New Clinical Study Launches to Evaluate Healing of Knee Cartilage Using a Patient’s Own Regenerative CellsJune 26, 2013 6:00 am | by Business Wire | News | Comments
InGeneron, Inc., an innovator in cell-based technologies for healthcare and veterinary medicine, announced today a study to assess the use of adult adipose derived regenerative cells to enhance cartilage healing after knee surgery. The study will utilize InGeneron’s patented Transpose RT system to prepare regenerative cells from the patient’s own fat tissue.
These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis. A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.
The conference program for MEDICA 2013, International Trade Fair with Congress – World Forum for Medicine, is undergoing a full re-launch. The content repositioning for MEDICA 2013 (to be held from November 20 – 23, 2103 in Düsseldorf, Germany) is designed to closely fit the program of the trade fair’s topics relevant to medical equipment users and to expand the international side of the program.
Synergy Biomedical, LLC has announced that it has recently received FDA clearance and will be launching its first bone graft product, BioSphere™ Putty. Utilizing a specialized form of 45S5 bioactive glass with a unique sphere shape and a narrow size range, BioSphere™ Putty provides an optimized bone graft material that outperforms other bioactive products.
Researchers are developing a new type of gripping arm for medical and engineering applications, using the the flexible armor of seahorses as a model. A team at the University of California San Diego says the creature's natural armor plating provides a degree of strength and flexibility that does not exist outside nature. Tara Cleary reports.
Much like other medical technology, implants are adapting to a post-depression economy brimming with new materials, new ideas, and ambitious plans for the future. The result is a focus on designing safer, more bio-compatible products for local markets.
Aesculap Implant Systems recently introduced the CeSpaceXP Interbody System for ACDF procedures. The CeSpaceXP fuses two proven materials, an innovative Plasmapore®XP osteoconductive porous Titanium coating and a PEEK-Optima® radiolucent core, that delivers enhanced implant stability, artifact-free imaging, and an optimal scaffold for cervical fusion procedures.
A new formulation of synthetic, biochemically absorbable polymers is creating opportunities in the medical device and pharmaceutical fields. These “bioabsorbable polymers” are materials designed to dissolve into compounds that the body can safely absorb or eliminate.
Mammals possess the remarkable ability to regenerate a lost fingertip, including the nail, nerves and even bone. In humans, an amputated fingertip can sprout back in as little as two months, a phenomenon that has remained poorly understood until now. In a paper published today in the journal Nature, researchers at NYU Langone Medical Center shed light on this rare regenerative power in mammals.
On this episode of The Pulse, rewired nerves from amputated limbs allow for prosthetic control with existing muscles, a bioengineered blood vessel is transplanted, diabetes is diagnosed through breath analysis alone, and a new technology is paving the way for low-cost electronic devices that work in direct contact with living tissue inside the body.
Medtronic Announces CE Mark of Its ReDuX(TM) Plier Instrument, an Innovative Device to Perform Osteotomies in Spinal Deformity SurgeriesJune 13, 2013 2:06 am | by The Associated Press | News | Comments
Medtronic, Inc. has announced the CE Mark and the European launch of the ReDuX Plier, a new instrument specially designed for use during osteotomies. With the launch of this first specially-designed surgical instrument in the spinal orthopaedic industry, physicians in the European community may now perform a more controlled osteotomy closure for people with a severe form of spinal curvature.
Abyrx, Inc., a privately-held therapeutic device company, today announced that the United States Food and Drug Administration has cleared its new Absorbable Hemostatic Bone Putty (AHBP) for clinical use in the United States. AHBP is provided ready-to-use (without requiring mixing or warming)...
Two new studies by researchers at Hospital for Special Surgery have shed light on joint replacement outcomes in patients with rheumatoid arthritis (RA). One study overturns the common belief that RA patients have worse outcomes after a total knee replacement (TKR) than patients who undergo the operation for osteoarthritis.
Researchers at Case Western Reserve University used a flat interface nerve electrode (FINE) to demonstrate direct sensory feedback. By interfacing with residual nerves in the patient's partial limb, some sense of touch by the fingers is restored. Other existing prosthetic limb control systems rely solely on visual feedback.
A team of researchers at the Rehabilitation Institute of Chicago (RIC) demonstrated a type of peripheral interface called targeted muscle re-innervation (TMR). By rewiring nerves from amputated limbs, new interfaces allow for prosthetic control with existing muscles. Former Army Staff Sgt. Glen Lehman, injured in Iraq, recently demonstrated improved TMR technology.
Since 2000, more than 2,000 servicemembers have suffered amputated limbs. DARPA’s breakthrough research with advanced prosthetic limbs controlled by brain interfaces is well documented, but such research is currently limited to quadriplegics; practical applications of brain interfaces for amputees are still in the future. In contrast, nerve and muscle interfaces allow amputees to control advanced prosthetics in the near term.
RTI Biologics Inc., a leading provider of orthopedic and other biologic implants, announced today its intent to acquire privately held Pioneer® Surgical Technology (Pioneer), headquartered in Marquette, Mich. Pioneer is a leading medical technology company that manufactures and distributes metal and synthetic products in the orthopedics, biologics, spine, trauma and cardiothoracic markets.
Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, announced today first implantations of a new hip replacement system designed to preserve a key portion of patients’ bone in total hip arthroplasty procedures.
The use of lasers in the development of medical devices through to their actual usage in the devices themselves has been a steadily growing trend. The capabilities and functionality they offer to both design engineers as well as healthcare professionals is varied and beneficial. This article looks at the advantages lasers offer in the development of medical devices.
Using a novel genetic 'editing' technique, Duke University biomedical engineers have been able to repair a defect responsible for one of the most common inherited disorders, Duchenne muscular dystrophy, in cell samples from Duchenne patients.
Cartilage injuries are difficult to repair. Bioengineers are interested in finding innovative ways to grow new cartilage from a patient’s own stem cells, and, thanks to a new study from the University of Pennsylvania, such a treatment is a step closer to reality.
SI-BONE, Inc. Announces Publication of Postmarket Surveillance Safety Data on First 5,319 Patients Treated with iFuse Implant SystemJune 5, 2013 7:00 am | by The Associated Press | News | Comments
SI-BONE, Inc. (San Jose, California), a medical device company that is pioneering the use of a minimally invasive surgical (MIS) device to fuse the sacroiliac (SI) joint, announced today the publication of the iFuse Implant System's@ postmarket surveillance safety data for the first 5,319 patients treated.
Blue Belt Technologies, Inc., an innovative medical technology company commercializing robotic-assisted solutions for orthopedic surgery, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its STRIDE™ Unicondylar Knee implant system.
Providence Medical Technology, Inc. (PMT) today announced it received 510(k) clearance from the FDA for its PMT Cervical Cage. PMT Cervical Cage is a novel minimally-invasive implant and delivery system for cervical fusion procedures. PMT Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level.
The growth in sales of medical technologies is set to outperform prescription medicines over the coming five years. Data from Evaluate Medtech indicates that over the period 2011 to 2018, the overall global compound annual growth rate for the sector will be 4.4%, in contrast to just 2.5% for drug products.