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Total 6373 results found since Jan 2013.

Black History Month: Five Questions With the U.S. Surgeon General
(MedPage Today) -- Jerome Adams, MD, MPH, discusses role models, improving care for African-Americans
Source: MedPage Today Public Health - February 25, 2019 Category: American Health Source Type: news

Mayo Clinic Minute: Avoiding overuse wrist injuries
It may seem hard to believe, considering that you use your hands and wrists to do almost everything, but some of the most common wrist injuries are caused by overuse and repetitive motion. Dr. Sanj Kakar, a Mayo Clinic orthopedic hand and wrist surgeon, says you have to get creative to avoid overuse injuries from [...]
Source: News from Mayo Clinic - February 25, 2019 Category: Databases & Libraries Source Type: news

Mass. judge sides with Amazon-backed startup in Optum lawsuit over employee
A federal judge has ruled that a new Amazon-backed health care startup should not be blocked from hiring an employee from Optum, asking the sides to come to a resolution in arbitration. Optum, a subsidiary of national health insurance giant UnitedHealth Group (NYSE: UNH), in January sued the health care venture over the hiring of former Optum employee David William Smith. The venture is headed by Brigham and Women's surgeon Atul Gawande and backed by Amazon (Nasdaq: AMZN), Berksh ire Hathaway and…
Source: bizjournals.com Health Care:Biotechnology headlines - February 22, 2019 Category: Biotechnology Authors: Jessica Bartlett Source Type: news

Guide to chronic wound treatment methods
  A wound becomes chronic when it fails to progress through the normal healing stages. According to Wound Source, if the wound doesn’t show significant signs of healing within 30 days, doctors should begin treating it as a chronic wound. In the event that a wound becomes chronic, doctors may prescribe one or more of the following treatment methods: Some chronic wounds require surgery to promote healing. Cleansing Chronic wounds require careful attention and cautious yet frequent cleansing between dressing changes to promote healing. The exact steps will vary depending on the wound. For instance, according t...
Source: Advanced Tissue - February 22, 2019 Category: Dermatology Authors: AdvancedTissue Tags: Wound Care Wound healing chronic wounds healing wounds Source Type: news

Could Better Post-Acute-Care Communication Impact Medtech?
Surgeons often struggle to follow up on patients after procedures, given the healthcare handovers that usually occur from hospitals to skilled nursing facilities, rehabilitation centers, or home health providers. Ben Forrest, who spent the last 5 years at Stryker working with surgeon customers, is well aware of such challenges. “Surgeons are discharging multiple patients to multiple post-acute-care companies and entities,” he told MD+DI. “There is very little now currently in place for collaboration between the acute team and the post-acute team. Hospitals have had to b...
Source: MDDI - February 21, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Software Source Type: news

NuVasive shares rise on Q4, 2018 EPS beat
Shares in NuVasive Inc. (NSDQ:NUVA) have risen slightly today after the medical device maker beat earnings per share expectations on Wall Street with its fourth quarter and full year 2018 earnings report. The San Diego-based company posted profits of approximately $12.2 million, or 23¢ per share, on sales of $288.3 million for the three months ended December 31, seeing profits shrink 48.2% while sales grew 6.3% compared with the same period during the previous year. After adjusting to exclude one-time items, earnings per share were 69¢, just ahead of the 63¢ consensus on Wall Street where analysts expected to see sales...
Source: Mass Device - February 21, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured MassDevice Earnings Roundup Wall Street Beat Nuvasive Source Type: news

Malawi: Malawi Hospital Carries Out Its First Successful Brain Surgery
[This is Africa] Malawian Dr Ken-Keller Kumwenda and a team of local doctors, nurses and anaesthetists have carried out that hospitals first ever brain tumour surgery. However, as the country does not meet the recommended surgeon ratio, does this present a career opportunity for the country's youth?
Source: AllAfrica News: Health and Medicine - February 21, 2019 Category: African Health Source Type: news

Hospital for Special Surgery Sports Medicine Research Fellowship 2019-20 with Dr. Ben Nwachukwu
Dr. Ben Nwachukwu is seeking bright, an ambitious medical student (years 2-4) who is interested in pursuing a year-long clinical research fellowship. Dr. Nwachukwu will be starting as an attending surgeon in the Department of Sports Medicine at the Hospital for Special Surgery (HSS) and in that role he will the Co-Director of Clinical Research for the Division. Dr Nwachukwu’s research fellow will work closely with residents, fellows, and faculty at HSS. The Research Fellow will have extensive opportunities for publication and presentation of research at national and international conferences.
Source: Orthogate - Latest News - February 20, 2019 Category: Orthopaedics Tags: Featured Job Opportunities News Source Type: news

UAB School of Dentistry completes renovations
Renovations to the UAB School of Dentistry Comprehensive Care Clinic have been completed and the building is open for patient care.   The multidisciplinary clinic, also known as the General Dentistry Clinic, is where third- and fourth-year students will provide general, cosmetic and operative dentistry services to patients.  “Investing in cutting-edge renovations to our patient clinic is a testament to our commitment of pr oviding unmatched care for our patients, as well as serving as a leading…
Source: bizjournals.com Health Care News Headlines - February 19, 2019 Category: Health Management Authors: Tyler Patchen Source Type: news

iHRIS Software Powers New Registry of Clinical Volunteers for Medical Missions
February 19, 2019TheG4 Alliance and the US Section of theInternational College of Surgeons (ICS) have launched a new registry to connect medical volunteers to international medical missions. IntraHealth International developed theSOTA Registry (which stands for surgical, obstetric, trauma, and anesthesia) using our open sourceiHRIS software.The SOTA Registry will serve as a hub for information on clinical volunteers from the surgical, obstetric, trauma, and anesthesia communities who are interested in short-term assignments in low- and middle-income countries. IntraHealth maintains the registry in a cloud-based environment...
Source: IntraHealth International - February 19, 2019 Category: International Medicine & Public Health Authors: cbishopp Tags: Digital Health HRIS Source Type: news

Single vs Multiport Lap Colectomy: Only Benefit Cosmetic? Single vs Multiport Lap Colectomy: Only Benefit Cosmetic?
Dr Lowenfels comments on a study that compares the outcomes of single-incision and multiport laparoscopy for colonic surgery.Medscape General Surgery
Source: Medscape Today Headlines - February 19, 2019 Category: Consumer Health News Tags: General Surgery Viewpoint Source Type: news

'Just like Iron Man': Calgary surgeon undergoes experimental spinal surgery
Dr. Richi Gill, who helped develop Calgary's bariatric surgery program, was involved in a freak accident on a boogie board during a family vacation in Hawaii one year ago.
Source: CBC | Health - February 18, 2019 Category: Consumer Health News Tags: News/Canada/Calgary Source Type: news

Innovasive rebrands as Amplify Surgical
Spinal device manufacturer Innovasive said yesterday that it is rebranding under the moniker Amplify Surgical. The Mission Viejo, Calif.-based company began the name change in January and said that it expects the rebranding process to continue through the end of the first quarter. “The Amplify Surgical name better emphasizes our commitment to delivering new, cutting-edge, surgical solutions that reestablish the standard of care for our surgeon customers and their patients. In addition, the new name and brand better represents the Company’s inventive culture and product pipeline,” CEO Andy Choi said in a press...
Source: Mass Device - February 15, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Spinal amplifysurgical Source Type: news

FDA goes after California stem cell doc for unapproved breast implant device
The FDA this week sent a warning letter to a Beverly Hills, Calif.-based surgeon for their marketing of an unapproved implantable device, dubbed the Pocket Protector, which the surgeon claims can prevent and treat capsular contracture, or scar tissue tightening, during breast implant procedures. In its letter, the federal watchdog also accuses the surgeon, Dr. Mark Berman, of “significant deviations from the FDA’s quality system requirements and current good manufacturing practices,” including charges related to the sterility of implantable devices. “This is not the first time the FDA has notified D...
Source: Mass Device - February 15, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cosmetic/Aesthetic Featured Food & Drug Administration (FDA) Stem Cells Source Type: news

New type of wound dressing shocks patients
  While Wound Source estimated that there are over 6,000 types of wound care dressings, the steep number doesn’t stop researchers from testing products for more advanced dressings. Engineers at the University of Wisconsin-Madison recently developed a new low-cost wound dressing designed to accelerate wound healing. Here are the details on this innovative wound dressing: How does this wound dressing work? While electricity can be beneficial for skin healing, most electrotherapy products require bulky equipment and complex wiring. This new dressing leverages the power of electrical pulses for healing, but is in ...
Source: Advanced Tissue - February 14, 2019 Category: Dermatology Authors: AdvancedTissue Tags: Wound care products wound dressings Source Type: news

Titan Medical hopeful for Q4 FDA IDE trial launch for Sport robotic platform
Robotic surgical platform developer Titan Medical (NSDQ:TMDI) said late yesterday that it is hoping to launch an FDA investigational device exemption trial of its Sport robotic surgery platform by the fourth quarter of this year. The news came as part of the Toronto-based company’s 2018 earnings report, with the robotic surgical company saying that it is hopeful it will finish verification and validation testing followed by design freeze and animal and cadaver studies to support regulatory clearance filings during the first half of 2019. Following that testing, Titan Medical said it hopes to submit an IDE study applica...
Source: Mass Device - February 14, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Clinical Trials Featured Robotics Surgical Titan Medical Inc. Source Type: news

The incredible precision of a heart transplant surgeon
Yale surgeon Dr. Ayyaz Ali is not only transplanting hearts, he is researching ways to make more donor hearts suitable for the patients who need them.
Source: Yale Science and Health News - February 14, 2019 Category: Universities & Medical Training Source Type: news

Is J & amp;J Becoming a Surgical Robotics Powerhouse?
Johnson & Johnson is making some significant noise in the surgical robotics space today as it is announcing a deal that would have it acquire Auris Health for $3.4 billion. The deal also calls for additional contingent payments of up to $2.35 billion in the event of Auris reaching certain milestones. J&J would make the acquisition through its Ethicon subsidiary. Redwood City, CA-based Auris Health develops robotic technologies that have been focused on lung cancer. The firm has the Monarch Platform, an FDA cleared system currently used in bronchoscopic diagnostic and therapeutic procedures. In November of 2018, Aur...
Source: MDDI - February 14, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Digital Health Source Type: news

Eating ‘ Ultraprocessed ’ Foods May Shorten Your Life, Study Says
(CNN) — The quick and easy noshes you love are chipping away at your mortality one nibble at a time, according to new research from France: We face a 14% higher risk of early death with each 10% increase in the amount of ultraprocessed foods we eat. “Ultraprocessed foods are manufactured industrially from multiple ingredients that usually include additives used for technological and/or cosmetic purposes,” wrote the authors of the study, published Monday in the journal JAMA Internal Medicine. “Ultraprocessed foods are mostly consumed in the form of snacks, desserts, or ready-to-eat or -heat meals,...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - February 13, 2019 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News CNN processed foods Source Type: news

U.S. Surgeon General Vows to Fight for Rural America
U.S. Surgeon General Jerome Adams, M.D., spoke to physicians and others at the Rural Health Policy Institute about the opioid epidemic and social determinants of health.
Source: AAFP News - February 13, 2019 Category: Primary Care Source Type: news

IBM Watson Health announces slew of AI-based research partnership deals
IBM Watson Health today announced a number of new partnership deals, including an expanded collaborative deal with the Broad Institute of MIT and Harvard and 10-year, $50 million collaborative research deals with the Brigham and Women’s Hospital and the Vanderbilt University Medical Center. The Cambridge, Mass.-based IBM division said that it inked an extended partnership with the Broad Institute looking to analyze and explore genomics data to better understand the intrinsic possibility individuals have for a certain disease. The newly inked initiative aims to incorporate population-based and hospital-based biobank ...
Source: Mass Device - February 13, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Software / IT IBM Watson Health Source Type: news

J & J to enter the robotic surgery market with $3.4B Auris Health buy
Johnson & Johnson (NYSE:JNJ) is stepping into the field of robotic surgery after saying today that its Ethicon subsidiary inked a $3.4 billion deal to pick up surgical robotics pioneer Dr. Fred Moll’s newest robotic surgical play, Auris Health, and its FDA-cleared Monarch platform. The New Brunswick, N.J.-based medtech giant said that the deal will include an additional $2.35 billion in milestone-based contingent payments, bringing the total value of the deal to approximately $5.75 billion. Redwood City, Calif.-based Auris Health’s robotic Monarch platform has FDA clearance for diagnostic and therapeutic bron...
Source: Mass Device - February 13, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Mergers & Acquisitions Robotics Wall Street Beat aurishealth johnsonandjohnson Source Type: news

AtriCure launches CryoIce CryoSphere probe
AtriCure (NSDQ:ATRC) today launched its CryoIce CryoSphere probe in the U.S. The Mason, Ohio-based company’s CryoSphere probe is designed to block pain by temporarily ablating peripheral nerves. The device features a bendable distal shaft and an ergonomic handle that enables cardiac, thoracic and general surgeons to easily target peripheral nerves. ArtiCure’s CryoSphere technology uses a freezing method to stop nerves from sending pain signals for several months, giving the patient’s body time to heal. “The addition of the CryoSphere probe to our pain management portfolio is a major breakthrough in...
Source: Mass Device - February 12, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Featured Pain Management Wall Street Beat AtriCure Inc. Source Type: news

Clarify Medical wins CMS reimbursement for phototherapy psoriasis treatment
Clarify Medical said today that it won reimbursement coverage through the U.S. Centers for Medicare & Medicaid Services for treatments with its Clarify Home light therapy system for treating psoriasis, effective immediately. The new decision from CMS falls under its National Coverage Determination for the treatment of psoriasis, which includes narrowband ultraviolet B phototherapy, San Diego-based Clarify Medical said. The company’s Clarify system uses narrowband ultraviolet B rays to penetrate the skin and slow the growth of affected skin cells. Studies have found that narrowband UVB rays help to clear psoriasis fas...
Source: Mass Device - February 12, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cosmetic/Aesthetic Clarify Medical Source Type: news

Worried about heart health? Yale Medicine expert has answers
Yale ’s new cardiac surgeon explains what patients need to know about cardiac surgery and keeping their hearts healthy.
Source: Yale Science and Health News - February 12, 2019 Category: Universities & Medical Training Source Type: news

Mercy Health scores team doctor deal with FC Cincinnati
Mercy Health is now providing team doctors to FC Cincinnati as part of a multiyear deal with the club, which transitioned to Major League Soccer this spring. Dr. Matthew Busam, an orthopedic surgeon and sports medicine expert, was named today as chief medical officer of FC Cincinnati. He has been a team physician for the Cincinnati Bengals and Elder High School. As official medical provider to FCC, Mercy Health will also designate a primary care sport s medicine physician, athletic trainers, physical…
Source: bizjournals.com Health Care:Physician Practices headlines - February 12, 2019 Category: American Health Authors: Barrett J. Brunsman Source Type: news

App Seeks to Ease Orthopedic Surgery Planning
A new solution for orthopedic surgery planning is now available through Siemens Healthineers Digital Ecosystem, an online platform that gives healthcare providers access to applications that can help “digitalize” healthcare. “Siemens Healthineers has created an OpenApp Store to share a new way to organize and discover apps from Siemens Healthineers and other vendors – directly on the syngo.via. The store enables [users] to browse, download, and test apps as well as request quotations. mediCAD Hectec with its software solution is one of the first partne...
Source: MDDI - February 12, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Digital Health Source Type: news

Science Saturday: The heart of art
This image is not a medical illustration. It's actually an enhanced CT scan that is as aesthetic as it is instructive. The patient had previously undergone coronary artery bypass surgery. You can see the connection points of the grafts to the aorta. Clips and wires used by the surgeon are also visible. The bypass grafts [...]
Source: News from Mayo Clinic - February 9, 2019 Category: Databases & Libraries Source Type: news

Orthofix wins FDA PMA nod for M6-C artificial cervical disc
Orthofix (NSDQ:OFIX) said yesterday that it won FDA approval for its M6-C artificial cervical disc, intended for treating patients suffering from cervical disc degeneration. The Lewisville, Texas-based company said that the M6-C artificial cervical disc was developed by Spinal Kinetics, which it acquired last April. The newly cleared M6-C is a next-gen artificial disc intended to replace an intervertebral disc damaged by cervical disc degeneration. The system is designed to restore physiological motion to the spine and is indicated as an alternative to cervical fusion, Orthofix said. Pre-market approval of the device cam...
Source: Mass Device - February 8, 2019 Category: Medical Devices Authors: Fink Densford Tags: Featured Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Spinal Orthofix Source Type: news

UPDATED: Cook Medical to pay $3m in damages in IVC bellwether
Updated to include a response from Cook Medical A federal jury in Indiana last week awarded $3 million in damages to a plaintiff in a bellwether case against Cook Medical over allegedly defective designs in the company’s Celect inferior vena cava filters. The plaintiff, Tonya Brand, sued Cook in 2014 alleging that the Celect IVC filter implanted prior to a spinal procedure fragmented and sent broken pieces into her thigh and near her spine. In her suit, Brand included claims for stricter liability and negligent failure to warn, negligent design defect, negligent manufacturing, negligence per se, breach of warranty, loss...
Source: Mass Device - February 7, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Catheters Featured Legal News Cook Medical Source Type: news

FDA files motion to delay Endo litigation, again
Endo International said Thursday it will not oppose a request by the Food and Drug Administration for a further stay through March 15 of the company's ongoing litigation against the federal agency.   The litigation challenges the FDA's process for allowing the bulk compounding of certain drugs, including vasopressin, that have not satisfied the legal requirements of the Drug Quality and Security Act amendments to the Federal Food, Drug, and Cosmetic Act.  One of Endo's subsidiaries, Par St erile…
Source: bizjournals.com Health Care:Pharmaceuticals headlines - February 7, 2019 Category: Pharmaceuticals Authors: John George Source Type: news

Do You Have What It Takes to Become the Next Intuitive Surgical?
Intuitive Surgical set a high bar for new entrants. But there are opportunities today that new surgical robotics companies can take advantage of that Intuitive didn't have when the company started out more than two decades ago. A panel of experts spoke at MD&M West in Anaheim, CA this week about the process of developing medical robotic tools and the valuable lessons learned from watching Intuitive rise to the top. "In the year 2000, if Intuitive Surgical walked into a room and said 'we're going to be worth $60 billion in 20 years' nobody on the planet would have believed them. Nobody," said Leo Petrossian,...
Source: MDDI - February 7, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: R & D Source Type: news

Romania detains Italian man who posed as plastic surgeon
Romanian police have detained an Italian man who allegedly posed as a plastic surgeon in clinics around Bucharest
Source: ABC News: Health - February 6, 2019 Category: Consumer Health News Tags: Health Source Type: news

Cook Medical to pay $3m in damages in IVC bellwether
A federal jury in Indiana last week awarded $3 million in damages to a plaintiff in a bellwether case against Cook Medical over allegedly defective designs in the company’s Celect inferior vena cava filters. The plaintiff, Tonya Brand, sued Cook in 2014 alleging that the Celect IVC filter implanted prior to a spinal procedure fragmented and sent broken pieces into her thigh and near her spine. In her suit, Brand included claims for stricter liability and negligent failure to warn, negligent design defect, negligent manufacturing, negligence per se, breach of warranty, loss of consortium and punitive damages. Cook filed ...
Source: Mass Device - February 6, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Catheters Featured Legal News Cook Medical Source Type: news

Atlanta Trauma Symposium
is designed for orthopaedic surgeons to enhance surgeon competency and provide strategies for fracture management.
Source: Orthogate - Latest News - February 6, 2019 Category: Orthopaedics Tags: Featured Meetings Events Source Type: news

Romania investigates man who posed as plastic surgeon
Romanian authorities are investigating an Italian citizen who allegedly posed as a plastic surgeon
Source: ABC News: Health - February 5, 2019 Category: Consumer Health News Tags: Health Source Type: news

Surgeon With Sexual Misconduct History Accused Again
(MedPage Today) -- Left New York after medical board sanction, faces new allegations in Wisconsin
Source: MedPage Today Surgery - February 5, 2019 Category: Surgery Source Type: news

Concerns raised over leading cosmetic surgery clinic
Government inspectors place Wimpole Aesthetic Centre under special measures Related items fromOnMedica Doctors' concerns over care are often ignored GMC urges patients considering cosmetic surgery to question doctors GPs should be told when patients have cosmetic surgery Whistle-blower consultant's concerns were valid MDU advises doctors on their new duty of candour
Source: OnMedica Latest News - February 4, 2019 Category: UK Health Source Type: news

January 2019 Briefing - Cosmetic Surgery
Here are what the editors at HealthDay consider to be the most important developments in Cosmetic Surgery for January 2019. This roundup includes the latest research news from journal articles, as well as the FDA approvals and regulatory changes...
Source: Drugs.com - Pharma News - February 1, 2019 Category: Pharmaceuticals Source Type: news

‘It's very hard to tell parents their child is no more', reveals paediatric heart surgeon
Dr Ramana Dhannapuneni, a consultant heart surgeon at Alder Hey Children's Hospital in Liverpool, features in tonight's episode of Hospital on BBC Two at 9pm.
Source: the Mail online | Health - January 31, 2019 Category: Consumer Health News Source Type: news

Liberia: U.S.-Based Liberian Surgeon Arrives to Help 'Underprivileged' Girls
[Observer] Dr. Grace Dinkins, a Liberian surgeon is in the country to contribute her quota.
Source: AllAfrica News: Health and Medicine - January 17, 2019 Category: African Health Source Type: news

Surgeon General Believes It ' s High Time For Marijuana Reclassification
The U.S. Surgeon General Jerome Adams called on the federal government to rethink marijuana ’s classification as a Schedule I substance. While the Surgeon General did not go so far as to condone legalization for recreational use, he did say marijuana should be studied like any other pain relief drug.
Source: Forbes.com Healthcare News - January 7, 2019 Category: Pharmaceuticals Authors: Nicole Fisher, Contributor Source Type: news

Surgeon General Believes It ' s High Time To Think About Science-Driven Policy For Cannabis Research
The U.S. Surgeon General Jerome Adams called on the federal government to rethink marijuana ’s classification as a Schedule I substance. While the Surgeon General did not go so far as to condone legalization for recreational use, he did say marijuana should be studied like any other pain relief drug.
Source: Forbes.com Healthcare News - January 7, 2019 Category: Pharmaceuticals Authors: Nicole Fisher, Contributor Source Type: news

I Spent My Fertile Years Training to Be a Surgeon. Now, It Might Be Too Late For Me to Have a Baby
“How do you envision your family looking?” My face crumpled and tears fell from my eyes as soon as the young doctor asked me this question. I reflexively reached for a tissue to cover my face and erase the signs of weakness. “I don’t know,” I said. “I just want to be able to have a family someday.” I was in a fertility clinic for an initial consultation about egg freezing. Of the people in the waiting room, I was the odd one out: a single woman among couples struggling to have children. As a surgeon, I can’t honestly say I have spent a lot of time looking for a partner. I&rsq...
Source: TIME: Health - January 3, 2019 Category: Consumer Health News Authors: Arghavan Salles Tags: Uncategorized Sex/Relationships Source Type: news

December 2018 Briefing - Cosmetic Surgery
Here are what the editors at HealthDay consider to be the most important developments in Cosmetic Surgery for December 2018. This roundup includes the latest research news from journal articles, as well as the FDA approvals and regulatory changes...
Source: Drugs.com - Pharma News - January 2, 2019 Category: Pharmaceuticals Source Type: news

Report: Despite settlement, patient seeks prosecution for off-label Seri scaffold breast surgery
A patient in Southern California who underwent breast reconstruction surgery using an off-label Seri surgical scaffold is pushing for the state to prosecute the operating plastic surgeon, despite having received $1 million in a settlement, over claims that he altered her medical records, according to a Pasadena Star News report. The patient, Wendy Knecht, underwent breast reconstruction in 2015 following a cancer-preventive double mastectomy procedure. She was treated by Dr. Max Lehfeldt, who used a Seri surgical scaffold, produced by Allergan (NYSE:AGN) at the time, despite the scaffold having no FDA indications for such...
Source: Mass Device - December 21, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cosmetic/Aesthetic Legal News Women's Health Allergan Serica Technologies Sofregen Medical Source Type: news

Bovie Medical seeks new FDA indications for J-Plasma, Renuvion tech
Bovie Medical (NYSE:BVX) said today it submitted a 510(k) premarket notification to the FDA seeking expanded clearance for its J-Plasma and Renuvion technology. The Clearwater, Fla.-based company, which is looking to rebrand under the new moniker Apyx Medical Corporation beginning next year, said it is looking to clear the system for use in dermal resurfacing procedures. The J-Plasma device is a plasma-based cutter and coagulator that uses helium ionization to produce a focused beam of ionized gas over a blade, used for cutting or coagulating during surgeries, Bovie Medical said. “We are pleased to announce this 510(K) ...
Source: Mass Device - December 21, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cosmetic/Aesthetic Food & Drug Administration (FDA) Regulatory/Compliance Bovie Medical Corp. Source Type: news