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 26, 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

NYSCF researchers develop novel bioengineering technique for personalized bone grafts
(New York Stem Cell Foundation) Scientists from the New York Stem Cell Foundation (NYSCF) Research Institute have developed a new bone engineering technique called Segmental Additive Tissue Engineering (SATE). The technique, described in a paper published online today in Scientific Reports, allows researchers to combine segments of bone engineered from stem cells to create large scale, personalized grafts that will enhance treatment for those suffering from bone disease or injury through regenerative medicine. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - July 18, 2018 Category: International Medicine & Public Health Source Type: news

Colorado medical device company raises $22 million
A Westminster company specializing in bone-grafting technology said it's raised $22 million in financing. Cerapedics, an orthobiologics company, said the financing was led by family investment fund KCK Group. The money, company officials said, will accelerate the development of Cerapedics' i-Factor peptide enhanced bone graft. "This financing will allow Cerapedics to further invest to increase physi cian access to i-Factor and to build clinical evidence for new indications," said Valeska Schroeder,… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - July 16, 2018 Category: Biotechnology Authors: Ben Miller Source Type: news

NuVasive launches Reline MAS midline spine implant system
NuVasive (NSDQ:NUVA) said today it launched its Reline MAS midline system designed to treat adjacent segment transition syndrome. The newly launched system features low-profile modular implants and system instrumentation designed for alignment and the potential reduction of adjacent segment transition syndrome, the San Diego-based company said. “RMM posterior fixation represents the most advanced midline cortical pedicle screw system on the market. The introduction of modular, low-profile tulip heads was designed to address concerns with adjacent segment facet joint impingement. This system furthers NuVasive&rsq...
Source: Mass Device - July 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Spinal Nuvasive Source Type: news

Cerapedics raises $22m
Cerapedics said late last week it closed a $22 million round of financing and added three new members to its board of directors The funding round was led by family investment fund KCK Group, the Westminster, Colo.-based company said, and will help support the company’s bone graft products. “We are pleased to announce that we have successfully completed an equity financing that will continue to accelerate the commercial release of i-Factor Peptide enhanced bone graft and support the execution of a second Level I investigational device exemption human clinical study that will broaden our market indication in...
Source: Mass Device - July 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Orthopedics Cerapedics Inc. Source Type: news

Skin Grafting in Pyoderma Gangrenosum Skin Grafting in Pyoderma Gangrenosum
This case of an allograft performed on a patient with pyoderma gangrenosum illustrates another option for this difficult-to-treat condition.ePlasty, Open Access Journal of Plastic Surgery (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - July 12, 2018 Category: Consumer Health News Tags: Plastic Surgery & Aesthetic Medicine Journal Article Source Type: news

Noninvasive Imaging Could Help Diagnose Rejection in Lung Recipients Noninvasive Imaging Could Help Diagnose Rejection in Lung Recipients
Probe-based confocal laser endomicroscopy (pCLE) could help identify acute cellular rejection (ACR) in lung allografts, a preliminary study suggests.Reuters Health Information (Source: Medscape Radiology Headlines)
Source: Medscape Radiology Headlines - July 5, 2018 Category: Radiology Tags: Transplantation News Source Type: news

Medical News Today: What to know about bone grafts
Doctors use bone grafts in the treatment of a variety of health issues, including fractures, bone infections, spinal fusions, tumors, and joint problems. In this article, learn about the different types of bone grafts and replacement materials. We also cover the possible risks, complications, and the recovery process. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - July 3, 2018 Category: Consumer Health News Tags: Bones / Orthopedics Source Type: news

Failing Implant #14: Thoughts on Treatment Plans?
This patient had a crestal sinus bone graft and implant placed in #14 site about 5 years.   The patient does not have any symptoms, but the radiographic images show implant failure.The postFailing Implant #14: Thoughts on Treatment Plans? appeared first onOsseoNews Dental Implants. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - June 29, 2018 Category: Dentistry Authors: osseonews Tags: Clinical Cases Surgical Source Type: news

Avita Medical touts publication of pivotal ReCell trial data
Avita Medical (ASX:AVH) today released results from a pivotal clinical trial of its ReCell autologous cell harvesting device in treating deep partial-thickness second-degree burns. 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, Avita said. Results from the trial were published in the Journal of Burn Care & Research, the Melbourne and Valencia, Calif.-based company said. Data from the 101-patient study indicated that burn sites treated with the ReCell device required 9...
Source: Mass Device - June 26, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Regenerative Medicine avitamedical Source Type: news

Can placental tissue implants limit back and leg pain?
Regenerative technology company StimLabs has enrolled the first patient in a clinical trial using shelf-stable placental tissue to reduce complications following herniated disc surgery. The multi-center, randomized controlled trial will evaluate the safety and efficacy of Revita, StimLabs’ full-thickness placental allograft, which surgeons will place following lumbar microdiscectomy procedures. Microdiscectomy is a common, minimally invasive procedure to remove the herniated or protruding portion of the intervertebral disc that is compressing the traversing spinal nerve root. Common post-surgical complicati...
Source: Mass Device - June 26, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Clinical Trials Neurological Surgical StimLabs Source Type: news

7 medtech stories we missed this week: June 22, 2018
[Image from unsplash.com]From Accuray’s India approval to Masimo and PositiveID launching a Bluetooth-enabled thermometer, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. India approves Accuray’s Radixact X9 radiation therapy device Accuray announced in a June 21 press release that it has received an Atomic Energy Regulatory Board Type Approval in India for its Radixact X9 System. The approval allows the company to sell the TomoTherapy platform while allowing hospitals throughout India to import the system. The Radixact and TomoTherapy Systems are radiation th...
Source: Mass Device - June 22, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Cardiovascular Diagnostics Endoscopic / Arthroscopic Food & Drug Administration (FDA) Hospital Care Imaging Patient Monitoring Regulatory/Compliance Ultrasound Accuray Inc. Arcuro Medical BTG Masimo MedTech NuSight P Source Type: news

Wright Medical raises $675m in private placement
Wright Medical (NSDQ:WMGI) said today it inked a deal for $675 million in debt to be offered by a wholly-owned subsidiary. The Amsterdam-based company is offering 1.625% convertible senior notes due 2023 in the offering, which was arranged between Wright, a subsidiary and both investors and institutional buyers, according to an SEC filing. Wright Medical said that it expects the notes will be issued on June 28. Along with the offering, Wright Medical said it inked a deal with holders of its 2% cash convertible senior notes due 2020 to exchange approximately $401 million in existing notes for $460 million in the newly ...
Source: Mass Device - June 21, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat wrightmedical Source Type: news

Bone graft in preparation for implants: recommendations?
I have a 51 year old healthy female referred for grafting to allow implants in areas #26 and #27. Thoughts on this case?The postBone graft in preparation for implants: recommendations? appeared first onOsseoNews Dental Implants. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - June 19, 2018 Category: Dentistry Authors: osseonews Tags: Clinical Cases Regenerative Source Type: news

Outcomes in Renal Allografts With Deceased Donors Outcomes in Renal Allografts With Deceased Donors
What does this study tell us about the effects of HLA matching on the outcomes of deceased-donor kidney allografts?American Journal of Transplantation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - June 19, 2018 Category: Consumer Health News Tags: Transplantation Journal Article Source Type: news

New, printable and flexible ceramic bone grafts could be a game changer
"Hyperelastic Bone" can be matched to patients or used off-the-shelf and could be cheaper, better and less painful than conventional bone tissue Full story at https://www.nsf.gov/news/special_reports/science_nation/printedbonegrafts.jsp?WT.mc_id=USNSF_51 This is an NSF News item. (Source: NSF News)
Source: NSF News - June 18, 2018 Category: Science Source Type: news

Osteochondral Allograft Effective in Some Knee Cartilage Repair
No abstract available (Source: Lippincott's Bone and Joint Newsletter)
Source: Lippincott's Bone and Joint Newsletter - June 15, 2018 Category: Orthopaedics Tags: Snapshot Source Type: news

Pediatric Kidney Recipients Often Have Subclinical Inflammation
FRIDAY, June 15, 2018 -- For pediatric kidney recipients, subclinical inflammation is associated with increased risk for acute rejection and allograft failure, according to a study published online May 15 in the American Journal of... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - June 15, 2018 Category: Pharmaceuticals Source Type: news

Wright Medical wins FDA PMA for Augment injectable bone graft
Wright Medical (NSDQ:WMGI) said today it won FDA premarket approval for its Augment injectable bone graft. The bone graft won clearance for the same indications as the Amsterdam-based company’s non-injectable Augment bone graft. The newly cleared Augment Injectable consists of both recombinant human platelet derived growth factor and a blend of Type I collagen and beta tri-calcium phosphate, the company said. “In Canada, my colleagues and I have been using Augment Injectable since 2011 based upon its ideal handling characteristics and impressive clinical results.  FDA approval of Augmen...
Source: Mass Device - June 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Orthopedics Pre-Market Approval (PMA) Regulatory/Compliance wrightmedical Source Type: news

NuVasive launches AttraX scaffold bone graft biologic
NuVasive (NSDQ:NUVA) said today it launched its AttraX scaffold ceramic-collagen bone graft in the US, touting that the scaffold’s surface has been shown to increase bone formation for faster fusion than standard ceramic bone grafts. The San Diego-based company claims that the Attrax scaffold features a unique microstructure and microporosity that are optimized for bone formation, and that its AttraX surface technology drives the differentiation of mesenchymal stem cells into bone-forming osteoblasts without the need for added growth factors. “AttraX scaffold was easy to use and maintained excellent handli...
Source: Mass Device - June 12, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Spinal Nuvasive Source Type: news

MiMedx Announces Executive to Lead its International Operations and Provides Update on Company's International Progress
MARIETTA, Ga., June 7, 2018 -- (Healthcare Sales & Marketing Network) -- MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced that John D. Harris has joined the Company as its Senio... Biopharmaceuticals, Regenerative Medicine, Personnel MiMedx Group, PURION, placental tissue, allograft (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 7, 2018 Category: Pharmaceuticals Source Type: news

Camber Spine wins FDA nod for combining existing tech
Camber Spine Technologies has won 510(k) clearance from the FDA to market its ENZA-A Titanium Anterior Lumbar Interbody Fusion (ALIF) system, which leverages two of its existing technologies. The new device borrows from the Wayne, Penn.-based company’s first-generation ENZA, which has dual-grip anchor technology, and from its Spira line, which use spiral support arches to increase fusion rates and stabilization. The FDA approved the original Spira device in August 2017. ENZA-A is indicated for use with autogenous bone graft in patients with degenerative disc disease at one or two contiguous levels from L2 to S1 and i...
Source: Mass Device - June 4, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Spinal camberspine Source Type: news

7 medtech stories we missed this week: May 25, 2018
[Image from unsplash.com]From Mauna Kea receiving FDA clearance to Medacta getting clearance for its pedicle screw placement guide, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Mauna Kea wins FDA nod for neurosurgery indication Mauna Kea announced in a May 24 press release that it has received FDA 510(k) clearance for its Celivizio 100 series F400 and F800 with new Confocal Miniprobe, the CranioFlex. The clearance allows the device to be used during neurosurgical procedures. The Cellvizio 100 with CranioFlex gives allows for imaging of tissue internal microstructures a...
Source: Mass Device - May 25, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Catheters Diagnostics Food & Drug Administration (FDA) Imaging Implants Patient Monitoring Regulatory/Compliance Bonesupport collagenmatrix crossroadsextremitysystems Implanet Mauna Kea Technologies MC10 Medacta xablec Source Type: news

How Orthopedics Innovation Doesn ’t Get Lost In Shuffle
What are some of the growing trends and unmet needs in the orthopedics market? If you’re a surgeon, just how do you convince the CEO of a hospital to invest in these technologies? During MDM East, held in New York from June 12-14,  Michael Levy, MD will be a part of two panels that will touch on some of these subjects. The panels are titled “Prominent Physicians Address Unmet Needs in Orthopedics” and “Selling Your Idea to Upper Management.” Levy is an expert in the field and has been involved in orthopedics for 34 years including basic research, orthopedic product development, and c...
Source: MDDI - May 24, 2018 Category: Medical Devices Authors: Omar Ford Tags: Orthopedics Source Type: news

FDA clears Zimmer Biomet ’ s 3D-printed titanium Zyston spinal implant
Zimmer Biomet (NYSE:ZBH) said yesterday it won FDA 510(k) clearance for its Zyston Strut open titanium interbody spacer system, touting it as the company’s first 3D-printed titanium spinal implant. The Zyston Strut open titanium system is a family of lumbar cages intended to enhance strength, graft capacity and visualization capabilities of interbody spacers in spinal fusion cases, the Warsaw, Ind.-based company said. The system also includes surgical instruments needed for insertion, manipulation and removal. The newly cleared cages will be available in a series of sizes to accommodate different patient anatomi...
Source: Mass Device - May 23, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Spinal zimmerbiomet Source Type: news

Therapies After Autograft Failure in a Patient With Melanoma Therapies After Autograft Failure in a Patient With Melanoma
This report describes a case of amelanotic melanoma of the foot initially diagnosed and treated as a pressure ulcer.Wounds (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - May 23, 2018 Category: Consumer Health News Tags: General Surgery Journal Article Source Type: news

Does anterior cruciate ligament reconstruction affect the outcome of osteochondral allograft transplantation? A matched cohort study with a mean follow-up of 6 years - T írico LEP, McCauley JC, Pulido PA, Bugbee WD.
BACKGROUND: Few studies have evaluated the influence of anterior cruciate ligament (ACL) reconstruction on the outcome of cartilage repair. Hypothesis/Purpose: The purpose was to investigate the association between ACL reconstruction and functional outcome... (Source: SafetyLit)
Source: SafetyLit - May 21, 2018 Category: International Medicine & Public Health Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news

Medtronic wins expanded indications for Infuse bone growth protein
Medtronic (NYSE:MDT) said today it won expanded approval from the FDA for its Infuse bone growth protein implant, marking the second expansion for the implant over the past two years. The Infuse implant contains the active ingredient rhBMP-2, a manufactured version of a bone growth protein normally present in the body. The Infuse device is designed for use with certain Medtronic interbody fusion devices to treat lumbar degenerative disc disease. “Different spine patients can have very different surgical needs, so the more options surgeons have to combine a clinically-proven bone grafting technology like Infuse with d...
Source: Mass Device - April 30, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Spinal Medtronic Source Type: news

Newly Founded Company, Datum Orthobiologics, to Apply Dental Technology in Orthopedics
Collagen Technology Mimics Nature, to Regenerate Bone and Cartilage NESS ZIONA, Israel, April 24, 2018 -- (Healthcare Sales & Marketing Network) -- Datum Biotech Ltd. has announced the founding of Datum Orthobiologics Ltd. Datum Orthobiologics will foc... Devices, Orthopaedic, Regenerative Medicine Datum Biotech, Datum Orthobiologics, bone graft, GLYMATRIX (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 24, 2018 Category: Pharmaceuticals Source Type: news

Infected tooth with sinus perforation treatment: feedback?
A middle aged woman presented with a swollen gingiva buccal to tooth #15 which had a previous RCT and crown. I am wondering if I should place a membrane and bone graft after extracting the tooth or if I should let it drain on its own?The postInfected tooth with sinus perforation treatment: feedback? appeared first onOsseoNews Dental Implants. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - April 17, 2018 Category: Dentistry Authors: osseonews Tags: Clinical Cases Regenerative Surgical Source Type: news

Spineology touts 1-year OptiMesh lumbar interbody fusion study results
Spinal tech developer Spineology today released 12-month results from a study of its OptiMesh deployable implant designed for use in instrumented lumbar interbody fusion procedures to treat degenerative disc disease. Results from the Scout trial were presented at the annual meeting of the International Society for the Advancement of Spine Surgery in Toronto, the St. Paul, Minn.-based company said. “We are grateful to Dr. Chi and all the Scout investigators for their dedication in helping us to complete this important clinical trial. We look forward to completing the patient follow-up and gaining the market ...
Source: Mass Device - April 12, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Spinal Spineology Source Type: news

Sinus Tract Next to Tenting Screw After Bone Graft and Implant Placement: How to Resolve?
After 5 months of uneventful healing of implants, I now see a small lesion resembling a sinus tract that is present in the immediate vicinity of one tenting screw.The postSinus Tract Next to Tenting Screw After Bone Graft and Implant Placement: How to Resolve? appeared first onOsseoNews Dental Implants. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - April 11, 2018 Category: Dentistry Authors: osseonews Tags: Clinical Questions Surgical Source Type: news