North Carolina medical device maker Baxano Surgical Inc. (NSDQ:BAXS) agreed to pay $6 million to close a Justice Dept. probe initiated nearly 2 years ago. The definitive settlement consummates a tentative agreement the spinal device company forged with federal regulators in December 2012, according to a Baxano Surgical statement.
Bioventus, a global leader in active orthopaedic healing, today unveiled the next generation of its market-leading 1 EXOGEN ® Ultrasound Bone Healing System. The new EXOGEN has begun shipping in Europe and will be released in the United States, Canada and Australia later this year.
Medtronic (NYSE:MDT) prevailed in an antitrust lawsuit filed over a bone mill made by Lenox MacLaren Surgical, with a federal judge ruling that Lenox misrepresented the size of the bone mill market and failed to adequately market its own device.
Some 55 U.S. hospitals agreed to pay a total of $34 million to settle U.S. Justice Dept. charges that they overcharged Medicare for Medtronic's (NYSE:MDT)'s kyphoplasty spine procedure, acquired in the $3.9 billion buyout of Kyphon in 2007, the Justice Dept. said today.
Minnesota medical device giant Medtronic (NYSE:MDT) confirmed today that it recalled certain of its already-troubled Infuse spinal fusion surgery kits after learning of possible contamination in sponges manufactured by Integra Lifesciences.
SpineGuard announced today that it has obtained regulatory clearance from COFEPRIS (the Mexican healthcare regulatory authority) to sell its Cannulated PediGuard® device in Mexico. SpineGuard has previously received clearance for its Classic PediGuard device, and over 50 Mexican spine surgeons have been trained on the technology.
A study by researchers at Hospital for Special Surgery has provided the first evidence that the shape of a person's knee could be a factor in the decision of whether a patient should undergo anterior cruciate ligament reconstruction after an ACL tear.
As more therapies are able to indicate implantable devices for treatment, incorporating drug delivery into them can be a significant additional benefit. Even when drug delivery is the primary function, implantable devices can be preferable. This article reviews some representative applications that device designers can leverage in developing new products for the implantable drug delivery market.
Is it possible, that in 2-3 years Brits, Germans, Scandinavians, and Russians will undergo cancer treatment, orthopaedic, or cardiac surgery procedures in Polish medical facilities more often? Treat teeth and get implants in dental clinics; take a cure in Polish sanatoriums?
The antibacterial effects of silver are well established. Now, researchers at Yonsei University in Seoul, Republic of Korea, have developed a technique to coat glass with a layer of silver ions that can prevent growth of pathogenic bacteria including Escherichia coli, Salmonella typhimurium and Campylobacter jejuni. The technology could be used to protect medical equipment.
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.