Month: August 2024

The Food and Drug Administration (FDA) has released finalized guidance for its Voluntary Malfunction Summary Reporting (VMSR) program aimed at medical device manufacturers. Initiated in 2018, the VMSR program allows participating manufacturers to report certain device malfunctions in a summarized quarterly format, rather than providing individual reports every 30 days. This approach was designed to […]

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The Association for Molecular Pathology (AMP) has initiated a legal battle against the Food and Drug Administration (FDA) by filing a lawsuit in the U.S. District Court for the Southern District of Texas. The suit challenges a newly finalized rule by the FDA that extends its regulatory oversight over laboratory developed tests (LDTs). AMP, which […]

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As the mpox outbreak continues to escalate in Africa, the U.S. Food and Drug Administration (FDA) has granted approval to Emergent BioSolutions’ vaccine, ACAM2000, aiming to prevent infection from the virus. This approval is a significant move by the FDA and might pave the way for further authorizations as the vaccine is considered by other […]

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Digital musculoskeletal care provider Hinge Health has joined forces with virtual care specialist Midi Health to create a novel partnership aimed at enhancing care for women experiencing menopausal symptoms. The collaboration is set to integrate Hinge Health’s movement-based therapies with Midi Health’s extensive virtual clinic services to form a comprehensive treatment approach for menopause and […]

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Qiagen announced a significant expansion of its collaboration with AstraZeneca, moving beyond oncology to focus on companion diagnostics for chronic diseases. This development marks a substantial new phase for the partnership, originally initiated a decade ago, which until now has predominantly centered around cancer. Qiagen is tasked with developing and validating a genotyping assay using […]

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Glytec, a leading diabetes and insulin management software company, has partnered with pharmaceutical giant Roche to integrate Glytec’s software with Roche’s cobas pulse system. This collaboration will be rolled out in both the U.S. and global markets, aiming to improve diabetes management in hospital settings. Roche’s cobas pulse is known for its advanced point-of-care smart-device […]

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Illumina, a prominent company in the field of genomic sequencing, has recently received approval from the Food and Drug Administration (FDA) for its TruSight Oncology (TSO) Comprehensive test. This advanced genetic test is designed to analyze variants across 517 genes using nucleic acids extracted from solid tumor tissue samples. The test employs Illumina’s Nextseq 550Dx […]

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Imidex, a medical device company leveraging AI for enhanced lung cancer detection, has recently formed a strategic partnership with Orbit Genomics, a specialist in DNA-sequencing technologies. Together, they aim to significantly reduce lung cancer fatalities by merging their distinctive technological solutions. Imidex is known for its FDA 510(k)-cleared VisiRad XR device, which efficiently detects lung […]

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Boston Scientific has achieved a significant milestone by receiving a CE mark for its latest transcatheter aortic valve replacement (TAVR) system, Acurate Prime. This new device represents an important improvement over its predecessor, the Neo2 valve system. Among the notable enhancements are the inclusion of a larger valve size, designed to cater to an additional […]

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Medicare, established in 1965, included a crucial mandate to cover only items and services deemed “reasonable and necessary” for treating illnesses or injuries. This guideline has traditionally meant that experimental or investigational treatments—those not yet fully proven effective—were not covered under Medicare, causing delays in adopting new, potentially beneficial medical technologies even after FDA approval. […]

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