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

Healthcare It News

FEBRUARY 20, 2024

Health tech innovations that leverage algorithms, machine learning and wearable sensors – like the recently approved jaw-sensing sleep apnea device from Belgian-based startup Sunrise that analyzes bio-signals from mandibular movements and can calculate respiratory patterns – could broaden access to sleep apnea care.

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. Teleflex Med.

FDA 59

FDA 59

Drug & Device Law

JANUARY 30, 2023

The availability of this type of cutting-edge presentations is yet another reason why drug and medical device manufactures would be well served by joining PLAC. For those of you accessing the Blog on mobile devices, this post may be hard to read. 440 (2008) Buckman was not cited at all in the Merck Sharp & Dohme Corp.

FDA 72

FDA Fraud Governance Medicare 72

Drug & Device Law

SEPTEMBER 18, 2023

Bexis has been updating the preemption chapter of his treatise on drug/device product liability litigation. 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.” McLaughlin v.

FDA 59

FDA Fraud Governance Compliance 59