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Cuffless Blood Pressure Monitoring – Not for the Faint-of-Heart (Pun Intended)

Healthcare IT Today

The excitement has been largely fueled by the renowned public health benefits of, and the seductive commercial opportunity for, a seamless hypertension management solution that is virtually invisible – part of what people are already wearing, such as smartwatches, earbuds, smart rings, and apparel.

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SQA Regulatory Surveillance Summary 5 | Monthly Update 2021

SQA

ISO 10651-5:2006, Lung ventilators for medical use – Particular requirements for basic safety and essential performance – Part 5: Gas-powered emergency resuscitators. Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden. United States FDA – Guidances for Devices.

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Prescription Drugs: From Costs and Bad Reputation to Civica Rx and Amazon to the Rescue

Health Populi

Over the ten years 2006 to 2016, deductibles increased an average of 176% and coinsurance, 67%. Wage growth over that decade was relatively flat, as workers covered by insurance through employers traded off health benefits for wage increases. They’ll begin to apply to the FDA in early 2019 to make and sell the generic drugs.

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Terrible Decision Contravenes the Vaccine Act’s Purpose and Would Gut Its Protections

Drug & Device Law

If the antivaxxers win in DeCostanzo , then society as a whole loses, because as the Supreme Court stated in Bruesewitz , “the elimination of communicable diseases through vaccination” is “one of the greatest achievements of public health in the 20th century.” 2006 WL 2038436, at *8 (N.D.N.Y. 2022 WL 17338047, at *1. . §§349-50,

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Supreme Court Halts OSHA Mandatory Large Employer Vaccination Mandate

Drug & Device Law

The Act empowers the Secretary to set workplace safety standards, not broad public health measures.”). OSHA draws a distinction between “hazards that employees face at work” and “broad public health measures.” for an emergency temporary standard. . . 655(c)(1). for an emergency temporary standard. . . 120, 159 (2000).

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Preemption and OTC Drugs

Drug & Device Law

It is fair to say that Bexis co-founded this blog (in 2006!) As Carter recounts, starting in 1976, FDA developed the OTC Cough and Cold Monograph, 21 C.F.R. in part to aid the cause of medical device and pharmaceutical manufacturers , targets in our lawsuit-obsessed country. Can you blame us? This is good stuff! at 1276.

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