Medical aesthetic company DBM Corporation Inc disclosed on Tuesday that it has passed the Food and Drug Administration (FDA) 510(k) clearance for MIRACU PDO Threads for the US aesthetic market.
The clearance for MIRACU PDO Threads is a huge accomplishment for the company as it marks the first PDO thread to receive US FDA 510 (k) clearance in the US.
DBM Corporation Inc, the official US representative of MIRACU PDO Threads, will now integrate this product listing with its ever growing exclusive medical portfolio.
MIRACU PDO Threads is a medical device indicated for use on soft approximation where absorbable sutures are appropriate. The device has a cannula (needle) with a surface coating smoother than that of traditional catgut sutures, coupled with ultra-thin walls for maximum pain relief. The threads are designed to remain in the body up 240 days, are converted into water and carbon dioxide and are fully absorbed without any residue, according to the company.
Additionally, the MIRACU PDO Threads are available in a variety of cannula types including but not limited to FC, FC45, FCL, and FCN, as well as bevy of PDO Thread types including but not limited to Mono, Screw, Cog and Forte.
In 2019, the company expects over 58% of Medical Practitioners will be integrating PDO Threads into their practice, with 78% by 2020 and 91% by 2021. All sales of MIRACU PDO Threads be made through an authorised distributor to ensure safety and effectiveness for patients.
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Precision Epigenomics partners with TruDiagnostic
Illumina's GRAIL divestment plan receives EC approval
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Ondine Biomedical's Steriwave approved for use by HCA UK
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial
Syros receives Fast Track Designation from FDA for tamibarotene in AML
Ligand Pharmaceuticals announces presentation of Captisol-enabled Topiramate Injection data