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.
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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
Boston Scientific wins UK NICE support for GreenLight laser therapy
Boston Scientific (NYSE:BSX) said Tuesday that the U.K.’s National Institute for Health and Care Excellence now provides guidance supporting the use of its GreenLight XPS laser therapy system used to treat prostatic enlargement in patients with benign prostatic hyperplasia.
NICE, which provides evidence-based guidance and standards to the U.K.’s National Health Service, said that adoption of the GreenLight XPS system to treat non high-risk patients with BPH can “significantly reduce costs for the NHS,” Marlborough, Mass.-based Boston Scientific said.
“The GreenLight XPS System is a well-estab...
Source: Mass Device - June 16, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Urology Boston Scientific Source Type: news
Duke cataract surgeon helps high-risk patient others turned down
Treatment Terms
Cataracts
Additional SEO Keywords
cataracts, cataract surgery, cataract surgeon,
SEO Meta Description
Duke Eye Center surgeon Dr. Alan Carlson, MD, adapts cataract surgery to restore vision of patient with life-threatening breathing problem.
Author
MaryAnn Fletcher
Overview
<p>For most people, <a href="/treatments/eye-care/cataracts">cataract surgery</a> is quick and relatively painless. You lie on your back, lightly sedated, while the surgeon uses a highly precise laser to remove the cloudy le...
Source: dukehealth.org: Duke Health News - June 15, 2016 Category: Consumer Health News Authors: mf205 at duke.edu Source Type: news
Cataract surgeon helps high-risk patient others turned down
Treatment Terms
Cataracts
Additional SEO Keywords
cataracts, cataract surgery, cataract surgeon,
SEO Meta Description
Duke Eye Center surgeon Dr. Alan Carlson, MD, adapts cataract surgery to restore vision of patient with life-threatening breathing problem.
Author
MaryAnn Fletcher
Overview
<p>For most people, <a href="/treatments/eye-care/cataracts">cataract surgery</a> is quick and relatively painless. You lie on your back, lightly sedated, while the surgeon uses a highly precise laser to remove the cloudy le...
Source: dukehealth.org: Duke Health News - June 15, 2016 Category: Consumer Health News Authors: mf205 at duke.edu Source Type: news
C-level exec leaves Laser Spine Institute post job cuts
The chief financial officer of Laser Spine Institute is leaving the Tampa-based medical firm.
Mark Andrzejewski has decided to pursue other interests, according to a LSI corporate statement. He will help support the company, including assisting during a transition, the statement said.
His departure comes a few days after LSI said it would reduce its global workforce by 6 percent. The company, which specializes in minimally invasive spine surgery, employs 1,200 people, 800 of them in Tampa.
It’s… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - June 10, 2016 Category: Biotechnology Authors: Margie Manning Source Type: news
C-level exec leaves Laser Spine Institute post job cuts
The chief financial officer of Laser Spine Institute is leaving the Tampa-based medical firm.
Mark Andrzejewski has decided to pursue other interests, according to a LSI corporate statement. He will help support the company, including assisting during a transition, the statement said.
His departure comes a few days after LSI said it would reduce its global workforce by 6 percent. The company, which specializes in minimally invasive spine surgery, employs 1,200 people, 800 of them in Tampa.
It’s… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - June 10, 2016 Category: Pharmaceuticals Authors: Margie Manning Source Type: news
FDA releases May 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD May 2016
TOTAL 510(k)s THIS PERIOD 213
TOTAL WITH SUMMARIES 205
TOTAL WITH STATEMENTS 8
May 2016 510(k) Clearances
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510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD May 2016
DEVICE: O-PEP
PARI RESPIRATORY EQUIPMENT, INC. 510(k) NO: K150044(Traditional)
ATTN: Michael Judge PHONE NO : 1 804 2537274
2412 PARI Way SE DECISION MADE: 27-MAY-16
Midlothian VA 23112 510(k) SUMMARY AVAILABLE FROM ...
Source: Mass Device - June 8, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
Considering laser eye surgery? New BLADELESS keyhole operation prevents risk of eye ‘flap’
A NEW type of laser eye surgery which involves a 2mm hole being created in the eye has now been tested on a patient. (Source: Daily Express - Health)
Source: Daily Express - Health - June 8, 2016 Category: Consumer Health News 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
6 Myths About Varicose Veins
SPECIAL FROM
Varicose veins, a vascular disease that causes swollen, twisted veins, affect up to 35 percent of the American population. They are usually found in the legs, but can appear elsewhere on the body. Also known as venous insufficiency, varicose veins occur when damaged veins have trouble sending blood from the legs to the heart.
There are a lot of myths out there about this condition. We talked to Kathleen Gibson, MD, vascular surgeon and vein specialist of Lake Washington Vascular, Bellevue, WA, to get the real deal:
Myth #1: Varicose veins are harmless.
Dr. Gibson: Varicose veins can be just a cosmetic i...
Source: Healthy Living - The Huffington Post - June 4, 2016 Category: Consumer Health News 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
Partnerships and the pursuit of innovation at large and small companies
Anne Sissel, managing director of Baxter Ventures and Adam Berman, CEO of TVA Medical, Inc. shared their perspectives on topics related to innovation and partnership between large, commercial organizations and small, venture-backed start-ups.
Anne E. Sissel, M.B.A., C.F.A. is managing director of Baxter Ventures and has been in that role since she joined the company in 2014. She previously served as a member of the founding team and vice president, head of finance and business development at Veracyte, Inc., a molecular diagnostics company. Prior to Veracyte, Anne was an investment banker with Goldman, Sachs & Co. and c...
Source: Mass Device - May 19, 2016 Category: Medical Equipment Authors: MassDevice Tags: Blog Baxter International TVA Medical Source Type: news
Performing cellular surgery with a laser-powered nanoblade
To study certain aspects of cells, researchers need the ability to take the innards out, manipulate them, and put them back. Options for this kind of work are limited, but researchers describe a 'nanoblade' that can slice through a cell's membrane to insert mitochondria. The researchers have previously used this technology to transfer other materials between cells and hope to commercialize the nanoblade for wider use in bioengineering. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - May 10, 2016 Category: Science Source Type: news
Femtosecond Laser Could Help in Challenging Cataract CasesFemtosecond Laser Could Help in Challenging Cataract Cases
Femtosecond laser-assisted surgery for cataract patients with shallow anterior chambers benefits both patients and surgeons, a new trial suggests. Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - May 9, 2016 Category: Consumer Health News Tags: Ophthalmology News 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
