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FDA approves sleep apnea tech from EnsoData, Samsung

Healthcare It News

Challenges in diagnosing sleep apnea and research that shows positive airway pressure treatment can lower healthcare costs motivate healthcare organizations and government agencies like the U.S. New FDA update on Philips Respironics' 2021 device recalls PAP machines which deliver oxygen through a mask, are one way to treat sleep apnea.

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Anti-Abortion Advocacy Groups’ Challenge to FDA-Approved Abortion Pill May Have Far-Reaching Consequences

Health Law Advisor

Food and Drug Administration (“FDA”) to withdraw approval of Mifepristone, an FDA-approved drug used to end pregnancies in the first trimester. [1] The lawsuit has sparked concern by both industry and the FDA. Twenty years later, Congress codified the pathway in the FDA Safety and Innovation Act (“FDASIA”) [4].

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Monthly Round-Up of What to Read on Pharma Law and Policy

Bill of Health

Biomarker qualification at the European Medicines Agency: a review of biomarker qualification procedures from 2008 to 2020. Experts’ Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care. A full posting of abstracts/summaries of these articles may be found on our? 2022 Feb 9.

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Access to Abortion Pill in Limbo: Navigating the Intricacies of Conflicting Federal Court Rulings in Texas and Washington State

Healthcare Law Blog

Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, has been curtailed following dueling federal court decisions in Texas and Washington. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. Following the U.S.

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4 Things Healthcare Facilities Should Know About Medical Device Recalls

HIT Consultant

And that’s just what we can see has been “posted” on the FDA site through June 25, 2021. The FDA has noted that recalled medical devices caused almost 100,000 deaths between 2008 and 2021 — but before and after this time period ? Recalls are voluntarily done by a manufacturer.

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Access to Abortion Pill on the Precipice: A Deep Dive into the Federal Court Rulings that will Decide the Fate of Mifepristone 

Healthcare Law Blog

Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. May 17, 2023 : The Fifth Circuit heard oral arguments from the FDA, Danco, and the Plaintiffs. Had the U.S.

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Monitor Improper Payments for Part C and Part D with Medicare Audit and Monitoring Software

Innovaare Compliance

Examples of improper payments include: Unusual quantities or administration frequency of Part B drugs; Drugs for non-FDA approved indications (e.g., Since 2008 Inovaare has provided healthcare organizations with cost-effective quality services to help them comply with Medicare regulations and improve their operations, thereby saving costs.