Cellmyx Announces FDA 510(k) Clearance for intelliFat® BOD™ (Ref.# K210528)

Summation

  • Kits are sterile, and disposable, and contain a full suite of proprietary and stand-alone components to harvest, process, and transfer autologous adipose tissue for use as an alternative, and/or as an adjunct, to surgery for filling soft tissue defects and promoting healing in orthopedics, plastic, and cosmetic surgery, and a multitude of other surgical procedures and specialties.
  • intelliFat® BOD™ is particularly attractive to physicians because it’s compliant with the latest FDA guidelines, preserving cellular and tissue micro-architecture of adipose, eliminating residual oil emulsion and blood, thereby providing a tissue byproduct that is minimally manipulated in accordance with FDA guidelines for Human Cell and Tissue Products.
  • Cellmyx, the authority on autologous adipose grafting and transfer, and a leader in medical technologies for orthopedic physicians, pain management and regenerative medicine, announces U.

Cellmyx, the authority on autologous adipose grafting and transfer, and a leader in medical technologies for orthopedic physicians, pain management and regenerative medicine, announces U.S. Food and Drug Administration (FDA) 510(k) clearance for intelliFat® BOD™ (Ref.# K210528). The most advanced, quickest and easiest, single use kit for macro, micro, and nano fat tissue harvesting, processing, and transfer.

Cellmyx notes U.S. regulators have cleared the way for this groundbreaking new medical appliance and technology for use in orthopedic, plastic, and cosmetic surgery procedures. intelliFat® BOD™ successfully uses a patient’s own body fat, clinically referred to as adipose tissue, to aid in patient recovery and healing.

In some cases, intelliFat® BOD™ is used in conjunction with traditional orthopedic surgery to further advance patient outcomes. intelliFat® BOD™ is particularly attractive to physicians because it’s compliant with the latest FDA guidelines, preserving cellular and tissue micro-architecture of adipose, eliminating residual oil emulsion and blood, thereby providing a tissue byproduct that is minimally manipulated in accordance with FDA guidelines for Human Cell and Tissue Products.

Kits are sterile, and disposable, and contain a full suite of proprietary and stand-alone components to harvest, process, and transfer autologous adipose tissue for use as an alternative, and/or as an adjunct, to surgery for filling soft tissue defects and promoting healing in orthopedics, plastic, and cosmetic surgery, and a multitude of other surgical procedures and specialties.

Physicians feel empowered. They have the assets they need right at their fingertips to perform this revolutionary procedure without incising, stitching, or scarring the patient. intelliFat® BOD™ streamlines procedure times to under 30 minutes with its patented and unparalleled harvesting, processing, and transfer system. Patients experience no discomfort or downtime during or post-procedure and may return to normal social activities immediately with clearance from their provider.

According to Associate Clinical Professor of Medicine, University of Connecticut School of Medicine, Fellow of the American Osteopathic Academy of Sports Medicine, and Board Certified in Sports Medicine & Regenerative Medicine Dr. Paul D. Tortland, D.O. FAOASM, RSMK:

“I began performing autologous fat derived treatments for orthopedic regenerative medicine in 2009, the first physician in New England, and among the earliest in the country. Over the years I’ve trialed most commercially available systems to harvest and prepare adipose for injection. I have found these systems are cumbersome to use, time-consuming, or produce suboptimal product for injection. But with intelliFat® BOD™ Cellmyx hit the mark. Their kit is elegantly simple, fast and easy to use, and produces a superlative final product that’s easy to inject. Most importantly, I’m seeing outstanding clinical results.”

The intelliFat® 510(k) specifically includes procedures for neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic, cosmetic, and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, laparoscopic surgery, arthroscopic surgery, and thoracic surgery.

Other FDA News of Interest

Indica Labs Receives FDA Clearance for HALO AP Dx Digital Pathology Platform for Use with Hamamatsu Images Acquired with the NanoZoomer® S360MD Slide Scanner

Indica Labs, an industry leader in AI-powered digital pathology solutions, and Hamamatsu Photonics K.K., a pioneer in whole slide imaging systems, announce that the...

FDA Grants AI-Powered Notal Vision Home OCT “SCANLY” De Novo Marketing Authorization

“We are very excited to receive FDA authorization to market SCANLY Home OCT as the first-ever patient self-operated, home-use device that gives physicians remote access to high-resolution, cross-sectional retinal images and AI-based analytical biomarkers of their patients eyes between office visits,” said Kester Nahen, PhD, CEO of Notal Vision. “We look forward to supporting our referring physicians in navigating their wet AMD patients’ care.”

Atraverse Medical Receives FDA Clearance for HOTWIRE™ Left Heart Access Device, Oversubscribes Seed Round with $12.5M Invested

The HOTWIRE system, invented by Atraverse Medical Co-Founders Dr. Steven Mickelsen and Eric Sauter, introduces a paradigm shift in left-heart access.

By using this website you agree to accept Medical Device News Magazine Privacy Policy