FDA Cracks Down on Surgical Staplers
After analyzing more than 41,000 adverse event reports logged between January 2011 and March 31, 2018, FDA found that the most commonly reported problems involve problems with surgical staplers and staples designed for internal use. The reports include an opening of the staple line or malformation of staples, misfiring, difficulty in firing, failure of the stapler to fire the staple, and misapplied staples (for example, the user may have applied staples to the wrong tissue or they may have applied staples of the wrong size to the tissue). Now, as part of the Medical Device Safety Action Plan, first revealed in April 2018, ...
Source: MDDI - April 24, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

Here ’ s what ’ s happening in OSEL to promote the innovation of newer, safer and more effective medical devices. https://www.youtube.com/watch?v=m-73PWZjIXI   … #FDA #MedicalDevice
Here’s what’s happening in OSEL to promote the innovation of newer, safer and more effective medical devices. https://www.youtube.com/watch?v=m-73PWZjIXI … #FDA #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 23, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Within CDRH ’ s Office of Science and Engineering Laboratories (OSEL) we have over 120 scientists and engineers who have a broad diversity of experience from microbiologists to experts in artificial intelligence. #FDA #MedicalDevice
Within CDRH’s Office of Science and Engineering Laboratories (OSEL) we have over 120 scientists and engineers who have a broad diversity of experience from microbiologists to experts in artificial intelligence. #FDA #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 23, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Providing patients with access to safe medical devices that meet their health care needs remains a top FDA priority. #FDA #MedicalDevice
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 23, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Did you know the @US_FDA ’ s Center for Devices and Radiological Health (CDRH) regulates over 190,000 medical devices including radiation emitting products and diagnostic tools on the US market? #FDA #MedicalDevice
Did you know the @US_FDA’s Center for Devices and Radiological Health (CDRH) regulates over 190,000 medical devices including radiation emitting products and diagnostic tools on the US market? #FDA #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 23, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Financing Paves Way for Rapid to Enter the U.S. Market
Rapid Medical said it has raised $20 million in a series C round to give its IDE trial a boost. The Yokneam, Israel-based company is developing minimally invasive stroke treatment and protection products. Rapid has been successfully enrolling patients in the TIGER IDE study in the U.S. since May of 2018. In addition, the proceeds will be used to develop a commercial presence in the U.S. ahead of regulatory approvals, expanding the company's sales and marketing efforts in Europe, as well as the development of additional innovative products. The financing round was led by JAM Capital Partners and MicroPort with participation...
Source: MDDI - April 23, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news

Could Secret Sales Bar Your Ability to Patent a Medical Device?
A recent Supreme Court decision could have a significant impact on medical device manufacturers. These companies must continue to exercise caution in engaging in confidential sales and offers with outside partners—such as in contracts for device prototype development or stockpiling of products—before filing patent applications. Medical device manufacturers should ideally file patent applications before entering into such agreements or, if not feasible, structure the agreements to reduce the risk of triggering the on-sale bar. These guidelines are based on the Helsinn Healthcare v. Teva P...
Source: MDDI - April 23, 2019 Category: Medical Devices Authors: Michelle Nyein and Michael J. Pomianek Tags: Regulatory and Compliance Source Type: news

There ’s a New Weight-Loss Device in Town and TPS Is Its Name
Earlier this year, MD+DI reported there were some significant changes occurring in the obesity treatment market. The latest change in the space is the addition of BAROnova’s weight-loss product to the U.S. market. The San Carlos, CA-based company won a nod from FDA TransPyloric Shuttle (TPS) device, a non-surgical obesity treatment technology for patients with a body mass index of 30 to 40kg/m2. BAROnova said the device is approved for up to one year of treatment, during which time patients undergo lifestyle modification counseling to help develop and maintain healthier habits. The TPS device is delivered...
Source: MDDI - April 23, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Today, we ’ ve announced actions to promote the safe use of surgical staplers and staples for internal use: proposed reclassification, draft guidance, and public panel meeting. Find more about these actions: https://go.usa.gov/xmBWr   #FDA #MedicalDevice
Today, we’ve announced actions to promote the safe use of surgical staplers and staples for internal use: proposed reclassification, draft guidance, and public panel meeting. Find more about these actions: https://go.usa.gov/xmBWr  #FDA #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 23, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

As part of the @US_FDA ’ s mission to protect the public health, last month, we alerted the public to concerns we identified regarding surgical staplers for internal use and implantable surgical staples.
As part of the @US_FDA’s mission to protect the public health, last month, we alerted the public to concerns we identified regarding surgical staplers for internal use and implantable surgical staples. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 23, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA permits marketing of first medical device for treatment of ADHD
The U.S. Food and Drug Administration permitted marketing of the first medical device to treat attention deficit hyperactivity disorder (ADHD). The prescription-only device, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, is indicated for patients ages 7 to12 years old who are not currently taking prescription ADHD medication and is the first non-drug treatment for ADHD granted marketing authorization by the FDA. (Source: World Pharma News)
Source: World Pharma News - April 23, 2019 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news

Haven ’t You Heard? Best Buy and Telehealth Are a Thing Now
Somewhere between laptops and the videogame section lies Best Buy’s latest commitment to healthcare. The retail giant – which has outlived many of its competitor, has formed a partnership with telemedicine specialist Tyto Care. Details of the partnership show that Best Buy will sell Israel based Tyto Care’s handheld examination device. The company said the TytoHome technology is now available exclusively on BestBuy.com for all customers and in select Minnesota Best Buy stores, with in-store availability coming soon in North Dakota, South Dakota, California and Ohio. Tyt...
Source: MDDI - April 23, 2019 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Business Source Type: news

FDA Drafts Guidance for Medical Devices Containing Nitinol
In March, FDA called for the public, scientists, and industry stakeholders to help the agency determine the current state of the science, critical gaps in the existing science, and what approaches should be considered to further the agency's understanding of medical device materials in order to improve the safety of devices for patients. The move is part of FDA's efforts to modernize its regulatory programs. Now the agency has released a new draft guidance focusing on medical devices containing the nickel-titanium alloy known as nitinol. As highlighted in the infographic above, the guidance proposes technical i...
Source: MDDI - April 22, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Materials Regulatory and Compliance Source Type: news

Surgical support software maker ExplORer raises $5M
ExplORer Surgical's platform offers support for providers  and medical device makers alike. (Source: mobihealthnews)
Source: mobihealthnews - April 22, 2019 Category: Information Technology Source Type: news

Monarch Becomes the 1st FDA-Cleared Device for ADHD
The Monarch external Trigeminal Nerve Stimulation (eTNS) System made history last week after it became the first device to win a nod from FDA to treat attention deficit hyperactivity disorder (ADHD). It should be noted the technology has had CE mark since 2015. Monarch was developed by NeuroSigma and is indicated to help treat 7 to 12-year-olds suffering from ADHD. What makes this de novo clearance from FDA so significant is that typically pharmaceutical solutions are used to treat patients suffering from the neurological disorder. Monarch is about the size of a cellphone. The device generates a low-level electrical pulse ...
Source: MDDI - April 22, 2019 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Source Type: news

FDA Approves First Medical Device To Treat ADHD In Children
(CNN) — The first medical device to treat childhood attention deficit hyperactivity disorder, or ADHD, was OK’d Friday by the US Food and Drug Administration. Designated for children ages 7 to 12 who are not currently on medication for the disorder, the device delivers a low-level electrical pulse to the parts of the brain responsible for ADHD symptoms. “This new device offers a safe, non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind,” Carlos Peña, director of the Division of Neurological and Physical Medicine Devices in...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - April 22, 2019 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News CNN ADHD Source Type: news

In the money April 22: More than $18M in deals for medical devices, space tech & more
The companies announcing new funding rounds and filing paperwork with the SEC included a company that is starting to gain traction for its tendon-fixing medical device and a startup that helps guide other businesses through space. (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 22, 2019 Category: Biotechnology Authors: Mike Cronin Source Type: news

FDA Approves Marketing of First Device to Treat ADHD
MONDAY, April 22, 2019 -- Marketing has been approved for the first medical device to treat attention-deficit/hyperactivity disorder (ADHD), the U.S. Food and Drug Administration announced Friday. The Monarch external Trigeminal Nerve Stimulation... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 22, 2019 Category: Pharmaceuticals Source Type: news

Health Highlights: April 22, 2019
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: FDA Approves First Device to Treat Children With ADHD The first medical device to treat children with attention-deficit/hyperactivity disorder... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - April 22, 2019 Category: General Medicine Source Type: news

CMS: Medicare Program; Update to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items That Require Prior Authorization as a Condition of Payment
Notice from the Centers for Medicare and Medicaid Services announcing the addition of 12 codes to the Healthcare Common Procedure Coding System (HCPCS) Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items that require prior authorization as a condition of payment. Implementation of Phase 1 of this rule will be effective on July 22, 2019 and Phase 2 will be effective on October 21, 2019. (Source: Federal Register updates via the Rural Assistance Center)
Source: Federal Register updates via the Rural Assistance Center - April 22, 2019 Category: Rural Health Source Type: news

CMS: Medicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items; Update to the Master List of Items Frequently Subject to Unnecessary Utilization
Notice from the Centers for Medicare and Medicaid Services adding four codes to the Healthcare Common Procedure Coding Systems (HCPCS) Master List of Items Frequently Subject to Unnecessary Utilization that could potentially be subject to prior authorization as a condition of payment. The rule is effective on May 22, 2019. (Source: Federal Register updates via the Rural Assistance Center)
Source: Federal Register updates via the Rural Assistance Center - April 22, 2019 Category: Rural Health Source Type: news

FDA OKs first medical device to treat ADHD in children
The first medical device to treat attention deficit hyperactivity disorder, or ADHD, was approved Friday by the Food and Drug Administration. Instead of medication, the device delivers a low-level electrical stimulation to the parts of the brain that regulate emotion, behavior and attention. (Source: CNN.com - Health)
Source: CNN.com - Health - April 20, 2019 Category: Consumer Health News Source Type: news

Can You Help ASCs Access the Latest Medtech Advances?
Ambulatory surgery centers (ASCs) are helping healthcare payers reduce costs and improve patient outcomes, Scott Leggett, CEO of Surgery One LLC, an ASC management company that works with outpatient surgical centers, told MD+DI. Outpatient surgical centers are quick to adopt new medical device technologies, he said, but they do have some tech needs that medical device manufacturers could help address. ASCs are poised for “huge” growth, Leggett predicted. “Any procedures now being done in hospitals for qualified outpatient candidates are being encouraged to be performed ...
Source: MDDI - April 20, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Business Source Type: news

FDA permits marketing of first medical device for treatment of ADHD
(Source: Food and Drug Administration)
Source: Food and Drug Administration - April 20, 2019 Category: American Health Source Type: news

The Time for AI-Based Medical Device Regulation Is Now
Artificial Intelligence (AI) and Machine Learning (ML) are poised to revolutionize the field of healthcare. Researchers are leveraging deep learning methods to find new ways to efficiently diagnose and treat diseases.  Although lacking a well-articulated AI strategy, the United States invested an estimated $2 billion on research and development for AI-based technologies in 2017. Since that time, the Department of Defense has also committed to providing up to an additional $2 billion per year in spending for AI technology and infrastructure over the next five years. Despite such investmen...
Source: MDDI - April 19, 2019 Category: Medical Devices Authors: Aaron Gin and Bryan Helwig Tags: Regulatory and Compliance Software Source Type: news

Intuitive Falls Short of Expectations in 1Q19
Intuitive Surgical’s momentum was dulled a bit last week when the surgical robotics company missed Wall Street expectations for 1Q19. The miss caused shares of the Sunnyvale, CA-based company to drop by about 6.2%. Intuitive’s revenue came in at about $973.7 million for the quarter, with analysts forecasting $980 million in 1Q19 sales. The company also posted earnings of $2.61 per share, on an adjusted basis. Earnings grew 7% but decelerated from 20% growth in the fourth quarter. The earnings also lagged the consensus of analysts polled by analysts for $2.70. One of the companyâ...
Source: MDDI - April 19, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Finally, a Wearable Neuromodulation Device for Overactive Bladder
As a urogynecology surgeon, Alexandra Haessler, MD, has seen firsthand the limitations of current overactive bladder (OAB) therapies. Aside from medication, the current gold standard for OAB is Medtronic's InterStim, an implantable sacral neuromodulation device that is FDA approved for the treatment of OAB as well as chronic fecal incontinence, and non-obstructive urinary retention. Haessler told MD+DI that the InterStim device works very well but it's an expensive treatment and access is limited because only a few subspecialists in any one metropolitan area are truly qualified to deliver the therapy. The InterStim is not ...
Source: MDDI - April 19, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

No More Patent Drama Between Neovasc and Edwards?
The mitral valve patent dispute between Neovasc and Edwards Lifesciences’ CardiAQ subsidiary has been settled. Vancouver-based Neovasc said it had resolved the three claims of correction of patent inventorship made by Edwards Lifesciences. These patents are related to the Tiara, a self-expanding mitral bioprosthesis specifically designed to treat mitral valve regurgitation. For reasons of efficiency and economy, and without reaching the merits of the dispute, the parties agreed to a judgment ordering CardiAQ's Jeremy Brent Ratz and Arshad Quadri be added as co-inventors of U.S. Patent No. 9,241,790, U.S. ...
Source: MDDI - April 19, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

AngioDynamics to Divest its Fluid Management Portfolio
AngioDynamics said it is selling its Namic fluid management portfolio to Medline Industries for about $167.5 million. Additionally, AngioDynamics’ primary Glens Falls, New York manufacturing facility, including all related manufacturing jobs and the sales & marketing teams that support the NAMIC business, will be acquired by Medline as part of the transaction. Upon completion of the transaction, Latham, NY -based AngioDynamics said it intends to use the net cash proceeds of about $160 million to pay down all outstanding debt. The cash balance of nearly $74 million will be used to support strategic inv...
Source: MDDI - April 19, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

4 Medtech Innovations That Are Tearing up the Script
Decision Resources Group (DRG) released a new report today, "4 Crazy Medtech Innovations" that identifies four areas of medtech innovation that are forecasted to shake up the treatment landscape within the next five years. "The reason we decided to look at crazy innovation in medtech was that a few people on our consulting team were doing that and to help them out we decided to do a scan talking to our different data experts, therapy experts, [to learn] what have people seen that's actually crazy innovation," Lexie Code, director of medtech learning at DRG, told MD+DI. After gathering intel from each of...
Source: MDDI - April 18, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

10 Deals That Shook up the Diagnostics Industry
(Source: MDDI)
Source: MDDI - April 18, 2019 Category: Medical Devices Authors: Omar Ford Tags: IVD Business Source Type: news

Supplier Stories for the Week of April 14
(Source: MDDI)
Source: MDDI - April 18, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Molding Source Type: news

Vaginal Mesh Is Just One of Boston Scientific & #039;s Headaches This Year
Boston Scientific expects to take a $25 million revenue hit after FDA ordered two of its surgical mesh products off the market this week, the company disclosed in an SEC filing. Unfortunately, that's not the only revenue headwind the company has to worry about this year. Boston Scientific is one of about a handful of companies that develop paclitaxel drug-coated balloons and drug-coated stents. Paclitaxel devices received some bad press in January after a meta-analysis showed an increased risk of death for patients treated with these devices in the femoral and/or popliteal arteries of the lower limbs. Two drug-...
Source: MDDI - April 18, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Regulatory and Compliance Source Type: news

Massachusetts Medical Device Development Center announces $200K Challenge winners
(University of Massachusetts Lowell) Entrepreneurs developing new technologies to treat blood clots, congestive heart failure, incontinence and more were the big winners at the Massachusetts Medical Device Development Center $200,000 Challenge, an annual pitch competition that showcases cutting-edge innovations in the medical-device and biotech fields. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - April 18, 2019 Category: International Medicine & Public Health Source Type: news

United Therapeutics sued by generic drug competitors
United Therapeutics Corp. has been sued for “unlawfully impeding competition” by Sandoz Inc. and RareGen LLC, the companies selling a generic form of a drug the Silver Spring biotech had under patent until last month. The lawsuit, filed April 16 in U.S. District Court for the District of New Jersey, alleges that United Therapeutics (NASD AQ: UTHR) placed restrictions on cartridges made by medical device manufacturer Smiths Medical ASD Inc. that are required to administer subcutaneous injections… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - April 18, 2019 Category: American Health Authors: Sara Gilgore Source Type: news

United Therapeutics sued by generic drug competitors
United Therapeutics Corp. has been sued for “unlawfully impeding competition” by Sandoz Inc. and RareGen LLC, the companies selling a generic form of a drug the Silver Spring biotech had under patent until last month. The lawsuit, filed April 16 in U.S. District Court for the District of New Jersey, alleges that United Therapeutics (NASD AQ: UTHR) placed restrictions on cartridges made by medical device manufacturer Smiths Medical ASD Inc. that are required to administer subcutaneous injections… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 18, 2019 Category: Biotechnology Authors: Sara Gilgore Source Type: news

Abbott Has Midas Touch with Its 1Q19 Earnings
Abbott Laboratories is off to a solid start in 2019 if its most recent earnings are any indication. The Abbott Park, IL-based company reported earnings that topped its own forecast. The firm posted first-quarter earnings from continuing operations of 63 cents per share, above the 61 cents expected by analysts, on $7.5 billion in sales. "We're right on track with our expectations to start the year," said Miles White, chairman and CEO, Abbott, said in a release. "All of our key long-term growth drivers are performing well and we're targeting another year of strong sales and earnings growth." Join us for N...
Source: MDDI - April 17, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Smooth or Textured: A Lesson in Biocompatibility
The objective of the textured surface is to limit movement and reduce the formation of overly tight scar tissue. It is noteworthy here that the function of the textured surface depends on its ability to alter tissue response. Yet this can lead to inconsistent thinking in which positive effects of surface changes are touted while negative effects are denied. Unfortunately, textured surfaces on breast implants have also been linked to the development of Anaplastic Large Cell Lymphoma (ALCL), an adverse effect beyond any associated just with the long-term presence of silicone. FDA has noted that factors influencing ALCL inclu...
Source: MDDI - April 17, 2019 Category: Medical Devices Authors: William A. Hyman Tags: Materials Source Type: news

One More Sign Best Buy Is Serious About Digital Health Business
Best Buy, seeking to remain relevant in the age of Amazon, is the first U.S. retailer to sell exclusively TytoHome medical device kit made by telehealth startup Tyco Care. Consumers can do different medical tests and connect with physicians live for diagnosis. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - April 17, 2019 Category: Pharmaceuticals Authors: Andria Cheng, Contributor Source Type: news

Best Buy Continues To Bet On Digital Health With New TytoHome Deal
Best Buy is the first U.S. retailer to exclusively sell the TytoHome medical device kit made by telehealth startup Tyco Care. Consumers can conduct different medical tests and connect with physicians live for diagnosis. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - April 17, 2019 Category: Pharmaceuticals Authors: Andria Cheng, Contributor Source Type: news

Learning to Walk Again
When someone suffers a stroke, he or she often loses some mobility, and some 60 percent of survivors are left with lower-limb deficits. “They usually have one leg that's more impaired than the other leg, and then they undergo rehabilitation and physical therapy. And often they don't fully recover,” said Conor Walsh, professor of engineering and applied sciences at the John A. Paulson Harvard School of Engineering and Applied Sciences and a core faculty member at the Wyss Institute for Biologically Inspired Engineering, in an interview with MD+DI. But a new device called ReSto...
Source: MDDI - April 17, 2019 Category: Medical Devices Authors: Susan Shepard Tags: Design Source Type: news

FDA Flips the Switch on Pelvic Mesh Manufacturers
After years of controversy surrounding the use of surgical mesh for transvaginal repair of pelvic organ prolapse (POP), FDA has ordered Boston Scientific and Coloplast to stop selling the mesh on the U.S. market immediately. The agency said the manufacturers have not demonstrated a reasonable assurance of safety and effectiveness for these devices, which is the premarket review standard that now applies to them since FDA decided they were high risk in 2016. “In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of ...
Source: MDDI - April 17, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

F.D.A. Halts U.S. Sales of Pelvic Mesh, Citing Safety Concerns for Women
Boston Scientific and Coloplast were the last two companies selling the medical devices, which have resulted in nearly $8 billion in settlements. (Source: NYT Health)
Source: NYT Health - April 17, 2019 Category: Consumer Health News Authors: SHEILA KAPLAN and MATTHEW GOLDSTEIN Tags: Pelvis Medical Devices Women and Girls Surgery and Surgeons Boston Scientific Corporation Food and Drug Administration Coloplast Corp. transvaginal mesh your-feed-science pelvic organ prolapse Source Type: news

FDA To Boston Scientific: Stop Selling Pelvic Mesh Tied To Injuries In Women
WASHINGTON (AP) — U.S. health regulators on Tuesday halted sales of a type of surgical mesh used to repair pelvic conditions in women, following years of patients’ reports of injuries and complications from the implants. The Food and Drug Administration ordered the two remaining makers of the mesh — Boston Scientific and Coloplast — to stop selling it immediately, saying the companies failed to show the mesh is safe for long-term use. Several other major manufacturers, including Johnson & Johnson, previously stopped making the mesh. The FDA action does not apply to surgical mesh used to treat ot...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - April 16, 2019 Category: Consumer Health News Authors: Health – CBS Boston Tags: Boston News Health Boston Scientific FDA Source Type: news

If you were planning to have mesh placed transvaginally for the repair of pelvic organ prolapse, discuss other treatment options with your doctor and check out the #FDA's order: https://go.usa.gov/xmb5F   #FDA #MedicalDevice
If you were planning to have mesh placed transvaginally for the repair of pelvic organ prolapse, discuss other treatment options with your doctor and check out the #FDA's order: https://go.usa.gov/xmb5F  #FDA #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 16, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

There is no need to take additional action if you are satisfied with your surgery and are not having any complications or symptoms. #FDA #MedicalDevice
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 16, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Women who have received transvaginal mesh for the surgical repair of pelvic organ prolapse should continue with their annual and other routine check-ups and follow-up care. #FDA #MedicalDevice
Women who have received transvaginal mesh for the surgical repair of pelvic organ prolapse should continue with their annual and other routine check-ups and follow-up care. #FDA #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 16, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The companies will have 10 days to submit their plans to withdraw these products from the market to the #FDA. #MedicalDevice
The companies will have 10 days to submit their plans to withdraw these products from the market to the #FDA. #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 16, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The #FDA has determined that the manufacturers have not demonstrated reasonable assurance of safety and effectiveness for these devices since the agency reclassified them in class III (high risk). #MedicalDevice
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 16, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today the @US_FDA ordered manufacturers of mesh products on the market for the transvaginal repair of pelvic organ prolapse to stop selling and distributing their products immediately.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 16, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news