Top

Category: Regulatory


News, Regulatory

Medical Tourism: Regulatory Trends

June 17, 2021

Via: medicaldevice-network.com

Stricter regulations and complicated market access pathways can inhibit the medical tourism industry from growing in certain countries. Regulatory Trends Listed below are the key regulatory trends impacting the medical related tourism theme, as identified by GlobalData. Rise of non-profit […]


Innovation, Med Tech, News, Regulatory

FDA authorizes marketing of a device to help diagnose autism spectrum disorder

June 2, 2021

Via: Medical News

Today, the U.S. Food and Drug Administration authorized marketing of a device to help diagnose autism spectrum disorder (ASD). The Cognoa ASD Diagnosis Aid is a machine learning-based software intended to help health care providers diagnose ASD in children 18 […]


News, Regulatory

HHS commits $4.8B to COVID-19 testing for the uninsured

May 26, 2021

Via: Healthcare Dive

The new funding is a slice of Biden’s $1.9 trillion American Rescue Plan approved in March. The economic stimulus package has helped spur a surge in enrollment in Affordable Care Act plans during a special signup period now underway and […]


Regulatory

The U.S. CDC’s Mask Guidance Ignores the Risks Workers Face Every Day

May 21, 2021

Via: Time Health

The U.S. Centers for Disease Control and Prevention’s (CDC) announcement last week that fully vaccinated people no longer have to wear masks or socially distance came as a great relief to millions of people who have been vaccinated. But it […]


News, Regulatory

New CDC mask guidance may spur more Americans to get Covid vaccine, says Dr. Scott Gottlieb

May 14, 2021

Via: CNBC

The CDC’s updated face mask guidance is likely to prompt vaccine-hesitant Americans to get a Covid shot, Dr. Scott Gottlieb told CNBC on Friday. “This is going to provide a pretty strong incentive for a lot people who might’ve been […]


News, Regulatory

CDC director defends widely criticized mask guidance: ‘We are following the science’

May 12, 2021

Via: CNBC

Centers for Disease Control and Prevention Director Dr. Rochelle Walensky defended the agency’s Covid-19 mask guidance policies amid widespread criticism from lawmakers and health officials. “These issues are complex, the science is evolving, the science is moving, and we are […]


News, Regulatory

Pfizer-BioNTech Has Requested Full Approval of Their COVID-19 Vaccine From the FDA

May 7, 2021

Via: Time Health

Pfizer-BioNTech announced on May 7 that they have requested that the U.S. Food and Drug Administration (FDA) start the process of fully approving their COVID-19 vaccine. The companies will continue to supply the agency with additional data on vaccination safety […]


News, Regulatory

FDA asks Emergent plant to pause manufacturing while it investigates botched Covid vaccines

April 19, 2021

Via: CNBC

The Food and Drug Administration has asked Emergent BioSolutions to temporarily stop producing materials for Covid-19 vaccines while U.S. regulators investigate its plant in Baltimore responsible for ruining millions of Johnson & Johnson shots, Emergent said in a regulatory filing […]


News, Regulatory

White House to spend $1.7 billion tracking dangerous new Covid variants

April 16, 2021

Via: CNBC

The Biden administration announced Friday it will allocate $1.7 billion toward tracking the highly infectious coronavirus variants that now pose a major threat to the United States’ fight against the pandemic. The funds, taken from the $1.9 trillion Covid relief […]


News, Regulatory

House Passes Bill to Forestall $18 Billion in Medicare Cuts

April 14, 2021

Via: MedPageToday

The House voted 384-38 Tuesday evening to rescind one of two scheduled Medicare cuts, sending the bill on to President Biden for his signature. “Today the house meets on the heels of huge milestones for our country — more than […]


Regulatory

White House says U.S. is working to accelerate doses of Pfizer, Moderna Covid vaccines

April 14, 2021

Via: CNBC

The Biden administration is working to accelerate doses of the Pfizer-BioNTech and Moderna Covid-19 vaccines after U.S. health officials advised states to hold off on using Johnson & Johnson’s shot while regulators investigate a rare blood-clotting issue, a top U.S. […]


Regulatory

FDA warns of patient deaths tied to reusable urological endoscopes

April 5, 2021

Via: Healthcare Dive

With its warning of risks associated with urological endoscopes, FDA’s focus expands to a second category of endoscopic devices that are used in multiple patients and disinfected between procedures. Its earlier concerns about contaminated duodenoscopes, which also have been linked […]


News, Regulatory

CDC Changes Tune on COVID Guidance for Vaccinated Travelers

April 2, 2021

Via: MedPageToday

Those fully vaccinated against COVID-19 are no longer required to test before or after traveling domestically or internationally from the U.S., the CDC said in updated guidance on Friday. Unless required to do so by the international destination, fully vaccinated […]


Regulatory

As Medicare sequester cut extension deadline looms, AHA urges Senate to act

March 24, 2021

Via: Healthcare Dive

If the Senate takes action before leaving town, “it sends a very strong signal to CMS to essentially hold those claims for about a week or so until the House can come back and hopefully approve the Senate action,” Pollack […]


News, Regulatory

Pandemic aid package includes relief from high premiums

March 9, 2021

Via: The Medical News

As President Joe Biden’s pandemic relief package steams through Congress, Democrats have hitched a ride for a top health care priority: strengthening the Affordable Care Act with some of the most significant changes to insurance affordability in more than a […]