FDA Clears Pure-Vu Slim Sleeve to Clean Out Colons Using Slim Colonoscopes

USA – FDA Clears Pure-Vu Slim Sleeve to Clean Out Colons Using Slim Colonoscopes

Motus GI, a company out of Fort Lauderdale, Florida, won FDA clearance for its Pure-Vu Slim Sleeve, an extension that allows the Pure-Vu System...
Cœur artificiel : la société Carmat ouvre sa première usine et vise une production de 500 prothèses par an

France – Cœur artificiel : la société Carmat ouvre sa première usine et vise...

À l'usine Carmat, il n'y a pas de chaîne de montage. La fabrication de cœurs artificiels se fait dans un grand laboratoire blanc à...
Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act

USA – Monetary Penalties for Failing to Report Trials: FDA Drafts Guidance

Failing to submit trial data to ClinicalTrials.gov may start to cost drug and device makers, the US Food and Drug Administration (FDA) said Thursday...
FDA Finalizes Guidance on Delayed Graft Function in Kidney TransplantationRay Imaging Devices With International Standards

USA – Device Makers Call for Changes to FDA’s Biliary Stent Guidance

Medical device makers Boston Scientific and Cook are calling for changes to the US Food and Drug Administration’s (FDA) draft guidance on 510(k) submissions...
Notify MHRA about a clinical investigation for a medical device

UK – Notify MHRA about a clinical investigation for a medical device

You may need to carry out a clinical investigation as part of the process to obtain a CE marking for your medical device. You...
MYnd Analytics stock rallies after FDA gives breakthrough status for company device

USA – MYnd Analytics stock rallies after FDA gives breakthrough status for company device

Shares of MYnd Analytics inc (NASDAQ:MYND) popped on Monday after the US Food and Drug Administration (FDA) granted breakthrough device designation for the company's...
Are You Really Ready For MDR?

Europe – Are You Really Ready For MDR?

Audrey Turley doesn’t shy away from speaking about biocompatibility topics related to medical devices. Turley serves as a senior biocompatibility expert for Nelson Labs....
Australian regulatory action on breast implants and breast tissue expanders

Australia – Australia Unveils Strategy for Engaging With Foreign Regulators

Australia’s Therapeutic Goods Administration (TGA) revealed a three-part plan on Monday to operationalize its strategy on engaging international regulators through FY 2019. TGA said the new plan...
Examining US FDA criteria for medical device cybersecurity and risk management

USA – FDA Follows Up on Alcon’s CyPass Withdrawal With Eye Damage Risk Alert

The US Food and Drug Administration (FDA) issued a safety communication on Friday to alert of a potential risk of eye damage in patients...
Special 510(k)s: CDRH’s Proposed Program Expansion Draws Mixed Reactions

USA – FDA rolls out plan to reduce third party 510(k) re-reviews

Dive Brief: Responding to a mandate in the FDA Reauthorization Act of 2017 (FDARA), the agency Thursday released draft guidance delineating how the agency...

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