article thumbnail

How Will New FDA Hearing Aid Regulations Impact Health Plans?

HIT Consultant

First, let’s examine the new regulatory framework the FDA established. – Prescription hearing aids will require a consumer to have a prescription for a hearing aid from a physician, audiologist or a licensed hearing instrument specialist. These OTC hearing aids do not require a prescription. . yet is largely untreated.

FDA 98
article thumbnail

Qualcomm Life signs deal with AlertWatch, PeriGen, and other digital health deals

Mobi Health News

Qualcomm Life announced an exclusive licensing agreement with AlertWatch, creator of an FDA-cleared intelligence care software that assists in the care of patients in the operating room. The deal will give Qualcomm Life the exclusive rights to sell AlertWatch, which the company plans to showcase at HIMSS 2018.

FDA 47
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Analysis: Seeking Balance in the Hyperactive Mental Health Tech Market

HIT Consultant

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.

article thumbnail

Better Health Care Tests, Faster

Healthcare IT Today

Esquivel says, “ixlayer partners with CLIA-accredited laboratories and performs a rigorous vetting process of their validations protocols and operational capabilities from the licensing perspective on a state-by-state basis. Hydreight , founded in 2018, offers at-home healthcare and wellness services in all 50 U.S.

COVID-19 103
article thumbnail

CareCloud CEO predicts what's around the corner for telehealth

Healthcare IT News - Telehealth

We launched our first fully integrated telehealth solution in the 2018-2019 timeframe. As more and more wearable devices are becoming common in the technology, they have even started to get some FDA approvals as well. But one priority to address is the licensing-based requirement.

COVID-19 162
article thumbnail

Federal Judge Refuses to Dismiss Florida Compounding Pharmacy’s FCA Suit

Pharmacy Law Blog

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. Copyright © 2018 The Health Law Firm. a Florida professional service corporation, since 1999.

Fraud 52
article thumbnail

CMS Updates IPPS Rates, Wage Index and DSH Uncompensated Care in 2024 Final Rule

Hall Render

New Medical Technologies Beginning in 2025, CMS will require add-on payment applicants to have completed an FDA marketing request and provide documentation of such filing and FDA acceptance of the application by May 1 (rather than the current July 1 deadline) of the year prior to the beginning of the FY in which CMS is considering the application.