The U.S. FDA recently released a guidance for non-invasive remote monitoring devices, which were granted tremendous leniency during the COVID-19 pandemic as a means of reducing the demands on hospitals and doctor’s offices. That policy has been extended for the non-COVID era as part of the agency’s strategic plan to improve health equity by ensuring that access to digital health technologies is enjoyed by diverse American populations in a variety of health care access-challenged geographical areas.
Results from a meta-analysis of magnetic resonance imaging (MRI)-guided adaptive radiation for prostate cancer by radiation oncologists from the Dana Farber Cancer Institute demonstrated the treatment reduces complications while comparing well to standard approaches. The study was published in Cancer.
The near $50 million cash injection Nvision Imaging Technologies GmbH recently received is “instrumental” as it will allow the company to take its hyperpolarized magnetic resonance imaging (MRI) technology to labs worldwide, CEO Sella Brosh told BioWorld. The German startup’s quantum technology makes MRI imaging up to 100,000 times more precise which will allow for the earlier diagnosis of cancer, better assessment of the risks involved and the ability to assess in a matter of days, whether treatment is working.
Whoever said beauty is only skin deep hasn’t looked below to see what Sientra Inc. has made available there recently. The medical aesthetics company now boasts the only tissue expander cleared in the U.S. for exposure to magnetic resonance imaging, an important screening tool for breast reconstruction patients. Sientra’s CTO Denise Dajles told BioWorld the newly cleared Allox2 Pro Tissue Expander builds on the original expander also cleared by the FDA. “No other expander in the market has an MRI compatibility indication because they are based on a metal, i.e., metallic ports and big magnets in them,” Dajles explained.
GE Healthcare Technologies Inc. has launched Sonic DL, a deep learning technology designed to significantly accelerate magnetic resonance imaging (MRI) exams, after receiving regulatory clearance from the U.S. FDA.
Results from a new study suggest that treatment with Magnus Medical Inc.'s Saint neuromodulation system causes abnormal brain signals to become normal by reversing the direction brain signals flow in severely depressed individuals. The researchers also identified a new biomarker that could help doctors diagnose and treat major depressive disorder (MDD).
Abbott Laboratories received U.S. FDA approval for an expanded indication for its spinal cord stimulator (SCS) devices to include treatment of chronic back pain for individuals who have not had or are ineligible for back surgery. The FDA based its decision on the positive results from the DISTINCT study which showed that 85.2% of patients implanted with the SCS devices achieved significant reduction in back pain compared to 7.1% of those who received conservative medical management.
The neonatology unit at Bonn University Hospital (UKB) in Germany conducted the world’s first study of portable magnetic resonance imaging at the bedside on children undergoing extracorporeal membrane oxygenation (ECMO) therapy. This procedure involves oxygenating the blood outside the body. The 10-strong neonatology team demonstrated that it is safe and feasible to perform portable MRI at the bedside in this patient population.
Perspectum Ltd. raised $19 million in the second close of its series C funding round bringing the total amount raised in the round to $55 million. The fundraising was led by Oppenheimer & Co. Inc., which sees the potential for long-term growth in Perspectum’s imaging and diagnostic technologies and invested $27 million.
The U.S. FDA granted 510(k) clearance to Hyperfine Inc. for improved artificial intelligence (AI)-powered software for its Swoop portable magnetic resonance imaging (MRI) device. The company launched the new software this week.