BioSig wins FDA nod for Pure EP system

BioSig Technologies (OTCQB: BSGM) said today it won FDA 510(k) clearance for its Pure EP electrophysiology system.

The Santa Monica, Calif.-based company said the PureEP system is designed for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology procedures.

The newly cleared system is intended to reduce noise and artifacts to produce high-fidelity cardiac signals, which the company claims could increase the diagnostic values of the signals.

Initial Pure EP systems were produced by Minnetronix, with a limited US launch at select sites planned, Biosig said.

“Our Pure EP System is the culmination of many years of scientific research and business development efforts. It is our goal to provide tangible benefits to electrophysiologists and improve the current standards of EP procedures in the clinical setting.  We are excited to bring the advanced platform to the U.S. market,” chair & CEO Kenneth Londoner said in a press release.

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7D Surgical wins FDA nod for MvIGS nav system Cranial Module

Canadian medical device firm 7D Surgical said yesterday it won FDA 510(k) clearance for a Cranial Module for its Machine-vision Image Guided Surgery system.

The Toronto-based company’s 7D Surgical System uses 3D optical technologies which require only natural light, as well as machine vision algorithms.

The system’s navigation technology is embedded in an overhead surgical light to reduce line of sight issues, and is controlled by the surgeon using a foot pedal to eliminate the need for non-sterile personnel for operation.

“We are incredibly excited to expand the MvIGS technology to cranial surgery.  The speed, accuracy and efficiency of this new application, coupled with astounding workflow and safety improvements we have already introduced for spinal image guidance, has resulted in a very compelling and cost-effective solution for surgeons and hospitals. Faster, better and cheaper is the new mantra in healthcare and the 7D Surgical System is perfectly positioned to meet these goals,” CEO Beau Standish said in a prepared statement.

The new module is designed to acquire thousands of virtual fiducials using the patient’s own anatomy, and allows for “nearly instantaneous” cranial registration, 7D Surgical said. The system can also register multiple datasets independently, and allows for the visualization of anatomy in multiple modalities.

“This approval allows our team to offer new cranial functionality alongside our game changing spinal application to our existing and planned installations in the U.S. hospitals have been asking us for cranial, and I am delighted to be able to offer this exciting application ahead of schedule and at a price point consistent with our value proposition,” sales & marketing VP Brian Stuart said in a press release.

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Intuitive Surgical wins FDA nod for 60mm stapler

Intuitive Surgical (NSDQ:ISRG) said today that the FDA cleared its fully-wristed 60 mm stapler, SureForm 60.

The device is a single-patient-use stapler featuring 120 degrees of fully-wristed articulation, which Intuitive touts as “an industry first.”

Beyond the 60 mm device, Intuitive’s stapling portfolio includes 30 and 45 mm stapler instruments.

The stapler uses Intuitive’s SmartFire software to measure tissue compression before and during staple firing, automatically adjusting to the firing process as staples are formed, the company explained.

Surgeons control Intuitive’s latest stapler via the daVinci console – it’s compatible with the da Vinci Xi and X systems. The SureForm 60 device has general, thoracic, gynecologic, urologic and pediatric indications, according to Intuitive.

“Intuitive continues our minimally invasive innovation with our 60mm stapler, rooted in extensive research and development and an understanding of surgeons’ needs,” Sal Brogna, EVP & COO, said in prepared remarks.

ISRG shares were trading at $487.39 apiece in late afternoon activity today, up +0.4%.

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Arthrosurface nabs 510(k) clearance for patellofemoral WaveKahuna arthroplasty system

Arthrosurface said last month that it won 510(k) clearance from the FDA for its patellofemoral WaveKahuna arthroplasty system.

The Franklin, Mass.-based company’s PF WaveKahuna device is designed to restore the articular surface geometry of the patella and femoral trochlea. The system tackles the challenging PF tracking and stability conditions and gives increased coverage of the trochlear groove, according to Arthrosurface.

The company also noted that the device’s design combines the clinical benefits of the anatomic and dome patella implants from the PF Wave system. The PF WaveKahuna femoral component can match up with the company’s PF Wave Fixation component, Arthrosurface added.

“As a market leader in patellofemoral arthroplasty, we are very excited to round out our line with the PF WaveKahuna System. The larger implants will allow a surgeon to choose from a wide range of size offerings to better serve the patient’s needs and allow them to maintain their quality of life,” Shane Shankle, VP of U.S. sales, said in prepared remarks.

“The FDA clearance comes shortly after data recently presented at ESSKA confirmed significantly improved postoperative outcomes with high patient satisfaction and no progression of knee arthritis at 5 years follow-up. The timing could not be better,” Dawn Wilson, VP of quality & regulatory, added.

In April, Arthrosurface won FDA 510(k) clearance for its OVOMotion shoulder arthroplasty system.

The company explained that its newly-cleared stemless total shoulder system is designed to minimize bone removal specifically for patients with painful or severely disabled shoulder joints from arthritis, traumatic events or avascular necrosis.

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Gel-E wins FDA OTC nod for gel-e Flex flowable hemostat

Early stage wound care company Gel-e said today it won FDA 510(k) clearance for its gel-e Flex as an over-the-counter flowable hemostat.

The College Park, Md.-based company said the clearance expands the labeling for the local management of lacerations and minor bleeding, and said the products were specifically designed to be usable by both trained professionals and patients.

“This clearance is the next step in expanding our OTC product line, and will be a key component of gel-e’s 21st Century First Aid Kit. We are continuing to develop a tool kit that will provide the best possible options for all manner of chronic and acute wounds. The versatility of these flowable and bandage formats represents an important progression towards our next-generation kit and eventually to products that can be used in surgery,” chief scientific officer Dr. Matthew Dowling said in a press release.

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Apollo Endosurgery wins expanded FDA nod for OverStitch Sx system

Apollo Endosurgery said today it won special FDA 510(k) clearance for its OverStitch Sx endoscopic suturing system, an accessory for its already cleared OverStitch Sx system intended to simplify attachment of the device to compatible endoscopes.

The Austin, Texas-based company said that the special clearance is the last regulatory nod it needed before it could introduce the system into the US market.

The newly cleared accessory makes the system, which was previously limited in compatibility to a select number of dual-channel endoscopes, compatible with a wider range of endoscopes, Apollo said in a press release.

Earlier this month, Apollo Endosurgery said it closed a $23.7 million round of financing.

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Renovis wins FDA nod for Tesera ALIF interbody spinal fusion system

Renovis Surgical Technologies said today that it won 510(k) clearance from the FDA for its Tesera SA hyperlordotic ALIF interbody spinal fusion system.

The company’s porous, titanium, stand-alone anterior lumbar interbody fusion system features a four-screw design and a locking cover plate designed to prevent screw backout.

Renovis’ Tesera implants are made using additive manufacturing, according to the company, and include a porous surface structure to enable bone attachment and in-growth to the implant.

With its latest regulatory win, Renovis’ portfolio of 3D-printed titanium implant systems include anterior cervical, anterior lumbar and posterior lumbar devices.

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Embolx wins FDA nod for next-gen Sniper balloon occlusion microcath

Embolx said today that it won FDA 510(k) clearance for its next-gen Sniper balloon occlusion microcatheters designed for pressure-directed arterial embolization therapy.

The Sunnyvale, Calif.-based company said that improvements to its next-gen Sniper microcath are intended to enhance access and navigation through small complex vascular structures. The catheter is available in 110 cm, 130 cm and 150 cm lengths to allow for access in either femoral or radial artery sites.

“The great thing about Sniper’s enhanced design and longer lengths is that it allows me to perform procedures using a transradial approach with the benefits of pressure-directed embolization. The ability to reverse blood flow using Sniper’s balloon helps me to not have to worry about non-target embolization. I can perform the procedure the way I want because of Sniper’s wide range compatibility with different guidewires, guide catheters, coils and therapeutic agents,” Dr. Aaron Fischman of the Icahn School of Medicine at Mount Sinai said in a prepared statement.

The Sniper Microcatheter is intended to alter blood flow dynamics by controlling pressure to allow for increased therapeutic agent delivery into target areas, and is currently used for treating cancerous tumors in the liver and other organs.

“Our next generation devices incorporate experience from more than 1,000 Sniper balloon occlusion microcatheters used to date. Now, interventional radiologists can do everything they would do with standard microcatheters, but with the added benefits of balloon occlusion. This is a big step forward and provides physicians with the most advanced transarterial delivery system for tumor and prostate treatment,” prez & CEO Michael Allen said in a press release.

In April, Embolx said that it landed a $2 million grant from the National Cancer Institute to fund development of its next-generation Sniper balloon occlusion microcatheter.

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FDA clears Shape Memory Medical’s Impede embolization plug

Shape Memory Medical said today it won FDA 510(k) clearance for its Impede embolization plug designed to obstruct or reduce the rate of blood flow in the peripheral vasculature.

The newly cleared device, which won CE Mark approval last August, is available in three sizes and is intended to treat vessels up to 10 mm in diameter.

The Impede device features shape memory polymer technology developed at Texas A&M University and the Lawrence Livermore National Laboratory, the Santa Clara, Calif.-based company said.

“The Impede embolization plug is an exciting development in embolization technology, expanding the options open to physicians treating conditions requiring occlusion of the peripheral vasculature,” prez & CEO Ted Ruppel said in a press release.

“It is exciting to see the approval of new developments in embolization technology, offering physicians a new alternative to embolization coils,” Jafar Golzarian of University of Minnesota Health said in a prepared statement.

Last August, Shape Memory medical said it raised $7 million in a new round of equity financing.

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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 is is intended to be used with additional FDA-cleared supplementary fixation systems implanted via a laparoscopic or an open anterior approach.

ENZA-A Titanium ALIF consists of a 3D printed titanium body with a roughened surface that encourages bone growth onto the cranial and caudal surfaces of the device, according to the company. The upper and lower faces are deliberately designed with pores that average 500 microns in diameter, the optimal environment for bone to grow and fully incorporate the implant with the vertebral bodies. It has multiple openings to allow a large volume of autogenous bone graft to be packed into the implant to further facilitate fusion. Similar to the original ENZA, it has two sharpened anchor plates housed within the 3D-printed body until they are deployed into the adjacent vertebrae to provide fixation.

The new ENZA was designed to be minimally invasive with single, inline instrumentation to insert the device, deploy the anchor plates, and lock it in place. Camber Spine expects to launch additional products later this year. This interbody, coupled with additional product launches expected later this year in the cervical and lateral markets, will continue to grow Camber Spine’s presence as a market leader and innovator in minimally invasive spine surgery technology advancements.”

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