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At FDA, a new goal, then a push for speedy device reviews

WASHINGTON — Dr. Jeffrey Shuren was adamant: The United States would never cut corners to fast-track the approval of medical devices. "We don't use our people as guinea pigs in the U.S.," Shuren said, ... read more

FDA’s push for speedy device reviews raises questions

Under Dr. Jeffrey Shuren, director of the FDA’s medical devices division, annual new device approvals have more than tripled, while warnings letters to device manufacturers about product safety and qu... read more

Has FDA’s ‘First In The World’ Ambition Contributed To Years Of High-Profile Safety Problems With Medical Devices?

The Associated Press: At FDA, A New Goal, Then A Push For Speedy Device Reviews Dr. Jeffrey Shuren was adamant: The United States would never cut corners to fast-track the approval of medical devices. ... read more

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FDA's 'flawed' device pathway persists with industry backing

The FDA's move came one day after the publication of a global investigation into medical device safety by more than 50 media ... adding that streamlined reviews are generally reserved for lower-risk d... read more


'I’m Possibly Alive Because It Exists:' Why Sleep Apnea Patients Rely on a CPAP Machine Hacker

CPAP users like Watkins are part of a new push by patients to take control ... their own sleep apnea therapy if they so choose" The FDA, meanwhile, told the Copyright Office at the time that any devic... read more

2018 Digital Health Year in Review: Focus on Care Coordination and Reimbursement

When we have no ongoing legitimate business need to process your personal information, we will either delete or anonymize it, or, if this is not possible (for example, because your personal informatio... read more

Report: ‘Right to try’ laws make safety and efficacy secondary to speedy access

State “right to try” laws can give terminally ill patients early access to experimental drugs and medical devices, but they arguably make safety and efficacy secondary to speedy access, according to a ... read more

FDA Changes Will Reward Medical Device Innovation: Here’s What Investors Need to Know

NEW ... device industry to bring better products to market, it makes sense to look for true innovators in this space. The FDA Will Push for Device Makers to Innovate The FDA's 510(k) clearance pathway ... read more

Investing In Advanced Wound Care? Avoid These 3 Costly Mistakes

Editor's note: Seeking Alpha is proud to welcome Diligence Wound Care Global LLC as a new contributor ... wound care and investment goals, we assess potential synergies within their current (or planne... read more

3DGence launches the DOUBLE P255 – technical specifications and pricing

Polish 3D printer manufacturer 3DGence has launched a new FFF 3D printer ... “One of the main design goals of 3DGence DOUBLE P255 was to create a reliable and versatile device. We have introduced a nu... read more

At FDA, a new goal, then a push for speedy device reviews

WASHINGTON (AP) — Dr. Jeffrey Shuren was adamant: The United States would never cut corners to fast-track the approval of medical devices. "We don't use our people as guinea pigs in the U.S.," Shuren ... read more

'Right to try' laws make safety and efficacy secondary to speedy access

State "right to try" laws can give terminally ill patients early access to experimental drugs and medical devices, but they arguably make safety and efficacy secondary to speedy access, according to a ... read more



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