Wednesday, October 4, 2023
Wednesday, October 4, 2023

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FDA Continues Co-sponsorship of MedCon Conference with AFDO/RAPS Healthcare Products Collaborative

FDA will continue its long-standing co-sponsorship of the MedCon Conference. With a focus on fostering open discussions of the most pressing issues facing the medical device industry, the AFDO/RAPS Healthcare Products Collaborative recently announced that their new partnership will carry on Xavier Heath’s 12-year legacy of delivering the MedCon Conference.

The MedCon 2022 Conference will be held virtually May 4 – 6, 2022. The event will bring together medical device regulators and industry experts from around the world for content-rich conference sessions that include uncommon collaboration, deep dialogue, and networking as close as your computer.

“The annual MedCon conference helps fulfill the Department of Health and Human Services’ and FDA’s important mission to protect public health,” says Gina Brackett, Director, Compliance Branch at FDA ORA Office of Medical Device and Radiological Health. “MedCon has historically provided outreach and engagement with our colleagues in the medical products industry to discuss trends, innovations, and challenges in an educational setting. We are pleased that this new partnership between AFDO and RAPS intends to continue that focus. We feel it is important to be key facilitator of the discussion.”

FDA has made education of the device manufacturing community a high priority to help ensure the quality of FDA-regulated medical products.

MedCon 2022 registration is now open. For more information and to view the virtual program details, visit www.healthcareproducts.org/MedCon. Information about the Collaborative and announcements for future events can be found at www.healthcareproducts.org.

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OTHER NEWS

4SC Receives Orphan Drug Designation (ODD) for resminostat (Kinselby) in CTCL from the US FDA

Jason Loveridge, Ph.D., CEO of 4SC, commented: “Receiving orphan drug designation for resminostat provides us with a number of important benefits, most crucially 7 years’ market exclusivity in the US, a key foundation of our efforts to commercialise Kinselby.  We are currently preparing a marketing authorisation application for Kinselby in the EU, which remains on track for submission in Q1 2024.”

Abyrx Receives FDA Clearance for MONTAGE ® Settable Bone Putty for Use in Cardiothoracic Surgery

By expanding the range of FDA-cleared surgical applications for MONTAGE, this latest milestone positions Abyrx to build upon the more than 25,000 units of MONTAGE that have been used to date by surgeons in trauma, orthopedics, sports medicine, foot and ankle, and craniomaxillofacial procedures.

FDA Grants Fast Track Designation to 9MW3011

9MW3011 has been approved to clinical study by NMPA and FDA, respectively. The first person has been dosed in the clinical study in China in March, 2023.

MicuRx receives FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation for Contezolid and Contezolid acefosamil

"We are pleased to gain the QIDP and Fast Track designations for DFI as recognition that contezolid and contezolid acefosamil are novel new agents to meet an important unmet need in this common and challenging infection", stated Dr Zhengyu Yuan, Chief Executive Officer at MicuRx. 

Via Nova Therapeutics Announces FDA clearance of Investigational New Drug (IND) Application for VNT-101

"We look forward to evaluating VNT-101 in the clinic," said Don Ganem MD, Co-Founder and CEO of Via Nova Therapeutics. "This is an important step to developing a flu antiviral with a novel mechanism of action, and a milestone for Via Nova Therapeutics as we advance our first compound into the clinic."

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