MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Sitemap


Articles from 2015 In December


Teknor Apex to Show Off New Materials at MD&M West

The materials specialist Teknor Apex is seeing shifts in demands from medical device companies. Its product offerings at the MD&M West tradeshow will reflect these changes.

Qmed Staff

Medalist Tubing Kit
The Medalist tubing sample kit from Teknor Apex is an examples of a product that will be on display at their booth (Booth #2438) at MD&M West 2016.

Custom compounder Teknor Apex (Pawtucket, RI) declares that it has assembled the broadest range of compounds in the medtech industry, which it will feature at MD&M West 2016 (Booth #2438) in Anaheim in February 9-11.

"We will be showing a new product selector guide, and a tubing 'kit' featuring tubing samples made with 13 different grades of Medalist tubing compounds positioned as alternatives to PVC, TPU, and silicone," says Ross van Royen, senior market manager for regulated products in the company's thermoplastic elastomer division. "These tubing samples make it easier for OEMs and processors to evaluate the haptics and opacity and translucency of our products versus injection molded plaque samples."

Teknor Apex is seeing a gradual shift in plastics specified by medical device companies--and the company says this change will be reflected in the products on display at its booth at MD&M West. "This year's emphasis will be on alternative material options to legacy plastics that have been historically used in medical devices, such as non-orthophthalate alternatives to DEHP and substitutions for Polycarbonate or ABS," says the firm's vinyl division industry manager, Peter Galland.

The company continues to offer DEHP-containing compounds that have been long used in the industry. Its line of

New products that will be on display at the show include the firm's Apex flexible PVC compounds with non-DEHP plasticizers, a Medalist TPE for solvent bonding, and a rigid PVC for connectors.

Its Apex line of tubing compounds also includes gamma-stable formulations and Apex rigid PVC products are offered for molded tubing connectors. The newest member to this product line is its Apex SCR, which provide strength similar to polycarbonate or ABS and excellent clarity. In addition, the product can reduce or eliminate the stress cracking that can occurs in PC or ABS at the interface with flexible PVC tubing.

Cannula
Cannula with Teknor Apex rigid PVC connectors.

Learn more about cutting-edge medical devices at MD&M West, February 9-11 at the Anaheim Convention Center in Anaheim, CA. 

Like what you're reading? Subscribe to our daily e-newsletter.

Next-Gen Google Glass Eyes Healthcare and Manufacturing

Having concluded that its Google Glass headset will not be a popular consumer item in the foreseeable future, Google is hoping healthcare and manufacturing institutions will boost the productivity of professionals ranging from doctors to assembly workers.

Brian Buntz

Google Glass version 2.0

Images have surfaced of the next version of Google's headset, which is referred to as model GG1 in FCC documents. While the new device looks similar to the first version of Google's head-mounted display, the potential audience for the new device is different; Google plans on selling the device to large corporations rather than to consumers directly. According to 9to5Google, the headsets will be offered with custom software to help companies meet specific tasks including manufacturing and medicine.

The new device, allegedly referred to internally as "Project Aura," features upgraded hardware--including Intel's Prism chip, a bigger prism, an upgraded battery, and support for 5 GHz Wi-Fi. The new Intel chip affords better heat management.

While Google has not yet officially acknowledged the new device, the documents from the FCC give credence to reports that the tech behemoth hadn't given up on its hopes for the headset after it failed to become popular with the public.

Despite a cool reception from the public, the device was enthusiastically embraced by many members of the medical community, who reported its benefits from everything from monitoring patients being transported via ambulance to surgeons who used the device to provide more information during operations. Also for surgery, the device potentially enables doctors to share their view of an operation with medical students or other physicians anywhere in the world. 

Learn more about cutting-edge medical devices at MD&M West, February 9-11 at the Anaheim Convention Center in Anaheim, CA. 

Like what you're reading? Subscribe to our daily e-newsletter.

FDA Debuts Plan to Improve Medical Device Warnings

Facing criticism from politicians and consumer advocates regarding its handling of medical device warnings, CDRH has announced draft guidance detailing how it will report possible medical device problems in the future.

Brian Buntz

Late in 2015, FDA commissioner nominee Robert Califf, MD was asked to address post-market surveillance of medical devices. Califf stated that he was not content with the current MAUDE database for tracking medical device events and stated that he supported revamping the process, using the agency's revamped method or reporting drug adverse events as a model.

Now, FDA has released draft guidance outlining its plans for revamping how it tracks what it calls "emerging signals" that a medical device poses a risk to patients. Such a system would catalog potential risks even before they have been validated.

"[W]e believe there also is a need to notify the  public about emerging signals that the Agency is monitoring or analyzing, even when the  information has not been fully analyzed, validated, or confirmed, and for which the Agency does not yet have specific recommendations," the agency said in its guidance.

The agency has been criticized by some politicians for being slow to identify medical risks linked to problem such as morcellators, duodenoscopes, metal-on-metal hip implants, and pelvic mesh.

The FDA Adverse Event Reporting System (FAERS) already offers such functionality although the number of drugs that are identified as posing a significant risk has fallen since 2012.

FAERS includes a mechanism for informing the public of potential drug-related dangers.

Critics of the MAUDE database have alleged that the database is hard to use and the data from it is hard to interpret. "It is my opinion, and that of most of the expert-literature, that-quantitative assessment of reporting rates to the FDA's spontaneous reporting systems (MAUDE for devices and AERS for drugs) cannot be used to prove assertions about actual incidence rates for any events," said John Lehmann, MD, MPH in an evaluation of a C.R. Bard vena cava filter.

Following the release of the draft guidance for its proposal to revamp its adverse event tracking for devices, the industry will have 60 days to offer their comments.

Learn more about cutting-edge medical devices at MD&M West, February 9-11 at the Anaheim Convention Center in Anaheim, CA. 

Like what you're reading? Subscribe to our daily e-newsletter.

Does Samsung Have a 'Pickax' in Wearables Gold Rush?

While the Korean electronics giant continues to make its own wearables, it also plans to sell processors to makers of next-gen fitness tracking devices.

Samsung's Welt
Samsung is both making its own wearables while hoping to sell chips to competitors. 

Brian Buntz

Despite the problems and the reservation from many consumers, the wearables field is booming, having expanded more than ten fold from 2010 to present--transforming from an industry worth $6.3 million to one worth more than $7 billion in five years. Statistica predicts the market to be worth over $12 billion by 2018.

Having struggled to carve out a sizable portion of the wearables market, consumer giant Samsung appears is hoping to sell processors to other wearable companies. Samsung hopes to convince other wearable companies to buy its Bio-Processor chip, which can monitor ECG levels, body fat, skin temperature, galvanic skin response, and heart rate. If the device proves popular with major wearables companies, the company could succeed as Levi Strauss and other like him in the California Gold Rush, who made their fortune not by finding gold, but by selling supplies to them.

Despite the fact that wearable sales are surging--having tripled in the past year, they are relatively expensive health toys. And the makers of the devices struggle to keep their users engaged in the long run. Roughly one third of FitBit users, for instance, ends up abandoning their device with six month's of purchase, according to one estimate.

While the most popular wearable devices cost around $100, similar step-tracking functionality can be had for less than $10 or even less than $5. To be fair, the most recent activity trackers have nice designs and throw in other features, like heart-rate monitoring and the ability to monitor incoming phone calls. But then again, inexpensive pedometers haven't been linked to skin rashes, either.

That doesn't mean that there isn't a lot of potential in the field of wearables. Potentially, wearable devices could be a boon for health tracking, enabling people to monitor everything from their skin temperature to their stress levels.

Samsung's BioProcessor may be an indication of where the future of wearables is headed. The chip, which the company says is the first that is able to monitor multiple metrics, was announced shortly before CES kicks off in Las Vegas. Coincidentally, January, the month of new year's resolutions, is also when consumer interest in fitness peaks, as reflected in Google search trends. Apparently, Google search volume for "FitBit" also surges in December and January.

Although Samsung has seen its overall market share in the wearables landscape decline recently, it is not resting on its laurels. The company will display three of its latest wearable devices at the upcoming CES show. These include the Welt belt-based lifestyle tracker, a controller for its Gear VR headset, and TipTalk, a new UX for smartwatch-based calls.

Learn more about cutting-edge medical devices at MD&M West, February 9-11 at the Anaheim Convention Center in Anaheim, CA. 

Like what you're reading? Subscribe to our daily e-newsletter.

Medtech Engineer Faces Jail Time for Theft of Trade Secrets

A former Boston Sci engineer was handed a one-year sentence for stealing plans for a medical device.

Qmed Staff

MustangAaron Q. Khieu, a former Boston Scientific engineer, admitted that he stole the design for a Mustang Plus balloon catheter. In afederal court in Minneapolis, Judge Patrick J. Schiltz handed Khieu a one-year prison sentence, which he said would serve as a deterrent to others tempting to steal secret product plans. According to the Star Tribune, he will likely spend 10 months in jail.

Khieu, 44, had argued that the plans had no value to him while federal prosecutors argued that he be liable for the $4.3 million sum that Boston Scientific had spent on R&D for the device. Prosecutors wanted Khieu to spend at least five years in jail and prior sentencing guidelines had recommended at least three years in prison. Ultimately, however, Khieu's actions didn't hurt his former employer's bottom line, which may have factored in the judge's decision to hand Khieu a relatively light sentence.

Charged in 2014, Khieu had been charged with 14 counts of trade secret theft and wire fraud.

Khieu had served on the design team for the Mustang Plus and the Mustang Catheter.

He was accused of saving the plans for the device on a USB drive and entertained plans of producing a version of the Mustang in Vietnam and sought funding from Minnesota investors for the product.

Khieu's attorney had portrayed his client as a hard-working family man, who immigrated from Vietnam to study engineering.

In court, Khieu tearfully apologized, calling the scheme: "the biggest mistake in my life."

According to his LinkedIn profile, Khieu had worked for the company from 2002 to 2013, having been hired initially as a engineer in the company's vascular division.

He is listed as an inventor on 12 patents.

The device in question was intended to offer cardiologists precise control of the placement of a balloon catheter, giving a unique degree of control over the ability to push aside plaque clogging blood vessels.

The company's Mustang balloon catheter, which makes use of the Mustang Plus design at the heart of this case, is currently on the U.S. market.

In its promotional literature, Boston Scientific says the device offers a unique dilation abilities and a thin sheath size.

Khieu will likely serve his time in a minimum-security federal prison in Duluth, MN starting February 1.

Learn more about cutting-edge medical devices at MD&M West, February 9-11 at the Anaheim Convention Center in Anaheim, CA. 

Like what you're reading? Subscribe to our daily e-newsletter.

Cololplast to Pay Millions to Settle Kickback Allegations

The FBI and DOJ accused Coloplast of paying kickbacks to five companies to help promote its products.

Brian Buntz

Coloplast has had a rough year in 2015. In September, it announced plans to pay nearly nearly half a billion dollars to settle vaginal mesh lawsuits. That same month, it was one of the worst-performing medical device companies of the year. Although its stock has recovered since then, legal woes continue to haunt the firm at the close of the year.

The company has agreed to pay $3,160,000 to settle kickback allegations against the firm brought by the U.S. Attorney's Office.

The U.S. government accused Coloplast of paying illegal kickbacks to five different companies: Byram Healthcare Centers, CCS Medical, Liberator Medical Supply, Liberty Medical, and Handi Medical. According to the complaint, Coloplast sought to to use the kickbacks to induce those companies' sales personnel to hawk its products.

"The payment of kickbacks to induce purchases of medical supplies undermines our federal health care programs, ultimately distorting consumer purchasing decisions, and increasing health care costs," U.S. attorney Carmen M. Ortiz was quoted as saying in an FBI press release. "Investigating claims of misguided business practices, at the expense of patient health, will continue to be a top priority in our healthcare enforcement efforts."

One of the companies receiving kickbacks, Liberator Medical Supply, Inc., has agreed to pay $500,000 for its alleged participation in the scheme. Much of Liberator's sales were related to Medicare reimbursement. The half-a-million settlement covers allegations that it received price concessions from Coloplast in exchange for promotion of Coloplast ostomy products to its customers.

"Both [Coloplast and Liberator] acted with their own self-interests in mind, putting profits over patient care," explained Harold H. Shaw, special agent in charge of the FBI, Boston Field Division in a statement. "The decision on which medical products to refer should be based on what is best for the patient, not on cash incentives or rebates."

While both of the aforementioned firms have settled government allegations filed against them, the whistleblowers' shares have not been determined yet.

Learn more about cutting-edge medical devices at MD&M West, February 9-11 at the Anaheim Convention Center in Anaheim, CA. 

Like what you're reading? Subscribe to our daily e-newsletter.

FDA Wants to Share Emerging Signals

FDA Wants to Share Emerging Signals

Marie Thibault

FDA is proposing a new policy to tell the public about emerging signals for medical devices in the postmarket setting. The agency has released draft guidance, "Public Notification of Emerging Postmarket Medical Device Signals" to describe what might qualify as an emerging signal and how and when such communications might be made public.

In the draft document, FDA acknowledges that it already uses press release, recalls, and safety communications to alert the public, but that it "believe[s] there also is a need to notify the public about emerging signals that the Agency is monitoring or analyzing, even when the information has not been fully analyzed, validated or confirmed, and for which the Agency does not yet have specific recommendations."

FDA explains that several issues might qualify as an emerging signal, including "a newly recognized type of adverse event associated with a medical device, an increase in the severity or frequency of reporting of a known event, new product-product interactions, device malfunctions or patient injuries potentially related to improper device use or design, or a reduction in benefit to the patient." 

The agency was careful to point out that an emerging signal communication wouldn't mean a causal relationship had been established or that device use should be limited. 

Telling the public about any emerging signals could help patients and providers make better informed decisions and knowledge of emerging signals might also lead to better adverse event reporting practices, FDA wrote.

The proposed guidance comes at the end of a year during which some patient advocates have questioned why prospective patients were not told earlier about adverse events potentially linked to certain medical devices, like the laparoscopic power morcellator or Essure permanent birth control.

In the draft guidance, FDA also outlines how it intends to determine whether an issue should be communicated as an emerging signal or not. Factors that will influence the agency's decision include how serious the adverse event(s) are, how likely the adverse event is to occur, how many people are affected, whether vulnerable patients such as children, the elderly, the chronically ill, or pregnant women are at higher risk, whether other therapies can be used, and how long FDA's analysis and recommendations might take, among other factors.
 
Check out the future of medical technology at the world's largest medical design and manufacturing event—register for the MD&M West Conference, February 9-11, 2016.

Marie Thibault is the associate editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @medtechmarie

[Image courtesy of SCOTTCHAN/FREEDIGITALPHOTOS.NET]

Rising STD Rates Spur Startups Toward New Point-of-Care Tests

Rising STD Rates Spur Startups Toward New Point-of-Care Tests

Frank Vinluan

Hoope's ring-shaped device uses a zap of electricity to block sensation from the device's needle stick for less painful STD testing.

 

Despite healthcare efforts to clamp down on sexually transmitted diseases (STDs), infections have been on the rise in the United States. Gonorrhea infection has reversed a decline started in the 1970s, according to Kalorama Information. The research firm notes that chlamydia infection rates have also increased despite a national eradication plan.

The growing number of STD cases may be due in part to improved screening efforts in recent years as testing has taken a greater share of healthcare spending. Nearly one out of every five dollars spent in infectious disease testing stems from tests for a sexually transmitted disease or women’s health, according to Kalorama Information.

BioMerieux, Hologic, and Becton Dickinson are among the large multinational companies serving the global in vitro diagnostics market for STDs. But the market opportunity in STD screening is enticing some medical device startups to develop alternatives to traditional laboratory testing. These companies are researching new point-of-care tests based on microfluidics. While these startups aren’t the first lab-on-a-chip diagnostic developers, they are going a step beyond the device companies that target clinicians, aiming instead to put new diagnostic tools directly in the hands of patients.

Vie Diagnostics is developing a test based on University of Washington research that the startup hopes will offer an alternative to laboratory testing for gonorrhea and chlamydia. The Seattle company pledges to offer automated DNA processing on a disposable chip. Preliminary tests show that the diagnostic can deliver results in about 10 minutes, said Charlie Corredor, a Vie cofounder and doctoral candidate in chemical engineering and nanotechnology at the University of Washington.

Last May, Vie beat out more than 100 teams to win the university’s annual business competition. Vie was awarded $25,000, which the company applied toward additional research. Corredor said Vie will need to raise funding in the future as it continues on a path toward an expected 510(k) application with FDA. For now, the company is focusing its efforts on R&D.

While the Vie technology could have applications in testing for various diseases, Corredor said market analysis identified a market need in STD testing. The World Health Organization calculates that more than 1 million new STDs are acquired every day. For herpes simplex virus alone, the WHO estimates that more than 500 million people have the infection.

Boston Microfluidics cites the size of the herpes market as its reason for developing a new test for the disease. The startup’s technology tests a small blood sample in a device that resembles a home pregnancy test—a form factor that is familiar to consumers. But KnowNow still requires users to prick a finger to get a blood sample, something that might unsettle some people.

Hoope, a virtual company whose cofounders are based in different countries, overcomes fears about needle pricks and pain with a ring-shaped device that uses a zap of electricity to block sensation from the ring’s needle stick. Test results for chlamydia, syphilis, gonorrhea, or trichomoniasis can be viewed on Hoope’s companion mobile app. Hoope cofounder Irina Rymshina says the test is as accurate as laboratory tests, and it costs less. One way Hoope keeps diagnostic costs down is by collecting the blood sample on an inexpensive and disposable paper-based microfluidic chip. This chip requires no power because it works by capillary action, Rymshina explained.

Cambridge, MA-based Diagnostics For All takes a similar approach, using a patterned paper technology as the basis for diagnostic tests it wants to make available for HIV testing in the developing world. Kalorama Information notes that HIV testing is not typically included among in vitro diagnostics for STDs. But Diagnostics For All is also developing its technology for syphilis, among other diseases. The nonprofit organization says its paper technology, which incorporates chemical or biological assays in wells patterned in the paper, allows for a lower-cost, disposable diagnostic test that could be made more widely available to more people. Diagnostics For All licensed its patterned paper technology from Harvard University.

Regardless of the disease target, these startups share the goal of developing tests that are easily accessible to consumers. Though Hoope plans to go through the formal regulatory process to secure FDA clearance, Rymshina said the nearer term goal is filing for an FDA waiver that would allow the company’s device on the market for home use. The company is eying a price of $50 for a Hoope Ring kit, which would include one disposable cartridge that can test for four different STDs. Replacement cartridges would cost $15. Hoope is exploring crowdfunding campaigns as a way to raise money for advance orders of its diagnostic.

“We want to eliminate the need to go to a clinic for STD testing,” Rymshina said. “It is more comfortable to do it from the privacy of your home.”

Don't miss the MD&M West conference and expo, February 9-11, 2016, in Anaheim, CA.

Frank Vinluan is a frequent contributor to MD+DI. Reach him at frankvinluan@gmail.com.

[image courtesy of HOOPE]

Right Patient, Right Drug, Right Time: How Can Big Data Cure the Incurable?

Right Patient, Right Drug, Right Time: How Can Big Data Cure the Incurable?

Big data is only beginning to transform everything from R&D to clinical trials.

Albert Bourla

Bourla

This past fall, at the esteemed Milken Institute’s London Summit, I had the privilege of joining several colleagues on stage for a spirited discussion about the power of big data to transform healthcare. It was a wide-ranging conversation about the enormous potential for data to rewrite the narrative in biomedical research—from revolutionizing how we develop and administer drugs to recasting the roles of healthcare provider and patient.

Like all compelling conversations, it inspired additional dialogue in the subsequent days—with one recurring realization: The future of big data is already visible in several corners of the healthcare field.

Each time we pick a program on Netflix or scroll through our Facebook feeds, we witness high-powered data processing at work. But no field stands to offer more positive impact to society through this technological sea change than healthcare, where big data promises to detect diseases earlier, develop appropriate medicines faster, and identify personalized options more effectively.

To be sure, we’ve only scratched the surface of this reality. But in research labs and healthcare facilities around the world, data-driven efforts that would marvel many of Silicon Valley’s best minds are already well underway.

Revolutionizing R&D to Customize Treatment

In research and development, big data is playing a critical role in unlocking key insights that are revolutionizing drug discovery. By linking real-world clinical, genomic, and lifestyle data, researchers are identifying new disease pathways and improving the drug discovery process.  For example, through a partnership with genetic testing startup 23andme, Pfizer researchers have been able to study the genetic profiles of patients with lupus to determine which ones are most likely to experience severe flares, as well as those most likely to respond to our treatment. Armed with that information, we are now able to explore customized treatment options that vary with genetic, dietary, and lifestyle factors.

Pfizer’s Precision Medicine Analytics Ecosystem, which is designed to connect the dots between several large, disparate datasets, also enables us to create targeted drugs based on what we know about patients. In lung cancer, for example, medical research revealed that about 5% of patients weren’t engaged in high-risk lifestyles, like heavy smoking, coal mining, or other activities that abused their lungs. Their common thread was a mutation in their ALK gene.  Supported by predictive analytics, Pfizer succeeded in developing a drug approved in 2011 specifically for lung cancer patients with the ALK gene mutation.

Improving Clinical Trials with Sensor Data and Patient Pinpointing

Another area ripe for big data-fueled innovation is clinical trials. Pfizer has worked to integrate sensor data into our clinical trials to ensure medication compliance, predict events, evaluate new clinical endpoints, and demonstrate how treatment impacts a patient’s overall quality of life. We have completed at least 10 studies with wearable devices during the past five years, and, going forward, many of our studies across a range of indications will include companion technology, such as wearables, to generate consistent streams of data from participating patients. 

Big data can also help determine which patients may benefit most from a drug and therefore should be included in clinical trials.  And it enables us to target very specific patient profiles. For example, subsequent to such an analysis, we could elect to focus a study only on female breast cancer patients over age 50, of Asian ancestry, who have tested positive for the BRCA1 gene mutation, and have failed first-round chemotherapy, and develop a more meaningful treatment for this specific population. Without big data, that kind of granular pinpointing just wouldn’t be possible.

Building Coalitions to Overcome Challenges

Still, despite the incredible progress, we, as a sector, have much to overcome. To start, healthcare organizations must improve mechanisms for protecting and securing patient data. Deidentifying and anonymizing patient data is one necessary step. And, of course, more must be done to prevent data breaches in the healthcare field (2015 was dubbed the “year of the healthcare hack,” unfortunately for good reason).  Regulators should do more to facilitate the use of these data by public or private organizations (provided the anonymity and security of data are well guarded). This will enhance our ability to produce medical solutions and better serve public health interest.

Additionally, although FDA and other regulatory bodies around the world are moving swiftly to accommodate big data, private and public sector organizations must work closer together as we transition to a more data-driven paradigm. Increasing access to clinical trial data and results holds a great deal of promise, but simply opening the floodgates is not the answer. Regulators will also need to address issues with pharmacovigilance reporting that will emerge, as a result of mining and correlating massive databases.

We must work as a healthcare community to define and build robust and sustainable ways to share data and ensure interoperability. To that end, we are working with a group of multinational government, patient, and industry stakeholders to identify practical strategies for advancing clinical trial transparency in fair and respectful ways.  Together with academic institutions, nonprofits, healthcare companies, and others in the global research community, we’re establishing data-sharing models that will ensure meaningful and scalable progress.

Now, more than ever before, we have the power to significantly improve the odds that we’ll die from old age—and in good health. We just need to bring the data-driven future we’re building to the mainstream.

Learn about how to keep the patient data your device captured secure in a conference session February 10 at MD&M West in Anaheim, CA.

Albert Bourla is group president of Pfizer’s oncology, vaccines, and consumer health businesses.

[image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]

Theranos Data Tampering Allegations Could Prove Devastating

The Wall Street Journal interviewed former employees at blood-testing firm Theranos who maintain the company had deleted unflattering quality control data. If true, the news could be a healthcare counterpart to the Volkswagen emissions scandal.

Kristopher Sturgis

Theranos ad
A promotional image from Theranos proclaims its vision of reshaping the future of lab testing. Recent press reports question if the technology sounds too good to be true.

The most-recent exposé published by the Wall Street Journal states that the company deleted inaccurate blood-testing results to make its technology seem more accurate than it was.  

Citing a former Theranos lab worker, the Journal states that the company has consistently had problems living up to the technological promise outlined by company founder and CEO Elizabeth Holmes. It also reports that a former employee had reported the data manipulation to the Centers for Medicare and Medicaid Services (CMS).

Theranos vehemently denies the allegations, stating that the entire incident "simply didn't happen," while confirming that lab worker who spoke to the WSJ about the alleged data-tampering has been fired for misconduct. The company also confirmed that they have not received a copy of the alleged complaint from CMS, and noted that the subject of lab ethics is something the company takes very seriously.

A report from Fast Company states that it is rare for healthcare technology companies to misrepresent quality-control data. While it is unclear whether FDA or CMS would have jurisdiction regarding this matter, lab-testing companies are typically legally required to maintain quality-control records for at least two years after they were created, a standard that is enforced by CMS under Clinical Laboratory Improvements Amendments.

While speaking at a tech conference on Monday, Theranos founder Elizabeth Holmes promised increased transparency as the company attempts to move forward in the coming months. Holmes started the company as an undergrad at Stanford University, and has since raised over $400 million in an effort to develop blood tests that are simpler and cheaper than current methods.

The company has also responded with an open letter to the WSJ, criticizing the Journal for relying upon and citing anonymous sources, as well as reporting on undisclosed and unconfirmed complaints

The potential breach of integrity suggested by the claims of data tampering could do irreparable harm to the company's image, which had already been tainted by multiple damning reports from the Wall Street Journal and other outlets.

The company's founder Elizabeth Holmes continues to be upbeat about the company's prospects, having said recently that its sales volume had never been higher.

Learn more about cutting-edge medical devices at MD&M West, February 9-11 in Anaheim, CA.

Like what you're reading? Subscribe to our daily e-newsletter.