Magnus Medical Inc. reported that the first participants have been treated for major depressive disorder during the Open Label Optimization clinical trial scheduled for nine different sites across the U.S. The trial is evaluating the effectiveness of the Magnus Neuromodulation System with Saint technology, potentially a key tool for treating the severe depression experienced by 60 million Americans. Early results indicate that Saint, which condenses the time needed for transcranial magnetic stimulation from five-plus weeks to five days, induces remission in up to 90% of those treated.
US CMS sticks with new mandates for Medicare new technology add-on payment
The U.S. Centers for Medicare & Medicaid Services finalized the Medicare inpatient prospective payment system for fiscal year 2024 with a number of new and renewed new technology add-on payments (NTAPs) for the coming fiscal year. Controversially, however, the agency retained a proposal from the draft that requires that a product have received market authorization from the FDA by no later than May 1 of the prior fiscal year to qualify for NTAP payment, a provision that industry has blasted as exclusionary of products that merit an NTAP payment.
Ultrasight’s AI cardiac imaging tool a ‘game changer’ for heart patients
The U.S. FDA’s recent clearance of Ultrasight Inc.’s artificial intelligence (AI)-powered ultrasound guidance technology will allow the widespread detection of heart diseases in the U.S. and ease bottlenecks in the healthcare system that currently restrict access for many people, Davidi Vortman, CEO of Ultrasight told BioWorld. Ultrasight’s software helps medical professionals without sonography experience acquire cardiac ultrasound images at the point of care in multiple settings.
Summertime blues: Baxter, Draeger and GE Healthcare hit with recalls
Device recalls pop up with no regard to human appreciation for seasonality, and thus it was that recalls involving three major medical device makers emerged as the steamy month of July gave way to the dismal heat of August. These recalls affected more than 7,500 units of the Trusignal pulse oximeter by GE Healthcare Technologies Inc., nearly 23,000 units of the Sigma Spectrum infusion pump by Baxter Healthcare Corp., and an unspecified number of units of the Carina ventilator by Drägerwerk AG, all of which adds a little more than the usual heat to the FDA’s deep summer blahs.
‘Made in America’ executive order steers clear of Titanic-sized iceberg
A huge sigh of relief from the life sciences industry greeted U.S. President Joe Biden’s executive order that’s intended to shore up domestic manufacturing of products developed with taxpayer support. “It’s like the Titanic, [but] we just missed the iceberg,” Joseph Allen, executive director of the Bayh-Dole Coalition, told BioWorld. The fear for the past few years has been that the administration would follow in the wake of the Department of Energy, which broadly expanded the current Bayh-Dole U.S. manufacturing preference.
Also in the news
Aviv Clinics, Bigomics Analytics, Biocomposites, Bio-Gate, Bodyport, Caredx, Click Therapeutics, Concertai, Dnanexus, Guardant, Gynesonics, Illumina, Immprev Bio, Karius, Mirada Medical, Perosphere Technologies, Talis Biomedical, US Medical Innovations, Vivosense