Latest changes
This category tracks 375 sources on GovPing, spanning Guidance, Enforcement, Rule, FAQ, Notice, and Consultation instruments across 3,281 total sources. There were 1,513 changes in the last 7 days.
The California Board of Pharmacy revoked 12 pharmacy licenses in Q2 2026 and 40+ pharmacy licenses in Q1 2026. The NJ Board of Veterinary Medical Examiners ordered Dr. Gerald Buchoff to pay $7,500 for negligence in treating a Yorkshire Terrier. Health Canada issued a Type I recall for Philips MRI systems over liver stiffness measurement errors.
Knee Tensioner-Balancer Method Patent B2
The USPTO granted Patent US12599377B2 to Dynamic Balancer Systems LLC on April 14, 2026. The patent covers a knee tensioner-balancer method using force sensors to evaluate human knee joints and generate digital geometric models. The invention tracks medial and lateral condyle contact points during knee flexion across a range of angles.
Ultrasound Patent for Measuring Physiological Properties
The USPTO granted patent US12599369B2 to FUJIFILM SonoSite, Inc. for ultrasound methods and systems measuring physiological properties. The technology measures vessel-wall displacement and blood-flow velocity at two locations of the same vessel to determine pulse-wave velocity and blood pressure without requiring ECG data. The patent includes 20 claims and was filed on March 1, 2024.
Biopsy Device Having Linear Motor
USPTO granted patent US12599373B2 to C.R. Bard, Inc. on April 14, 2026. The patent covers a biopsy device with a linear motor featuring dual feedback circuits that simultaneously control axial advancement and compensate for user movement. The 20-claim patent names Chad Van Liere and Aseem Singh as inventors.
FUJIFILM US12599368B2 Patent - Blood Vessel Aggregate Detection
USPTO granted patent US12599368B2 to FUJIFILM Corporation on April 14, 2026, covering an information processing apparatus, method, and program for detecting blood vessel aggregate regions in ultrasound images. The patent claims a blood vessel aggregate detection unit that identifies regions where three or more blood vessels are aggregated, and a highlight display unit that visually emphasizes these regions in the ultrasound image for medical diagnostic purposes.
GE Precision Healthcare 3D Pleural Surface Ultrasound Patent US12599367B2
USPTO granted GE Precision Healthcare LLC Patent US12599367B2 for methods and systems generating 3D pleural surfaces from ultrasound imaging. The patent covers generating a 3D pleural surface viewed from inside the lung using 2D or 3D ultrasound images with virtual light source shading. The patent contains 16 claims and names five inventors.
US12599371B2 - Apparatus and Separation Cell for Separating Drops of Biological Liquid from Transport Air
USPTO granted patent US12599371B2 to NISO BIOMED S.R.L. covering an apparatus with a separation cell for separating drops of biological liquid from transport air in flows from endoscopes. The separation cell features an inner chamber with upper inlet connectable to an endoscope, a bottom outlet for biological liquid connected to a suction pump and collection/analysis element, and an upper outlet for transport air connected to a vacuum source. The cell forms a V-shaped depression determining the transport air path. Patent includes 9 claims.
Double-Bending Flexible Surgical Tool System
USPTO granted Patent US12599374B2 to Beijing Surgery Robotics Company Limited for a double-bending flexible surgical tool system. The system includes a mechanical arm with four continuum segments forming two dual continuum mechanisms, driven by a transmission unit to enable opposing bending movements. The patent contains 13 claims and covers surgical robotics technology for enhanced precision in surgical procedures.
FUJIFILM Ultrasound Diagnostic System with Transducer Verification Mode
The USPTO granted FUJIFILM Corporation Patent US12599370B2 for an ultrasound diagnostic system with a verification mode for detecting failed transducer channels. The system analyzes ultrasound image data to identify failed channels and adjusts detection criteria based on the influence on image quality. Application 18778868 was filed on July 19, 2024, and the patent contains 11 claims.
NY DOH Recognizes Black Maternal Health Week, Hosts Roundtable and Launches Social Media Campaign
The New York State Department of Health recognized Black Maternal Health Week (April 11-17) by hosting a roundtable discussion at Ancient Song Doula Services in Brooklyn with healthcare providers, community leaders, and policymakers to discuss critical issues affecting Black maternal health. The Department also launched a social media campaign, 'Healthy Mothers. Strong Communities,' to raise awareness about maternal health disparities and promote equitable health outcomes for Black mothers and birthing people across New York State.
Wearable Device for Hands-Free Operation of an Ultrasound Probe
The USPTO granted patent US12599363B2 to GE Precision Healthcare LLC on April 14, 2026, for a wearable device enabling hands-free operation of an ultrasound probe. The invention comprises a mount with a spherical outer surface and opening to receive a probe, a base with an inner circumferential surface for selective rotation about at least one axis, and a lock to secure the probe position and orientation. The patent contains 20 claims.
Stethoscope Kit
USPTO granted patent US12599355B2 to BINJIANG INSTITUTE OF ZHEJIANG UNIVERSITY on April 14, 2026. The patent covers a stethoscope kit including a storage cylinder, protective shell, and electronic stethoscope with integrated charging capability. Inventors are Weize Xu and Qiang Shu, with 6 claims allowed under CPC classifications A61B 7/04 and A61B 2562/0204.
Ultrasound Diagnostic Apparatus and Method - US12599359B2
USPTO granted Fujifilm Corporation Patent US12599359B2 for an ultrasound diagnostic apparatus and control method capable of displaying blood vessel measurements within an ultrasound image display range. The apparatus includes features for detecting regions of interest and positioning blood vessel information display accordingly. The patent includes 20 claims and was filed on January 31, 2022.
US12599362B2 - TERUMO - 3D Medical Image Processing Device
USPTO granted patent US12599362B2 to TERUMO KABUSHIKI KAISHA for an image processing device that displays three-dimensional biological tissue data as a 3D image with 2D cross-sectional views. The patent covers technology for forming cutting regions in 3D medical imaging data to expose lumens and display corresponding cross-sections.
Boston Scientific Scimed - Ultrasonic Imaging ICE Catheter System Patent
USPTO granted Patent US12599361B2 to Boston Scientific Scimed, Inc. for an ICE imaging system featuring an intracardiac echocardiography catheter with a micro-electromechanical phased array ultrasound transducer. The patent covers a catheter with 6 French or smaller outer diameter designed for delivery through venous systems into heart chambers for pacemaker and ICD lead placement imaging. The patent protects the electronic flex cable architecture and signal processing methods for constructing heart images from ultrasound beam transmissions.
US Patent B2, Fetal Heart Rate Monitoring System, Philips
The USPTO granted Patent US12599356B2 to Koninklijke Philips N.V. for an AI-assisted ultrasound fetal heart rate monitoring system. The system uses a trained object detection model to automatically locate a fetal heart in ultrasound images and switches the probe to Doppler mode for heart rate computation. This patent provides Philips with enforceable property rights for the disclosed technology.
Methods and Systems for Ultrasound Imaging of a Body in Motion
The USPTO granted Patent US12599358B2 to inventors Philippe Cormier, Jonathan Poree, and Jean Provost for methods and systems enabling ultrasound imaging of a body in motion. The patent covers computing Lagrangian coordinates from Eulerian-based ultrasound images and forming Lagrangian-based ultrasound images using those coordinates. The patent contains 20 claims and was filed on August 5, 2021.
Stabilizing Transnasal Balloon Sheath Patent US12599365B2
USPTO granted patent US12599365B2 to Medtronic, Inc. for a transnasal transesophageal balloon catheter with compliant balloons, fluid channels, and a probe guide lumen of less than 15 French. The patent covers technology for slidably and rotatably receiving an ultrasound probe during transnasal procedures.
Ultrasound Simulation System Patent, Simhawk Ltd
USPTO granted patent US12599364B2 to Simhawk Ltd on April 14, 2026, for an ultrasound simulation system. The invention comprises a camera, physical tridimensional reference element attached to an ultrasound transducer, and processing module that digitally images the reference element, determines spatial data relative to a virtual location-identifying orientation, and displays ultrasound data when spatial data matches. The patent contains 24 claims under CPC classification A61B 8/4245.
Boston Scientific Scimed Ultrasonic Imaging Ablation Catheter Patent
The USPTO granted Patent US12599360B2 to Boston Scientific Scimed, Inc. covering an integrated ultrasonic imaging and ablation catheter system. The invention utilizes MEMS-based Piezoelectric Micromachined Ultrasonic Transducer (pMUT) technology and dual electrode carrier assemblies for cardiac ablation procedures. The patent contains 15 claims and was filed on October 24, 2022.
Background Material for Docket FDA-2026-P-4022
FDA published background material under docket FDA-2026-P-4022 on April 14. The document contains supporting information related to a regulatory matter before the agency. No specific regulatory requirements, compliance deadlines, or penalties are stated in the available filing.
Complaint Filed by Center for Tobacco Products
The FDA Center for Tobacco Products (CTP) filed a complaint with tracking number FDA-2026-H-3841. The complaint was submitted on April 14 and is now accessible via regulations.gov. Only a PDF attachment of the complaint is available for download; no summary documents are viewable on the regulatory portal.
B.E. Meyers & Co. Variance Application - CDRH
B.E. Meyers & Co., Inc. has submitted a variance application to the FDA Center for Devices and Radiological Health (CDRH). The application requests permission to deviate from specific regulatory requirements applicable to the company's medical device operations. FDA has received and posted the application for public access via Regulations.gov under docket FDA-2025-V-4733-0001.
FDA Center for Tobacco Products Complaint Regarding Retailer Violation
The FDA Center for Tobacco Products (CTP) filed a complaint (FDA-2026-H-3866-0001) on April 14. The complaint relates to potential violations of federal tobacco product regulations, specifically concerning retailer compliance with sales and marketing requirements. The document represents a formal complaint filing within the FDA's regulatory enforcement process.
Variance Amendment - SRS Visual, CDRH
FDA's Center for Devices and Radiological Health (CDRH) issued a variance amendment related to SRS Visual. The variance was filed under docket FDA-2026-V-2145. The specific regulatory requirements being modified and the scope of the variance cannot be determined from available metadata as the full document content is not accessible.
Variance Application, Christ The King Lutheran Church, FDA, North Carolina
Christ The King Lutheran Church in North Carolina submitted a variance application to the FDA Center for Devices and Radiological Health (CDRH) under docket FDA-2026-V-3505. The specific regulatory requirements or medical device standards at issue are not disclosed in the available metadata. No documents are currently available for public review on Regulations.gov.
ECG Electrode Positioning Method and Device (US12599354B2)
USPTO granted patent US12599354B2 to Analog Devices International Unlimited Company on April 14, 2026. The patent covers methods for positioning six ECG chest electrodes based on body height to ensure reproducible placement in serial measurements, and a device implementing the method. The invention addresses placement accuracy issues, particularly in obese subjects, by eliminating reliance on subjective anatomic landmarks.
Speed Variable TDS Operation in X-Ray Imaging Systems
The USPTO granted patent US12599348B2 to GE Precision Healthcare LLC covering TDS (Time-Delayed Summation) acquisition systems in x-ray imaging with variable scan speed capability. The patent (19 claims, filed September 7, 2023) enables constant sampling distance between strobes regardless of scan velocity, producing undistorted images. Inventors include Adam Manders, Michael R. Buchholz, and James Wear.
Support Apparatus System and Method for Positioning a Patient
USPTO granted patent US12599345B2 to Qfix Systems LLC covering a knee and foot support apparatus system for positioning patients during radiotherapy and imaging procedures. The patent claims adjustability features for superior-inferior axis positioning in gross and fine increments. The patent contains 15 claims and was filed on September 14 2020.
Visualization of Touch Panel to Object Distance in X-ray Imaging
USPTO granted patent US12599353B2 to Siemens Shanghai Medical Equipment Ltd. on April 14, 2026. The patent covers methods and apparatus for visualizing touch panel to object distance in X-ray imaging, including generating three-dimensional images of detected subjects and creating identifiers to represent distances. The patent contains 18 claims.
CT Imaging Method for Vasa Vasorum Density Measurement in Vascular Wall
USPTO granted Patent US12599350B2 to inventor Morteza Naghavi on April 14, 2026. The patent covers a computed tomography method for imaging vasa vasorum density in blood vessels including coronary and carotid arteries and the aorta. The method involves administering a contrast agent, performing contrast-enhanced CT scans, measuring Hounsfield distribution, and analyzing data to determine vasa vasorum density metrics for assessing cardiovascular risk and recommending diagnostic or therapeutic next steps.
Pet Health Radar Monitoring Patent - Franklin Technology
The USPTO granted Patent US12599343B2 to Franklin Technology Inc. on April 14, 2026, covering a radar-based apparatus and method for monitoring pet health status. The invention measures heart rate and breathing rate of pets using radar sensors, detects health abnormalities, and transmits notification messages to pet owners' electronic terminals. The patent includes 7 claims and covers A61B classifications related to physiological measurement.
Taking The Pulse Episode 273: Navigating FDA Regulation for Life Sciences Companies
Maynard Nexsen published Episode 273 of its 'Taking The Pulse' healthcare and life sciences video podcast discussing FDA regulatory developments for life sciences companies. The episode features attorney Christin Carey covering tariffs affecting pharma and biotech, evolving FDA guidance for digital health and clinical decision support tools, and the agency's approach to AI, cybersecurity, and emerging technologies.
FDA Reversal on Injectable Peptides Creates Investor Risk
Guidepost Solutions analyzes FDA's reversal of its 2023 ban on 14 injectable peptides, including BPC-157, ipamorelin, and Thymosin Alpha-1. The regulatory shift, driven by HHS Secretary Kennedy's advocacy, allows these compounds to return to Category 1 where licensed compounding pharmacies can prepare them under physician prescription. However, FDA's scientific leadership reportedly retains safety concerns including immunogenicity, organ toxicity, and product impurity that drove the original restrictions.
FY 2027 HHS Budget Proposes Cuts, Restructuring
Holland & Knight LLP summarizes the Trump Administration's FY 2027 HHS Budget released April 3, 2026. The budget proposes targeted funding reductions across federal health programs, structural changes aligned with the Make America Healthy Again (MAHA) agenda, and increased oversight. Major entitlement reforms are notably absent, with the administration potentially pursuing Medicare and Medicaid changes through regulatory or congressional engagement rather than the budget process.
Two Years On: How UPC Has Impacted European Patent Litigation in Life Sciences
A&O Shearman examines two years of Unified Patent Court (UPC) operations since its June 2023 launch. Over 480 patents have been litigated in the court, with actions steadily increasing. Initially reluctant pharmaceutical players have begun utilizing UPC proceedings, attracted by efficient case management and patentee-friendly decisions. The Court of Appeal has issued harmonizing guidance on key patent validity issues including claim interpretation, inventive step, added matter, sufficiency, and plausibility.
FDA Proposes 20+ Changes Streamlining Biosimilar, Generic Development
The FDA's FY 2027 budget justification includes more than 20 legislative proposals spanning drug and biologic approval pathways, supply chain oversight, and advertising standards. Key provisions include amending Section 351 of the Public Health Service Act to remove the separate statutory standard for biosimilar interchangeability, creating an abbreviated licensure pathway for biological products analogous to the 505(b)(2) pathway, and strengthening supply chain transparency requirements. The FDA has approved 83 biosimilars to date, with 37 approved between January 2024 and January 2026 alone.
CMS Finalizes Contract Year 2027 Medicare Advantage and Part D Final Rule and Rate Announcement
CMS issued the CY 2027 Medicare Advantage and Part D Final Rule on April 2, 2026, along with the CY 2027 Rate Announcement on April 6, 2026. The Rate Announcement projects a net average increase in MA payments of 2.48%, representing over $13 billion in additional payments to plans. The Final Rule makes significant changes to the Star Ratings system, codifies IRA provisions, refines supplemental benefits regulations, and implements deregulatory measures under Executive Order 14192.
National AI Legislative Framework: Healthcare Entity Implications
The White House issued a National Policy Framework for AI on March 20, 2026, calling on Congress to establish a federal policy that preempts state AI laws imposing 'undue burdens.' The Framework has six objectives including protecting children and encouraging AI innovation. No legislation has been passed; current state AI laws (Utah AI Act, Colorado AI Act, California AI amendments) remain in effect. The Framework does not create a new federal rulemaking body—existing agencies like CMS, DOJ, and FDA will continue governing healthcare AI.
FinCEN Health Care Fraud Advisory and Proposed Whistleblower Rule
FinCEN issued a health care fraud advisory on March 30, 2026, urging financial institutions to identify and report suspicious activity tied to Medicare, Medicaid, and other federal and state health care benefit program fraud, in coordination with the FBI and HHS Office of Inspector General. One day later, FinCEN published a proposed rulemaking to implement its whistleblower incentives and protections program under the Anti-Money Laundering Act of 2020 and AML Whistleblower Improvement Act of 2022.
EU Pharma Faces New Environmental Risk Assessment Requirements Under Revised Pharmaceutical Legislation
A&O Shearman analyzes EU environmental and sustainability legislation affecting pharmaceutical manufacturers, including provisional agreements on the Corporate Sustainability Due Diligence Directive and Corporate Sustainability Reporting Directive. The analysis focuses on new environmental risk assessment requirements under revised pharmaceutical legislation that will be integrated into marketing authorization applications, with provisions allowing authorities to refuse, suspend, or revoke marketing authorizations for insufficient ERAs or unaddressed environmental risks.
EU Commission Proposes MDR and IVDR Revision to Simplify Medical Device Rules
The EU Commission published a 170-page proposal on December 16, 2025, revising the Medical Device Regulation (EU) 2017/745 and In Vitro Diagnostic Regulation (EU) 2017/746. The proposal aims to streamline requirements and reduce administrative burden for manufacturers and notified bodies while maintaining public health protection. Key changes include unlimited certificate validity, revised classification rules for surgical instruments and software, relaxed PRRC requirements for small enterprises, and reduced post-market surveillance reporting frequency.
Q&A: Why Data Provenance Is Critical to AI-Powered Drug Discovery
A&O Shearman published a Q&A article examining data provenance considerations for AI-powered drug discovery. The article addresses transaction risks, IP ownership, data usage rights, and regulatory compliance in AI-biotech partnerships. It discusses challenges around patient consent for secondary use of clinical trial data in machine learning training and the importance of understanding where data comes from and under what terms it can be used.
DOJ Indicts Osteopathic Physician for Receiving, Selling Misbranded Peptide Drugs
The DOJ indicted a licensed osteopathic physician in Utah for allegedly receiving and selling misbranded drugs from China, marking an escalation in federal peptide enforcement. A Massachusetts medspa owner also pleaded guilty to importing merchandise contrary to law and selling counterfeit drugs and devices. This enforcement wave aligns with the FDA's first warning letter to a clinic regarding unapproved drug sources for aesthetic treatments.
Healthcare Sector Targeted in 12% of 2025 Activist Campaigns
Healthcare Sector Targeted in 12% of 2025 Activist Campaigns
Nucleic Acid Complexes with Cationic/Anionic Polymers and RNA Molecules
The USPTO published patent application US20260096998A1 for nucleic acid complexes comprising cationic polymers, anionic polymers, and monomeric RNA molecules. The disclosed complexes feature a core structure where the cationic polymer and RNA molecule are encapsulated by the anionic polymer. The application covers linear and non-linear configurations of these complexes for therapeutic uses.
Method and System for Confirmation of Microneedle-Based Analyte-Selective Sensor Insertion via Electrical Interrogation
USPTO granted patent US12599337B1 to Biolinq Incorporated on April 14, 2026, covering a system and method for confirming microneedle sensor insertion into viable tissue using electrical interrogation. The invention applies electrical stimulus between electrodes within an analyte-selective sensor array (200-2000 μm vertical extent) to measure a response and compare it against a reference value to determine insertion success. If insertion fails, the user is instructed to apply additional force or re-apply the sensor.
Hyperspectral Image-Guided Ocular Imager for Alzheimer's Disease Pathologies
USPTO granted patent US12599331B2 to RETISPEC INC. on April 14, 2026, for a non-invasive hyperspectral eye imaging device designed to detect Alzheimer's Disease-associated Tauopathy biomarkers. The device uses spectral reflectance imaging with a fundus camera to identify pathology indicators in retinal tissue.
Non-invasive Assessment of Glymphatic Flow and Neurodegeneration from Wearable Device
USPTO granted patent US12599332B2 to Applied Cognition, Inc. for a computer-implemented method and system that processes neurophysiological and neurovascular data recorded during sleep from wearable devices to assess glymphatic flow and predict neurodegeneration markers. The patent covers function mapping from the recorded data to target markers including glymphatic flow markers, molecular analysis markers, and neuroimaging markers of neurodegeneration. The patent contains 30 claims.
Deflectable Elongated Guidewire Assembly
USPTO granted patent US12599338B2 to Boston Scientific Medical Device Limited on April 14, 2026 for a deflectable elongated guidewire assembly used in medical procedures. The patent covers a guidewire with a distal segment configured to be selectively maneuvered along an introducer assembly and to transmit tenting force to biological walls. The patent application was filed May 25, 2021 and contains 11 claims.
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