The U.S. FDA has granted breakthrough device designation for Righteye LLC’s eye movement-tracking vision system as a test for Parkinson’s disease. Developed by researchers at PADRECC and Virginia Commonwealth University with funding from the Michael J. Fox Foundation, and licensed to Righteye in 2016, the test requires patients to sit in front of an all-in-one tablet-looking device and follow a series of moving targets. The goal is to identify ocular tremors, a persistent issue with Parkinson’s patients that prevents steady fixation on objects and images. The noninvasive test, which measures an individual’s ability to follow objects on a screen, could help doctors not only confirm the difficult-to-diagnose disease, but also detect it at earlier stages.

Menlo Park, Calif.-based startup Tusker Medical Inc. has received U.S. FDA approval to market its breakthrough-designated system for inserting tympanostomy tubes into the eardrum to treat recurrent ear infections. The Tubes Under Local Anesthesia (Tula) system is the first delivery system for tympanostomy tubes, commonly known as ear tubes, that can be performed in young children under local anesthesia in a doctor’s office. The Tula system consists of the ionic anesthetic Tymbion, Tusker Medical tympanostomy tubes and several devices for inserting the anesthetic and tubes into the ear drum. A low-level electrical charge delivers the anesthesia to the eardrum prior to tube placement, allowing for quick and needle-free numbing of the tympanic membrane.

BEIJING – Shenzhen-based Xbiome Co. Ltd., said to be China’s first AI-based microbiome drug development company, closed a series B financing round to pocket ¥100 million (US$14 million).

Radiologist burnout is a common problem. To combat this issue, Berkeley, Calif.-based Rad AI has launched with a $4 million seed round led by Gradient Ventures, Google's AI-focused venture fund. Other participants in the round were UP2398, Precursor Ventures, GMO Venture Partners, Array Ventures, Hike Ventures, Fifty Years VC and various angels.

The research challenge facing the scientific founders of newly launched Immunitas Therapeutics Inc. was getting human samples to deeply analyze in their quest to understand autoimmunity. While the research continued slowly, the science raced ahead. 

TORONTO – If you’ve successfully expanded your medical technologies business once, why not do it a second time? The answer was quick in coming Nov. 5, when Quebec City-based Opsens Inc. announced its next goal: To accelerate development of products beyond its current line of technologies for measuring coronary pressure into the structural cardiology space.

HONG KONG – South Korean pharmaceutical giant Yuhan Corp. has invested ₩3 billion (US$2.6 million) in SL Bigen Co. Ltd., a Korean biotech based in Seongnam, Gyeonggi-do, that is focused on chimeric antigen receptor-directed natural killer (CAR-NK) therapy.

Urinary tract infections (UTIs) are a common reason for women to visit their doctor. While virtual doctor visits have been possible to detect UTIs, patient-reported symptoms typically have drove diagnoses. Now, Los Angeles-based Scanwell Health is bringing its at-home smartphone-enabled test and treatment service for UTIs to all 50 states. Scanwell said its offering its the first U.S. FDA-cleared urine testing app available over-the-counter without a prescription.