MiMedx Appoints Timothy R. Wright as Chief Executive Officer
Healthcare Industry Veteran to Lead Next Phase of MiMedx MARIETTA, Ga., May 9, 2019 -- (Healthcare Sales & Marketing Network) -- MiMedx Group, Inc. (OTC PINK: MDXG) ("MiMedx" or "the Company"), an industry leader in advanced wound c... Devices, Wound Care, Personnel MiMedx Group, PURION, placental tissue, allograft (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - May 9, 2019 Category: Pharmaceuticals Source Type: news

New AlphaGRAFT DBM Fiber Technology Improves Regenerative Capacity
Optimized handling enables combination with allograft or autograft for use in spinal fusion procedures Provides moldable allograft with cohesive handling characteristics and osteoconductive scaffold for delivery of autologous stem cells Regenerative capacity exhibits all five elements of new bone formation in validated animal modelsThis story is related to the following:Surgical Implants (Source: Industrial Newsroom - Health, Medical and Dental Supplies)
Source: Industrial Newsroom - Health, Medical and Dental Supplies - May 7, 2019 Category: Medical Devices Source Type: news

How CareDx Is Bringing AI to Transplant Care
Brisbane, CA-based CareDx has partnered with Cibiltech, a French company that develops artificial intelligence-based products for predictive medicine, to commercialize Predigraft.  Predigraft is a data analysis tool designed to provide an early prediction of a patient's risk of allograft rejection and transplant loss. It was developed from Cibiltech’s software algorithm called iBox, which is built off the outcomes data from tens of thousands of transplant patients. The deal is yet another example of how AI is disrupting the status quo in medtech. MD+DI recently publishe...
Source: MDDI - May 3, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Software Source Type: news

FDA clears moldable OssiMend bioactive bone graft from Collagen Matrix
Collagen Matrix said today that it won FDA 510(k) clearance for its line of OssiMend Bioactive Moldable bone graft matrix products, intended for use in spinal procedures. The Oakland, N.J.-based company said that the newly cleared OssiMend product is composed of anorganic carbonate apatite bone mineral, 45S5 bioactive glass and highly purified Type I collagen, and that it can be molded into putty for filling irregular defect sites. The moldable Ossimend product is designed to be slowly resorbed and replaced by new bone tissue, and comes in various sizes, Collagen Matrix said. “We continue to expand our product portfo...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Spinal collagenmatrix Source Type: news

Miach Orthopaedics touts results of two-year study on ACL repair
Miach Orthopaedics said that a study of its bio-engineered implant for autograft anterior cruciate ligament (ACL) repair revealed results similar to those achieved by traditional ACL repair surgeries two years post-procedure. The non-randomized, two-arm study conducted at Boston Children’s Hospital enrolled 10 patients treated with Miach Orthopaedics’ bridging scaffold-enhanced ACL repair (BEAR) implant with hamstring autograft ACL reconstruction and was conducted under an FDA Investigational Device Exemption. The BEAR implant was designed to be surgically placed between the torn ACL ends at the time of re...
Source: Mass Device - March 13, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Clinical Trials Featured Implants News Well Orthopedics Research & Development Surgical Miach Orthopaedics Source Type: news

Wright Medical closes rights agreement for BioMimetics buyout
Wright Medical (NSDQ:WMGI) said yesterday that it closed a contingent value rights agreement connected to its acquisition of BioMimetic Therapeutics. Wright agreed to pay $380 million in cash, stock and milestone payments to pick up BioMimetic and its Augment bone graft back in 2013. The FDA cleared the bone graft with indications as an alternative autograft for ankle and hindfoot fusion procedures in September 2015. The Amsterdam-based company said that the agreement, dated March 1, 2013 between it and American Stock Transfer & Trust, is terminated effective March 1, according to a press release. The Augment bone...
Source: Mass Device - March 12, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat wrightmedical Source Type: news

S & amp;N Expands Reach into Regenerative Medicine with M & amp;A
Smith & Nephew is taking a deeper dive into the regenerative medicine market through its $660 million acquisition of Osiris Therapeutics. The London-based company said it hopes to close the deal in 2Q19 and made the announcement of the pending merger at the American Academy of Orthopedics Annual Meeting held this week in Las Vegas. Columbia MD-based Osiris Therapeutics delivered revenue of $102 million for the nine-months ended 30 September 2018, an 18.7% increase over the comparable period in 2017. Revenue was $36.5 million for the three-month period ended 30 September 2018, a 22.4% increase year on year. Osiris is ex...
Source: MDDI - March 12, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Orthopedics Source Type: news

Smith and Nephew expands in high growth regenerative medicine market through acquisition of Osiris Therapeutics, Inc.
LONDON, March 12, 2019 -- (Healthcare Sales & Marketing Network) -- Smith & Nephew plc (LSE: SN,NYSE: SNN), the global medical technology business, announces that it has agreed to acquire Osiris Therapeutics, Inc. (NASDAQ: OSIR), a fast growing company de... Devices, Orthopaedic, Mergers & Acquisitions Smith & Nephew, Osiris Therapeutics, dermal graft, bone graft (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - March 12, 2019 Category: Pharmaceuticals Source Type: news

Timing of Medicare Loss Linked to Kidney Transplant Outcomes
MONDAY, March 11, 2019 -- Kidney transplant recipients receiving Medicare who lose coverage before or after the current three-year policy time point have an increased risk for allograft loss, according to a study published online March 5 in the... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - March 11, 2019 Category: Pharmaceuticals Source Type: news

Medtronic launches Grafton DBM in Japan
Medtronic (NYSE:MDT) said today that it launched its Grafton demineralized bone matrix bone grafting product in Japan. The Fridley, Minn.-based company touted the Grafton DBM as the first and only demineralized bone matrix product available in Japan, having won clearance from the country’s PMDA last August. The newly launched Grafton DBM is a bone graft extender, bone graft substitute and bone void filler intended for use in bony voids or gaps in the skeletal system. The company added that the Grafton DBM has consistently high osteoconductivity scores and that it is the “most utilized and scientifically-st...
Source: Mass Device - February 28, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Orthopedics Spinal Medtronic Source Type: news

Orthofix wins FDA PMA nod for M6-C artificial cervical disc
Orthofix (NSDQ:OFIX) said yesterday that it won FDA approval for its M6-C artificial cervical disc, intended for treating patients suffering from cervical disc degeneration. The Lewisville, Texas-based company said that the M6-C artificial cervical disc was developed by Spinal Kinetics, which it acquired last April. The newly cleared M6-C is a next-gen artificial disc intended to replace an intervertebral disc damaged by cervical disc degeneration. The system is designed to restore physiological motion to the spine and is indicated as an alternative to cervical fusion, Orthofix said. Pre-market approval of the de...
Source: Mass Device - February 8, 2019 Category: Medical Devices Authors: Fink Densford Tags: Featured Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Spinal Orthofix Source Type: news

Sirakoss wins CE Mark for Osteo3 bone graft substitute
Sirakoss said yesterday that it won CE Mark clearance in the European Union for its Osteo3 novel nanosynthetic bone graft substitute. The Aberdeen, Scotland-based company said that its Osteo3 consists of an inorganic matrix intended to be completely reabsorbed into the bone. Sirakoss added that the newly cleared bone graft substitute features a unique surface chemistry designed to catalyze rapid and complete bone regeneration following a fracture or for support after corrective surgeries. “Osteo3 is the first of our new generation of bone substitute products to receive CE Mark, a major milestone for Sirakoss. We...
Source: Mass Device - February 1, 2019 Category: Medical Devices Authors: Fink Densford Tags: Orthopedics Regulatory/Compliance sirakoss Source Type: news

Plasma Marker Predicts Allograft Failure in Lung Transplant
THURSDAY, Jan. 24, 2019 -- Donor-derived cell-free DNA (ddcfDNA) is a potential biomarker that can predict allograft failure after lung transplantation, according to a study published online Jan. 23 in EBioMedicine. Sean Agbor-Enoh, M.D., Ph.D.,... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 24, 2019 Category: Pharmaceuticals Source Type: news

Bioventus launches Osteomatrix+ bone graft
Bioventus announced today that it has started selling Osteomatrix+ – a moldable bone graft substitute intended for a variety of orthopedic and spine bone remodeling applications. Bioventus officials boast that Osteomatrix+ has improved moldability, flexibility and versatility versus its predecessor. “Osteomatrix+ represents the first of several next-generation products that will be added to the Bioventus portfolio in the next five years,” Bioventus CEO Tony Bihl said in a news release. Get the full story on our sister site Medical Design & Outsourcing.  The post Bioventus launches Osteomatri...
Source: Mass Device - January 17, 2019 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News News Well Orthopedics Bioventus LLC Source Type: news

New RBI for Kidney Allografts: Can It Replace Routine Tests? New RBI for Kidney Allografts: Can It Replace Routine Tests?
Dr Desai reviews a study examining the usefulness of a new renal biopsy index (1-RBI). Could it be used in place of invasive routine biopsies in deceased-donor kidney transplant recipients?Medscape Nephrology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 14, 2019 Category: Consumer Health News Tags: Nephrology Viewpoint Source Type: news

Pirfenidone in RAS After Lung Transplantation Pirfenidone in RAS After Lung Transplantation
How might pirfenidone benefit lung transplant recipients with restrictive allograft syndrome?American Journal of Transplantation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 10, 2019 Category: Consumer Health News Tags: Transplantation Journal Article Source Type: news

New Data Boosts Value Proposition of AlloSure
When our kidneys fail to function as they should, our treatment options generally begin with dialysis and end with a kidney transplant. Unfortunately, transplanted kidneys last, on average, between 12 years and 15 years (depending on if the donor is living or deceased, and if they are a relative or not). Some recipients are lucky if they even get five good years out of their transplanted kidney. CareDx has already established the clinical value of AlloSure, a donor-derived cell-free DNA test designed to assess allograft health in kidney transplant patients, and new data demonstrates the test's clinical utility in patients ...
Source: MDDI - January 9, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: IVD Source Type: news

Kuros raises $16m for bone-growth protein
Kuros Biosciences (SIX:KURN) said this week that it raised more than $16 million for clinical trial of its bone-growth protein as it expands the commercial footprint for its MagnetOs bone graft substitute. Proceeds from the CHF 16.1 million round are earmarked for a Phase II trial of the Fibrin-PTH protein in spinal fusion procedures and for the commercialization of MagnetOs, which won 510(k) clearance from the FDA in August 2017 and CE Mark approval in the European Union in May. Kuros won CE Mark approval in the European for its Neuroseal dural sealant in June 2017. The Zurich-based company said it plans to laun...
Source: Mass Device - December 19, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured Funding Roundup Orthopedics Regenerative Medicine kurosbiosciences Source Type: news

Hamstring injuries in Major League Baseball pitchers: implications in graft selection for ulnar collateral ligament reconstruction - Howard DR, Banffy MB, Elattrache NS.
BACKGROUND:: Hamstring tendons are commonly harvested as autograft for ulnar collateral ligament reconstruction. There is no consensus in the literature whether the hamstring tendon should be harvested from the ipsilateral (drive) leg or contralateral (lan... (Source: SafetyLit)
Source: SafetyLit - December 19, 2018 Category: International Medicine & Public Health Tags: Ergonomics, Human Factors, Anthropometrics, Physiology Source Type: news

MiMedx accounting firm quits
The troubles at MiMedx (NSDQ:MDXG) continued last week with the resignation of the accounting firm tapped to audit its books in the wake of a financial scandal. Marietta, Ga.-based MiMedx last July ousted ex-CEO Parker Petit and president & COO William Taylor amid a board-directed independent investigation that had already prompted the departure of CFO Michael Senken and treasurer John Cranston in June. At the time, MiMedx said it would restate all of its earnings reports going back to 2012 and was cooperating with U.S. Securities & Exchange Commission and Justice Dept. investigations into ...
Source: Mass Device - December 10, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured Regenerative Medicine Wall Street Beat MiMedx Group Inc. Source Type: news

Globus Medical launches ExcelsiusGPS in EU
Globus Medical (NYSE:GMED) said yesterday that it launched its ExcelsiusGPS robotic guidance and navigation system in the global market, having completed installations of the system in several European countries. The ExcelsiusGPS system won CE Mark clearance in the EU in early 2017 with indications for use in both minimally invasive and open procedures for orthopedics and neurosurgery, including procedures for the spine, long bones and cranium. The system is designed to integrate with Globus Medical implants and instruments, with compatibility with pre- and intra-operative CT and fluoroscopic imaging, the co...
Source: Mass Device - December 7, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Robotics Globus Medical Source Type: news

FDA warns Globus subsidiary HBT over ViaCell production facility issues
The FDA this week released a warning letter it sent to a Globus Medical (NYSE:GMED) subsidiary Human Biologics of Texas, which produces the company’s ViaCell allograft product, over issues it found during an inspection of the facility in April. The federal watchdog noted multiple infractions during the initial inspection, and also provided a response to corrective actions the company said it was taking in response to the earlier noted issues. In its in inspection, FDA investigators noted failures to document and investigate deviations in its production of the ViaCell product as well as trends of deviations away ...
Source: Mass Device - December 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regenerative Medicine Regulatory/Compliance Globus Medical Source Type: news

Pushing 3D Printing Forward
Researchers and students have demonstrated that inks can be used instead of thermoplastic filaments to 3D print functional biomedical devices. Michael McAlpine, Benjamin Mayhugh Associate Professor of Mechanical Engineering at the University of Minnesota, described such advances in the ESC Minneapolis keynote, “3D Printing Functional Materials & Devices.” A lot of the inks McAlpine’s group uses are nanometer-scale particle inks printed at a line-width scale of 10 microns and above for printing devices at the macro level. They have developed software as well as a hig...
Source: MDDI - December 4, 2018 Category: Medical Devices Authors: Daphne Allen Tags: MD & M Minneapolis 3-D Printing Source Type: news

RTI Surgical wins coverage nod for Simmetry implant
RTI Surgical (NSDQ:RTIX) said today that non-profit healthcare organization HealthPartners issued a positive coverage decision covering the company’s minimally invasive sacroiliac joint fusion surgery using the Simmetry system, effective November 1. The Simmetry system is a minimally invasive surgical solution using decotrication technology, bone graft and threaded fixation to facilitate bone fusion and provide long-term pain relief, Alachua, Fla.-based company said. “As a surgeon in the HealthPartners network who has experience using the Simmetry System, this positive coverage decision is a win for patien...
Source: Mass Device - November 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Spinal RTI Surgical Source Type: news

NuVasive wins FDA nod for Cohere XLIF implant components
NuVasive (NSDQ:NUVA) said today it won FDA 510(k) clearance for Cohere porous PEEK implants that are part of its Extreme Lateral Interbody Fusion surgical spinal procedures. The San Diego-based company touted that its porous PEEK technology offers both three-dimensional architecture and the radiolucent properties of PEEK, which it claims provides “increased clarity in postoperative x-rays and imaging.” “Cohere XLIF with its one-of-a-kind Porous PEEK technology provides surgeons the best implant for treating patients. It is designed to allow early incorporation of bone into the inter-body spacer, whic...
Source: Mass Device - November 9, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Spinal Nuvasive Source Type: news

Orthofix Q3 beats The Street
Orthofix (NSDQ:OFIX) today posted third quarter earnings that topped both sales and earnings per share expectations on Wall Street. The Lewisville, Texas-based company posted losses of $1.2 million, or 7¢ per share, on sales of $111.7 million for the three months ended September 30, seeing a 135% swing into the red while sales grew 6.1% compared with the same period during the previous year. Adjusted to exclude one-time items, earnings per share were 43¢, well ahead of the 36¢ consensus on Wall Street where analysts expected to see sales of approximately $110.7 million for the quarter. “In additio...
Source: Mass Device - October 29, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured MassDevice Earnings Roundup Wall Street Beat Orthofix Source Type: news

NuVasive inks spinal tech IP licensing deal with Biedermann Tech
NuVasive (NSDQ:NUVA) said this week it inked a strategic partnership deal with spinal and extremity surgery tech company Biedermann Technologies. Through the deal, NuVasive was granted license to Donaueschingen, Germany-based Biedermann Tech’s spinal technology platform intellectual property. San Diego-based NuVasive said that it will integrate Biedermann’s proprietary screw technology into its Reline portfolio. The combined tech system is expected to be commercially available to surgeons during the first half of next year. “Partnering with Biedermann Technologies —a highly innov...
Source: Mass Device - October 11, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Spinal Nuvasive Source Type: news

First-of-Kind Trial Studies OS in Post-allograft –Relapsed AML
The research, published inJAMA Oncology, evaluates  survival outcomes of a second allogeneic hematopoietic cell transplant vs donor lymphocyte infusion. (Source: CancerNetwork)
Source: CancerNetwork - October 11, 2018 Category: Cancer & Oncology Authors: Naveed Saleh, MD, MS Source Type: news

Bone Graft with Implant Placement: What option do you recommend?
This graft at the site has been in place for 6 months. The bone is generally good except for some gaps notably around the lingual aspect. Which implant option do you recommend?The postBone Graft with Implant Placement: What option do you recommend? appeared first onOsseoNews Dental Implants. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - October 4, 2018 Category: Dentistry Authors: osseonews Tags: Clinical Cases Regenerative Surgical Source Type: news

Chronic Allograft Injury Common Among Pediatric Liver-transplant Recipients Chronic Allograft Injury Common Among Pediatric Liver-transplant Recipients
A substantial proportion of pediatric liver-transplant patients with normal liver tests have varying degrees of subclinical chronic allograft injury, according to new findings.Reuters Health Information (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - October 2, 2018 Category: Allergy & Immunology Tags: Gastroenterology News Source Type: news

Efficacy of dHAMA for Extravasation Injuries in Neonates Efficacy of dHAMA for Extravasation Injuries in Neonates
A dehydrated human amniotic membrane allograft may be safe and effective in the treatment of neonatal wounds developed due to IV extravasations.Wounds (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - September 26, 2018 Category: Consumer Health News Tags: Critical Care Journal Article Source Type: news

Avita Medical wins FDA PMA for Recell severe burn treatment device
Avita Medical (ASX:AVH) said today that it won FDA premarket approval for its Recell autologous cell harvesting device, now cleared for use in treating severe thermal burns in patients 18 and older, and that it plans to launch the device in the fourth quarter. The Recell autologous cell harvesting device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and cosmetic procedures, the Valencia, Calif.-based company said. “Patients are at the center of everything we do at Avita Medical, and we are pleased to be able to provide an innovative solut...
Source: Mass Device - September 21, 2018 Category: Medical Devices Authors: Fink Densford Tags: Featured Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regenerative Medicine Regulatory/Compliance avitamedical Source Type: news

MiMedx: Ouster of top brass was for cause
MiMedx (NSDQ:MDXG) said yesterday that the ouster this summer of four top executives was “for cause” after a probe into its accounting practices turned up “conduct detrimental to the business or reputation of the company.” Marietta, Ga.-based MiMedx makes regenerative and therapeutic biologics using human placental tissue allografts. Last July CEO Parker Petit and president & COO William Taylor were ousted amid a board-directed independent investigation that had already prompted the departure of CFO Michael Senken and treasurer John Cranston in June. At the time, MiMedx said it would r...
Source: Mass Device - September 21, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured Legal News Regenerative Medicine Wall Street Beat MiMedx Group Inc. Source Type: news

BoneSupport forecasts mid-double-digit growth after 2019
BoneSupport said today that it expects to see sales growth of greater than 40% beyond 2019 as a result of initiatives enacted as a result of an internal strategic review. The Lund, Sweden-based company said that its new strategic initiatives will focus on innovation, strong clinical and HEOR evidence and an effective commercial platform, according to a press release. BoneSupport also said that it is building its own chain of distributors in the US to gain control of its business in the region after Zimmer Biomet (NYSE:ZBH) withdrew from an exclusive distributorship deal with BoneSupport in June. “The strategic r...
Source: Mass Device - September 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Orthopedics Bonesupport Source Type: news

Baxter wins FDA nod for Actifuse Flow bone graft substitute
Baxter (NYSE:BAX) said today it won FDA clearance for its Actifuse Flow bone graft substitute, indicated for use in a variety of orthopedic surgical procedures. The Actifuse Flow graft uses proprietary silicate-substituted technology from the Deerfield, Ill.-based company’s Actifuse bone graft substitute, intended to enhance silicon levels to accelerate bone formation. The newly cleared graft requires no mixing or preparation and is designed to maintain a flowable consistency throughout surgical procedures, the company said. “Baxter’s Actifuse Bone Graft Substitute has been demonstrated in ...
Source: Mass Device - September 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Orthopedics Regulatory/Compliance Baxter Source Type: news

DePuy Launches New Interbody Implant For Degenerative Disc Disease
DePuy Synthes, an orthopedic and neurosurgery company owned by Johnson & Johnson, recently announced the launch of their new flagship technology, the CONCORDE LIFT Interbody Implant. The new implantable device was designed to help treat patients suffering from degenerative disc disease, a condition that can cause extreme pain from a damaged disc in the spine. The implantable device was designed as part of a new procedural solution that can simplify minimally invasive spine surgery procedures used to help restore disc height in the spinal column. This is typically done through the process of spinal fusion, a surgical pr...
Source: MDDI - August 20, 2018 Category: Medical Devices Authors: Kristopher Sturgis Tags: Orthopedics Source Type: news

BoneSupport wins Canadian approval for Cerament G bone graft substitute
BoneSupport said today it won Health Canada approval for its Cerament G bone graft substitute. The Lund, Sweden-based company touted it as the first and only CE Marked gentamicin-eluting injectable ceramic bone graft substitute on the market. Bonesupport said it is currently engaged in a trial of Cerament G exploring it’s ability to improve standard-of-care management of patients with open fractures of the tibial diaphysis. The study is slated to enroll 230 patients at 30 centers in the US and Europe, with primary endpoints including the absence of deep infection at the fracture site and a lack of secondary proc...
Source: Mass Device - August 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Orthopedics Regulatory/Compliance Bonesupport Source Type: news

Return to play among elite basketball players after osteochondral allograft transplantation of full-thickness cartilage lesions - Balazs GC, Wang D, Burge AJ, Sinatro AL, Wong AC, Williams RJ.
BACKGROUND: Osteochondral allograft transplantation (OCA) is a recognized option for full-thickness articular cartilage defects of the knee, especially in the setting of large lesions or those involving the subchondral bone. Previous heterogenous studies o... (Source: SafetyLit)
Source: SafetyLit - August 17, 2018 Category: International Medicine & Public Health Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news

Doxycycline with bone graft for lateral sinus lift?
Have any of you used doxycycline with bone graft for a lateral sinus lift?The postDoxycycline with bone graft for lateral sinus lift? appeared first onOsseoNews Dental Implants. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - August 15, 2018 Category: Dentistry Authors: osseonews Tags: Clinical Questions Regenerative Source Type: news

Bone graft at the time of implant placement or earlier?
I am getting conflicting advice regarding whether to graft at the time of implant placement to improve the emergence profile or graft earlier and then later place the implant.The postBone graft at the time of implant placement or earlier? appeared first onOsseoNews Dental Implants. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - August 14, 2018 Category: Dentistry Authors: osseonews Tags: Clinical Cases Regenerative Surgical Source Type: news

Wright Medical shares rise on Q2 earnings Beat
Shares in Wright Medical (NSDQ:WMGI) rose today in pre-market trading after the medical device maker beat expectations on Wall Street with its second quarter results. The Amsterdam-based company posted losses of $67.7 million, or 64¢ per share, on sales of $205.4 million for the three months ended July 1, seeing losses grow 64.5% while sales grew 14.3% compared with the same period last year. Adjusted to exclude one-time items, losses per share were 3¢, just ahead of the 6¢ loss-per-share consensus on The Street, where analysts were looking for sales of $196.8 million, which the company also topped. &ld...
Source: Mass Device - August 9, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat wrightmedical Source Type: news

7 medtech stories we missed this week: August 3, 2018
[Image from unsplash.com]From Esaote launching its new ultrasound device to Nipro’s Infraredx launching in Japan, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Esaote launches new ultrasound devices Esaote announced in an Aug. 2 press release that it has launched its new MyLab X7, MyLab X6 and MyLab X5 ultrasound systems. The MyLab X7 offers faster and more reliable ultrasounds with intuitive usability and ergonomics. MyLab X5 has zero-click automatic that speeds up assessments and enhances image quality. 2. Bonesupport inks deal with MTF Biologics Bonesuppor...
Source: Mass Device - August 3, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Catheters Diagnostics Food & Drug Administration (FDA) Hospital Care Imaging Regulatory/Compliance Software / IT Ultrasound Bonesupport Esaote InfraReDx Inc. ivwatch MedTech Mindshare Medical Modulated Imaging MTF Bi Source Type: news

Can you re-sterilise unused portions of synthetic bone graft material?
If I have large portions of unused synthetic graft material like CaSO4 or bTCP, can I re-sterilize it?The postCan you re-sterilise unused portions of synthetic bone graft material? appeared first onOsseoNews Dental Implants. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - July 31, 2018 Category: Dentistry Authors: osseonews Tags: Clinical Questions Regenerative Source Type: news

Cerapedics launches P-15L peptide-enhanced bone graft IDE trial
Cerapedics said today it launched a new investigational device exemption trial looking to explore the safety and efficacy of its next-gen P-15L peptide enhanced bone graft in transforaminal interbody fusion surgeries. The Westminster, Colo.-based company said it has enrolled the first patients in the study, which aims to enroll a total of 364 patients with degenerative disk disease at 30 sites across the US. “We are pleased to announce enrollment of the first patients in our IDE study in TLIF procedures. More than 300,000 people in the U.S. suffer from degenerative disk disease that leads to pain and nerve irrit...
Source: Mass Device - July 30, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Orthopedics Cerapedics Inc. Source Type: news

7 medtech stories we missed this week: July 27, 2018
[Image from unsplash.com]From the FDA clearing LifeSignal’s wireless ECG to Zavation receiving FDA clearance for its expandable corpectomy cage, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears LifeSignal’s wireless ECG LifeSignals announced in a July 26 press release that it has received FDA clearance for its wireless LP1100 Life Signal Patch. The patch is designed to be used in wearables and healthcare monitoring devices. The clearance allows the company to use the Life Signal Processor to develop ECG and other vital sign monitoring wearables ...
Source: Mass Device - July 27, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Diagnostics Food & Drug Administration (FDA) Hospital Care Imaging Patient Monitoring Prosthetics Regulatory/Compliance DoseOptics FBC Device Flashback Technologies Health.io LifeSignal Medi-Lynx Cardiac Monitoring MedTe Source Type: news

Osseous distraction: alternative to grafting?
Do you think that osseous distraction can be used as an alternative to bone grafts?The postOsseous distraction: alternative to grafting? appeared first onOsseoNews Dental Implants. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - July 27, 2018 Category: Dentistry Authors: osseonews Tags: Clinical Questions Surgical Source Type: news

Bioventus Sheds its BMP Business For Undisclosed Sum
Bioventus is divesting its next generation bone morphogenetic protein (BMP) development program to a newly formed by Viscogliosi Brothers LLC for an undisclosed sum. The deal is expected to close in late Q318. When completed, Bioventus will receive an equity stake in the new company formed by Viscogliosi Brothers that will work on the BMP program. In addition, Bioventus will have an observational board seat to follow the progress being made as the work continues. The parties have agreed not to disclose the sale price. “Divesting the BMP program gives us the opportunity to increase the R&D investment in other are...
Source: MDDI - July 24, 2018 Category: Medical Devices Authors: Omar Ford Tags: Orthopedics Business Source Type: news

3D Printer of PEKK Implants Expanding in Asia
After receiving accreditation as a foreign medical device manufacturer by the Japanese Ministry of Health, Labour, and Welfare, Oxford Performance Materials Inc. (OPM) has forged a partnership to establish manufacturing and marketing in Japan. Known for its 3D printed PEKK OsteoFab implants, its contract manufacturing services, and its OXPEKK materials technology, OPM has partnered with Tokyo-based materials supplier JSR Corp. (JSR) to form OPM Asia. The OPM Asia license includes Japan, China, Taiwan, Korea, Brunei Darussalam, Cambodia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, and India. Manuf...
Source: MDDI - July 20, 2018 Category: Medical Devices Authors: Daphne Allen Tags: 3-D Printing Source Type: news

Medtronic agrees to $43m deal to settle shareholder Infuse lawsuit
Medtronic (NYSE:MDT) shareholders are seeking approval for a $43 million settlement deal to clear up claims related to its Infuse bone graft product, according to court documents. Shareholders in the case allege that Fridley, Minn.-based Medtronic engaged “in a scheme and course of conduct to defraud the investing public” in regards to clinical trials of the Infuse bone graft to inflate stock prices. Plaintiffs in the case filed a class action complaint in November 2013, according to court documents, and after a protracted dispute said they believe a settlement is the best move for the class. “Plaint...
Source: Mass Device - July 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Legal News Orthopedics Medtronic Source Type: news

Bioengineering technique created for personalized bone grafts
Combining segments of bone engineered from stem cells, scientists have developed a technique for personalized bone grafts for patients with disease of injury. (Source: Health News - UPI.com)
Source: Health News - UPI.com - July 18, 2018 Category: Consumer Health News Source Type: news