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Banner Health CEO Amy Perry Recognized for Leadership in Healthcare Innovation

Banner Health CEO Amy Perry Recognized for Leadership in Healthcare Innovation

Amy Perry, President and CEO of Banner Health, has been named among Modern Healthcare's 100 Most Influential People in Healthcare for the second consecutive year. Since joining Banner Health in 2021, Perry has led the organization to become a model for future healthcare by integrating clinical excellence, advanced technology, and financial strength. Banner Health, one of the largest nonprofit healthcare systems in the U.S., operates 33 hospitals and serves 3.5 million people annually across six states. Under Perry's leadership, the organization has expanded the use of artificial intelligence and clinical research to improve health outcomes and access. Banner Health's commitment to innovation and community-centered care has positioned it as a national leader in value-based care.

AI Integration in Medicare Sparks Legislative Pushback Over Patient Care Concerns

AI Integration in Medicare Sparks Legislative Pushback Over Patient Care Concerns

The Centers for Medicare and Medicaid Services (CMS) introduced the 'Wasteful and Inappropriate Service Reduction' (WISeR) model to enhance Medicare payment efficiency through AI and machine learning. This initiative, set to begin in six states on January 1, aims to reduce waste and fraud by scrutinizing claims. However, it has faced opposition from lawmakers, including Rep. Ami Bera, who argue that healthcare decisions should remain in the hands of doctors, not algorithms. The debate centers on the balance between technological efficiency and maintaining human clinical judgment in patient care.

FDA Approves First Antibiotic Under National Priority Scheme to Address Supply Chain Issues

FDA Approves First Antibiotic Under National Priority Scheme to Address Supply Chain Issues

The U.S. Food and Drug Administration (FDA) has approved the first drug under its new Commissioner's National Priority Voucher (CNPV) program, which aims to expedite the review process for essential medicines. The approved drug is a U.S.-manufactured version of the antibiotic Augmentin XR (amoxicillin-clavulanate potassium). This initiative is part of a broader effort to address vulnerabilities in the supply chain for active pharmaceutical ingredients (APIs), many of which are not produced domestically. The CNPV program allows for a significantly faster review process, reducing the typical 10-12 month period to as little as one to two months. The program was introduced to ensure quicker access to important therapies and to strengthen domestic manufacturing capabilities.

CLEAR Partners with CMS to Enhance Identity Verification in Healthcare

CLEAR Partners with CMS to Enhance Identity Verification in Healthcare

CLEAR, a company known for its identity verification technology, has signed a contract with the Centers for Medicare & Medicaid Services (CMS) to improve identity verification in the U.S. healthcare system. This partnership is part of CMS's 'Kill the Clipboard' initiative, which aims to modernize Medicare by enhancing interoperability and reducing fraud. CLEAR's technology uses biometric data and document checks to verify identities, allowing patients and providers to confirm their identities with a simple selfie. The initiative is expected to streamline healthcare processes and improve security.

U.S. Industry Groups Challenge Texas Ingredient Labeling Law

U.S. Industry Groups Challenge Texas Ingredient Labeling Law

Several major U.S. food and beverage trade associations have filed a lawsuit against Texas over a new law requiring warning labels on products containing certain artificial colors and additives. The legislation mandates that products with over 40 specified substances, including synthetic food dyes, must carry labels warning consumers that these ingredients are not recommended for human consumption by authorities in Australia, Canada, the EU, or the UK. The American Beverage Association, Consumer Brands Association, National Confectioners Association, and FMI, the Food Industry Association, argue that the labels are misleading, as the ingredients have been safely used in the U.S. for decades. The lawsuit seeks to block the law, which is set to take effect in 2027.

Welldoc Partners with CLEAR to Enhance Health Data Integration for Chronic Care

Welldoc Partners with CLEAR to Enhance Health Data Integration for Chronic Care

Welldoc, a leader in AI-driven cardiometabolic care, has announced a strategic partnership with CLEAR, a secure identity company, to integrate CLEAR1 identity verification into the Welldoc App by the first quarter of 2026. This collaboration aims to streamline the process of authenticating and aggregating fragmented medical records from multiple sources, addressing a significant bottleneck in digital health. The integration is part of the CMS Health Tech Ecosystem initiative, which seeks to modernize the health system by ensuring patient data travels with the patient. By embedding CLEAR1, Welldoc aims to create a 'trusted identity layer' that allows for secure and seamless access to sensitive medical records, enhancing the app's ability to provide personalized coaching for managing chronic conditions like diabetes and obesity.

AI-Powered Platforms Transform Clinical Trials by Enhancing Patient Data Capture

AI-Powered Platforms Transform Clinical Trials by Enhancing Patient Data Capture

The integration of AI-powered platforms in clinical trials is revolutionizing the way patient experience data is captured and utilized. These platforms, particularly in the field of obesity research, are enhancing the quality and fidelity of data by eliminating manual data entry and enabling real-time health monitoring. The use of electronic clinical outcome assessment (eCOA) platforms allows for seamless interoperability between medical devices and digital health technologies. This integration is crucial as it supports the growing demand for patient-focused drug development, driven by regulatory bodies like the FDA. The obesity therapeutics market is expanding rapidly, with projections estimating it could reach $150 billion by 2035. This growth necessitates streamlined, patient-centric trials that can handle long-term engagement and multiple endpoints, reducing patient burden and improving trial retention rates.

FDA Grants IDE Approval to Airiver Medical for Chronic Rhinosinusitis Clinical Study

FDA Grants IDE Approval to Airiver Medical for Chronic Rhinosinusitis Clinical Study

Airiver Medical, a clinical stage company focused on respiratory tract conditions, has received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA). This approval allows the company to initiate a pivotal clinical trial for its Airiver ESSpand Sinus Drug Coated Balloon (DCB) in patients with chronic rhinosinusitis (CRS). The study will involve up to 300 patients across the United States, assessing the safety and efficacy of the ESSpand DCB as an adjunct to endoscopic sinus surgery (ESS). The device is designed to maintain symptom relief and prevent scarring by applying a paclitaxel drug coating during balloon dilation of sinus drainage passageways. This trial is a critical step towards Airiver Medical's regulatory submission and potential commercialization of the device in the U.S.

FDA Launches TEMPO Pilot to Accelerate Digital Health Tools for Chronic Diseases

FDA Launches TEMPO Pilot to Accelerate Digital Health Tools for Chronic Diseases

The U.S. Food and Drug Administration (FDA) has introduced a new pilot program named TEMPO (Technology-Enabled Meaningful Patient Outcomes) aimed at expediting the market entry of digital health technologies (DHTs) for chronic diseases. This initiative aligns with the deregulatory approach of the FDA under Commissioner Marty Makary. The TEMPO pilot is designed to facilitate access to digital health devices while ensuring patient safety. It will operate within the Centers for Medicare and Medicaid Services' (CMS) ACCESS model, which is testing an outcome-aligned payment approach for Medicare. The pilot will initially focus on four clinical areas: early and later-stage cardio-kidney-metabolic conditions, chronic musculoskeletal pain, and behavioral health interventions. Up to 10 device manufacturers in each area will be selected to participate, with the opportunity to bypass certain regulatory requirements like premarket authorization. The FDA and CMS will collaborate to monitor and report real-world perform...

CLEAR Partners with CMS to Enhance Identity Verification in Medicare

CLEAR Partners with CMS to Enhance Identity Verification in Medicare

CLEAR, a company known for its identity verification technology, has announced a new contract with the Centers for Medicare & Medicaid Services (CMS) as part of the CMS Health Tech Ecosystem Initiative. This partnership is a significant step in the CMS's 'Kill the Clipboard' initiative, aimed at modernizing Medicare by improving interoperability and reducing fraud. CLEAR's technology, which uses biometric data and document checks, will be implemented to verify identities across healthcare organizations. This initiative is expected to streamline processes for Medicare beneficiaries and providers, allowing them to create and recover accounts and access healthcare information more securely. The technology is set to roll out on Medicare.gov in early 2026 and is compliant with HIPAA and IAL2 standards, ensuring patient data protection.

US Industry Groups Challenge Texas Ingredient Labeling Law Over Misleading Claims

US Industry Groups Challenge Texas Ingredient Labeling Law Over Misleading Claims

Several major food and beverage trade associations have filed a lawsuit against the state of Texas over a new law mandating warning labels on products containing certain artificial colors and additives. The legislation, passed in June, requires that products with over 40 specified substances, including synthetic food dyes and bleached flour, display a label warning consumers that these ingredients are not recommended for human consumption by authorities in Australia, Canada, the European Union, or the United Kingdom. The American Beverage Association, Consumer Brands Association, National Confectioners Association, and FMI, the Food Industry Association, argue that these claims are false and misleading, as the ingredients have been safely used in the U.S. for decades. The groups contend that the law will lead to increased costs for manufacturers, either through labeling changes or recipe modifications, and that some of the ingredients are already banned at the federal level.

Transpire Bio's Florida Facility Passes FDA Pre-Approval Inspection

Transpire Bio's Florida Facility Passes FDA Pre-Approval Inspection

Transpire Bio's Florida Facility Passes FDA Pre-Approval Inspection