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John P. Mello Jr.
New Stem Cell Treatment Offers Dramatic Burn-Healing Potential
06/13/17 5:00 AM PT | TechNewsWorld | 676 Words

The company is awaiting FDA approval of its CellMist System so that it can begin clinical trials.

The FDA isn't the only hurdle for RenovaCare to clear on its road to bringing its medtech to market, however.

Avita Medical has...

Peter Vogel, Eric Levy, and Eddie Block
Intertwining Artificial Intelligence With Blockchain
05/18/17 9:11 AM PT | E-Commerce Times | 933 Words

As a matter of fact, the use of Watson's artificial intelligence recently has expanded beyond the FDA deal to other important areas. For instance, IBM earlier this year began offering Watson/Blockchain as a Service , so we likely will see even more...

Jack M. Germain
FDA Aims to Shore Up Medical Device Cybersecurity
10/06/14 7:00 AM PT | TechNewsWorld | 699 Words

They require device makers to submit documentation to the FDA about identified risks and existing controls to mitigate those risks.

They also recommend manufacturers submit their plans for providing patches and updates to operating systems and medical software.

However, these new...

John P. Mello Jr.
FDA Guidelines Target IoT Medical Device Security
01/28/16 5:00 AM PT | TechNewsWorld | 1599 Words

Networked medical devices, like other networked computer systems, incorporate software that may be vulnerable to cybersecurity threats," the FDA says in its proposal.

"The exploitation of vulnerabilities may represent a risk to the safety and effectiveness of medical devices and typically requires...

Richard Adhikari
FDA Gives Thumbs-Up to 'Luke' Prosthetic Arm
05/12/14 3:48 PM PT | TechNewsWorld | 636 Words

"We are happy the FDA has approved the Deka Arm for commercialization," Tom Doyon, Deka's project manager for the device, told TechNewsWorld. "This will let us focus on manufacturing and bringing to market this system."

Statistics on Arm Loss

Erika Morphy
FDA: iPods Don't Cause Pacemakers to Go on the Fritz
02/04/08 3:00 PM PT | TechNewsWorld | 383 Words

Refuting Findings
However, an in-vitro study carried out by FDA researchers found the iPod's interference with the pacemaker device to be nonexistent. Researcher Howard Bassen led a team who measured the magnetic fields produced by four different iPod models, along...

Sonia Arrison
High-Tech Healthcare Will Improve Lives, If Given a Chance
05/05/04 7:52 AM PT | TechNewsWorld | 845 Words

In January, the FDA warned that "the long-term effects of repeated ultrasound exposures to the fetus are not fully known." Given that it's not unusual for expectant mothers to get more than one ultrasound in a doctor's office , either the FDA...

Chet Dembeck
Is Regulation of Online Pharmacies Doomed to Failure?
01/24/00 12:00 AM PT | E-Commerce Times | 411 Words

FDA Cyber Patrol

The FDA would use the funds to crack down on the many illicit online drug peddlers that allegedly are based in the United States. Offenders would be subject to a $500,000 fine per violation.


Curt Finch
21 CFR Part 11 Compliance: Tracking Time, Processes and Procedures
04/19/07 4:00 AM PT | CRM Buyer | 808 Words

This overhaul resulted in FDA regulation 21 Code of Federal Regulations (CFR) Part 11, which places certain demands on drug makers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries regarding their use of technology -- specifically, defining the criteria under...

Sonia Arrison
Transcending Biology Calls for Transcending Red Tape
10/14/05 5:00 AM PT | TechNewsWorld | 743 Words

Reform Past Due
"Right now in the United States, we have a five-to-ten-year delay on new health technologies for FDA approval (with comparable delays in other nations). The harm caused by holding up potential lifesaving treatments (for example, one million...

Kevin W. FitzMaurice
Pfizer Brings Legal Barrage Against Online 'Viagra' Sales
08/03/04 12:39 PM PT | E-Commerce Times | 899 Words

Each action alleges that the accused are using the Viagra trademark in bad faith to sell products that have not been approved by the FDA.

Law Enforcement Involved

In addition, the company said it is working with...

E-Commerce Times Staff
One Year Ago: Clinton Cracks Down On Online Prescription Sales
12/29/00 3:57 PM PT | E-Commerce Times | 580 Words

However, the FDA has recently become concerned with the proliferation of prescription drugs such as Viagra being sold via the Internet to patients, without them actually being examined by a doctor.

The recent case of a 53 year-old Chicago, Illinois man,...

E-Commerce Times Staff
Clinton Cracks Down On Online Prescription Sales
12/28/99 12:00 AM PT | E-Commerce Times | 569 Words

However, the FDA has recently become concerned with the proliferation of prescription drugs such as Viagra being sold via the Internet to patients, without them actually being examined by a doctor.

The recent case of a 53 year-old Chicago, Illinois man,...

Erika Morphy
Mobile CRM May Widen the Big Data/Privacy Divide
05/06/14 10:00 AM PT | CRM Buyer | 705 Words

The guidance "indicated the FDA's intention of exercising enforcement discretion for most mobile medical apps and expressed the FDA's opinion that such apps pose minimal risk to consumers," wrote attorneys Stephanie L. Zeppa and Lauren Lewis.

Nevertheless, "the FDA's seemingly...

Jennifer LeClaire
Perrigo Recalls 11 Million Bottles of Acetaminophen
11/09/06 3:09 PM PT | TechNewsWorld | 549 Words

"Based on information currently available, the FDA believes the probability of serious adverse health consequences is remote ; however, if a consumer were to swallow an affected caplet, it could result in minor stomach discomfort and/or possible cuts to the mouth...

Mary Hillebrand
Federal Agencies Issue Warnings About Online Rx Sales
07/30/99 12:00 AM PT | E-Commerce Times | 673 Words

In testimony before the House Oversight and Investigations Subcommittee, the FDA's Dr. Janet Woodcock said "It is not safe right now to purchase drugs online from a pharmacy that is not a well-known entity." Jodie Bernstein, director of the FTC's bureau of...

John P. Mello Jr.
St. Jude Medical Patches Cardiac Machine's Cybersecurity Flaw
01/11/17 9:51 AM PT | TechNewsWorld | 745 Words

An unauthorized user could exploit the vulnerabilities in Merlin@home to modify commands to an implanted device, which could result in rapid battery depletion or administration of inappropriate pacing or shocks, the FDA explained.

There have been no reports of patient harm...

Katherine Noyes
The Med-Tech Industry's Relentless Pursuit of Cures - and Cash
11/03/07 1:30 AM PT | TechNewsWorld | 1268 Words

The drug then gets reviewed by the FDA -- a process that can take up to two years -- and, if it's approved, makes its way to market. On average, only one of the original 5,000 to 10,000 that began the process make...

Katherine Noyes
Online Rx, Part 1: Prescription for Trouble
06/02/07 1:30 AM PT | E-Commerce Times | 808 Words

To wit: A 2005 FDA search at major U.S. airports found that 85 percent of arriving drugs labeled "Canadian" actually came from 27 other countries around the globe. Many were counterfeit as well.

Whether their prices are any lower is also...

Erika Morphy
Google Shells Out $500M to DoJ Over Shady Drug Ads
08/24/11 2:50 PM PT | E-Commerce Times | 501 Words

The FDA said the button violated its requirements to disclose side effects.

The year before that, the FDA's Division of Drug Marketing, Advertising and Communications sent notices to 14 pharmaceutical manufacturers regarding sponsored link ads. Again, the FDA cited the requirement to...

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