Doctors and researchers around Boston are working to make drugs and healthcare delivery more individualized than ever. And patients will play a bigger role both in medical research and in their own healthcare, experts told the Herald.

Click here to read the article from the Boston Herald by Priyanka Dayal McCluskey.

Officials from Topera Inc., a medical device company that has developed a suite of products to assist in the identification of sources that sustain complex cardiac arrhythmias, announced that the company has received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for the latest generation of its 3D Mapping System.

“Topera pioneered the field of advanced electrophysiologic mapping with the introduction of our 3D Mapping System in 2011. We remain committed to building upon this platform to further aid electrophysiologists (EP’s) in diagnosing complex arrhythmias and allowing them to tailor therapies to deliver improved clinical outcomes for their patients,” said Edward Kerslake, CEO, Topera Inc.

The new system processes information in seconds, providing near-instantaneous intra-procedural mapping and re-mapping capabilities. In addition, the system incorporates a new color-imaging module to aid identification of ‘Rotors,’ an electrophysiologic phenomenon previously shown to sustain atrial fibrillation. These functionalities enable EP’s to more efficiently diagnose complex arrhythmias.

“Atrial fibrillation is an incredibly challenging arrhythmia to treat and the complexity of this disorder has defied interpretation and visualization by traditional EP mapping approaches,” said Eric Prystowsky, MD, director, Clinical Electrophysiology at St. Vincent Hospital in Indianapolis, Indiana. “Topera’s technology is the first to demonstrate an ability to reflect faithfully the complex mechanism(s) of this arrhythmia and provide a reliable way to visualize the tissue sources sustaining it.”

In addition to FDA 510(k) clearance for Topera’s 3D Mapping System, the Company also obtained regulatory clearances and launched its proprietary FIRMap panoramic contact-mapping basket catheter in the U.S. and Europe in late 2013. FIRMap is the first and only contact-mapping basket catheter cleared by the FDA for use in all cardiac chambers to assist in the diagnosis of complex arrhythmias.

Source: Topera Inc.

Invacare Corp. officials announced that, while it has made significant progress on the final third-party expert certification audit relating to the quality systems at its corporate and Taylor Street manufacturing facilities in Elyria, Ohio, it has recently received additional input from the third-party expert.

In a release, the company noted that this input has clarified that some additional work is required in a few particular areas before the final certification report can be provided to the United States Food and Drug Administration (FDA). The final third-party certification audit is a review of the company's compliance with the FDA's Quality System Regulation (QSR) at the impacted Elyria facilities. The company has already completed two third-party expert certification audits, and the FDA has found the results of both to be acceptable. In the first two audits, the third-party expert certified that the company's equipment and process validation procedures and its design control systems were compliant with the FDA's QSR.

At a meeting on Friday, December 20, 2013, the third-party expert indicated that its remaining observations from the final certification audit are largely focused on the sustainable compliance of the company's updated complaint and risk review processes. As part of the remediation, the company conducted an overhaul of its complaint handling system. This change has led to an increase in the backlog of complaints, as the updated procedure now requires the funneling of all sources of complaint data through one system. The launch of this new process initially outpaced the company's ability to add and train new associates to thoroughly address and conduct standard investigations of complaint data. This backlog, combined with the breadth of Invacare's product offerings and the complexity associated with its highly configurable medical devices, provided a challenge to the company's ability to investigate and close complaints in a timely manner, classify and code the issues when complaint data provided to the Company is not complete and demonstrate consistent use of the risk review process.

The new complaint handling system has been operating for several months, and the company has been closing significantly more complaints than are opened. The company has added additional contractors to further expedite clearing the backlog in order to achieve and demonstrate sustainable improvement.

"We are formalizing an action plan to address the observations of the third-party expert, who we would expect to return in February to commence their re-audit of the quality system. While we are disappointed that the final certification report is not ready to be filed, we have made significant progress in our quality systems improvements over the past two years. Notwithstanding our extension of the timeline resulting from the complexities of this process, the fact remains that our associates have done an incredible amount of work. We remain fully committed to meeting the expectations of our third-party auditor and ultimately the FDA, so we can return to full operations at our corporate and Taylor Street manufacturing facilities," said Gerald B. Blouch, president and chief executive officer.

At this point, the company cannot predict the timing of the completion of the third-party's final certification report. However, when the expert's final certification report is completed and submitted to the FDA, along with the company's own report as to its compliance as well as responses to any observations in the certification report, the FDA will inspect the company's corporate and Taylor Street facilities to determine whether they are in compliance with the FDA's QSR. The FDA has the authority to reinspect these facilities at any time. Once satisfied with the company's compliance, the FDA will provide written notification that the company is permitted to resume full operations at the impacted facilities.

The company will provide an update on the consent decree process in its year-end earnings release.

Source: Invacare Corp.

The announcement from Kinsa officials marks the first-ever approval by the FDA for a mobile-connected version of the world's most common medical device. 

Like traditional thermometers, the Kinsa Smart Thermometer can be used orally, under-the-arm or rectally. It's been designed with parents and children in mind and leverages the smartphone to make taking a temperature a more engaging and informative process. The thermometer connects to a smartphone or other mobile device via the headphone jack and uses the display, power and processing of the smartphone to determine a precise temperature reading – with fewer components in the thermometer, it is compact, thin, and highly flexible, making it more comfortable to use. Kinsa uses the smartphone's display screen to provide fun, animated visuals throughout a temperature reading – calming, distracting, and engaging children throughout the process. The display also shows reading progress and alerts parents if the thermometer slips out of place. Users can create individual profiles for the whole family and, with a few taps, track their fever, symptom and illness history. 

Kinsa is adding additional software features and, as its user base grows, will provide alerts when there is an illness outbreak in the user's local area or at her child's school.

"By combining a thermometer with a smartphone, we've created a communication channel with the ill, providing users with far more value than today's thermometers can," explained Inder Singh, founder and CEO of Kinsa.

The company's ultimate goal is to create the 'health weather,' a real-time understanding of what illnesses are spreading and where. The company will accomplish this by combining data from its products with other sources. Kinsa aspires to work closely with health agencies like the U.S. Centers for Disease Control, the World Health Organization, and state and local health departments to accomplish its mission. 

Singh explains, "With the Kinsa Smart Thermometer, we can transform the way people care for their families. And by piggy-backing off of the most widespread medical behavior in the world – a parent taking a child's temperature at the first sign of illness, even before scheduling a doctor's appointment – we can simultaneously create a highly accurate, first-of-its-kind system to track the spread of illness, revolutionizing health across the globe."

Children are often the earliest to get sick from a contagious illness like the flu and can spread it rapidly, so a real-time, geo-located understanding of early illness indicators like fever and symptoms, can help to stop the spread. 

"The world is seeking better ways to track infectious disease both at the level of the individual and the community. Kinsa's approach is exciting because it engages consumers – it can provide real value for individuals – and at the same time aggregates information in a way that could help predict and hopefully prevent illnesses like influenza," explained Ken Staley, MD, former White House Director for Biodefense and an advisor to Kinsa. 

Source: Kinsa Health