In March 2013, EarlySense Ltd. gained a US patent for the respiratory trending analysis portion of its EarlySense System, a touch-free monitoring system that detects a patient’s heart rate, respiration, and movement using a sensor placed under the bed mattress. The company is initially targeting the estimated two million medical surgical beds in US and European hospitals in hopes of improving patient safety and reducing preventable adverse events.
GlaxoSmithKline will fund nonprofit labs across several biomedical and engineering disciplines and offer a $1 million cash prize to probe the role of neural activity in disease. The goal is to build new devices that treat a range of diseases “in their own electrical language.”
Owning the Disease represents a powerful new business model for medical technology companies as they seek to adapt to health care reform and a changing environment. Organizations that successfully own a disease align their incentives with those of other stakeholders in the market by developing the capabilities to deliver compelling new value propositions.
Certain 510(k)-cleared blood glucose meters do not perform at the regulatory standards for which they were cleared after they hit the market, stakeholders agree. FDA is working on the matter, but no clear plan of action was laid out at a Diabetes Technology Society meeting last week.
Emerging technologies in peripheral nerve stimulation are expected to play a pivotal role in opening up new markets and driving growth in the neuromodulation device market in the years ahead. As a result, the pipeline is rich with products designed to address a growing number of patients with long-term pain and other chronic conditions, many of whom have no other treatment options.
Women trying to get pregnant are seeking personalized, accurate, actionable information about fertility, and health IT and medtech start-ups are answering this need via the power of data. Profiles of Fertility Focus, OvuLine, and Univfy.
Covidien President and CEO Joe Almeida is positioning the company to continue its dynamic growth. Having run up an impressive track record over the past several years, where will – where can-- Covidien go from here?
In addition to the more than 1,300 ablation procedures completed outside the U.S. with the unique visually guided ablation catheter, the venture-backed company is conducting an IDE trial in 21 U.S. centers, which it expects to complete in 2014.
Recent progress on the US regulatory front is generating renewed interest in device-based glaucoma therapies, which potentially could grow to a multibillion-dollar industry. The list of companies targeting this space continues to expand, as does the variety of potential device-based solutions: the current pipeline includes several innovative and less invasive products and technologies designed to improve surgical outcomes, a growing number of advanced drug-delivery inserts to address the patient noncompliance issue that is so common in this arena, and some unique patient monitoring devices.
Fertility Focus has two products that it says address 85% of the causes of female infertility, and assist in earlier diagnosis and treatment: the OvuSense home-use ovulation detection and fertile period predictor and the FertiloScope, a trans-vaginal laparoscopic instrument that is designed to diagnose and treat the main physical causes of female infertility in one minimally invasive outpatient procedure.
