Cervical vertebral body replacement system made from PEEK-Optima HA receives FDA 510(k) clearance
Omnia Medical (Morgantown, WV) has been granted the first FDA 510(k) clearance for a cervical vertebral body replacement (VBR) system manufactured from PEEK-Optima HA Enhanced polymer from Invibio Biomaterial Solutions (Thornton Cleveleys, UK). The so-called Boxcar system is designed for use in cervical-corpectomy procedures, the replacement of a collapsed, damaged or unstable vertebral body located in the cervical spine.
Robert Gewirtz, a neurosurgeon based in Columbus, OH, collaborated on the development of the Boxcar VBR product. “I see many patients that require a cervical corpectomy, and it's excitin...
Source: MDDI - September 24, 2019 Category: Medical Devices Tags: Plastics Today Source Type: news
NuVasive wins expanded FDA nod for Monolith corpectomy system
NuVasive (NSDQ:NUVA) said yesterday that it won expanded FDA 510(k) clearance for its Monolith corpectomy system, now cleared for use in cervical corpectomy procedures.
The system is now cleared for procedures in the cervical spine, between the C3-C7 vertebral bodies, to treat diseased or damaged vertebral body caused by fractures, tumors, osteomyelitis or to support reconstruction following corpectomy for the decompression of the spinal cord and neural tissue in cervical degenerative disorders, the San Diego-based company said.
The device was initially cleared in 2015 for use in thoracolumbar corpectomy procedures, NuVas...
Source: Mass Device - December 11, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Featured Regulatory/Compliance Spinal Nuvasive Source Type: news
K2M posts mixed-bag Q2
K2M (NSDQ:KTWO) today posted second quarter earnings results that beat Wall Street expectations on sales, but missed on loss-per-share consensus.
The Leesburg, Va.-based company posted losses of $10.8 million, or 25¢ per share, on sales of $73.6 million for the three months ended June 30, seeing losses grow 19.2% on sales growth of 12% compared with the same period last year.
Losses per share were just behind the 19¢ consensus on The Street, where analysts were looking for sales of $70.9 million, which the company topped.
“Our second quarter total revenue growth of approximately 12% year-over-year reflects strong...
Source: Mass Device - August 1, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat K2M Source Type: news
7 medtech stories we missed this week: July 27, 2018
[Image from unsplash.com]From the FDA clearing LifeSignal’s wireless ECG to Zavation receiving FDA clearance for its expandable corpectomy cage, here are seven medtech stories we missed this week but thought were still worth mentioning.
1. FDA clears LifeSignal’s wireless ECG
LifeSignals announced in a July 26 press release that it has received FDA clearance for its wireless LP1100 Life Signal Patch. The patch is designed to be used in wearables and healthcare monitoring devices. The clearance allows the company to use the Life Signal Processor to develop ECG and other vital sign monitoring wearables with wir...
Source: Mass Device - July 27, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Diagnostics Food & Drug Administration (FDA) Hospital Care Imaging Patient Monitoring Prosthetics Regulatory/Compliance DoseOptics FBC Device Flashback Technologies Health.io LifeSignal Medi-Lynx Cardiac Monitoring MedTe Source Type: news
K2M shares up on mixed-bag Q1
Shares in K2M (NSDQ:KTWO) have risen today after the orthopedic-focused posed mixed-bag second quarter earnings that beat the Street on sales but missed on loss-per-share consensus.
The Leesburg, Va.-based company posted losses of $11.4 million, or 26¢ per share, on sales of $67.9 million for the three months ended March 31, seeing losses grow 4.8% while sales grew 9.7% compared with the same period during the previous year.
K2M’s 26¢ per share losses were just behind the 22¢ consensus on Wall Street, where analysts were expecting to see sales of $65.8 million.
“Our first quarter total revenue growth of approxi...
Source: Mass Device - May 2, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat K2M Source Type: news
Orthopedic companies see mixed bag on Q4, FY2017 earnings
Orthopedic companies K2M (NSDQ:KTWO) and SeaSpine (NSDQ:SPNE) reported their fourth quarter and full year 2017 earnings, with K2M seeing a drop in share value while SeaSpine saw a mild rise.
Leesburg, Va.-based K2M posted losses of $8.8 million, or 20¢ per share, on sales of $67.8 million for the 3 months ended December 31, seeing losses shrink 29.8% while sales grew 9.7% compared with the same period last year.
Loss-per-share expectations were just below the 19¢ analyst’s consensus on Wall Street.
For the full year, K2M posted losses of $37.2 million, or 87¢ per share, on sales of $258 million, seeing losses sh...
Source: Mass Device - March 1, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat K2M SeaSpine Source Type: news
5 medtech stories we missed this week: Dec. 29, 2017
[Image from unsplash.com]From NanoVibronix’s new Indian regulatory and distribution agreement to Guided Therapeutics’s Turkish distribution deal, here are five medtech stories we missed this week but thought were still worth mentioning.
1. NanoVibronix inks deal with Indian regulatory and distribution consultant
NanoVibronix announced in a Dec. 20 press release that it has signed Morulaa HealthTech as its regulatory and marketing partner in India. Morulaa HealthTech will help bring NanoVibronix’s products to India, including its UroShield, WoundShield and PainShield. Morulaa HealthTech also has an in-hou...
Source: Mass Device - December 29, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Business/Financial News Cardiovascular Catheters Regulatory/Compliance Guided Therapeutics Inc. Impulse Dynamics K2M MedTech Muscle Activation Technique nanovibronix neuxtechnologies Source Type: news
K2M Holdings beats on Q3 earnings, misses on sales
K2M (NSDQ:KTWO) yesterday topped the earnings consensus for its third-quarter but missed expectations for sales and lowered its earnings outlook for the rest of the year.
The Leesburg, Va.-based orthopedics company posted losses of -$8.5 million, or -20¢ per share, on sales of $62.7 million for the three months ended Sept. 30, widening its losses by 7.0% on sales growth of 5.6% compared with Q3 2016.
The results topped Wall Street’s consensus outlook on earnings by a penny but missed The Street’s $66.0 million sales forecast.
“Our revenue results for the third quarter of 2017 reflect total revenue growth of...
Source: Mass Device - November 2, 2017 Category: Medical Devices Authors: Brad Perriello Tags: MassDevice Earnings Roundup Orthopedics Wall Street Beat K2M Source Type: news
K2M acquires Cardinal Spine ’ s Palo Alto cervical corpectomy cage
K2M (NSDQ:KTWO) said today it acquired Cardinal Spine‘s Palo Alto cervical static corpectomy cage system desigend as a cervical vertebral body replacement device and all associated intellectual property for an undisclosed amount..
Leesburg, Va.-based K2M touted the device as the first and only static corpectomy cage to receive a cervical FDA 510(k) clearance.
“We are excited to expand our complex cervical offerings by adding the first and only FDA-cleared static cervical vertebral body replacement device. We look forward to fully integrating this clinically supported technology into our differentiated product...
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Spinal Cardinal Spine LLC K2M Source Type: news
FDA releases April 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD April 2016
TOTAL 510(k)s THIS PERIOD 239
TOTAL WITH SUMMARIES 224
TOTAL WITH STATEMENTS 15
DEVICE: Applanation Tonometer
SHANGHAI MEDIWORKS PRECISION INSTR510(k) NO: K142263(Traditional)
ATTN: Weida Zhan PHONE NO : 8621 542 60421
Zone A, 2nd Floor, No. 69, Lane 19SE DECISION MADE: 15-APR-16
SHANGHAI CN 200237 510(k) STATEMENT
DEVICE: Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test
Sugentech, Inc. 510(k) NO: K142754(Traditional)
ATTN: Mijin Sohn PHONE NO : 82 42 3645001
Daejeon Bioventure Town, 1662, YusSE DECISION MADE: 07-A...
Source: Mass Device - May 9, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
NuVasive Receives First Ever FDA 510(k) Clearance Of Cervical Corpectomy Cage
NuVasive, Inc. has received the first ever FDA 510(k) clearance of a cervical corpectomy cage. The X-CoreMini Cervical Corpectomy System is an expandable titanium vertebral body replacement device designed to provide enhanced stability following a corpectomy procedure. (Source: Medical Design Online News)
Source: Medical Design Online News - October 13, 2015 Category: Medical Equipment Source Type: news
MassDevice.com +3 | The top 3 medtech stories for October 12, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
3. NuVasive wins FDA nod for X-Core cervical corpectomy cage
NuVasive Inc. said that it won 510(k) clearance from the FDA for its X-Core mini cervical corpectomy cage, claiming it as the 1st such device cleared for the U.S. market.
The X-Core device is designed to replace vertebrae in the cervica...
Source: Mass Device - October 12, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news
NuVasive Receives First Ever FDA 510(k) Clearance of Cervical Corpectomy Cage
SAN DIEGO, CA--(Healthcare Sales & Marketing Network) - NuVasive, Inc. (NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced today the first ever FDA 510(k) cl... Devices, Orthopaedic, Neurosurgery, FDANuVasive, X-Core Mini VBR, corpectomy, spine surgery (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 12, 2015 Category: Pharmaceuticals Source Type: news
NuVasive wins FDA nod for X-Core cervical corpectomy cage
NuVasive Inc. (NSDQ:NUVA) said today that it won 510(k) clearance from the FDA for its X-Core mini cervical corpectomy cage, claiming it as the 1st such device cleared for the U.S. market.
The X-Core device is designed to replace vertebrae in the cervical spine (C3 to C7), San Diego-based NuVasive said. It must be used with supplemental fixation such as the company’s Archon Reconstruction corpectomy plate.
“This assembly of best-in-class cervical products into a cohesive procedural offering further reinforces NuVasive’s commitment to providing single-source, integrated procedural solutions to our custome...
Source: Mass Device - October 12, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Orthopedics Spinal Nuvasive Source Type: news
