Sonion Announces New CEO & President: Niels Svenningsen

February 11, 2020

Sonion today announces the appointment of Niels Svenningsen as CEO & President of the Sonion Group. Niels Svenningsen was most recently President of Northern Europe in Schneider Electric and brings a wealth of commercial and management experience acquired in the IT and technology sectors. He will start in his new position on March 1st, 2020.

“We look very much forward to welcoming Niels. He brings an extensive commercial and general management experience to Sonion. We expect Niels to further develop our strong position of Sonion in the current market and develop new products to serve the potential of adjacent markets.” says Walther Thygesen, Chairman of the Sonion Board.

Niels Svenningsen (55 years old) was President of Northern Europe in Schneider Electric (2015-2019) and before that CEO of GN NetCom (2013-2015). Niels also has extensive experience with Sales and Marketing from large IT companies such as Hitachi Data Systems (2007-2013; Senior Vice President & General Manager EMEA 2011-2013), Hewlett Packard (Managing Director, Enterprise & Major Accounts 2002-2004; Sales Director 1996-2000) and IBM Denmark (1988-1996).

”I am very happy to be joining Sonion. This is a global company, well run and with a lot of potential, operating in an attractive market for high-tech medical components. I look forward to – together with the Sonion management team – taking Sonion further on its growth journey and exploring new attractive opportunities on the market.” says Niels Svenningsen.

Sonion is a global leader in the development and manufacturing of micro acoustic and micro mechanical solutions for hearing instruments, high-end hearables, and in-ear earphones. Sonion is owned by Novo Holdings A/S, the holding company within the Novo Group that manages the assets of the Novo Nordisk Foundation.

Titan Medical Announces Resignation of Domenic Serafino

February 11, 2020

Domenic Serafino has resigned as a Director of Titan Medical. The news was announced today. The company is seeking a qualified replacement.

In tendering his resignation to the Titan Medical Board, Mr. Serafino cited the increased amount of time he will be spending as CEO and a Director of Venus Concept following its November 2019 merger and subsequent transition to being publicly traded on Nasdaq.

“Dom has been a valuable member of Titan’s Board of Directors since June of 2018. We thank him for his service to our Company and our shareholders, and extend best wishes for continued professional success,” said David McNally, President and CEO of Titan Medical.

FDA Grants De Novo Clearance to Bluegrass Vascular Technologies for the Surfacer® Inside-Out® Access Catheter System

February 11, 2020

Bluegrass Vascular Technologies announced today that the U.S. Food and Drug Administration (FDA) has granted a De Novo classification order for its Surfacer^® Inside-Out^® Access Catheter System. The Surfacer System is intended to obtain central venous access to facilitate catheter insertion into the central venous system for patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods. The Surfacer System employs a novel Inside-Out approach.

The company reports that the Surfacer® Inside-Out® Access Catheter System will be available in select U.S. centers in the coming months. The system received CE Mark in 2016 and is available in Europe, Canada, Singapore and the Middle East.

“The Surfacer System offers a safe and effective approach to reliably preserve and restore critical upper body vascular access sites,” stated Mahmood Razavi, MD, Interventional Radiologist at St. Joseph Hospital in Orange, California and lead principal investigator of the SAVE-US (Surfacer^® System to Facilitate Access in VEnous Occlusions – United States) IDE study. “This is an unmet clinical need for patients who require life-saving therapies, such as dialysis, and who have limited options due to venous obstructions.”

The Surfacer System is the first FDA cleared medical device to facilitate upper body central venous access in patients with venous obstructions or other conditions that preclude access by conventional methods. Approval is based on the results of the SAVE-US trial. Of the thirty enrolled patients, 90% met both the primary and secondary efficacy endpoints despite a complex patient population comprised largely of Type 3 and 4 obstructions (3 or more obstructed vessels). No device-related adverse events were reported, confirming the safety and performance of the Surfacer System.

“Thoracic central venous obstruction (TCVO) is a costly problem associated with increased patient morbidity and reduced quality of life,” stated Bart Dolmatch, MD, Interventional Radiologist at The Palo Alto Medical Foundation. “We’ve recently published reporting standards that create a common language for understanding and describing signs, symptoms, functional impairment and anatomy of TCVO. BVT incorporated elements of these reporting standards into the SAVE-US trial, demonstrating the clinical impact of the Surfacer System. Now that it has been FDA cleared, the Surfacer will be part of the treatment algorithm for my patients with TCVO.”

Thoracic central venous obstruction occurs in roughly 40% of patients where hemodialysis is performed via a central venous catheter.¹ While permanent arteriovenous fistulas are the preferred form of vascular access for hemodialysis patients, central venous catheters continue to serve as an important bridge to securing long-term access for life-saving hemodialysis treatment. The current approach for most patients with central venous obstructions is to use an alternative vein, which reduces the ability to place and mature a functioning fistula, resulting in increased catheter days and costs.

“We are thrilled BVT has reached this important milestone. For the first time ever, physicians in the U.S. can offer patients a reliable and repeatable solution to treat central venous obstructions and restore access to the right internal jugular vein – the preferred access site,” stated Gabriele Niederauer, Ph.D., CEO, and President of Bluegrass Vascular. “Through our experience in Europe and other international sites, the Surfacer System has consistently demonstrated a positive clinical impact. We are eager to bring the Surfacer System and its important benefits to patients in the US.”

Soliton Files Special 510(k) with FDA for its Generation II RAP Acoustic Pulse Device

February 11, 2020

Soliton, Inc., a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center today announced that it has filed for Special 510(k) Premarket Notification with the U.S. Food and Drug Administration (“FDA”) for its Generation II Rapid Acoustic Pulse (“RAP”) device.

The Generation II RAP device delivers the same tattoo-removal therapy as the Generation I device but is slightly modified for improved ease of use in the physician’s office. The Generation II RAP device constitutes the underlying technology of the RAP device that will be deployed in the limited U.S. commercial launch planned for mid-year 2020. Although, similar technology was utilized in the Company’s pivotal cellulite and proof of concept keloid scar trials, only the tattoo removal indication will be reviewed by the FDA in this submission and enabled during this initial launch.

The Special 510(k) filing states the device is indicated as an accessory to the 1064 nm Q-Switched laser for tattoo removal on the arms, legs and torso in Fitzpatrick Skin Type I-III individuals. Clinical trials have demonstrated that using the Company’s RAP device, in conjunction with a Q-switched laser, allows for multiple passes of laser treatment in a single treatment session, resulting in accelerated fading in comparison to stand-alone laser treatment.

BD Completes Clinical Trial for BD Libertas Wearable Injector Completed

February 11, 2020

Becton, Dickinson and Company) today announced the completion of a 50-subject human clinical trial with the BD Libertas Wearable Injector.

The award-winning injector* is a subcutaneous drug delivery system, currently, in development, that is designed to require no patient assembly and deliver biologics with viscosities up to 50 cP in 2-5 mL and 5-10 mL configurations.

The BD independently sponsored and conducted study was designed to evaluate the performance of the 5 mL BD Libertas device in human subjects, including tissue effects, skin reactivity, and patient acceptance. The results are expected to be announced in early 2020.

The study represents the most recent in a series of over 50 BD conducted pre-clinical and clinical studies intended to measure the performance of the BD Libertas™ Wearable Injector, demonstrate feasibility of 2-10 mL biologic injections into subcutaneous tissue and characterize tissue response to large volume injections in human and animal subjects.

Commenting on the study, Peter Nolan, Worldwide President, BD Pharmaceutical Systems, said, “BD is committed to bringing value to our pharma partnerships, including providing them with independent BD sponsored and generated study data to accelerate combination product development. The recent study reflects BD’s continued investment in solutions to meet pharma’s needs by expanding the design space for biologics delivery.”

DYSIS Medical Announces John Pedersen Named Chairman of the Board

February 10, 2020

DYSIS Medical today announced that John Pedersen has assumed the position of Board Chairman. Pedersen most recently served as CEO of Augmenix, a privately held company that manufactured and sold minimally invasive hydrogel products to improve outcomes following cancer radiotherapy. Augmenix was sold to Boston Scientific in 2018 for $600M.

Prior to joining Augmenix, Pedersen served as a Senior Healthcare Advisor for two healthcare private equity funds – The Gores Group and The Pritzker Group. In addition, he served on the Boards of Directors of two medical device companies – Clinical Innovations and Therakos. Prior to this, Pedersen was President of the Urology and Women’s Health Division at Boston Scientific.

“I’m looking forward to working closely with our CEO Darin Hammers and the other board members to continue moving this organization forward,” Pedersen said. “It’s an exciting time to be a part of DYSIS as we continue to expand the company and bring our advanced cervical imaging technology to clinicians worldwide.”

Pedersen earned an MBA from The Harvard Graduate School of Business Administration and an AB degree from Princeton University.

“We are excited to have John join our board as we work to make our innovative DYSIS Ultra device the standard of care for colposcopy. He brings a tremendous amount of leadership experience in the medical device field and a proven track record of commercial success,” said Casper Breum of Lundbeckfondon Ventures.

FDA Clears LUNGguard for Donor Lung Preservation System

February 10, 2020

Paragonix announced clearance of a Pre-Marketing Notification (510(k)) with the US Food and Drug Administration (FDA) for its Donor Lung Preservation System – LUNGguard^1,2.

The Paragonix LUNGguard Donor Lung Preservation System is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs. The intended organ storage time for LUNGguard is up to 8 hours. Donor lungs exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.³

LUNGguard is designed to function with ease in the often extremely stressful, fast-paced environments of donor and transplant centers. The current standard-of-care for donor lungs is to package the lungs in a series of sterile bags placed on crushed ice without the ability to maintain, monitor and report environmental conditions of the organ. LUNGguard is designed to overcome current preservation limitations and provide reporting of preservation and transport data. LUNGguard will be commercially available to all US lung transplant centers in Q2 of 2020.

“Donor lungs for transplant are fragile, precious cargo that are by necessity packaged and transported over great distances. Quality management and control over the environmental conditions of the donor lung is critical to the success of the operation,” commented Matthew Hartwig, MD, lung transplant surgeon at Duke University Lung Transplant Program. “We are looking forward to evaluating this innovative technology in clinical practice and implementing additional quality management over the donor lung transport process using LUNGguard.”

“Patients on the lung transplant waitlist must be given every possible advantage in their journey of becoming a lung transplant recipient,” commented Jeff Goldstein, CEO of the Lung Transplant Foundation. “Based on my own experience as a lung transplant recipient, technologies are critically needed that support and complement the incredible clinical effort afforded by surgical teams and Organ Procurement Organizations as well as the wonderful gift from a donor family.”

“The recent addition of LUNGguard to our expanding portfolio of organ preservation devices serving all solid organs will provide an important tool for the transplant community,” said Bill Edelman, Chairman and CEO of Paragonix Technologies. “We are thrilled to contribute to improved lung preservation with LUNGguard.”

References

¹On January 16, 2020, FDA cleared for commercial distribution the SherpaPak™ Lung Preservation System 510(k) pre-market submission.
²Patents pending.
³Partial lungs can be transported via the LUNGguard Donor Lung Preservation Device by packaging lungs per institutional protocol and UNOS guidelines.
⁴Thorac Dis. 2010 Jun; 2(2): 111–116.
⁵Orphanet J Rare Dis. 2008; 3: 8.
⁶https://www.who.int/respiratory/copd/burden/en/
⁷https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/
⁸https://www.transplants.org/faq/how-much-does-transplant-cost
⁹Milliman Research Report, “2014 US Organ and Tissue Transplant Cost Estimates and Discussion”

Bioventus Updates Indications for Use of Their EXOGEN Ultrasound Bone Healing System

February 10, 2020

Bioventus has updated the indications for use for its EXOGEN Ultrasound Bone Healing System. EXOGEN uses process and promote fracture healing. It has an 86% heal rate for fractures not healing on their own1 and provides 38% faster healing of indicated fresh fractures.2, 3

The updated label now prominently features indications for using EXOGEN as an adjunctive non-invasive treatment of established nonunions in patients:

With internal or external fracture fixation hardware present
Undergoing treatment for infection at the fracture site
Believed to have diminished bone quality

“This label update underscores important usage scenarios where fracture management protocol may have limited consideration. Now, EXOGEN may be confidently prescribed in these indications,” said Peter Shaw, MBBS DRCOG, Chief Medical Officer, Bioventus. “Patients with comorbidities such as osteoporosis and bone infection can benefit from use of EXOGEN by helping to progress fracture healing and resolve nonunion. In addition, EXOGEN will heal fractures in the presence of infection at the fracture site and also serve as an important adjunctive therapy when stabilizing fractures with instrumented fixation.”

Summary of Indications for Use

EXOGEN is indicated for the non-invasive treatment of established nonunions† excluding skull and vertebra. The EXOGEN device has also been reported as effective as an adjunctive non-invasive treatment of established nonunions† in patients:

o With internal or external fracture fixation hardware present. EXOGEN cannot penetrate metal and therefore should not be applied directly over hardware.

o Undergoing treatment for infection at the fracture site. EXOGEN is not intended to treat the infection.

o Believed to have diminished bone quality. EXOGEN is not intended to treat diminished bone quality.

EXOGEN is also indicated for the acceleration of fresh fracture heal time, repair following osteotomy, repair in bone transport procedures and repair in distraction osteogenesis procedures. There are no known contraindications for the EXOGEN device. Safety and effectiveness have not been established for individuals lacking skeletal maturity, pregnant or nursing women, patients with cardiac pacemakers, on fractures due to bone cancer, or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel. Full prescribing information can be found in product labeling at exogen.com or by calling Bioventus Customer Service at 800-836- 4080.

References

† A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.

1. Nolte PA, van der Krans A, Patka P, Janssen IM, Ryaby JP, Albers GH Low-intensity pulsed ultrasound in the treatment of non- unions. J Trauma. 2001; 51(4):693−703.
2. Heckman JD, Ryaby JP, McCabe J, Frey JJ, Kilcoyne RF Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound. J Bone Joint Surge [Am].1994; 76(1):26−34.

3. Kristiansen TK, Ryaby JP, McCabe J, Frey JJ, Roe LR Accelerated healing of distal radial fractures with the use of specific, low- intensity ultrasound. A multicenter, prospective, randomized, double-blind, placebo-controlled study. J Bone Joint Surg [Am]. 1997; 79(7):961−973.

BrainsWay Announces Data from Feasibility Study of Deep Transcranial Magnetic Stimulation System

February 10, 2020

BrainsWay Ltd. today announced results from a randomized controlled double-blind clinical trial (NCT01196910) assessing the safety and efficacy of the Company’s proprietary H6-coil deep transcranial magnetic stimulation (dTMS) System for the treatment of adults with attention deficit hyperactivity disorder (ADHD).

ADHD is characterized as a disorder with an ongoing pattern of inattention and/or hyperactivity that can negatively impact a person’s quality of life and how they function at school, work and socially. It is estimated that ADHD affects nearly 1-in-10 adults in the United States in their lifetimes. Current treatments for ADHD are primarily stimulant medications that are often associated with risks and side effects, especially if misused or abused. It is estimated that approximately 5 million American adults are misusing prescription stimulants.

Researchers at Tel Aviv Sourasky Medical Center, Tel Aviv University, Ben Gurion University, and BrainsWay conducted the study, which used functional magnetic resonance imaging (fMRI) to assess the effect of dTMS on clinical, cognitive and neural activity in adults with ADHD. Results showed a statistically significant improvement in patient-reported assessments of inattention, together with a significant increase in activity that was observed within the dorsolateral prefrontal cortex (DLPFC), a brain area previously shown to express reduced activity in adults with ADHD.

“Reduced activity of the DLPFC, a brain region that controls the ability to respond to changing attentional demands, has previously been observed in patients with ADHD,” said Dr. Maya Bleich-Cohen, senior investigator at Tel Aviv Sourasky Medical Center and an investigator on the study. “The results of this initial study indicate that dTMS can be effective in modulating the DLPFC and that this may be a feasible technique to improve attention symptoms in adults with ADHD. Additional study of this non-invasive treatment approach in this population is warranted.”

More About This Study
The study enrolled 75 adults, ages 18-60 years, with ADHD who had not previously received TMS. The study included one treatment group with the dTMS coil targeting the right prefrontal cortex (N=27), a second group with the dTMS coil targeting the left prefrontal cortex (N=28), and a control group with a sham coil (N=20). Participants underwent a treatment phase consisting of 15 daily dTMS sessions, which were conducted five days a week for three consecutive weeks using the BrainsWay dTMS H6 (or sham) coil. Each patient underwent fMRI before and after the treatment phase. Two additional treatment sessions were performed at the second and third follow-up visits, which were performed one and two months after completion of the acute treatment phase, respectively. At each treatment session, subjects also performed six minutes of computerized cognitive training consisting of an immediate recall task and a sustained attention task, each of three-minute duration. Patients underwent clinical evaluation at screening, after the three-week treatment phase and then at four and eight weeks after completion of the treatment phase, which included symptom assessment using validated questionnaires, and a full cognitive assessment including evaluation of memory, executive function, and attention skills.

Topline findings from the study include:

Significant improvements were observed in the Inattention/Memory Problems subscale of the Conners’ Adult ADHD Rating Scale (CAARS) self-report questionnaire, in both right and left treatment arms compared with the sham control group (p=.033)
- In a post-hoc analysis, improvements in the right and left stimulation groups were each significantly greater than that of the sham group (p<0.00005 and p<0.05, respectively)
Interestingly, increased fMRI brain activation in the right DLPFC during a working memory task were only apparent following treatment in the right stimulation group (p=0.01)
- In a post-hoc analysis, activation in the right stimulation group was greater than that of the left stimulation or sham groups (p<0.005)
- Additionally, this increased right DLPFC activation was associated with larger symptom improvement exclusively in the right stimulation group (p<0.05)
- Other regions associated with the brain’s attentional network showed similar increased activation during the task in the right stimulation group (i.e. Right Inferior Parietal Sulcus, Right Inferior Frontal Gyrus)
The response rates (defined as at least a 25% reduction in the CAARS observer questionnaire) measured one month following treatment were 26%, 23% and 18% for the right, left and sham arms, respectively. These differences, however, were not statistically significant in the limited sample size of this feasibility study
No serious adverse events were reported in the study

The authors, led by principal investigator Elissa L. Ash, MD, from Tel Aviv Sourasky Medical Center and Sackler Faculty of Medicine at Tel Aviv University, are preparing the data for publication in a peer-reviewed forum.

“The medications commonly used to treat adults with ADHD have adverse side effects that may lead to treatment discontinuation have been reported in approximately 50% of patients,” said Christopher R. von Jako, president and CEO of BrainsWay. “dTMS with our H1 and H7-coils has been shown to provide benefit in the treatment of major depressive disorder and obsessive-compulsive disorder, respectively, and this initial feasibility study with our proprietary H6-coil suggests that it may provide benefit in the treatment of adults with ADHD. This study underscores our ability to innovate new coils and technologies that can potentially be optimized to the specific neurologic features of particular diseases. We are excited about the potential of dTMS in the treatment of adults with ADHD and will continue to evaluate this non-invasive approach in this patient population.”

This study adds to the growing body of clinical evidence demonstrating the potential clinical benefits of dTMS in the treatment of ADHD. A prior study, results of which were reported in 2016, compared dTMS using the BrainsWay H6-coil targeting the right prefrontal cortex with focal TMS using a figure-8 coil or sham TMS. In that study, the percentage of patients who showed a reduction of 30% or more in the CAARS observer questionnaire was 33% in the dTMS group, 8% in the sham group, and 15% in the focal TMS group. A significant average improvement of 8.25 points (p=0.0001) was observed in total CAARS scores in the dTMS group compared with pre-treatment baseline values, and no significant changes were observed in the focal TMS or sham groups. These findings correlated with electrophysiological activity in the right prefrontal cortex and suggested a substantial therapeutic advantage for deep and widespread stimulation of the right prefrontal cortex with BrainsWay’s proprietary H6-coil overstimulation with a focal figure-8 coil in patients with ADHD. The study was recently published in the Neuroimage Clinical scientific journal.

DynaNail Mini Fusion System for Subtalar Fusion Procedures Shows Positive Early Results

February 10, 2020

The initial clinical outcomes with the DynaNail Mini Fusion System for subtalar fusion procedures were reported today by MedShape. First used clinically under a limited market release in 2019, the DynaNail Mini has been implanted by over 50 orthopedic surgeons in over 50 hospitals across the United States.

The DynaNail Mini Fusion System features MedShape’s patented superelastic nickel-titanium (NiTiNOL) technology and is the first device designed for subtalar fusion that offers maintained active compression post-surgery.

Compression across the joint is important not only for ensuring the bones remain tightly apposed, but also in promoting the appropriate bone healing response.¹ Screws currently represent the primary surgical treatment option in subtalar fusion procedures, but these devices are unable to hold compression following surgery when bone resorption and joint settling inherently occur. The DynaNail Mini features an internal NiTiNOL Compressive Element that allows for dynamic compression to be maintained post-surgery. The superelastic properties of NiTiNOL enable the DynaNail Mini to automatically adapt and respond to changes in the joint throughout the healing process while also allowing for immediate dynamization upon weight-bearing. Furthermore, the device includes two transverse locking screws to help provide additional joint stability and improved fixation.

Sam Adams, MD (Duke University) was one of the first surgeons to implant the DynaNail Mini and has performed numerous surgeries with the longest follow-up results now at 9 months. According to Dr. Adams:

“The DynaNail Mini with its internal NiTiNOL element is an unrivaled device for subtalar fusion. Its maintained post-operative compression and transverse locking screws give me the confidence that I can achieve successful outcomes where traditional compression screws might fail. To date, my Mini patients have all successfully fused with no complications. The device is truly a gamechanger!”

The DynaNail Mini has been used to address a number of different pathologies and indications including revisions of prior failed fusions, calcaneal fractures, and severe deformity. Most notably according to the literature, patients who have a prior ankle fusion have shown to be significantly more at risk for subtalar non-union.² Another early adopter, Terrence Philbin, DO (Orthopedic Foot & Ankle), is seeing successful outcomes with the DynaNail Mini:

“Overall, I have been pleased with the results I have achieved with the DynaNail Mini to treat classically challenging indications,” said Dr. Philbin. “In particular, I have implanted the DynaNail Mini in two patients with prior ankle fusions. At 6 and 3 months post-surgery, both patients have shown successful bony union on CT and are doing well clinically. I look forward to expanding my indications for use with this innovative product.”

The DynaNail Mini joins its predecessor, the DynaNail® TTC Fusion System, in MedShape’s growing NiTiNOL product portfolio that also includes the DynaClip® Bone Fixation System. Commercially available since 2013, the clinical power of the DynaNail to treat complex hindfoot pathologies in high-risk patient populations has been demonstrated in numerous peer-reviewed articles^3,4suggesting the potential clinical utility of the DynaNail Mini for other foot & ankle applications.

“We are very pleased with the market acceptance and clinical results observed so far for the DynaNail Mini,” said Kurt Jacobus, Ph.D. (MedShape, Inc. President & CEO). “Building off the momentum of the DynaNail TTC System, the Mini is poised to be another revolutionary device in joint fusion.”

The DynaNail Mini Fusion System is now available in full market release for subtalar fusion in a variety of diameter and length offerings.

Note: The DynaNail Mini will be featured at the upcoming American College of Foot & Ankle Surgeons Scientific Conference in Austin, Texas at the company’s booth #935.

References

¹Dupont KM, Shibuya N, Bariteau JT. Tibiotalocalcaneal Arthrodesis with Intramedullary Nails – Mechanobiological Background and Evolution of Compressive Technology. Global J of Orthopedics Research, 2019. 1(5): 1-8.
²Zanolli DH, Nunley JA, Easley ME. Subtalar Fusion Rate in Patients With Previous Ipsilateral Ankle Arthrodesis. Foot & Ankle Int, 2015. 36(9): 1025-1028.
³Steele JR, Easley ME, Nunley JA, Adams SB, et al. Comparison of Tibiotalocalcaneal Arthrodeses Using a Sustained Dynamic Compression Nail Versus Nondynamized Nails. Foot & Ankle Spec, 2019 (in press: doi: https://journals.sagepub.com/doi/10.1177/1938640019843332).
⁴Ford SE, Kwon JY, Ellington K. Tibiotalocalcaneal Arthrodesis Utilizing a Titanium Intramedullary Nail With an Internal Pseudoelastic Nitinol Compression Element: A Retrospective Case Series of 33 Patients. J Foot Ankle Surg, 2019. 58(2): 266-272.

Becton, Dickinson and Company) today announced the completion of a 50-subject human clinical trial with the BD Libertas Wearable Injector.

Paragonix announced clearance of a Pre-Marketing Notification (510(k)) with the US Food and Drug Administration (FDA) for its Donor Lung Preservation System – LUNGguard1,2.

Bioventus has updated the indications for use for its EXOGEN Ultrasound Bone Healing System. EXOGEN uses process and promote fracture healing. It has an 86% heal rate for fractures not healing on their own1 and provides 38% faster healing of indicated fresh fractures.2, 3

Medical Device News Magazine

Paragonix announced clearance of a Pre-Marketing Notification (510(k)) with the US Food and Drug Administration (FDA) for its Donor Lung Preservation System – LUNGguard^1,2.