Search Results for “medical device” – Page 33 – media

New MDSAP rules from Health Canada will raise cost for audit and force some companies out of Canada.

Health Canada’s new safety audit rules are going to increase costs and expected to expel some medical devices players out of the country, the new rules are expected to bring a huge shortage of products for the patients in Canada.
- Source: Ddu -Jophy Joseph
- 595
- May 7, 2018
Canada medical device Policies
Three Misconceptions and Four Suggestions to Pay Attention to in Foreign Trade

Foreign trade is a highly competitive field with numerous potholes and hidden issues. As a leader in the online pharmaceutical and medical device B2B industry, Ddu staff have in-depth knowledge of these matters. Today we’ll share our take on three misconceptions that are often overlooked and four important suggestions on how to approach your clients.
- Source: Ddu
- 6,742
- May 4, 2018
Ddu College misconceptions suggestions
As FDA’s Pre-Cert plan takes shape, worries emerge about overreach

Yesterday morning, the FDA published its 17-page first draft of a working model for its pre-certification program for software as a medical device (SaMD). Though still preliminary (the agency is asking for comments by the end of May), the publication comes with some long-awaited details about how the program might work.
- Source: MobiHealthNews
- 615
- April 27, 2018
FDA medical device products Policies
Urotronic gets OK for advanced trial to treat narrowed urethras

Plymouth-based medical device maker Urotronic is ramping up clinical research on its Optilume drug-coated balloon to treat men with narrowed urethras, accelerating the data-gathering process for its novel device.
- Source: StarTribune
- 1,917
- April 26, 2018
FDA medical device medtech Researches
FDA clears new Dexcom CGM that requires no patient calibration earlier than expected

Medical device maker DexCom announced Tuesday that the company has received a de novo clearance from the FDA to sell its latest continuous glucose monitoring system — the G6 — that requires no fingerstick calibration.
- Source: MedCityNews
- 711
- March 29, 2018
diabetes FDA insulin New Approvals
Ddu Priority Products Recruitment Activity Online

In collaboration with Google, Facebook, Yahoo and LinkedIn, Ddu recently launched their priority products rally to help users on the platform capture business opportunities, hosting an online medical device product fair to get mass exposure for users' quality products.
- Source: Ddu
- 1,647
- March 22, 2018
Ddu News medical device
CFDA Continues to Expand Oversea Inspection

On Feb 27th, China Food and Drug Administration (CFDA) published their inspection reports for eight international medical device manufacturers located in U.S., Europe, Japan, and Australia under its Medical Device Good Manufacturing Practice.
- Source: drugdu
- 662
- March 14, 2018
CFDA medical device products Policies
Cardiovascular Systems, Inc. and OrbusNeich Announce FDA Clearance of the First and Only 1.0mm Coronary Balloon in the U.S.

Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the OrbusNeich® 1.0mm Sapphire® II PRO coronary balloon.
- Source: Enhancedonlinenews
- 499
- March 5, 2018
artery disease New Approvals Sapphire
Ddu Attended Arab Health A Perfect Match for International Trade

The Arab Health Exhibition 2018 was successfully held at the Dubai International Convention & Exhibition Centre from January 29th to February 1st, 2018. Ddu, the leading global pharmaceutical & medical device B2B online platform, attended the exhibition along with three priority members, taking home valuable resources.
- Source: Ddu
- 1,317
- March 2, 2018
Arab Health Exhibitions & Activities medical device
Cognoa’s AI platform for autism diagnosis gets first FDA stamp

Cognoa has gained regulatory recognition for its machine learning software as a class II diagnostic medical device for autism — meaning the digital health startup is now positioned to submit an application for full FDA clearance.
- Source: Techcrunch
- 600
- February 27, 2018
AI autism FDA New Approvals

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