1. Medtech Insight
  2. >>Geography
  3. >>North America
  4. >>United States

Gottlieb Wants To 'Bring Medtech Manufacturing Home' In 2019 Budget Request

 
• By Sue Darcey

US FDA would use a proposed $128m, 39% budget authority increase in 2019 Center for Devices funding over the prior year to promote domestic device manufacturing, and let low-risk digital health products receive streamlined approvals, among other budget priorities, says FDA Commissioner Scott Gottlieb.

FDAEntrance_1200x675
• Source: shutterstock.com

The Trump administration has proposed increasing FDA's device center's spending to about $636m in FY 2019, a 26% increase over the $505m allotted for 2018.

Budget authority for devices would rise from $327m to $455m in 2019 under the proposal. The $636m, 2019 total would...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from United States

Even ‘Small’ Leaks After Left Atrial Appendage Occlusion Raises Stroke Risk, Study Finds

 
• By Brian Bossetta

A Japanese study of Watchman LAA closure devices found that leaks of any size after implantation raise the risk of stroke. The study comes shortly after the US FDA issued an early alert for the Watchman access systems.

23andMe Genetic Tests Among 12 New FDA Classifications

 
• By Elizabeth Orr

A late-August batch of device classifications from the US FDA includes genetic tests from 23andMe, hand-held spinal surgery tools, and several IVDs.

Luna Health Raises $23.6M, Furthering Launch Of ‘World’s Smallest’ Insulin Pump

 
• By Natasha Barrow

Luna Health has raised $23.6m in Series A funding to support regulatory submissions, clinical studies and manufacturing for its insulin patch pump.

NeuroOne Prepares To Launch Trigeminal Nerve Ablation System

 
• By Elizabeth Orr

The US FDA has cleared NeuroOne's OneRF trigeminal nerve ablation system for the treatment of trigeminal neuralgia. This minimally invasive method utilizes radio frequency energy to alleviate pain, offering an alternative to traditional medications and surgeries. A fall commercial launch is planned.

More from North America

NeuroOne Prepares To Launch Trigeminal Nerve Ablation System

 
• By Elizabeth Orr

The US FDA has cleared NeuroOne's OneRF trigeminal nerve ablation system for the treatment of trigeminal neuralgia. This minimally invasive method utilizes radio frequency energy to alleviate pain, offering an alternative to traditional medications and surgeries. A fall commercial launch is planned.

Philips Announces Major Investment In US Manufacturing And Expansion Of Pennsylvania Facility

 
• By Brian Bossetta

Philips says the expansion of its facility in Reedsville, PA, will not only boost its capacity to produce AI-enabled ultrasounds that are used in hospitals across the US but will also create 120 well-paying jobs.

Breathing Easy: Freespira Works To Expand Access To Panic And PTSD Treatment

 
• By Elizabeth Orr

Freespira’s device has been FDA-approved to treat panic disorders and PTSD. CEO Joe Perekupka told Medtech Insight the company’s innovative approach includes patient coaching, insurance partnerships to identify potential users, and lobbying for broader insurance coverage for digital therapeutics.