The Laser Probe, The iKnife and The Cutting Edge of Surgery
If the thought of going under the knife fills you with fear, be reassured.
No longer is surgery the brutal and hazardous experience faced by our ancestors.
Thanks to wonders such as laparoscopy, robotic solutions, and, more recently, the iKnife and the laser probe, surgical intervention is getting safer all the time.
Archaeologists believe that people have been carrying out surgery for up to 11,000 years. Cranial surgery, known as trephination, probably dates back to the Neolithic era. It involved drilling a hole in the skull of a living person.
Speculation suggests it was done to cure disorders such as convulsions, fr...
Source: Healthy Living - The Huffington Post - August 31, 2016 Category: Consumer Health News Source Type: news
Teleflex launches Percuvance percutaneous laparoscopic system
Teleflex (NYSE:TFX) said yesterday it launched its 2nd-generation Percuvance percutaneous surgical system designed for percutaneous laparoscopic procedures in the U.S.
The company said that along with the launch, the 1st clinical use of the device, in a sleeve gastrectomy, Roux-en-Y gastric bypass, and laparoscopic gastric band removal, were recently performed at the Duke Center for Metabolic and Weight Loss Surgery
“These are increasingly common but often challenging procedures. Our experiences with the new system are consistent with other clinical studies, which showed that its handling and functionality were sim...
Source: Mass Device - August 16, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Catheters Surgical Teleflex Source Type: news
TransEnterix sees light on Q2 release, shares tick up
TransEnterix (NYSE:TRXC) hasn’t had the best luck in 2016, with the FDA denying its 510(k) clearance submission in April and shareholders suing the company in June over the nixed project, but things are looking up for the robotics company with the release of 2nd quarter earnings that beat the street and sent shares up nearly 7%.
The Research Triangle, N.C.-based company reported losses of $80.1 million, or 70¢ per share with operating expenses of $80.7 million for the 3 months ended June 30.
That amounts to an over 700% growth in losses and operating expenses compared with the same quarter in 2015. After adjusting to e...
Source: Mass Device - August 5, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup TransEnterix Source Type: news
Ask these questions before mitral valve surgery
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Questions to ask if you need treatment for mitral valve regurgitation or mitral valve stenosis.
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Overview
Mitral valve regurgitation can do serious damage to your heart. A leaky mitral valve causes blood to flow back into your heart, which makes it harder for oxygen-rich blood to be pumped out to your body. Because mitral valve regurgitation can lead to life-threatening heart failure, arrhythmias, and other abno...
Source: dukehealth.org: Duke Health News - August 3, 2016 Category: Consumer Health News Authors: dg62 at duke.edu Source Type: news
MassDevice.com +5 | The top 5 medtech stories for August 2, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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.
Get this in your inbox everyday by subscribing to our newsletters.
5. Alcyone Lifesciences seeks FDA nod for ReFlow neuro cath
Alcyone Lifesciences is seeking formal commercial approval for its device to treat fluid buildup in the brain, following its successful implant in 4 patients in an ongoin...
Source: Mass Device - August 2, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
TransEnterix sells 1st ALF-X unit
TransEnterix (NYSE:TRXC) said today it sold the 1st ALF-X surgical robotic system to Milan, Italy’s Humanitas Hospital.
The company acquired the Telelap ALF-X robot-assisted surgery device from Italy’s Sofar SpA last September. The Telelap ALF-X device has CE Mark approval in the European Union for minimally invasive surgery procedures.
“We are pleased to announce the first global sale of our ALF-X System. Humanitas is an outstanding academic hospital with a respected multi-specialty surgical program. The ALF-X enables an enhanced surgical program through the use of advanced robotic technology with responsib...
Source: Mass Device - August 2, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Robot-Assisted Surgery Robotics TransEnterix Source Type: news
Intuitive partners with Dextera on robotic surgery stapler
Intuitive Surgical (NSDQ:ISRG) said it inked a joint development deal with Dextera Surgical (NSDQ:DXTR) to develop a surgical stapler and cartridge for Intuitive’s da Vinci robotic surgical system.
The company said the new development follows completion of a 6-month feasibility evaluation of Dextera’s MicroCutter as part of an ongoing deal between the companies.
“This partnership with Intuitive Surgical is a significant step in the progress we have achieved in enhancing and expanding the long term opportunity of the MicroCutter technology. Intuitive Surgical is a leader in advancing robotic and minimally...
Source: Mass Device - August 1, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Research & Development Robot-Assisted Surgery Robotics Surgical Dextera Surgical Intuitive Surgical Inc. Source Type: news
Intuitive Surgical Tops Expectations
Intuitive Surgical Inc., a maker of robotic systems that enable minimally-invasive surgery, easily topped second-quarter expectations, thanks to solid demand in the U.S. for its systems. (Source: WSJ.com: Health)
Source: WSJ.com: Health - July 19, 2016 Category: Pharmaceuticals Tags: PAID Source Type: news
Mazor touts studies showing advantage of robotic assistance in MIS spinal procedures
Mazor Robotics (NSDQ:MZOR) said today it is releasing data from 2 retrospective studies touting the benefits of robotic assistance and surgical guidance with its Renaissance device during minimally invasive spinal surgery procedures.
The company said it presented t the data at the 23rd International Meeting on Advanced Spine Techniques in Washington, D.C.
“These studies validate the clinical and economic value proposition of Renaissance by delivering the positive results that surgeons and hospital administrations expect from advanced technologies. While MIS adoption for spine surgeries is improving in general, the...
Source: Mass Device - July 19, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Robot-Assisted Surgery Robotics Mazor Robotics Ltd. Source Type: news
Cardica rebrands as Dextera Surgical
Cardica (NSDQ:CRDC) said today it is rebranding under the name Dextera Surgical, shifting its Nasdaq ticker to the new symbol “DXTR,” effective this Wednesday.
The company said its new name reflects “an evolution for the company,” as its portfolio of offerings, including its MicroCutter surgical stapling tech, has expanded the company’s focus beyond its anastomotic product lines originally introduced for use in cardiac surgery.
“Today, we are helping to advance minimally invasive surgery around the world, with products that are helping surgeons operate more effectively in tight spaces th...
Source: Mass Device - June 20, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardica Inc. Dextera Surgical Source Type: news
MassDevice.com +5 | The top 5 medtech stories for June 16, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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.
Get this in your inbox everyday by subscribing to our newsletters.
5. Si-Bone touts updated 510(k) clearance indications, MAC reimbursement wins for iFuse
Si-Bone said this week it won updated 510(k) clearance indications for its iFuse implant system and reimbursement coverage for its minimally in...
Source: Mass Device - June 16, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Si-Bone touts updated 510(k) clearance indications, MAC reimbursement wins for iFuse
Si-Bone said this week it won updated 510(k) clearance indications for its iFuse implant system and reimbursement coverage for its minimally invasive surgery sacroiliac joint fusion systems through Medicare Administrative Contractor FCSO.
Si-Bone said the FDA modified the indication statement for its iFuse sacroiliac joint fusion system to include that clinical studies have demonstrated that treatment with the system can improve pain, patient function and quality of life.
“SI-BONE’s strong clinical evidence demonstrating consistently positive results across multiple clinical trials makes it much easier for our...
Source: Mass Device - June 16, 2016 Category: Medical Equipment Authors: Fink Densford Tags: 510(k) Business/Financial News Food & Drug Administration (FDA) Orthopedics Regulatory/Compliance Si-Bone Source Type: news
ReCor pulls in $10m
Renal denervation device developer ReCor Medical raised $10 million in a new round of debt financing, according to an SEC filing posted today.
The Palo Alto, Calif., and Amsterdam-based company is developing the Paradise renal denervation system designed to treat overactive nerves leading to the kidney through a minimally invasive surgery.
The system uses a small flexible catheter, inserted in an incision near the groin, to deliver ultrasound energy to the tissue surrounding the energy to decrease over-activity of the nerves leading to the kidney.
The funds in the round all came from 1 anonymous investor, according to the ...
Source: Mass Device - June 10, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Catheters ReCor Medical Source Type: news
Laser Spine Institute to slash jobs
Tampa’s Laser Spine Institute is reducing its workforce.
“To maintain Laser Spine Institute’s commitment to exceptional patient care, we determined after thoughtful consideration, that there were steps we needed to take to be more effective and pursue transformation of our business,” the company said in a statement to the Tampa Bay Business Journal. The company has built a global business offering minimally invasive surgery for patients with back and neck pain. “We recently had to make… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - June 7, 2016 Category: Pharmaceuticals Authors: Alexis Muellner Source Type: news
FDA clears Mauna Kea’s Cellvizio Confocal miniprobes
Mauna Kea (ENT:MKEA) said today it won 510(k) clearance from the FDA for its Confocal miniprobes designed for use with the company’s Cellvizio platform.
The newly-cleared Confocal miniprobes are indicated for use in urological and minimally invasive surgical applications along with the near-infared Cellvizio platform, Mauna Kea said. The company touted the regulatory win as its 12th in the U.S.
“This FDA clearance is another step forward in expanding the utility of the Cellvizio platform in minimally invasive surgery and urological applications. Our near-infrared imaging products are designed to provide a posi...
Source: Mass Device - May 25, 2016 Category: Medical Equipment Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Imaging Regulatory/Compliance Mauna Kea Technologies Source Type: news
