FDA approves AI powered Automated Plate Assessment System

Clever Culture Systems AG (CCS), the Swiss based joint venture between Australian medical technology company LBT Innovations Limited and Hettich AG (Switzerland) has received clearance of its 510(k) de novo submission to the US Food and Drug Administration (FDA) for APAS® as a Class II medical device.

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Medrobotics Otolaryngology and Colorectal Robotic Surgery System CE Approved

Medrobotics Corp. received CE Mark regulatory clearance in Europe for colorectal applications with the Flex® Robotic System. Medrobotics is the first robotic company to offer minimally invasive, steerable and shapeable robotic products for colorectal procedures. With this expanded indication, the Flex® Robotic System becomes the first robotic surgical platform offering the ability to access hard to reach anatomy in both otolaryngology and colorectal procedures without the limits imposed by straight, rigid instruments.

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Smart-device ultrasound for ambulatory and home use by healthcare professionals

Royal Philips announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its innovative S4-1 cardiac transducer for Lumify, its smart-device diagnostic ultrasound solution. The pocket-sized and lightweight S4-1 transducer now offers advanced sensitivity and exceptional high-resolution 2D image quality, along with new exam pre-sets, allowing clinicians to quickly triage and assess their patients like never before.

Introduced in 2015, Lumify, the Philips solution, helps healthcare professionals make fast, informed decisions.  Now Lumify is the first Philips ultrasound device for ambulatory use, and with the S4-1 transducer, its clinical applications are expanded to include a full offering of in-demand cardiac, abdominal including lung, OB/GYN, and FAST exam pre-sets. With Lumify’s full suite of point-of-care transducers, physicians in emergency care situations can take advantage of every crucial moment without the time and mobility restrictions of locating an ultrasound cart, which is often in use and/or in another department.

“Lumify is a game-changing innovation,” said Dr. John Bailitz, emergency ultrasound physician and leader with ACEP and the Social Media and Critical Care (SMACC) organization. “The affordability, flexibility and versatility of Lumify make it appealing to those working in emergency settings, and now with the S4-1 cardiac probe and FAST exam pre-sets, we can conduct critical exams at the point-of-care, resulting in more efficient triage of patients.”

The Lumify app and all three transducers (L12-4, C5-2, and S4-1) completed rigorous environmental and durability testing to ensure reliability for emergency, critical care, and ambulance use. The S4-1 transducer and cable weighs 152 grams and is smaller than a smartphone, adding to its versatility and mobility. Beyond integrating with everyday technology, such as off-the-shelf, compatible smart devices, Lumify also uses cloud-enabled technology to connect with PACS, shared networks and system directories. Additionally, data will be accessible on the Philips HealthSuite Digital Platform, an open and secure, cloud-based IT infrastructure, allowing clinicians and health systems access to powerful data and analytics to help improve patient care.

“Our vision for smart-device ultrasounds is focused on putting high-quality devices in the hands of more professionals to serve more patients in more locations,” said Randy Hamlin, VP and Point-of-Care Business Leader for Philips Ultrasound. “With the S4-1 transducer and clinical pre-sets, Lumify is further extending the reach of ultrasound by delivering exceptional image quality, now for routine cardiac exams, and creating better connections between clinicians and their patients.”

Source: Philips


Fortimedix launches single-port laparoscopy in USA

Fortimedix Surgical today announced the official launch in the U.S. of symphonX™, the world’s first single-port surgery solution that is compatible with a standard 15mm trocar for use in minimally invasive abdominal laparoscopic surgery, during the American College of Surgeons (ACS) Clinical Congress.

“We are thrilled to formally launch the symphonX™ Surgical Platform in the U.S., which we believe has the potential to deliver on the promise of single-port surgery and elevate the standard of care in laparoscopy,” said Tom Dempsey, VP Sales of Fortimedix Surgical. “The technology was developed under the engineering code name FMX314 in close collaboration with leading surgeons to ensure that the platform addresses the needs of the medical community, and by extension the patient community. Our early clinical experience underlines its potential for improved patient satisfaction and health outcomes, including fewer port-site complications, less post-operative pain, faster recovery and exceptional cosmesis.”

symphonX™ addresses unmet needs in minimally invasive surgery by providing the medical community with a surgical solution that is small, simple and secure. Emulating conventional, multi-port laparoscopy, makes symphonX™ easy to use and enables surgeons to perform procedural steps ergonomically, allowing for a comfortable and secure single-port approach.

The first two U.S. commercial procedures with symphonX™ were recently performed at UC San Diego Health by Dr. Horgan, following 510(k) clearance in the U.S. and CE Mark approval in Europe. The European commercial launch is planned for 2017.

Source: Fortimedix Surgical


A step forward in building functional human tissues

Toward the ultimate goal of engineering human tissues and organs that can mimic native function for use in drug screening, disease modeling, and regenerative medicine, a Wyss Institute team led by Core Faculty member Jennifer Lewis, Sc.D., has made another foundational advance using three-dimensional (3D) bioprinting.

This work builds upon their demonstrated ability to bioprint tissue constructs composed of multiple types of living cells patterned alongside a vascular network in an extracellular matrix. The Wyss team has also previously shown that these constructs could be scaled up to create thick, vascularized tissue constructs, sustained viable for more than a month in vitro. Now, in close collaboration with Roche scientist Annie Moisan, they have leveraged their bioprinting and materials expertise to construct a functional 3D renal architecture containing living human epithelial cells, which line the surface of tubules in the kidney. The study appears online in the journal Scientific Reports.

“The current work further expands our bioprinting platform to create functional human tissue architectures with both technological and clinical relevance,” said Lewis, who is also the Hansjörg Wyss Professor of Biologically Inspired Engineering at the Harvard John A. Paulson School of Engineering and Applied Sciences.

The 3D renal architecture created by Lewis’ team mimics a proximal tubule, a serpentine hollow tube that is an essential part of each nephron. Every human kidney has over one million nephrons, which perform the vital function of transferring components between blood and urine. Inside the convolutions of a nephron’s proximal tubules, 65-80% of nutrients are reabsorbed and transported from the renal filtrate back into the bloodstream. Therefore, the bioprinted 3D renal architecture recapitulates a very small — yet critical — subunit of a whole kidney.

Lewis’ team achieved this advance by adapting their earlier approach for bioprinting living cells to form thick tissues. Using a customizable, 3D-printed silicone gasket as a mold, they begin by casting an engineered extracellular matrix as a base layer. Next, a “fugitive ink” (which is eventually liquefied and removed from the final architecture) is printed in a convoluted, winding tubular shape similar to the structure of natural renal proximal tubules. This printed feature is then encapsulated with another layer of extracellular matrix.

Lewis’ team achieved this advance by adapting their earlier approach for bioprinting living cells to form thick tissues. Using a customizable, 3D-printed silicone gasket as a mold, they begin by casting an engineered extracellular matrix as a base layer. Next, a “fugitive ink” (which is eventually liquefied and removed from the final architecture) is printed in a convoluted, winding tubular shape similar to the structure of natural renal proximal tubules. This printed feature is then encapsulated with another layer of extracellular matrix.

Co-first authors of the study Kimberly Homan, Ph.D., a Wyss Research Associate, and David Kolesky, Ph.D., a Wyss Postdoctoral Fellow, stress that the most exciting aspect of the work is that — far beyond mimicking the form of the kidney’s proximal tubule — it is a credible in vitro model that functions like living kidney tissue, representing a significant advance from traditional 2D cell culture. The team devoted great effort to characterizing the structure and biological function of the model.

As a result, their approach could one day be scaled up and translated into an implant or organ-assistive device. In the near term, it may offer clinicians a patient-specific tool for assessing treatment options or diagnosing diseases and also give the pharmaceutical industry a powerful way to determine how drugs impact the health and function of the kidney’s nephrons.

“The use of functional tissue-like models during pre-clinical studies will provide unprecedented insights into human-relevant drug response prior to clinical development,” said Moisan, a Laboratory Head in Mechanistic Safety at Roche and author of this study.

As a fabrication platform, the approach is flexible, scalable, and adaptable, meaning that in addition to working towards larger, scaled-up kidney constructs, the team also plans to explore development of other types of complex functional human tissues and organs.

“We have initially targeted this renal architecture, because the kidney represents such a pressing clinical need across the world,” said Lewis. “While thus far we have merely demonstrated a functioning subunit within the kidney, we are actively scaling up the method and its complexity to enable future in vivo applications.”

“This advance in 3D printing of living tissues that recapitulate crucial organ functions by Jennifer and her team opens a new path to engineering model systems for drug development, as well as for creating more functional extracorporeal devices and whole organ implants in the future,” said Donald Ingber, M.D., Ph.D., Founding Director of the Wyss Institute, Judah Folkman Professor of Vascular Biology at Harvard Medical School and Boston Children’s Hospital, and Professor of Bioengineering at SEAS.

Source: Wyss Institute for Biologically Inspired Engineering at Harvard University