Will There be More Clarity About the CGM Landscape at ATTD?
There could be an opportunity to gain more insight into how the continuous glucose monitoring (CGM) market will pan out this year at the 2020 International Conference on Advanced Technologies & Treatments for Diabetes (ATTD). The leading companies in the space are slated to release data and give investors more clarity about CGM offerings, according to a report from Canaccord and Genuity analyst Kyle Rose. Abbott Laboratories’ upcoming Freestyle Libre 2 will be a major topic in the CGM conversation during ATTD because it will reshape the market’s landscape. Already patients and invest...
Source: MDDI - February 15, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business Digital Health Source Type: news

FDA fully supports partners looking to develop new diagnostic tools for #COVID19. Apply now to help! https://twitter.com/DepSecHargan/status/1228326692239880193   …
FDA fully supports partners looking to develop new diagnostic tools for #COVID19. Apply now to help! https://twitter.com/DepSecHargan/status/1228326692239880193 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 14, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Find more about the upcoming meeting and register today! https://go.usa.gov/xdRBx  
Find more about the upcoming meeting and register today! https://go.usa.gov/xdRBx  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 14, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The purpose of the workshop is to bring together experts from several disciplines and multiple sectors to discuss the appropriate study designs needed to demonstrate the safety and effectiveness of ctDNA cancer screening tests and to support claims of cancer screening.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 14, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The @US_FDA supports the continued research and advancement of cancer screening tests. Join us on March 9, 2020 from 8:30 AM to 4:30 PM, as we discuss, “ Detecting Circulating Tumor DNA for Cancer Screening. ” pic.twitter.com/Bbs6Xnd5D7
The @US_FDA supports the continued research and advancement of cancer screening tests. Join us on March 9, 2020 from 8:30 AM to 4:30 PM, as we discuss, “Detecting Circulating Tumor DNA for Cancer Screening.” pic.twitter.com/Bbs6Xnd5D7 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 14, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Right now, there are 83 FDA Commissioned Corps from #USPHS deployed around the country to support our #COVID19 response efforts. These professionals are on the frontline and working to keep Americans safe. https://twitter.com/HHS_ASH/status/1228125040853516288   …
Right now, there are 83 FDA Commissioned Corps from #USPHS deployed around the country to support our #COVID19 response efforts. These professionals are on the frontline and working to keep Americans safe. https://twitter.com/HHS_ASH/status/1228125040853516288 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 14, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Registration is required by 4:00 PM EST on April 6, 2020. Find out more about the workshop. https://go.usa.gov/xdRb7  
Registration is required by 4:00 PM EST on April 6, 2020. Find out more about the workshop. https://go.usa.gov/xdRb7  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 14, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The purpose of this public workshop is to discuss modeling and simulation practices currently used in health technologies by industry and to develop a framework for evaluating and assessing the utility of computational modeling and simulation in health technologies
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 14, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Join us on April 13-15, 2020 (3 days), the @US_FDA will host a public workshop entitled “ Towards Good Simulation Practices in Health Technologies. ” pic.twitter.com/navUtbZK7N
Join us on April 13-15, 2020 (3 days), the @US_FDA will host a public workshop entitled “Towards Good Simulation Practices in Health Technologies.” pic.twitter.com/navUtbZK7N (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 14, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The @US_FDA wants to continue to promote the advancement of the use of safe and effective technology in health care. In recent years, computational modeling has become an increasingly powerful tool for evaluating #MedicalDevices.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 14, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Happy #ValentinesDay from all of us at FDA!pic.twitter.com/brzjC8TRIO
Happy #ValentinesDay from all of us at FDA! pic.twitter.com/brzjC8TRIO (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 14, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

3 Things I Learned at MD & amp;M West on Day 3
1. Passion Is Overrated For me, the highlight of the entire three-day event was the closing keynote, "Adventurous 10X Thinking – Building the Resilient Mindset for Better Innovation" presented by multi-award-winning inventor and adventurer Sally Dominguez. Contrary to an infamous Steve Jobs quote about how you must be passionate about what you are doing in order to do great work, Dominguez says that's not actually true at all in terms of thinking and coming up with a truly disruptive, innovative idea. "In fact you can have amazing insight if you look from outside an industry tha...
Source: MDDI - February 14, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Open Call SC1-HCO-18-2020: Developing Methodological Approaches for Improved Clinical Investigation and Evaluation of High-Risk Medical Devices
In May 2017, a new Regulation on medical devices, Regulation (EU) 2017/745 entered into force that will come into effect in spring 2020. This new Regulation sets forth reinforced rules for the generation of clinical evidence: for instance, clinical investigations for high-risk devices will be compulsory and the requirements regarding the clinical evaluation throughout the product lifetime are more stringent. (Source: eHealth News EU)
Source: eHealth News EU - February 14, 2020 Category: Information Technology Tags: Featured Open Calls Source Type: news

Best Bargain Schools for Biomedical Engineering
(Source: MDDI)
Source: MDDI - February 14, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: R & D Source Type: news

Legionella Conference 2020 will focus on waterborne pathogens in health care facilities
Discussions at Legionella Conference 2020: Prevention of Disease and Injury From Waterborne Pathogens in Health Care will focus on hazards related to medical devices, cleaning and disinfection in sterile settings and water quality requirements in hospitals and health care facilities. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - February 14, 2020 Category: International Medicine & Public Health Source Type: news

Medtronic Makes Noise in Surgical Robotics with New M & amp;A
*Updated to include comments from Megan Rosengarten, vice president and general manager of Medtronic’s Surgical Robotics business. Medtronic just turned up the volume in the surgical robotics market by a few decibels. The Dublin-based company – which has had a flurry of news come out in the last six months, is building out its upcoming surgical robotics platform with the acquisition of London-based Digital Surgery, an artificial intelligence specialist. Dr. Jean Nehme, surgeon, CEO and co-founder of Digital Surgery spoke with MD+DI about the acquisition and noted the two comp...
Source: MDDI - February 14, 2020 Category: Medical Devices Tags: Business Digital Health Source Type: news

#DYK African American women often have more heart attack risk factors than white women, such as high blood pressure, high cholesterol & diabetes? Get tips on managing these conditions & making #HeartHealthy decisions: http://www.fda.gov/womenshearthealth   … via @FDAWomen
#DYK African American women often have more heart attack risk factors than white women, such as high blood pressure, high cholesterol & diabetes? Get tips on managing these conditions & making #HeartHealthy decisions: http://www.fda.gov/womenshearthealth … via @FDAWomen (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 13, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

We're looking forward to this meeting! #PatientEngagement https://twitter.com/MDIConline/status/1225552020368699392   …
We're looking forward to this meeting! #PatientEngagement https://twitter.com/MDIConline/status/1225552020368699392 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 13, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

INVO Bioscience Announces Appointment of Inger Britt Carlsson as VP of Medical Affairs
SARASOTA, Fla., Feb. 13, 2020 -- (Healthcare Sales & Marketing Network) -- INVO Bioscience, Inc. (OTCQB: IVOB), a medical device company focused on treating infertility with its FDA-cleared INVOcell® product, today announced the appointment of Inger B... Devices, Personnel INVO Bioscience, INVOcell, Assisted Reproductive Technology (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 13, 2020 Category: Pharmaceuticals Source Type: news

Jabil Healthcare Unites Several Businesses
Jabil Inc. is consolidating its healthcare businesses under Jabil Healthcare. These include Jabil’s embedded-sensors business, its injection molding business through Nypro, and its orthopedics, spine, trauma, and medical instruments operations acquired from Johnson & Johnson. The company’s strategy “allows us to be unified in our approach to our customers, to understand their needs and roadmap, and to understand how to offer them value,” Steve Borges, CEO and EVP of Jabil Healthcare (pictured above), told MD+DI. One of those needs includes keeping ...
Source: MDDI - February 13, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Contract Manufacturing Source Type: news

Supplier Stories for the Week of February 9
(Source: MDDI)
Source: MDDI - February 13, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Components Source Type: news

Johnson & Johnson to Participate in the 9th Annual SVB Leerink Global Healthcare Conference
New Brunswick, NJ (Feb. 12, 2020) -- Johnson & Johnson (NYSE: JNJ) will participate in the 9th Annual SVB Leerink Global Healthcare Conference on Wednesday, Feb. 26th, at Lotte New York Palace, NY. Ashley McEvoy, Executive Vice President, Worldwide Chairman, Medical Devices will represent the Company in a session scheduled at 2:00 p.m. (Eastern Time). This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.A webcast replay will be available approximately two hours after the live webcast. (Source: Johnson and Johnson)
Source: Johnson and Johnson - February 13, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news

FDAnews Announces — Top Customs and FDA Enforcement Issues for Imports...
What customs or FDA laws and regulations should one follow when importing medical devices and drugs products into the U.S.?(PRWeb February 13, 2020)Read the full story at https://www.prweb.com/releases/fdanews_announces_top_customs_and_fda_enforcement_issues_for_imports_of_pharmaceuticals_biologics_and_medical_devices_webinar_feb_25_2020/prweb16910636.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - February 13, 2020 Category: Pharmaceuticals Source Type: news

More healthcare professionals to be allowed to prescribe
The Medicines and Medical Devices Bill will expand number of prescribers of low-risk medicines to reduce GP workload Related items fromOnMedica Variations in uptake of prescribing guidance impact on patients Antibiotic scrip rates lower in CAM-trained practices Pharmacists could offer high-dose statins direct to patients Clinicians need better options if we are to stop over-medication NI launches ‘One Health’ plan to tackle antimicrobial resistance (Source: OnMedica Latest News)
Source: OnMedica Latest News - February 13, 2020 Category: UK Health Source Type: news

New bill gives hospitals power to develop personalised treatment
NHS hospitals will be able to use innovative, personalised medicines for unique cancers and diseases, following the introduction of the Medicines and Medical Devices Bill this week. (Source: NHS Networks)
Source: NHS Networks - February 13, 2020 Category: UK Health Source Type: news

A missing or broken retainer ring could cause under or over delivery of insulin. This may cause patient injury or death. Find out more about the recall. https://go.usa.gov/xd59C  
A missing or broken retainer ring could cause under or over delivery of insulin. This may cause patient injury or death. Find out more about the recall. https://go.usa.gov/xd59C  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 12, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Medtronic Recalls MiniMed Insulin Pumps for incorrect insulin dosing.pic.twitter.com/qcg5tFiznt
Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Medtronic Recalls MiniMed Insulin Pumps for incorrect insulin dosing. pic.twitter.com/qcg5tFiznt (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 12, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

3 Things I Learned at MD & amp;M West on Day 2
1. Temperature Is a Really Big Deal. Remember calling "time and temp" when you were a little kid? Growing up in the landline era, there were few things as exciting to me as being able to dial a local number on our rotary-dial telephone and hear a pleasant female voice tell me the exact time and temperature. I was reminded of this childhood pastime during a chat with Peter Smith at TE Connectivity's booth at MD&M West on Wednesday. "Temperature is the single most measured parameter in the world, except for time," said Smith, senior manager of sensor product knowledge and training at TE Connectivity. ...
Source: MDDI - February 12, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

This guidance is intended to help manufacturers evaluate their device, enhance consistency of performance testing, and promote the safe use of these devices in clinical settings. Find out more. https://go.usa.gov/xd58F  
This guidance is intended to help manufacturers evaluate their device, enhance consistency of performance testing, and promote the safe use of these devices in clinical settings. Find out more. https://go.usa.gov/xd58F  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 12, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @US_FDA issued the final guidance titled, Peripheral Vascular Atherectomy Devices – Premarket Notification [510(k)] Submissions. The guidance applies to atherectomy devices used in the peripheral vasculature, which are classified by the FDA as class II devices.pic.twitter.com/IcedRwj5DZ
Today, the @US_FDA issued the final guidance titled, Peripheral Vascular Atherectomy Devices – Premarket Notification [510(k)] Submissions. The guidance applies to atherectomy devices used in the peripheral vasculature, which are classified by the FDA as class II devices. pic.twitter.com/IcedRwj5DZ (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 12, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Intuitive Surgical & #039;s Latest Acquisition Is Just One Piece of a Much Bigger Puzzle
There has been an imeasurable amount of disucssion in the medical device industry in recent years about the future of robotic surgery as the market pioneer Intuitive Surgical welcomes an influx of competition into the space. One of the ways Intuitive is continuing to innovate in the field is through connectivity and data analytics. Through an intriguing discussion at MD&M West, along with Intuitive's announcement earlier this week that it has acquired Orpheus Medical, MD+DI gained a clearer understanding of how those trends are being put to work at Intuitive to turn expert surgeons into super-ex...
Source: MDDI - February 12, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Medical device manufacturers face challenges preparing for ‘stringent’ new EU Regulation
Trade association raises concern that new regulatory system is not ready to support the transition of technology. (Source: mobihealthnews)
Source: mobihealthnews - February 12, 2020 Category: Information Technology Source Type: news

Panel Gives Bold Prediction about Bioelectronic Medicine ’s Future
Bioelectronic medicine isn’t new and has been around since the first implantation of the pacemaker. However, in recent years there has been sort of an explosion of the space – with devices. A panel at MD&M West discussed the recent transformation of bioelectronic medicine and where the space was going. “Within the last five years bioelectronic medicine has gotten really exciting,” Barry Keenan, vice president of engineering at BioSig Technologies said. “That’s probably why we’re having this sess...
Source: MDDI - February 12, 2020 Category: Medical Devices Authors: Omar Ford Tags: Electronics Implants Source Type: news

This local pharmacist designed a new system for liquid drugs. Now she ’s pushing it to the hospital floor.
Sue Carr was in pharmacy school when she first saw the dangers of administering liquid pharmaceuticals. But it wasn ’t until returning to the hospital arena after years as a retail pharmacist that the issue came back to haunt her. “I saw the same problem I saw 17 years ago,” she recalls, “and no one ever fixed it.” So in 2012, Carr started a medical device company to create a better filter needle — the mechanism attached to all liquid medication containers that sifts out glass chards,… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - February 11, 2020 Category: Biotechnology Authors: Sara Gilgore Source Type: news

Soliton Files Special 510(k) with FDA for its Generation II RAP Device
Key step towards limited launch mid-2020 HOUSTON, Feb. 11, 2020 -- (Healthcare Sales & Marketing Network) -- Soliton, Inc., (Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device company with a novel and proprietary platform ... Devices, Dermatology, FDA Soliton, Rapid Acoustic Pulse, tattoo removal, Q-switched laser (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 11, 2020 Category: Pharmaceuticals Source Type: news

3 Things I Learned at MD & amp;M West on Day 1
1. The Ever-Evolving Digital Age Is Creating Super Surgeons Using his fellow panelist Christopher Macomber, MD, as an example, Kyle Miller, MD, explained how emerging technology like machine learning and automated performance metrics can create "super surgeons." But it's going to require acceptance by the surgeons. Miller is the senior global clinical marketing manager at Irvine, CA-based Intuitive Surgical, and Macomber is chair of robotic surgery at Minneapolis, MN-based Abbott Northwestern Hospital, part of Allina Health Surgical Specialists. "If you think about a user like Chris, ...
Source: MDDI - February 11, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Minimally Invasive Surgery Through the Eyes of a Surgeon
One of the best parts of an event like MD&M West is the opportunity to put a cross-section of experts from industry in the same room as engineers and end-users and talk about the biggest trends in medical devices. One such discussion that took place here in Annaheim, CA on Tuesday included an expert robotic surgeon, an expert from Intuitive Sugical (which, as you likely know by now, pioneered robotic surgery a little more than 20 years ago), and a new robotic surgery company that is trying to to take this technology beyond the surgical suite. I shared a few insights from this lively panel discussion here, but prior to...
Source: MDDI - February 11, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Fayer Chronicles Her Journey in Medtech to Improve Women ’s Health
Marissa Fayer, a 20-year medtech executive, entrepreneur, and philanthropist stopped in to speak with MD+DI about the changes she has seen in healthcare and how women have helped shaped the medtech industry. She is the CEO and founder of non-profit HERHealthEQ and the president of advisory firm Fayer Consulting LLC,. MD+DI: You’ve made a tremendous impact in the healthcare industry – but tell me what led you to this field? Also, when you started your career how did the landscape in the profession look? Was it particularly diverse? How has it changed since you first started? Y...
Source: MDDI - February 11, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Is age a risk factor for heart disease? Hear what women like you had to say about heart disease, including risk factors & heart attack symptoms. #HeartMonthpic.twitter.com/xkYqcolCOz
Is age a risk factor for heart disease? Hear what women like you had to say about heart disease, including risk factors & heart attack symptoms. #HeartMonth pic.twitter.com/xkYqcolCOz (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 11, 2020 Category: Medical Devices Authors: ( at FDAWomen) Source Type: news

CMS: Medicare Program: Update to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Items That Require Prior Authorization as a Condition of Payment
Notice from the Centers for Medicare and Medicaid Services announcing updates additions to the list of Healthcare Common Procedure Coding System (HCPCS) codes on the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS). These changes are effective January 1, 2020 and will be implemented in two phases beginning May 11, 2020 and October 8, 2020. (Source: Federal Register updates via the Rural Assistance Center)
Source: Federal Register updates via the Rural Assistance Center - February 11, 2020 Category: Rural Health Source Type: news

A New Year ’s Integrity Resolution For Your Company
This article has been prepared for informational purposes only and does not constitute legal advice. This information is not intended to create, and receipt of it does not constitute, a lawyer-client relationship. Readers should not act upon this without seeking advice from professional advisers. (Source: MDDI)
Source: MDDI - February 11, 2020 Category: Medical Devices Authors: Deeona Gaskin, Sidley Austin LLP Tags: Regulatory and Compliance Source Type: news

Union Health Ministry notifies medical equipment used on humans or animals as "drugs"
"In pursuance of sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby specifies the following devices intended for use in human beings or animals as drugs with effect from the April 1, 2020," the notification read. (Source: The Economic Times)
Source: The Economic Times - February 11, 2020 Category: Consumer Health News Source Type: news

Central Ohio firm forms joint venture with Cincinnati hospital
Christ Hospital has entered a joint venture with Dasco Home Medical Equipment, which specializes in respiratory equipment such as home oxygen as well as walkers, wheelchairs and adjustable beds. The joint venture, called Dasco-TCH Home Medical Equipment, opened a facility Feb. 1 at 4760 Red Bank Expressway, Suite 232, in Madisonville. The location is open weekdays from 9 a.m. to 5 p.m. Home delivery and shipping are also available. A 24-hour call center will accept orders every day of the week. The… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - February 10, 2020 Category: Pharmaceuticals Authors: Barrett J. Brunsman Source Type: news

Central Ohio firm forms joint venture with Cincinnati hospital
Christ Hospital has entered a joint venture with Dasco Home Medical Equipment, which specializes in respiratory equipment such as home oxygen as well as walkers, wheelchairs and adjustable beds. The joint venture, called Dasco-TCH Home Medical Equipment, opened a facility Feb. 1 at 4760 Red Bank Expressway, Suite 232, in Madisonville. The location is open weekdays from 9 a.m. to 5 p.m. Home delivery and shipping are also available. A 24-hour call center will accept orders every day of the week. The… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - February 10, 2020 Category: Biotechnology Authors: Barrett J. Brunsman Source Type: news

FDA has experts fully engaged in efforts to develop diagnostics, vaccines & therapeutics for #2019nCoV. We are working closely with our government & international partners on these efforts to share information & collaborate. https://www.fda.gov/novelcoronavirus   …
FDA has experts fully engaged in efforts to develop diagnostics, vaccines & therapeutics for #2019nCoV. We are working closely with our government & international partners on these efforts to share information & collaborate. https://www.fda.gov/novelcoronavirus … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 10, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Since 1994, FDA ’ s Office of Women ’ s Health has funded studies providing valuable insight into sex differences in the diagnosis & treatment of heart disease, leading to a better understanding of the disease in women. Learn about current research here: https://go.usa.gov/xmuxW   pic.twitter.com/JfaOhoY2q9
Since 1994, FDA’s Office of Women’s Health has funded studies providing valuable insight into sex differences in the diagnosis & treatment of heart disease, leading to a better understanding of the disease in women. Learn about current research here: https://go.usa.gov/xmuxW  pic.twitter.com/JfaOhoY2q9 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 10, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Heart disease is the leading cause of death for U.S. men and women. And many @US_FDA regulated devices are used to treat various heart issues. Find out more about these devices that help keep the heart beating. https://go.usa.gov/xd9mB   #HearthHealthMonth
Heart disease is the leading cause of death for U.S. men and women. And many @US_FDA regulated devices are used to treat various heart issues. Find out more about these devices that help keep the heart beating. https://go.usa.gov/xd9mB  #HearthHealthMonth (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 10, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA will join the global observance of Rare Disease Day 2020 raising awareness about the 7,000 known rare diseases, many of which have no treatment. #FDARare2020 #rarediseaseday Join us at our public meeting on February 24, 2020 https://go.usa.gov/xdTqf   pic.twitter.com/nDS7LA0MrO
FDA will join the global observance of Rare Disease Day 2020 raising awareness about the 7,000 known rare diseases, many of which have no treatment. #FDARare2020 #rarediseaseday Join us at our public meeting on February 24, 2020 https://go.usa.gov/xdTqf  pic.twitter.com/nDS7LA0MrO (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 10, 2020 Category: Medical Devices Authors: ( at FDAPatientinfo) Source Type: news

Increasing Surgical Precision
This spring orthopedic trauma surgeons will have a new digital tool for implant, instrument, and anatomic alignment procedures that rely on fluoroscopic imaging—PhantomMSK Trauma, which just received FDA 510(K) clearance. Created by OrthoGrid Systems, the PhantomMSK platform aims to correct image distortion caused by external electromagnetic interference and the mapping of the planar image on a curved input phosphor, the company explained in a news release. Such distortion can impact image integrity and risk malalignment. In addition to PhantomMSK Trauma, the platform supports Hip and Hip Preservation app...
Source: MDDI - February 10, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Orthopedics Source Type: news

Public Inspection: CMS: Medicare Program: Update to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Items That Require Prior Authorization as a Condition of Payment
Pre-publication notice from the Centers for Medicare and Medicaid Services announcing updates additions to the list of Healthcare Common Procedure Coding System (HCPCS) codes on the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS). These changes are effective January 1, 2020 and will be implemented in two phases. (Source: Federal Register updates via the Rural Assistance Center)
Source: Federal Register updates via the Rural Assistance Center - February 10, 2020 Category: Rural Health Source Type: news