Health Populi

JULY 28, 2020

Twelve years ago, when I began to attend CES, digital health was a nascent category featured with products featured in a couple of aisles in exhibit booths then dominated by Fitbit, Nike and UnderArmour. The company’s Core ScanWatch was a CES 2020 Honoree in the category of Fitness/Sports and Wearable Technologies.

Public Health 116

Public Health COVID-19 Telemedicine FDA 116

Health Law Advisor

FEBRUARY 1, 2022

The United States Food and Drug Administration (FDA) for many years has been trying to increase the participation of minorities in clinical trials to help ensure that regulated products are tested and labeled in an appropriate cross-section of Americans. National Library of Medicine, with support from FDA.

FDA 52

FDA Compliance 52

Healthcare It News

FEBRUARY 20, 2024

EnsoData announced Tuesday that it has received FDA 510(k) clearance for an AI algorithm called EnsoSleep to support the diagnosis of sleep disorders using any FDA-cleared pulse oximeter, which measures the saturation of oxygen carried in red blood cells. between 2008 and 2021, CBS News said in a story on how to apply.

FDA 269

FDA Governance 269

Drug & Device Law

APRIL 18, 2022

The Wisconsin guest post let us know about a pending decision that – we all hoped – would take that state out of the “no state appellate precedent” category altogether: Wisconsin has recently made it to the red zone, and may soon cross the goal line, with the Wisconsin Court of Appeals’ forthcoming decision in Rennick v. 2008); Herzog v.

FDA 59

FDA 59

Drug & Device Law

DECEMBER 14, 2023

It has also been the case for a long time that the use of citizen’s petitions to FDA has been a tool by the plaintiff bar to shape, and sometimes sidestep, the science. ( 2008) (cited in Paraquat, 2023 WL 8372819, * 3 n.3). See, e.g. , here.) See, e.g. , here.) Probably not from the journal that published it.

FDA 52

FDA 52

Drug & Device Law

JANUARY 30, 2023

440 (2008) Buckman was not cited at all in the Merck Sharp & Dohme Corp. 470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Kent , 552 U.S. Lohr , 518 U.S.

FDA 72

FDA Fraud Governance Medicare 72

Drug & Device Law

SEPTEMBER 18, 2023

He came across several preemption decisions involving defendants who employed the FDA’s “alternative summary reporting” (“ASR”) system that the agency operated for about 20 years, “from 1997 through June 2019.” without adversely affecting FDA’s ability to monitor and react to such events.

FDA 59

FDA Fraud Governance Compliance 59