7 medtech stories we missed this week: Jan. 19, 2018

missed medtech aug 4

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From Privi Medical’s FDA clearance to OrthoXel getting FDA clearance and CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning.

1. Privi Medical wins FDA nod for hemorrhoid device

Privi Medical has received FDA clearance for its Instalief Hemorrhoids Treatment device, according to a Jan. 18 news release. The device is disposable and uses an advanced instant cold compression technology to treat hemorrhoids.

2. Centric Medical gets FDA 510(k) clearance for foot & ankle screws

Centric Medical announced in a Jan. 16 news release that it has received FDA 510(k) marketing clearance for its Cannulated Screw Internal Fixation System. The system features foot and ankle screws that can be used in foot and ankle reconstruction procedures. It is a multi-component system made of titanium alloy that comes in a variety of diameters and lengths.

3. BioPoly receives CE Mark for knee implants

BioPoly has received CE Mark for its RS Partial Resurfacing Trochlea system, according to a Jan. 16 news release. The partial resurfacing knee portfolio can treat focal cartilage defects in femoral condyles, trochlear facts, trochlear groove and patella. The company plans to launch the system in the next few months.

4. Avacen launches dry-heat therapy autism device in India

Avacen announced in a Jan. 17 press release that it has launched its Avacen 100 dry-heat therapy autism device in India. The device is an FDA-cleared, CE Mark Class II therapy device designed to provide relief of autistic behavior. Avancen 100 safely and non invasively warms the body by infusing heat into the circulatory system. The device has been shown to improve speech impediments, increase classroom participation and an improvement of school grades.

5. FDA approves Zoll Medical’s full AED line

Zoll Medical has received premarket approval from the FDA to market and distribute its full line of defibrillators in the U.S., according to a Jan. 9 press release. The company’s R Series, X Series, AED Pro and AED Plus have all received premarket approval. Each device uses Zoll’s rectilinear biphasic waveform to deliver maximum current to high-impedance patients.

6. Sealantis wins CE Mark for surgical sealant

Sealantis announced that it has received CE Mark for its Seal-G surgical sealant, according to a Jan. 12 press release. The sealant is designed to reduce leaks after gastrointestinal procedures. Seal-G stops anastomotic leaks by reinforcing suture or staple lines during post-surgery. The sealant will be available in Europe as it has not yet received FDA approval.

7. OrthoXel wins FDA nod, CE Mark for Apex tibial nailing device

OrthoXel announced in a Jan. 16 press release that it has received FDA 510(k) clearance and CE Mark approval for its Apex Tibial Nailing System. The company can now commercialize the system in the U.S. and Europe. The device allows surgeons to have a wide range of locking options of intramedullary nail. Its micromotion locking mode allows for controlled axial movement with torsional stability.

NuVasive wins expanded FDA nod, launches interbody fusion devices

NuVasive Inc. (NSDQ:NUVA) said today it won expanded FDA 510(k) clearance for its Cohere cervical interbody fusion device and that it launched the Coalesce thoracolumbar interbody fusion device.

Both the launch and updated clearance comes from the company’s acquisition of Vertera Spine, which it closed last September.

The Cohere and Coalesce implants use porous version of the material polyetheretherketone, or PEEK, and are designed to provide three-dimensional achitecture to elicit and encourage bone growth, San Diego, Calif.-based NuVasive said.

“Our strategy in building our AMS portfolio is to provide unprecedented, innovative technologies that enhance the surface, structure and visualization properties of these implants. Our launch of Coalesce and the expanded clearance of Cohere and Coalesce are all part of our continued commitment to bring disruptive technology to market and investment into our comprehensive AMS portfolio, which converge to provide a better surgical experience and improve patient quality of life,” chair & CEO Gregory Lucier said in a prepared statement.

The company said that the Coalesce device is now available for TLIF and PLIF procedures in multiple footprints, heights and lordotic options. Its indications include use for one or two adjacent levels in the thoracolumbar spine with both autograft and allograft for treating degenerative disc disease and degenerative spondylolisthesis and multi-level degenerative scoliosis.

NuVasive said that the expanded FDA indications for its Cohere device clear it for use at multiple levels in the cervical spine with both autografts and allografts.

“Patients can gain significant pain relief and improved functional outcomes through the stabilization and fusion of the degenerated spinal motion segment. Cohere and Coalesce contribute to these outcomes by retaining the biomechanical properties necessary for intradiscal spinal applications, while helping facilitate osseointegration and bone growth. The use of these new Porous PEEK implants may enhance fusion and limit the risk of stress-shielding, subsidence and implant failure,” Dr. Kenneth Burkus of The Hughston Clinic said in a press release.

Last month, NuVasive said it inked a deal to acquire intraoperative neurophysiological monitoring service provider SafePassage for an undisclosed amount.

The post NuVasive wins expanded FDA nod, launches interbody fusion devices appeared first on MassDevice.

Mevion wins FDA 510(k) for S250i proton therapy system

Mevion Medical Systems said yesterday it won FDA 510(k) clearance for its Mevion S250i proton therapy system featuring pencil beam scanning technology, and touted that the first unit was installed at MedStar Georgetown University Hospital in Washington D.C.

The Mevion S250i features improved pencil beam scanning fields and Hyperscan pencil beam scanning tech to allow for faster energy layer switching, the Littleton, Mass.-based company said.

“The S250i system represents the next generation of intensity modulated proton therapy (IMPT) delivered in the most compact proton therapy platform. We are proud that the MEVION S250i system now has received both FDA clearance and CE mark. This is a very important milestone in our efforts to make precision proton therapy available to more patients in the fight against cancer,” CEO Joseph Jachinowski said in a prepared statement.

The system also features the company’s Adaptive Aperture multi-leaf collimator designed for multi-layer conformal field delivery, Mevion said, which it claims provides dose gradients with up to 3 times sharper lateral penumbra.

Mevion said that the system installed at MedStar Georgetown University Hospital is undergoing onsite testing this month, and will be operable after the testing is completed.

“We are excited to be not only the first and only proton therapy system in the Washington, D.C. area, but also the first in the world to offer these advanced proton therapy treatment capabilities to our patients and community. Currently, patients who seek proton therapy need to leave the metropolitan D.C. area, which can be a significant burden on families. We will now be delivering advanced proton therapy, fully integrated into our broad set of comprehensive cancer care offerings. This is critical to the patients we serve,” Dr. Brian Collins of the MedStar Georgetown Proton Therapy Center said in a press release.

The company submitted an application seeking 510(k) clearance last September.

The post Mevion wins FDA 510(k) for S250i proton therapy system appeared first on MassDevice.

Pavmed files FDA 510(k) for CarpX carpal tunnel device



Pavmed (NSDQ:PAVM) said today it filed a 510(k) application with the FDA for its CarpX minimally invasive device designed to treat carpal tunnel syndrome.

The CarpX is a percutaneous device designed to allow the operating physician to relieve compression of the median nerve without a surgical incision. The system combines a balloon catheter with bipolar radio-frequency cutting electrodes and is positioned through guidance with ultrasound, the company said.

“I have had the opportunity to use Pavmed’s highly innovative CarpX device in pre-submission testing and am very impressed with its performance. As a busy hand surgeon, I strongly believe that CarpX will be a game-changer in the treatment of carpal tunnel syndrome, providing patients with a much less invasive option and significantly shorter recovery times than traditional open carpal tunnel surgery. I eagerly await CarpX’s regulatory clearance and the opportunity to offer this ground-breaking innovation to my patients suffering from carpal tunnel syndrome,” Dr. David Kelly of Gilbert, Ariz.’s Center for Dermatology and Plastic Surgery said in a press release.

Upon activation, the CarpX device creates a space within the tunnel to confirm the nerve is protected from the cutting electrode and decompresses the median nerve by dividing the transverse carpal ligament.

“We designed CarpX to closely mimic the anatomic results of traditional invasive carpal tunnel surgery but to do so much less invasively, using catheters, balloons, radiofrequency energy and other established tools that have contributed to the percutaneous and minimally invasive revolutions in the treatment of other conditions. Our balloon catheter device is designed to be inserted under the scarred ligament in a minimally invasive fashion, while pushing the nerve and tendons away. When activated, bipolar radiofrequency electrodes precisely cut the ligament from the inside out in a matter of seconds. The device design provides physicians with ongoing feedback to optimize the safety and completeness of the procedure,” Pavmed chief medical officer Dr. Brian deGuzman said in prepared remarks.

Pavmed said it is hopeful that the CarpX device can decrease costs and move procedures out of operating rooms, as well as decreasing postoperative pain and hospital stays before patients can return to their day-to-day lives.

“We are very excited to have reached this most important milestone in Pavmed’s corporate history. CarpX has become the most commercially promising and clinically exciting product in our pipeline and we believe it will revolutionize the treatment of carpal tunnel syndrome, a widely prevalent condition that exacts a significant clinical and economic burden on society in the U.S. and worldwide. Based on epidemiological and market research data we estimate CarpX’s addressable market opportunity to exceed $1 billion,” Pavmed chair & CEO Dr. Lishan Aklog said in a prepared statement. “As with all of our products, CarpX’s development and regulatory testing were performed using our unique business model focused on speed to market and capital efficiency. We are proud to have achieved this milestone within a timeframe and with capital expenditures to date that beat our model’s benchmarks. We believe we have assembled a strong submission and are targeting clearance in the first half of 2018. Upon successful regulatory clearance, we anticipate an aggressive commercialization strategy using well-established independent sales channels targeting the appropriate physician specialties.”

Earlier this month, Pavmed saw shares rise after the medical device maker beat expectations on Wall Street with its third quarter results

Masimo wins FDA nod for NomoLine capnography sampling lines



Masimo (NSDQ:MASI) said today it won FDA clearance for its NomoLine capnography sampling lines.

The newly cleared NomoLine sampling lines are compatible with both Masimo and third-party OEM NomoLine monitors to allow for sidestream capnography and gas monitoring the Irvine, Calif.-based company said. The lines are designed for both intubated and non-intubated patients in low and high humidity applications.

Masimo touted that the NomoLine sampling lines feature no-moisture sampling technology designed to eliminate issues associated with conventional sidestream gas sampling line systems. The NomoLines feature the company’s patented polymer and allow water in sampling lines to continuously evaporate into the surrounding air and leave oxygen, carbon dioxide and anesthetic gases unaffected.

“With NomoLine, we’ve developed innovative moisture-wicking technology – and then applied that breakthrough to an entire line of cannulas, including neonatal airway adapter sets. Masimo continues to automate noninvasive monitoring with solutions such as NomoLine that are reliable and easy to use,” founder & CEO Joe Kiani said in a press release.

Earlier this month, Masimo reported third-quarter results that crushed the consensus earnings forecast and raised its sales and earnings outlook for the rest of the year.

7 medtech stories we missed this week: Nov. 17, 2017

missed medtech

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From Skyline Medical’s joint venture to Lensar receiving FDA clearance and CE Mark, here are seven medtech stories we missed this week but thought were still worth mentioning.

1. Skyline Medical launches JV deal with Helomics

Skyline Medical announced in a Nov. 15 press release that it has signed a joint venture agreement with Helomics. The agreement comes after a strategic collaboration between the companies that allows Skyline to reach more markets. The joint venture leverages the Helomics D-Chip platform to develop and market new approaches for personalized cancer diagnostics and care.

2. iReliev launches wearable arthritis-treatment EMS/Tens patch

iReliev recently introduced its PlayMakar Wireless EMS + TENS Unit that helps treat chronic pain from arthritis on the go, according to a Nov. 15 press release. The device features two functions that include transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS). TENS helps block pain signals from the brain to provide pain relief while EMS stimulates muscles for conditions, strengthening and recovery using gentle electrical impulses. It has two rechargeable receivers that connect to electrode pads to allow for it to work wirelessly. The device has 14 preset therapy mode for personalized treatment and additional receivers can be added on for treating bigger areas.

3. Mortise Medical gets FDA clearance

Mortise Medical announced in a Nov. 14 press release that it has received FDA 510(k) clearance for its SyndesMetrics Syndesmosis Repair System. The system addresses clinical needs for syndesmotic disruption injuries like predictable and repeatable anatomic reduction, restoration of physiological motion and restoration of ankle stability. The SyndesMetrics implant system has minimal hardware prominence, no suture prominence and a reversible locking mechanism that secures high strength suture that that connects tibial and fibular implant components.

4. InnerScope announces new distribution deal

InnerScope Hearing Technologies has announced that it has signed an exclusive distribution deal with Speechlab Advanced Technologies, according to a Nov. 14 press release. The deal allows for resell rights of InnerScope’s BlackCat Personal Sound Amplifier Product (PSAP). The BlackCat is a personal audio controller that is designed to help people understand speech better in noisy environments.

5. Mevion receives CE Mark for proton therapy system

Mevion announced in a Nov. 13 press release that it has achieved CE Marking clearance for its Mevion S250i Proton Therapy System. The system features Hyperscan technology and pencil beam scanning (PBS) for faster, sharper and more robust proton treatments. It also uses the fastest energy layer switching, optimized spot sizes and the Adaptive Aperture proton multi-leaf collimator system.

6. Nexstim wins FDA nod for NBT depression device

Nexstim has been cleared by the FDA to market and distribute its Nexstim NBT system, according to a Nov. 13 press release. The system is designed to treat major depressive disorder through stimulation of the brain using repetitive transcranial magnetic stimulation (TMS), which has been proven to be effective in treating depression. The company plans to begin to market and sell its system in early 2018.

7. Lensar gets FDA clearance, CE Mark for laser eye surgery marker

Lensar announced in a Nov. 10 press release that it has received FDA 510(k) clearance and CE Mark for its IntelliAxis-L. It is a unique reference mark that uses the company’s integrated pre-operative diagnostic capabilities, iris registration and intraoperative imaging to identify the location of steep corneal axis at the capsular plane for toxic IOL alignment.

Alcyone Lifesciences wins FDA nod for Alivio hydrocephalus shunt flusher


alcyone lifesciences

Alcyone Lifesciences said yesterday it won FDA 510(k) clearance for its Alivio ventricular catheter and flusher system designed for treating hydrocephalus.

The newly cleared Alivio device is designed for the non-invasive retrograde flushing of the ventricular catheter to unblock occluded inlet holes or open a relief membrane to restore or increase cerebrospinal fluid flow in non-flowing shunts, the Lowell, Mass.-based company said.

“For the first time in over half a century there has been a game changing improvement in the field of hydrocephalus treatment.  Ventricular shunting can help save lives and improve the quality of life that otherwise most patients with hydrocephalus would never experience.  However, shunt failures can be abrupt, without warning, carry significant morbidity, and be life-threatening. The implantation of Alcyone’s new Alivio Shunt System will enable neurosurgeons with the ability to provide emergency treatment during shunt malfunctions, delivered completely non-invasively, preventing neurological decline and allowing time for patients to reach definitive neurosurgical care,” Dr. Ramin Eskandari of the Medical University of South Carolina said in a prepared release.

Alcyone said the device is intended to offer an alternative to revision surgeries often required to prevent shunt failures in patients with hydrocephalus.

“Patients and families dealing with hydrocephalus deserve a better quality of life and It is our hope that the Alivio System will provide peace-of-mind to these patients, and families, living in fear and worry of potential abrupt shunt occlusions. We are grateful to the patients and families with hydrocephalus, and clinicians treating these patients, for the encouragement and support.  We are excited to launch this product in the US and EU early in 2018,” Alcyone founder & CEO PJ Anand said in a press release.

According to the Hydrocephalus Association, at least 50% of patients implanted with shunts suffer shunt failures and blockages within 2 years and require revision surgeries. Approximately 40% of obstructions have also been shown to occur within the 1st year post-surgery.

“We are tremendously excited about the FDA clearance of this new technology focused on potentially reducing the number of emergency surgeries that may be required for members of our community. The Hydrocephalus Association is committed to finding a cure and improving the lives of people living with hydrocephalus through research, advocacy, education and support services,” Hydrocephalus Association prez & CEO Diana Gray said in a prepared statement.

Last August, Alcyone said it was seeking FDA approval for its device to treat fluid buildup in the brain, following its successful implant in 4 patients in a study at Boston Children’s Hospital.

FDA clears Innovative Health Solutions opioid withdrawal treating neuromod


Innovative Health Solutions

Innovative Health Solutions won FDA clearance for a new indication for its NSS-2 Bridge device, now cleared to reduce symptoms of opioid withdrawal, according to an FDA release.

The NSS-2 Bridge device is a small electrical nerve stimulator designed to be placed behind a patient’s ear and emit electrical pulses to stimulate branches of certain cranial nerves, which may provide relief from opioid withdrawal symptoms.

Clearance came based of a single-arm clinical study of 73 patients undergoing opioid physical withdrawal symptoms, with researchers evaluating clinical opiate withdrawal scale scores.

Prior to using the device, patients had an average reported COWS score of 20.1. After treatment, all patients showed a COWS score reduction of at least 31% within 30 minutes of using the device. A total 88% of patients transitioned to medication assisted therapy after 5 days of using the device, according to the FDA press release.

“Given the scope of the epidemic of opioid addiction, we need to find innovative new ways to help those currently addicted live lives of sobriety with the assistance of medically assisted treatment. There are three approved drugs for helping treat opioid addiction. While we continue to pursue better medicines for the treatment of opioid use disorder, we also need to look to devices that can assist in this therapy. The FDA is committed to supporting the development of novel treatments, both drugs and devices, that can be used to address opioid dependence or addiction, as well as new, non-addictive treatments for pain that can serve as alternatives to opioids,” FDA Commissioner Dr. Scott Gottlieb said in a press release.

The NSS-2 Bridge device, previously known as the Electro Auricular Device, was originally cleared for use in 2014 in acupuncture, according to the FDA.

7 medtech stories we missed this week: Nov. 3, 2017

medtech missed

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From Hologic’s new product launch to CapsoVision gettting CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning.

1. Hologic launches new MyoSure device

Hologic announced in a Nov. 1 press release that it has launched its MyoSure Manual Device in the U.S. The device is designed to help doctors resect and remove intrauterine tissue easily in an office setting if used with the MyoSure hysteroscope.

2. IntraFuse wins FDA clearance for FlexThread fibula pin

IntraFuse has received FDA 510(k) clearance for its FlexThread Fibula Pin System, according to a Nov. 1 press release. The system is designed to help improve outcomes for orthopedic extremity procedures. It has a percutaneous fixation of distal fibula fractures like Danis-Weber B type fractures or trans-syndesmotic fractures.

3. Skyline Medical, Helomics ink personalized cancer care deal

Skyline Medical and Helomics have announced their collaboration in a Nov. 1 press release to develop new approaches for personalized cancer diagnosis and care using the Helomics D-CHIP. D-CHIP uses an artificial intelligence-powered bioinformatics engine to show insights from cancer patient data to help with disease diagnosis and develop new diagnostics and therapies.

4. Sensus Healthcare wins Mexico nod

Sensus Healthcare has been cleared to sell its SRT-100 in Mexico, according to an Oct. 31 press release. The system has been approved to treat non-melanoma skin cancer and keloids and is set to be placed on the National Registry by February 2018.

5. Vesalio wins CE Mark for NeVa thrombectomy device

Vesalio announced in an Oct. 31 press release that it has received CE Mark certification for its NeVa neurotheomectomy platform for treating strokes. The mechanical thrombectomy technology was designed to improve first pass success and capture and remove clots that can create sudden blockages in blood flow to the brain.

6. BRH Medical wins FDA nod

BRH Medical has received FDA 510(k) clearance for its BRH-A2 device that reduces pain and promotes healing of deep wounds, according to an Oct. 31 press release. The technology engages and stimulates the wounded area from below the wound bed using ultrasound and electric field modalities to affect the tissues and muscles in the region of and below the wound. It can be used with any treatment modally and is portable enough to be used in clinics and hospitals.

7. Capsovision gets CE Mark

Capsovision announced in an Oct. 25 press release that it has received CE Mark approval for its CapsoCam Plus System for patients who are age 2 and older. It is a wire-free capsule endoscopy system that gives physicians a full 360º panoramic lateral image of the small bowel mucosa.

Here’s what we missed last week.

OptiScan CEO: Glucose monitor approval is biggest advancement for ICU care in 10 years

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  • How to mitigate heating in a handheld surgical tool

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  • Medtech stories we missed this week: Oct. 20, 2017

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  • The 11 most innovative medical devices of 2017

    The nominees for the best medical technology of 2017 were recently announced for the 11th Annual Prix Galien USA Awards. The Galien Foundation, the host of the awards, hands out the the Prix Galien Award annually to examples of outstanding biomedical and technology product achievement designed to improve human condition. Before candidates can qualify for […]

  • How to add recyclability and sustainability into medtech plastics

    Recyclability and sustainability have become very important across the medical device marketplace, and some companies are taking note. Jason Middleton, Ray Products Some implement sustainability to appeal to consumers. Others look to cut costs or align their business practices with their company mission. Whatever the motivation, 13% of company CEOs see sustainability as their top priority, […]

  • Self-propelled catheter moves through bronchi like an earthworm

    Japanese researchers have created a catheter that can navigate by itself through some of the thinnest branches of the bronchi. Pulmonary lesions are biopsied to diagnose or treat respiratory illnesses like lung cancer. Bronchoscopy is the standard method for manual biopsies. The bronchi branches into different directions and progressively gets thinner and more difficult to […]

  • Crescent touts video on secondary services

    Crescent Industries has a new video out touting its contract assembly and packaging services. Crescent offers a wide range of contract assembly and packaging services. For Crescent, assembly – the process of making various plastic components into subassemblies or complete assemblies – includes: Build custom fixtures to aid in the assembly process Simple to complex assembly operations Some […]

  • Millstone Medical recruits microbiologist to sterile packaging facility

    Millstone Medical announced that it has added microbiologist Joshua Browning to its Fall River, Mass. sterile packaging facility staff. Browning has been a quality control analyst in microbiology at Nanotherapeutics prior to joining Millstone Medical. There, he was responsible for facility process qualifications and validations of ISO 7 and ISO 8 cleanrooms, validated gas systems […]

  • PE Firm Genstar Capital acquires TekniPlex

    Private equity firm Genstar Capital said this week it acquired advanced product manufacturer TekniPlex for an undisclosed amount. Wayne, Pa.–based Tekni-Plex develops products including medical tubings and compounds, pharma barrier films, dispensing components, closure liners and food packaging, the company said. “We are excited to be partnering with a proven, energetic and action-oriented management team.  […]

  • UK design firm touts new device as the ‘Nespresso of auto-injectors’

    People living with chronic diseases often have to treat themselves at home using a medical device like an auto-injector. The process can be nerve-wracking, because it requires the patient to follow a number of important steps – like properly storing their drugs and warming them to the correct temperature at the time of injection. These […]

  • This surgical glue seals wounds in 60 seconds

    A potentially life-saving surgical glue that is highly elastic and adhesive can quickly seal wounds in seconds without the need for common staples or sutures. The surgical glue, called MeTro, is a development from biomedical engineers at the University of Sydney and biomedical engineers from Harvard University. MeTro has a high elasticity that can seal […]