The FDA has granted clearance of Siemens Medical Solutions Inc.’s photon-counting computed tomography (CT) scanner, Naeotom Alpha. The new diagnostic imaging device uses a photon-counting detector that measures individual X-rays that pass through a patient's body, as opposed to current systems that use detectors that measure the total energy contained in X-rays at once. The scanner then transforms the information from the X-ray photons into a detailed three-dimensional image, which can be used by physicians to assist diagnosis or treatment preparation planning.

A series A fundraising round lifted the mood at Genetikaplus Ltd. (Genetika+), raking in $10 million, a healthy 33% more than the initial target of $7.5 million. Proceeds from the round will go to fund trials of the Jerusalem-based company’s “brain-in-a-dish” technology for evaluating the best antidepressant for each patient. Greybird Ventures led the round, with participation by Meron Capital, Jumpspeed Ventures and Sapir Venture Partners.

A cloud-based web application for long-term brain monitoring has received a CE mark to support personalized management of neuro-disorders such as epilepsy. Developed by Swiss neuroscience research organization Wyss Center, Epios Cloud displays and reviews electroencephalogram (EEG) recordings made by EEG devices using scalp and sub-scalp electrodes, heart rate and accelerometer measurements.

Shanghai Wision AI Co. Ltd. (Wision AI) has shared positive data from a first-of-its-kind study on the use of artificial intelligence (AI) computer-aided polyp detection (CADe) system during colorectal cancer screening in a U.S. patient population. Published in the journal Clinical Gastroenterology and Hepatology, it marks the world’s first external independent randomized controlled trial of AI in the medical field conducted in the U.S.

As if it were needed, Amicus Therapeutics Inc.’s spin-off of its gene therapy work and PDUFA VII’s provisions to increase the capacity of the FDA’s Center for Biologics Evaluation and Research offered further proof this week of the global explosion that’s happening in the regenerative medicine field.

The EU’s Medical Device Regulation is now in full implementation mode, but the In Vitro Diagnostic Regulation (IVDR) won’t kick in until May 2022. Oliver Bisazza, director general of Medtech Europe, said that only six notified bodies are currently certified to review IVDs under the new regulatory framework, a predicament which suggests that many these tests will never again be available to patients.

Nonagen Bioscience Corp. received FDA breakthrough device designation for its liquid biopsy assay designed to predict response to treatment for bladder cancer. The test, Oncuria, measures 10 protein biomarkers in a urine sample and uses an algorithm to predict whether patients will respond to Bacillus Calmette-Guerin (BCG), the first-line treatment for bladder cancer, or should proceed to another treatment option.

Selux Diagnostics Inc. has received breakthrough device designation from the FDA for its Next Generation Phenotyping (NGP) platform for positive blood culture and sterile body fluid samples. The NGP technology is a diagnostic platform designed to help with the delivery of personalized antimicrobial therapies within 24 hours. The Boston-based company is hoping the technology can tackle the global antibiotic resistance crisis. According to the World Health Organization, antimicrobial resistance is one of the top 10 global public health threats facing humanity.

PERTH, Australia – As Australia prepares to reopen the country after strict lockdown measures, the TGA is making a new regulation to allow companies to supply their COVID-19 rapid antigen self-tests for home use beginning Nov. 1. “There’s light at the end of the tunnel for Australians on a number of fronts,” said Health Minister Greg Hunt in a Sept. 28 press conference.

TORONTO – Health Gauge Inc. (HG) and AI-on-Call Inc. will soon deploy a digital remote patient monitoring solution for early prediction of sepsis at three seniors' facilities located in British Columbia. HG’s smartwatch and AI-driven cloud platform capture an array of vital signs data, including blood pressure, heart and respiratory rates, and will be supported by AI-on-Call software that alerts medical staff to early signs of sepsis and acute illness.