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47 Total results for product and free and sample content found

Medtech Insight: 世界の医療機器・医療技術の最新情報

FDA Device Panel Delivers Thumbs Up For Breakthrough Heart-Failure Device

By elizabeth-orr 05 Dec 2018

A US FDA panel overwhelmingly supported a heart-failure device designed to use cardiac contractility modulation to improve heart function. The Optimizer Smart system from Impulse Dynamics is apparently the first in FDA’s Breakthrough Devices program to go before an advisory panel.

Topic fda

Medtech Insight: 世界の医療機器・医療技術の最新情報

Philippines Gets Moving On Reg Reform: Asian Medtech Associations Regulatory Networking, October 2018

26 Oct 2018

The Asian Medtech Associations Regulatory Networking discussions this month focus on regulatory reforms in the Philippines, where good progress is being made on embedding a new set of medical device, IVD and labeling regulations. Also, updates from Thailand, Hong Kong and India. This series is hosted by Medtech Insight, along with the Asia Regulatory and Quality Consultancy (ARQon) and the Asia Regulatory Professionals Association (ARPA).

Topic FDA

Medtech Insight:世界の医療機器に特化したニュース配信

Proposed 510(k) Changes Elicit Some Industry Skepticism

By elizabeth-orr 18 Oct 2018

Two 510(k) pilots from US FDA indicate the agency's desire for faster, easier clearances. But some observers aren’t sure if they’ll lead to real improvements.

Topic fda

Medtech Insight:世界の医療機器に特化したニュース配信

Medtronic Slapped With 2 FDA Warning Letters For Problems At Minnesota, Puerto Rico Sites

By Shawn M. Schmitt 12 Sep 2018

Two Medtronic facilities that make cardiac rhythm management devices were sent warning letters by US FDA because of quality systems issues. The sites were inspected by the agency after the firm initiated high-risk class I recalls for an array of CRM products earlier this year.

Topic fda

Medtech Insight:世界の医療機器に特化したニュース配信

'Quik' Review Program Builds On US FDA eSubmission Efforts

06 Sep 2018

The agency says 510(k)s submitted via an electronic template for any of about 40 product types might get a speedier review under a new pilot program.

Topic fda


Shire Could Reclaim HAE Prophylaxis Market From CSL Behring

By Joseph Haas 30 Aug 2018

Offering better efficacy than Shire’s existing HAE therapies and dosing convenience compared to CSL Behring’s prophylactic Haegarda, the specialty pharma may take back market share lost to its competitor and consolidate its leadership in the space.

Topic FDA

Pink Sheet:世界の薬事規制と承認審査に関するニュース

US FDA To Withdraw Pain Drug Guidance As Part Of Response To Opioid Epidemic

By nielsen-hobbs 30 Aug 2018

"At least four" guidances will replace it, Commissioner Gottlieb notes in frank update which states "I don’t want to look back ten years from now and wish there were more policies we had pursued, or more steps we had taken, to stop the advance of this crisis."

Topic fda

Medtech Insight:世界の医療機器に特化したニュース配信

Top Medtech Lobbyist Doubts Legislative Repercussions Of New Netflix Documentary

By ferdous-al-faruque 30 Aug 2018

AdvaMed's top lobbyist says a new documentary critical of the medical device industry and US FDA's device review pathways is unlikely to result in Congressional action. However, the group is talking to members on Capitol Hill to make sure they fully understand the context within which devices are reviewed and marketed.

Topic fda medtech





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