Digital Health Startup Alyve Health Secures $6M in Series A Funding Round and Additional News Briefs
Alyve Health, an emerging player in the Indian digital health market, recently secured a substantial $5.5 million in Series A financing. This funding round was led by Axilor Ventures and saw participation from 1Crowd Fund, InHealth Ventures, and Trifecta Capital. Since its inception in 2020, Alyve Health has been on a mission to revolutionize personalized […]
Philips BiPAP Recall Associated With 65 Fatalities, 952 Injuries
In a recent development dated June 28, 2024, a Philips spokesperson, Lu Yu, issued a statement contending the numbers of reported injuries and deaths cited by the FDA notice a day earlier regarding their bilevel positive airway pressure (BiPAP) machines, namely the A30 and A40 models. Philips acknowledges receiving reports of 10 serious injuries and […]
FDA Releases Draft Guidance on Action Plans for Increasing Diversity in Clinical Trials
The Food and Drug Administration (FDA) recently released a draft guidance aiming to improve the diversity of participants in clinical trials by establishing a framework for diversity action plans. This initiative, prompted by legislation passed by Congress in 2022, mandates that drug and device makers submit these plans to the FDA. The legislation set a […]
Essential Actions for Your First Year
On May 6, 2024, the FDA announced a Final Rule marking significant changes in the regulation of lab developed tests (LDTs). The new regulations classify in vitro diagnostics (IVDs) as devices, bringing them under FDA jurisdiction similarly to other medical devices, regardless of whether the manufacturer is a laboratory. This directive ends the previous enforcement […]
Baxter Issues Recall for Ventilation Systems Due to Charging Malfunctions
Baxter has issued a recall for over 2,500 Life2000 ventilation systems in the United States due to the risk of the devices failing to charge or only intermittently charging. This recall has been categorized by the Food and Drug Administration (FDA) as a Class I event, which denotes the highest level of severity, according to […]
House Committee Votes on Including Obesity Drugs in Medicare Coverage
On Thursday, the House Ways & Means Committee moved forward with four significant pieces of legislation aimed at enhancing Medicare coverage and modifying certain regulatory frameworks. These bills, passed with robust bipartisan support, address the inclusion of obesity drugs and cancer screening tests under Medicare and implement changes concerning Medicare’s discretion in the coverage of […]
Medicare Announces Reimbursement Rule for Breakthrough Devices Expected by Summer
In Washington, there are ongoing developments concerning a federal rule that intends to simplify the reimbursement process for breakthrough medical devices. This rule is anticipated to be finalized early this summer according to Dora Hughes, the director of the clinical standards center at the Centers for Medicare and Medicaid Services (CMS). Hughes communicated this timeline […]
Novo Nordisk’s Medication Unsuccessful in Crucial Trial for Hypertension and Chronic Kidney Disease
A key investigational drug from Novo Nordisk, intended for the treatment of hypertension and chronic kidney disease, has failed to meet its goals in a critical Phase 3 trial. This outcome has consequently hindered the Danish pharmaceutical company’s ambitions to offer a new treatment alternative that hoped to surpass the safety and efficacy of existing […]
Peter Marks from CBER Discusses New Rare Disease Hub and Upcoming Guidance on Accelerated Approvals: An Exclusive Analysis in Life Science
I’m sorry, but I’m unable to provide a summary for the content as there isn’t enough detailed information available in your request to summarize it to 800 words. The text provided mentions Peter Marks, director of FDA’s Center for Biologics Evaluation and Research (CBER), speaking at the Drug Information Association (DIA) annual meeting about a […]
Unlocking Market Adoption: The Essential Guide
In a critical discussion on the Global Medical Device Podcast, hosted by Etienne Nichols, Shaherah Yancy, CEO of Research Lifecycle Solutions, shared her profound insights on key strategies for MedTech companies, particularly focusing on the importance of clinical and regulatory frameworks. Here’s a breakdown of their conversation and the valuable takeaways for anyone involved in […]