Tag: mhealth

The U.S. Food and Drug Administration (FDA) has officially granted premarket approval to the Autus valve, a groundbreaking medical device developed by Edwards Lifesciences designed to address the unique physiological needs of pediatric patients with congenital heart defects. This approval marks a transformative moment in pediatric cardiology, as the Autus valve represents the first surgical…

Medtronic, a global leader in medical technology, has achieved significant regulatory milestones with the receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance and a CE mark for its latest cardiac mapping and navigation software. The approvals for the Affera Prism-2 software and expanded capabilities for the PulseSelect Pulsed Field Ablation (PFA) system mark…

Medtronic has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its IN.PACT drug-coated balloon (DCB) specifically for use in below-the-knee (BTK) applications. This regulatory milestone represents a significant step forward in the treatment of advanced peripheral artery disease (PAD), a condition that affects millions of patients worldwide and…

The U.S. Food and Drug Administration (FDA) has officially moved into the next phase of its Home as a Healthcare Hub initiative by selecting five pioneering medical technology companies to participate in the Resilient Extended Analysis and Design for Home (READI-Home) Innovation Challenge. This strategic program, orchestrated by the FDA’s Center for Devices and Radiological…

GE HealthCare has officially named Rodolphe Katra as its new Global Chief AI Officer, marking a significant strategic hire as the medical technology giant seeks to solidify its leadership in the rapidly evolving field of artificial intelligence. The appointment, disclosed by GE HealthCare Chief Executive Officer Peter Arduini via LinkedIn, signals a renewed focus on…

The Trump administration announced on Sunday that the newly established U.S.-China Board of Trade has recommended a significant de-escalation in trade tensions, proposing reduced tariff treatment for "non-sensitive" goods totaling approximately $30 billion in imports for each nation. This $60 billion reciprocal framework, emerging just days after a historic state visit by Chinese President Xi…

Abbott has announced that its SimpleScreen colorectal cancer (CRC) blood test is now covered by Medicare, marking a significant milestone in the medical community’s effort to increase screening rates among average-risk adults. The diagnostic tool, which utilizes advanced circulating cell-free DNA (cfDNA) technology, is specifically designed for individuals aged 45 and older who are at…

Sofinnova Partners, a leading European venture capital firm specialized in life sciences, has officially announced the activation of its latest investment vehicle, Sofinnova MD Start IV. This new fund represents a continuation of the firm’s dedicated strategy to identify, incubate, and scale breakthrough medical technologies that address significant unmet clinical needs. With a history spanning…

Oura, the prominent health technology company and manufacturer of the industry-leading Oura Ring, announced on Tuesday that it has officially delayed its planned initial public offering (IPO) due to prevailing market uncertainty. The decision marks a significant pivot for the wearable technology unicorn, which had been widely expected to debut on the public markets following…

Dr. Heidi Overton, President Donald Trump’s nominee to lead the Food and Drug Administration (FDA), appeared before the Senate Health, Education, Labor, and Pensions (HELP) Committee on Thursday, signaling a commitment to scientific integrity and the rule of law. In a testimony that balanced her history as a White House policy adviser with the rigorous…