After five years, the U.S. FDA finally released a final rule for over-the-counter hearing aids along with an associated guidance, a development that was stipulated by the FDA Reauthorization Act (FDARA) of 2017. Xavier Becerra, Secretary of the U.S. Department of Health and Human Services, was among several HHS officials who appeared on the Aug. 16 briefing to tout the rule, each of which promised that the rule would spark competition that would in turn take a significant bite out of the cost of acquiring a hearing aid. Read More
Monod Bio Inc. raised a $25 million seed financing round to advance its protein-based biosensor technology. The round was led by Matrix Capital, with participation from the Global Health Investment Corp., Cercano Management, the Washington Research Foundation, Boom Capital Ventures, Sahsen Ventures, and Pack Ventures. The funds will be used to create protein biosensors for rapid point-of-care medical diagnostics and biotechnology applications. Read More
Guardant Health Inc. tripled the number of cancers that can be monitored for minimal residual disease (MRD) or risk of recurrence using its Reveal liquid biopsy, adding breast and lung cancers. The test is currently used to detect circulating tumor DNA in blood for patients treated for stage II or III colorectal cancer (CRC). Read More
“If you can see the future, you can change it. People say your eyes are the window to your soul, but the eyes are actually the window to your future health,” Toku Eyes Ltd. Founder and CEO Ehsan Vaghefi told BioWorld. Read More
Med-tech financings are still down by 55% in comparison with the same time frame last year, but they have gained some ground by narrowing the gap with the pre-pandemic year of 2019. Read More
The field of artificial intelligence (AI) is beginning to mature, but this is also becoming a competitive space, with several governmental entities declaring their intent to develop policies to maintain national competitiveness. The U.S. has now entered the fray with a request for information by the International Trade Administration seeking information on policies that might foster the export of AI products developed by U.S. companies, but also on the policies that might enable small and medium enterprises to remain competitive. Read More
“It’s now law,” U.S. President Joe Biden said after he signed H.R. 5376 Aug. 16. His signature made Medicare drug pricing negotiations a near-term reality, along with new inflationary rebates, new caps on annual out-of-pocket drug spending and monthly insulin copays for Medicare beneficiaries, and tax changes that could affect the bottom line for several multinational drug and device companies beginning next year. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avails Medical, Boston Scientific, Dante Genomics, Evonetix, Mainz Biomed, Mobilab, Obsidio, Transmed7, Wetrade. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cerrzone, Heartbeam, Improvita, Millar, Viseon. Read More
