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.
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.
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.
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.
Hemoalgae, from Cartago, Costa Rica, is moving forward with the extraction and development of molecules of hirudin, a peptide with anticoagulant properties, which impacts the biotech and med-tech sectors. Their uniqueness? Sourcing the anticoagulant hirudin from algae.
Drug addiction has often proven resistant to the best efforts for treatment. New York-based startup Medicasafe Inc. hopes to provide another tool in the arsenal to boost opioid use disorder (OUD) treatment. Rather than send a recovering addict home every couple of weeks with an unmonitored and uncontrolled supply of buprenorphine and naloxone, it has developed a drug-device combination product that digitally enables and tracks patient retrieval of these drugs.
TORONTO – On average, radiology specialists diagnose fewer than 50% of cases of collapsed lung or pneumothorax using chest X-rays, said systems design engineer Hamid Tizhoosh. The Insignio system developed at Tizhoosh's Kitchener, Ontario-based Kimia Lab has gone further by identifying 75% of cases of collapsed lungs using artificial intelligence (AI) to search a database of 550,000 patients and compare 30,000 cases of pneumothorax there to X-rays of new patients with unknown conditions.
Preclinical animal and cellular models are notoriously bad at predicting drug candidate toxicity in humans. Animal biology is often fundamentally different on this front than in humans, while cells in the lab can't be counted on routinely to replicate the bodily response.
TORONTO – Developed by Edmonton, Alberta-based Itraumacare Inc., the Itclamp has undergone multiple independent and peer-reviewed studies demonstrating its efficacy controlling blood flow from wounds to the head and neck during military combat in the Middle East. That's been enough for the U.S. Department of Defense's Committee on Tactical Combat Casualty Care to officially recommend its acquisition for use on battlefields.