Jane Sarashon

DECEMBER 27, 2021

Digital health as a category has been a growing feature at CES for over a decade, starting with the early wearable tech era of Fitbit, Nike, OMRON and UnderArmour, early exhibitors at CES representing the category. It’s timely, then, that CES launched the Global Women’s HealthTecb Awards collaborating with the World Bank.

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HIT Consultant

MAY 12, 2022

Notable transactions in the consumer and member tech category include: Pear Therapeutics , software-based medicine provider, made its mark in 2017 as its tool became the first digital therapeutic approved by the FDA with claims to improve clinical outcomes. buyout, which was quickly followed by its IPO in June 2021. .

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Health Law Advisor

JUNE 1, 2022

Most companies want to avoid FDA warning letters. To help medical device companies identify violations that might lead to a warning letter, this post will dive deeply into which specific types of violations are often found in warning letters that FDA issues. How does FDA define the terms used in this part? Background.

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Health Populi

MAY 30, 2018

This is important because in 2017, one in four new drugs approved by the FDA were designed to treat a small population, falling. into the precision medicine category. The team analyzed data-sharing guidelines across 230 policy documents published between 1996 and 2017. They are certainly inter-related.

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HIT Consultant

OCTOBER 17, 2021

Since DTx plays such a substantive role in the therapeutic process, these apps must meet the same standards of clinical evidence required by the FDA and other regulatory agencies for approval of conventional medical treatments. DTx Product Categories, Digital Therapeutic Alliance. FDA website, March 27, 2018.

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Health Populi

JANUARY 31, 2018

In 2017, Hugh Langley wrote in Wareable that, “blood pressure is wearable tech’s next challenge.” Omron is submitting the HeartGuide watch for FDA review this year and once cleared, the device will be the first blood pressure monitor that accurately reads BP right from the wrist.

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Dot Compliance

FEBRUARY 8, 2022

To determine whether a particular software falls under the category of SaMD or whether it is considered a member of one of the three other subclasses, two questions must be answered: Does the software provide a direct medical benefit when used (correctly), and can it place the patient at risk if it is used incorrectly or malfunctions?

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Health Populi

JANUARY 9, 2019

By 2017, these costs were $11 on average for a generic, $33 for a brand on the approved list, and $59 for a third-tier brand off the formulary. Thus, the difference between a Tier 1 generic and Tier 3 off-formulary drug was nearly $50 in 2017. The patient is a consumer is a payor, right? $50

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Bill of Health

APRIL 4, 2024

Beyond the health care sector-specific Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), this mix of AI & Data related regulatory requirements stems from a series of generalized, cross-sectoral EU laws of the last 5 years.

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SQA

DECEMBER 16, 2022

The CMDE published additional documents (link in Chinese) that outline the recommended paths for clinical evaluation of certain devices under select sub-categories of the Medical Device Classification Catalog. The EC presented a first draft for public comment to the revision of Annex 1 in 2017. CMDE Announcement No.

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SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

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SQA

MAY 24, 2023

MDCG 2023-3 , Questions and Answers on Vigilance Terms and Concepts as Outlined in the Regulation (EU) 2017/745 on Medical Devices, provides additional information on key vigilance terms. PCPC’s current priority is to work with the FDA to effectively implement the Modernization of Cosmetics Regulation Act of 2022.

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Kaiser Health News

JANUARY 12, 2023

On one hand, the FDA has relaxed some of the risk evaluation and mitigation strategies (REMS) from the prescribing rules surrounding abortion pills. The FDA puts these extra restrictions or safeguards in place for certain drugs to add additional protection. Some advocates say these pills simply do not bring that level or risk.

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Kaiser Health News

FEBRUARY 9, 2023

The FDA is at the center of the abortion pill case, which challenges its approval of the drug decades ago and could set a precedent for legal challenges to the approval of other drugs. I also want to point out that neither Republicans nor Biden have yet said that they consider Medicaid in that same untouchable category.

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HIT Consultant

FEBRUARY 3, 2023

Figure 1: Summary of Digital Pathology VC Investment from 2017-2022. Certainly, investment in the market has slowed since, as there has been no funding recently raised that’s comparable to PathAI or Paige.ai’s 2021 rounds, which both received over $100M respectively.

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Health Populi

JANUARY 2, 2020

Hearables have been emerging at CES for a few years, and now vision will be a newer category to watch. (As Subsequently, ResMed joined with Dr. Oz to launch SleepScore Labs – an exhibitor at CES 2020 in the fast-growing sleep category at the Show. Forbes ran a column on CES 2020 discussing AI in hearing and vision.

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Health Populi

AUGUST 3, 2018

adults favor having the FDA approve more generic, over-the-counter (non-prescription, or switched Rx’s), and biosimilar drugs to encourage more competition. This is often the scenario when an Rx has moved to the generic Tier 1 category on a PBM formulary. Check out the table’s third row: overall, 2 in 3 U.S.

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Drug & Device Law

AUGUST 22, 2022

The plaintiff in Jacob sued the manufacturer of a Class III, FDA premarket-approved medical device. First, the plaintiff’s non-parallel claims were “preempted to the extent” that they would have imposed “alleged labeling or manufacturing requirements that are different from, or in addition to, those imposed by the FDA.” 84 (9th Cir.

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Drug & Device Law

SEPTEMBER 9, 2022

470 (1996), has nothing useful to say about the FDA’s current system for clearing medical devices. FDA: A Lesson from Pelvic Mesh Litigation on Relative Competence to Decide a Legal Question,” 76 Food & Drug L.J. The FDA reviewed the notices but did not then have to grant permission before the device could be sold.

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