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 company said.
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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 from the...
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 patients s...
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, which ma...
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 addition to solid finan...
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 innovative medical device...
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 10, 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 solution for ...
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 restate a...
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 revie...
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 preclinical mode...
Source: Mass Device - September 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Orthopedics Regulatory/Compliance Baxter Source Type: news
