“We are thrilled to be working with TEDCO toward building the future of our company. Our mission is to find the link between therapies and patients and improve their lives,” said BullFrog AI’s Founder and CEO, Vin Singh.

BALTIMORE (PRWEB)
April 07, 2020

BullFrog AI, Inc, a precision pharmaceutical company built around a powerful artificial intelligence (AI) platform, proudly announces TEDCO’s Seed Fund made its first investment of $200,000. TEDCO’s Seed Fund invests in and partners with early-stage companies. Through seed funding and start-up related services, TEDCO works with the entrepreneurs to ensure they have the tools they need for success.

“We are thrilled to be working with TEDCO toward building the future of our company. Our mission is to find the link between therapies and patients and improve their lives,” said BullFrog AI’s Founder and CEO, Vin Singh. “Using our proprietary technology platform, we aim to predict which patients will benefit from which medications, effectively improving clinical outcomes and eliminating the problem of trial-and-error prescriptions.”

BullFrog AI uses a proprietary artificial intelligence platform called bfLEAPTM that enables biopharmaceutical companies to be more successful in their clinical development programs. The Seed Fund money will contribute to additional development work with John Hopkins University Applied Physics Laboratory not-for-profit research center. The funds will also support commercial activities to create partnerships with biopharmaceutical companies for clinical development projects.

“BullFrog AI’s precision pharmaceutical platform has the potential to make a huge impact on next generation clinical development programs,” said Frank Glover, Lead Director, TEDCO Seed & Director, MVF. “Vin Singh is an experienced entrepreneur and TEDCO is excited to be partnered with Vin and BullFrog.”

For more information on BullFrog AI, visit http://www.bullfrogai.com.

About BullFrog AI

BullFrog AI is an innovator in artificial intelligence. Its proprietary bfLEAPTM analytics engine is the only tool of its kind, designed to analyze massive, complex, multi-factorial clinical data sets. BullFrog AI’s technology is poised to revolutionize drug development, enabling researchers and clinicians to match therapies to patients, streamlining clinical trials, reducing development costs and accelerating R&D cycle time to drug approval and commercial launch. BullFrog AI has an exceptional team of life science industry leaders, AI technologists, scientists, physicians and advisors, all determined to make BullFrog AI become the undisputed leader in precision medicine.

About TEDCO

TEDCO provides resources and connections that early-stage technology and life sciences companies need to thrive in Maryland. TEDCO’s mission is to discover, invest in, and help build great Maryland-based companies. Learn more at http://www.tedcomd.com.

For more information regarding BullFrog AI, contact:

Vin Singh, Founder and CEO

Vin@Bullfrogai.com

301-367-2055

http://www.BullFrogAI.com

For Media Inquiries, please contact:

Liz Thibodeau, Thibodeau Media Group

Liz@thibmedia.com

http://www.ThibMedia.com

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“This designation recognizes Dr. Jeffrey Stern as a UroLift Center of Excellence for his commitment to providing safe and effective treatment to patients with BPH,” said Dave Amerson

PLEASANTON, Calif. (PRWEB)
April 07, 2020

NeoTract, a wholly owned subsidiary of Teleflex Incorporated (NYSE:TFX) focused on addressing unmet needs in the field of urology, today announced that Jeffrey Stern, M.D., Academic Urology in Sun City West, AZ has been designated as a UroLift® Center of Excellence. The designation recognizes that Dr. Stern has achieved a high level of training and experience with the UroLift® System and demonstrated a commitment to exemplary care for men suffering from symptoms associated with Benign Prostatic Hyperplasia (BPH), also known as enlarged prostate.

Recommended for the treatment of BPH in both the American Urological Association and European Association of Urology clinical guidelines, the FDA-cleared Prostatic Urethral Lift procedure using the UroLift System is a proven, minimally invasive technology for treating lower urinary tract symptoms due to BPH. The UroLift permanent implants, delivered during a transurethral outpatient procedure, relieve prostate obstruction and open the urethra directly without cutting, heating, or removing prostate tissue.

The UroLift Center of Excellence program is designed to highlight urologists who are committed to educating their patients on BPH and the UroLift System as a treatment option and consistently seek to deliver excellent patient outcomes and experiences.

“This designation recognizes Dr. Jeffrey Stern as a UroLift Center of Excellence for his commitment to providing safe and effective treatment to patients with BPH,” said Dave Amerson, president of the Teleflex Interventional Urology business unit. “We are pleased to see the continued acceptance of the UroLift System as a standard of care treatment that may allow men to discontinue the use of BPH medications and improve their quality of life.”

Over 40 million men in the United States are affected by BPH, a condition that occurs when the prostate gland that surrounds the male urethra becomes enlarged with advancing age and begins to obstruct the urinary system. Symptoms of BPH often include interrupted sleep and urinary problems and can cause loss of productivity, depression and decreased quality of life.

Medication is often the first-line therapy for enlarged prostate, but relief can be inadequate and temporary. Side effects of medication treatment can include sexual dysfunction, dizziness and headaches, prompting many patients to quit using the drugs. For these patients, the classic alternative is surgery that cuts, heats or removes prostate tissue to open the blocked urethra. While current surgical options can be very effective in relieving symptoms, they can also leave patients with permanent side effects such as urinary incontinence, erectile dysfunction, and retrograde ejaculation.

About the UroLift® System

The FDA-cleared UroLift System is a proven, minimally invasive technology for treating lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). The UroLift permanent implants, delivered during a minimally invasive transurethral outpatient procedure, relieve prostate obstruction and open the urethra directly without cutting, heating, or removing prostate tissue. Clinical data from a pivotal 206-patient randomized controlled study showed that patients with enlarged prostate receiving UroLift implants reported rapid and durable symptomatic and urinary flow rate improvement without compromising sexual function*1,2. Patients also experienced a significant improvement in quality of life. Over 100,000 men have been treated with the UroLift System in the U.S. Most common adverse events reported include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence. Most symptoms were mild to moderate in severity and resolved within two to four weeks after the procedure. The Prostatic Urethral Lift procedure using the UroLift System is recommended for the treatment of BPH in both the American Urological Association and European Association of Urology clinical guidelines. The UroLift System is available in the U.S., Europe, Australia, Canada, Mexico and South Korea. Learn more at http://www.UroLift.com.

About NeoTract | Teleflex Interventional Urology

A wholly owned subsidiary of Teleflex Incorporated, the Interventional Urology Business Unit is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. Our initial focus is on improving the standard of care for patients with BPH using the UroLift System, a minimally invasive permanent implant system that treats symptoms while preserving normal sexual function*1,2. Learn more at http://www.NeoTract.com.

About Teleflex Incorporated

Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit http://www.teleflex.com.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rusch®, UroLift® and Weck® – trusted brands united by a common sense of purpose

# # #

For Teleflex Incorporated:

Jake Elguicze, 610.948.2836

Treasurer and Vice President, Investor Relations

Media:

Nicole Osmer, 650.454.0504 nicole@healthandcommerce.com

*No instances of new, sustained erectile or ejaculatory dysfunction

1. Roehrborn, J Urology 2013 LIFT Study

2.McVary, J Sex Med 2016

MAC00968-01 Rev A

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WCG FDAnews

FALLS CHURCH, Va. (PRWEB)
April 07, 2020

FDA’s Regulation of Digital Health Wearables & Sensors

An FDAnews Webinar

Tuesday, April 21, 2020 • 1:30-3:00 p.m. EDT

https://www.fdanews.com/wearablesandsensors

The digital health wearable and sensors market is rapidly growing.

What is one’s understanding of how and when the FDA is regulating these medical device products?

Get to know how these technologies are regulated by the FDA. And discover which innovative strategies one can implement to support faster, streamlined approvals for wearable and sensor products.

Join FDAnews and experts Kristin Davenport and Christina Kuhn for a comprehensive overview of the FDA’s regulation of digital health wearables and sensors:

●Evaluate the developing landscape for digital health wearables and sensors, including examples of the breadth and depth of their development processes

●Determine which FDA’s policies apply when wearables are regulated, including how to comply with the FDA’s guidances on clinical decision support

●Specify differences between platforms and individual apps

●Assess considerations for artificial intelligence and the intersection of artificial intelligence with the FDA regulation

●Identify which medical device requirements are for regulated wearables

Implement innovative strategies for faster, streamlined approvals of your wearables and sensors.

Interested in registering multiple sites?

Call 888.838.5578 in the U.S. or +1 703.538.7600 globally

to learn about our special multisite discount.

Webinar Details:

FDA’s Regulation of Digital Health Wearables & Sensors

An FDAnews Webinar

Tuesday, April 21, 2020 • 1:30-3:00 p.m. EDT

https://www.fdanews.com/wearablesandsensors

Tuition:

$287 per site

Easy Ways to Register:

Online: https://www.fdanews.com/wearablesandsensors

By phone: 888.838.5578 or 703.538.7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations

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COVID-19 Stimulus Grants for Biotech Research Companies

“We are committed to helping biotech companies get through this coronavirus pandemic and our software will help them more easily meet the FDA requirements for quality and vendor management,” said Dr. Richard Soltero, President of InstantGMP.

CARY, N.C. (PRWEB)
April 07, 2020

We’re all affected by the current COVID-19 crisis and we understand that preclinical and clinical research may be slowing down. InstantGMP, Inc. wants to help by awarding COVID-19 Stimulus Grants that can help biotech companies keep up with their tasks in a virtual environment.

The grant includes a subscription to the InstantQMS™ software, a full set of manufacturing and quality Standard Operating Procedures, an integration with a Learning Management System and 50 hours of Implementation support.

Here’s everything that is included in InstantQMS Quality Management System:

• 
  Incident Log
• Complaint Log
• CAPA Log
• Audit Log
• Training Log
• Vendor Management
• Contract Management
• Document Management
• File Vault
• Full set of Standard Operating Procedures for a virtual biotech
• Full set of templates and forms for vendor management
• Integration with on-line learning management system

The software is an all-in-one quality and vendor management system that makes it easy to organize records and to keep traceability and training up to date. It comes complete with all the SOPs, templates and guided workflows that make it simple to get started and to stay in compliance with FDA and quality guidelines.

More information about the COVID-19 Stimulus Grants can be found at InstantGMP.com/covid-19-stimulus-grant.

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KN95 mask pic

5 Stars! Amazing Product! I have been searching for a quality mask and found it. Review by Isabella D. (verified buyer) on April 4, 2020

POMPANO BEACH, Fla. (PRWEB)
April 06, 2020

The alarm has been sounded regarding the desperate shortage of PPE, especially N95 rated masks, for Health Care Workers and First Responders. The shortage is so severe, that many doctors, nurses, and first responders are being asked to use the same mask for multiple shifts, which puts them at much greater risk for exposure and infection.

In response to the crisis, the CDC has listed KN95 masks as an alternative to N95 masks and after comparing the masks, a technical bulletin from 3M™ confirms that “it is reasonable to consider China KN95….as equivelant to US NIOSH N95 and European FFP2 respirators.”

Although the KN95 masks are in greater supply than any other mask in the world, until Friday, the FDA had still delayed regarding approval of their importation. The main concern seemed to be related to the possibility of fraudulent products.

However, Greg Blackledge, C.E.O. of Med Lab Supply, states, “Med Lab Supply ensures that the KN95 masks that they are importing are manufactured by an FDA registered company and due to our vetted procurement process, including requiring safety certificates and lab reports, we can guarantee the highest level of Authenticity and Quality Control throughout the purchasing and supply chain process. And although these masks do not presently have a 510k FDA clearance, they are CE certified for FFP2 protective mask (EN 149-2001), and they meet KN95-level requirements (GB 2626-2006), which meet the same standards as NIOSH N95.”

He continues, “Our mission has always been to do our best to make sure that we remain a valuable resource to our loyal customers, especially our Health Care Workers, and First Responders. Obviously, we are not a non profit organization and we have many workers relying on our company to pay their bills, however, that does not change our sense of community and our desire to help our neighbors. Our top priority is, and will always be people, not profit. Now that the FDA has approved the importation of these high quality KN95 masks, it is our mission to import as many of them as possible in order to make them available to everyone who desperately needs them. We are also providing very special discounts to those individuals who have the credentials of a Health Care Worker or First Responder. We also offer custom bulk purchasing quotes to hospitals, clinincs, urgent care facilities, as well as police and fire departments.”

As a result, many customers have expressed appreciation for the effort that Med Lab Supply has made to keep vitally needed supplies in stock while maintaining the consistently ethical pricing practices it operates its business with.

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