Norlase Received FDA 510(k) Clearance and CE Mark Approval For ECHO™ Green Pattern Laser

On May 5, 2023, Norlase, a leading global ophthalmic laser manufacturer developing next-generation laser solutions, received both 510(k) US Food and Drug Administration clearance and CE Mark approval for the ECHO Green Pattern Laser photocoagulator. 

ECHO is a portable scanning laser photocoagulator that uses MEMS technology and is a first for the field. One delivery device that connects to compatible slit lamps contains both the laser and the scanner entirely integrated therein. No external fiber, a wireless user interface, the µSec Mode for tissue-sparing treatment, and voice control of patterns and parameters are additional unique features. ECHO’s low cost will enable pattern scanning technology to be used by more medical professionals globally, giving them the means to treat patients more quickly and effectively.

Early users of the ECHO pattern laser have expressed satisfaction with its performance and therapeutic outcomes. As a part of Norlase’s line of transportable and reasonably priced laser solutions, which are quickly modernizing the way doctors treat their patients, ECHO is the third product announcement since the beginning of 2019.

“The FDA clearance and CE mark approval of ECHO is our most significant milestone to date,” said Oliver Hvidt, CEO and Co-Founder of Norlase. “The launch of ECHO as the first and only truly portable pattern scanning laser brings a new paradigm to ophthalmologists that treat retina and glaucoma conditions. Our goal has been to develop a pattern laser that is accessible to all ophthalmologists while maintaining our high level of innovation and precision. ECHO provides all of this in a smart, highly-intuitive product design, enabling surgeons to treat with ease.”

“The ECHO laser is easy to use, intuitive, and efficient,” said Dr. Firas Rahhal, Partner, Retina-Vitreous Associates Medical Group. “It provides excellent power and good uptake, even when used at lower power settings. The visualization on the slit lamp delivery is excellent, and in one of the cases I performed, this was true despite the presence of significant cataracts. Due to these characteristics, along with others like the easy-to-use screen and controls, the ECHO is currently the best available slit lamp pattern laser that I’ve used.”

As per DelveInsight’s Ophthalmic Laser Devices Market” report, the global ophthalmic laser devices market was valued at USD 1.32 billion in 2022, growing at a CAGR of 6.12% during the forecast period from 2023 to 2028 to reach USD 1.88 billion by 2028. The ophthalmic laser devices market is expected to witness growth due to the rising number of ophthalmic disorders, increase in the elderly population, wide acceptance of these devices, and advancements in new technologies.

HAPPE Spine Announced FDA Clearance for INTEGRATE-C™ Interbody Fusion System

On May 8, 2023, HAPPE Spine, a medical device company focused on bringing innovative materials to orthopedic implants, announced that its INTEGRATE-C™ Interbody Fusion System received 510k clearance from the FDA. 

The first interbody fusion cage that is fully integrated with porosity and hydroxyapatite to offer a superior healing environment is INTEGRATE-C™, which is powered by the HAPPE® platform. From endplate to endplate, the interconnected, cancellous porosity encourages bone ingrowth. All surfaces have hydroxyapatite exposed to encourage cell signaling and bone on-growth. The INTEGRATE-C™ offers superior intraoperative and postoperative imaging because it is both radiolucent and radiovisible.

To accommodate patient anatomy, the INTEGRATE-C™ system provides a wide range of sizes and lordotic angles. To establish efficacy with clinical data, the company’s commercialization strategy is currently concentrated on a limited user release.

Andrew Iott, CEO of HAPPE Spine said, “We are very excited to have gained 510K clearance for HAPPE’s new innovative technology and look forward to launching game-changing product solutions in the near future. The combination of cancellous porosity with hydroxyapatite exposed on all pore surfaces represents a true leap forward in interbody fusion devices.”

Dr. Stephen Smith, MD, Neurosurgeon at the Beacon Health System and a co-inventor of the HAPPE technology said, “Our team at HAPPE is proud and excited to share this advancement with our colleagues. We have achieved our goal of developing an ACDF that is distinguished from all other existing devices used for interbody fusion. The HAPPE INTEGRATE-C™ delivers superior radiographic visibility, optimum biomechanical properties for both load bearing and healing, and true graft incorporation.”

According to DelveInsight’s “Spinal Fusion Devices Market” report”, the global spinal fusion devices market was valued at USD 6.49 billion in 2022, growing at a CAGR of 4.55% during the forecast period from 2023 to 2028 to reach USD 8.47 billion by 2028. The rise in demand for spinal fusion devices is primarily attributed to the rising prevalence of spinal disorders such as degenerative disc disorders, spondylolisthesis, spinal stenosis, and disc herniation, among the growing old-age population worldwide; the increase in demand for minimally invasive surgeries. In addition, technological advancement in the product line, and new product launches among others are also expected to drive the global spinal fusion market.

Soterix Medical Announced Patient Recruitment for Parcel-Guided rTMS Depression Trial

On May 8, 2023, Soterix Medical Inc. (SMI), a global leader in non-invasive stimulation and synergistic brain monitoring technologies, announced the beginning of patient recruitment for its treatment-resistant depression trial funded by the National Institute of Health in New York City.

SMI is actively recruiting trial participants who underwent repetitive transcranial magnetic stimulation (rTMS) but did not respond well enough. Each trial site is in charge of examining potential participants to see if they meet the requirements for enrollment. SMI is creating cloud-based targeting software based on parcel-guided rTMS (pg-rTMS) using Columbia University-licensed technology. The pg-rTMS approach uses data from the Human Connectome Project (HCP) atlas, machine learning (ML), and anatomical MRI to design personalized rTMS therapy that is both effective and customized.

Dr. Abhishek Datta, CEO and CTO of Soterix Medical explained, “Parcel-guided rTMS represents a major technical advance in rTMS therapy by combining three unique SMI technologies. One, Soterix Medical provides the unique FDA-cleared navigation system, not interrupted by line-of-site issues. Two, Soterix Medical has developed seamless cloud-based systems for neuromodulation optimization. And three, the TMS targeting approach developed by Columbia University provides the key to delivering rTMS therapy optimized to each patient’s brain-circuit.”

Dr. Dennis Truong, Scientist at Soterix Medical and Principal Investigator of the project said, “We are excited for this next stage in the validation of parcel-guided rTMS therapy for depression. This trial is intended to confirm that personalized TMS delivery is crucial to deliver the fullest therapeutic value of TMS, to all patients, even those that did not respond adequately to conventional rTMS.”

According to DelveInsight’s Transcranial Alternating Current Stimulation (tACS) Market” report, the global transcranial alternating current stimulation (tACS) market is estimated to grow in the coming years. The demand for transcranial alternating current stimulation (tACS) is primarily being boosted by the increasing patient population suffering from various neurological diseases such as Alzheimer’s Disease and Parkinson’s disease among others, as the surge in cases of psychiatric comorbidities such as bipolar disorder, obsessive-compulsive disorder, and others, rising awareness regarding mental health, growing preference for non-invasive treatment methods, and innovation in product development among others, thereby contributing to the overall growth of the transcranial alternating current stimulation (tACS) market during the forecast period from 2023-2028.

Akura Medical Announced Successful First-in-Human Use of its High-Performance Mechanical Thrombectomy Platform 

On May 10, 2023, Akura Medical, a Shifamed portfolio company focused on a differentiated approach to delivering an effective solution to address the major challenges of venous thromboembolism (VTE), announced the initiation of its first-in-human clinical study of the Akura Mechanical Thrombectomy Platform. 

The Akura platform is a discrete option created to make it simple to access and successfully remove large volume, mixed morphology clots while also removing any element of uncertainty from the process. The first five cases—which involved the use of mechanical thrombectomy for pulmonary embolism (PE) in Georgia—were carried out there.

“The Akura platform is differentiated with a state-of-the-art design that aims to address the major challenges of today’s options, specifically catheter clogging and having to confirm contact with the clot prior to initiating removal,” said Dr. Mathews, MD, FACC, FSCAI, Bradenton Cardiology Center in Florida. “The system’s integrated aspiration and maceration technology is equally efficient against mixed morphology thrombus without clogging the catheter. Additionally, physicians can inject contrast at any time to identify catheter position relative to the clot and capture the clot without crossing it.”

“Akura’s platform incorporates continuous monitoring of hemodynamic data which will change how we approach thrombus removal. This information can enable physicians to know when a substantial clot has been removed and provides actionable metrics around the procedure,” added Mahmood Razavi, MD, FSIR, FSVM, Vascular & Interventional Specialists of Orange County in California.

According to DelveInsight’s “Neurovascular Thrombectomy Devices/Neurothrombectomy Devices Marketreport, the global neurovascular thrombectomy devices/neurothrombectomy devices market was valued at USD 722.78 million in 2022, growing at a CAGR of 6.15% during the forecast period from 2023 to 2028 to reach USD 1033.33 million by 2028. The rise in demand for neurovascular thrombectomy devices/neurothrombectomy devices is predominantly imputed to the rising prevalence of neurovascular disorders across the globe which require neurovascular thrombectomy devices/neurothrombectomy devices for their treatment such as ischemic stroke and hemorrhagic stroke, the growing burden of old age population. In addition, the shifting focus of key players on developing technologically advanced products and initiatives to increase awareness regarding neurovascular diseases and their prevention are some of the factors among others that are likely to upsurge the market for neurovascular thrombectomy devices/neurothrombectomy devices. 

Intelivation Technologies Launched Golden Isles™ Minimally Invasive Pedicle Screw System

On May 9, 2023, Intelivation Technologies, a medical device company with a cutting-edge orthopedic and spine implant product portfolio announced the launch of its new minimally invasive pedicle screw system. 

A percutaneous system called the Golden Isles™ Minimally Invasive Screw gives surgeons greater visualization and procedural flexibility while causing the patient’s soft tissue to be disrupted as little as possible.

Mark Moldavsky, Director of Scientific Affairs, remarked, “The addition of MIS to the Golden Isles™ platform gives us a comprehensive thoracolumbar product portfolio for the ASC and hospital setting. The modularity of the Golden Isles™ system, now combined with a minimally invasive approach, provides surgeons the ability to customize the approach on a per-patient basis.”

“The surgeon feedback from the product launch has been astounding,” commented President Amit Sinha. He added, “As we continue to introduce Golden Isles™ MIS across the country, we anticipate continued outstanding clinical results for surgeons and their patients. Golden Isles™ MIS yields a bespoke solution for patients. We are looking forward to expanding this unique platform and releasing additional novel products out of our Center of Excellence.”

According to DelveInsight’s “Orthopedic Implants Market” report, the global orthopedic implants market is estimated to grow at a CAGR of 5.46% during the forecast period from 2023 to 2028. The orthopedic implants market is slated to witness prosperity owing to factors such as the increasing prevalence of orthopedic diseases such as arthritis, osteoporosis, and others, a growing burden of the geriatric population, the rising number of road accidents associated and other injuries, and the growing focus on improving the safety, affordability, and usability of orthopedic implants for people are further expected to result in the appreciable revenue growth in the orthopedic implants market during the forecast period (2023-2028).

Signifier Medical Technologies Announced Partnership with Sunrise, the Company Revolutionizing Home Sleep Testing for Sleep Apnea Diagnosis

On May 10, 2023, Signifier Medical Technologies LLC, a Boston-based medical technology company, announced its partnership with Sunrise, a health tech company offering a quick and easy way to help in the diagnosis of sleep apnea from home. This collaboration combined Sunrise’s cutting-edge artificial intelligence solutions and the innovative technologies of daytime sleep apnea therapy, eXciteOSA, to improve patient care through more efficient diagnostics and treatments. 

“We are excited to partner with Signifier Medical Technologies, starting with the UK market, and offer our innovative home sleep test to more patients suffering from OSA,” said Laurent Martinot, CEO of Sunrise.

Akhil Tripathi, Signifier’s co-founder, and CEO, said, “We look forward to offering this innovative home sleep test to provide millions of patients suffering from OSA with easier access to diagnostics and personalized treatment.”

According to DelveInsight’s Sleep Apnea Diagnostic Devices Market” report, the global sleep apnea diagnostic devices market was valued at USD 4.89 billion in 2022, growing at a CAGR of 6.92% during the forecast period from 2023 to 2028 to reach USD 7.30 billion by 2028. The increase in demand for sleep apnea diagnostic devices is primarily attributed to the rising prevalence of sleep apnea diseases worldwide due to unhealthy lifestyles and excess body weight. Moreover, the increasing geriatric population and the increasing prevalence of comorbidities such as hypertension, diabetes, obesity, and cardiovascular diseases will propel the market growth of the device in the market. Additionally, the increasing awareness about the symptoms of sleep apnea across the world is anticipated to bolster the market, thereby contributing to the growth of the sleep apnea diagnostic devices market during the forecast period from 2023-2028.