Astigmatism
(Source: eMedicineHealth.com)
Source: eMedicineHealth.com - July 5, 2016 Category: Journals (General) 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
MassDevice.com +5 | The top 5 medtech stories for May 17, 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. Biostage unveils $5 million offering for organ regeneration tech
Organ regeneration specialist Biostage, formerly know as Harvard Apparatus Regenerative Technology, announced that it will offer $5 million worth of common stock ...
Source: Mass Device - May 17, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Staar Surgical wins Health Canada nod as shares hit 52-week low
Implantable contact lens maker Staar Surgical (NSDQ:STAA) said it earned Health Canada approval to sell its EVO Visian ICL in the country.
The device to correct myopia and astigmatism is permanently implanted between the iris and the eye’s natural lens. Staar sells 3 implantable lenses under its Visian franchise, but none are available in the U.S., according to the company’s website.
“We are very pleased with Health Canada’s approval that allows us to offer the EVO ICL for myopia, with a broad power range of -3.0 to -18.0 diopters, to our surgeons and their patients in Canada. This represents an i...
Source: Mass Device - May 17, 2016 Category: Medical Equipment Authors: Varun Saxena Tags: MassDevice Earnings Roundup Optical/Ophthalmic Regulatory/Compliance Wall Street Beat Source Type: news
FDA releases February 2016 510(k) clearances
February 2016 510(k) Clearances
510(k) summaries or 510(k) statements for final decisions rendered during the period February 2016.
TOTAL 510(k)s THIS PERIOD 224
TOTAL WITH SUMMARIES 213
TOTAL WITH STATEMENTS 11
February 2016 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD February 2016
DEVICE: ANI Monitor
MDOLORIS MEDICAL SYSTEMS SAS 510(k) NO: K142969(Traditional)
ATTN: MATHILDE COLLET PHONE NO : 011 333 62092081
6, RUE DU PR LAGUESSE SE DECISION MADE: 23-FEB-16
LILLE FR 59037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DBSWIN and VistaEasy Imaging Software
Durr Dental...
Source: Mass Device - April 5, 2016 Category: Medical Equipment Authors: MassDevice Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
Medtech approvals: FDA releases December 2015 PMAs
The Food & Drug Administration today released a list of pre-market approvals granted in December 2015:
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 81
Summary of PMA Originals Under Review
Total Under Review: 58
Total Active: 32
Total On Hold: 26
Summary of PMA Supplements Under Review
Total Under Review: 599
Total Active: 423
Total On Hold: 176
Summary of All PMA Submissions
Originals: 3
Supplements: 92
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 81
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 163.1
FDA Time: 140....
Source: Mass Device - February 2, 2016 Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
Medtech approvals: FDA releases October 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in October 2015:
Summary of PMA Originals & Supplements Approved
Originals: 9
Supplements: 133
Summary of PMA Originals Under Review
Total Under Review: 58
Total Active: 32
Total On Hold: 26
Summary of PMA Supplements Under Review
Total Under Review: 597
Total Active: 433
Total On Hold: 164
Summary of All PMA Submissions
Originals: 7
Supplements: 74
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 133
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 161.5
FDA Time: ...
Source: Mass Device - December 4, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
Health Tip: Managing Astigmatism
Title: Health Tip: Managing AstigmatismCategory: Health NewsCreated: 10/27/2015 12:00:00 AMLast Editorial Review: 10/27/2015 12:00:00 AM (Source: MedicineNet Eyesight General)
Source: MedicineNet Eyesight General - October 27, 2015 Category: Opthalmology Source Type: news
Medtech approvals: FDA releases May 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in May 2015:
Summary of PMA Originals & Supplements Approved
Originals: 5
Supplements: 51
Summary of PMA Originals Under Review
Total Under Review: 55
Total Active: 26
Total On Hold: 29
Summary of PMA Supplements Under Review
Total Under Review: 547
Total Active: 379
Total On Hold: 168
Summary of All PMA Submissions
Originals: 1
Supplements: 62
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 51
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 109.5
FDA Time: 86.4 D...
Source: Mass Device - August 6, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
Cataract Basics and Beyond: Why Treatments Are Now Better Than Ever
Kira Manusis, MD
Assistant Professor of Ophthalmology
Co-Director, Cataract, Cornea and Refractive Surgery
New York Eye and Ear Infirmary of Mount Sinai
__________________________
If you are fortunate to live long enough, you will probably develop a cataract, the leading cause of vision loss in the United States.
According to the National Eye Institute, more than half of all Americans develop a cataract by age 80. As our nation's senior population expands, the number of people aged 40 or older with cataracts is expected to double from 24.4 million to about 50 million by 2050.
Cataract Basics
A cataract is a clouding ...
Source: Healthy Living - The Huffington Post - June 10, 2015 Category: Consumer Health News Source Type: news
Consumer Information on: STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System - P930016S044
The STAR S4 IR Excimer Laser System (Laser System) and iDesign Advanced WaveScan Studio System (iDesign System) reduces or eliminates nearsightedness (myopia) and/or astigmatism. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 5, 2015 Category: Medical Equipment Source Type: news
Outcomes After Diffractive Multifocal Toric IOL ImplantationOutcomes After Diffractive Multifocal Toric IOL Implantation
An evaluation of this procedure finds good visual and refractive outcomes in patients with corneal astigmatism. The British Journal of Ophthalmology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - April 10, 2015 Category: Consumer Health News Tags: Ophthalmology Journal Article Source Type: news
Toric Lens May Improve Astigmatism After Cataract RemovalToric Lens May Improve Astigmatism After Cataract Removal
The toric intraocular lens also proved rotationally stable, but not everyone has found the data to be convincing. Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - January 27, 2015 Category: Consumer Health News Tags: Ophthalmology News Source Type: news
Pioneering plastic lens combats poor vision and cataracts
The lenses, offered at London’s Claremont Clinic for around £3,900 each, promise to restore vision to those plagued by failing eyesight as well as cataracts or astigmatism. (Source: the Mail online | Health)
Source: the Mail online | Health - December 22, 2014 Category: Consumer Health News Source Type: news
Revolutionary lens restores complete vision to ageing eyes
New implant improves vision for older people struggling with cataracts, astigmatism, or long and short-sightedness. (Source: Telegraph Health)
Source: Telegraph Health - December 22, 2014 Category: Consumer Health News Tags: lenses short sighted. vision. restore long sighted catarcts Source Type: news
