could be a game changer for assessing cell therapy.