Nonin Medical's 4100 Patient Module OEM wrist-worn pulse oximeter was among the first Bluetooth-enabled medical devices, and now the company hopes to again beat the competition by being the first to get a Bluetooth low energy–enabled medical device on the market. Nonin Medical hopes to introduce a Bluetooth low energy-enabled pulse oximeter in early 2013. It will be launched...
Why There Hasn't Been a Homerun mHealth App The mobile health movement has generated huge buzz over the last several years with its promise of bringing better, more personalized care at a cheaper cost to a wider number of engaged consumers. So it’s only natural to wonder if and when mHealth will give birth to its own Instagram. It hasn’t happened yet but it’s “a...
iPad 3 Hits Stores The third iteration of the iPad went on sale Friday morning in the US, greeted by the usual throngs of early adopters...at the company’s flagship 5th Ave. store — ground zero in New York — hundreds lined up for the new iPad, which reviewers have said introduces some powerful new processor and graphics features but lacks the “wow” factor of the...
St. Jude is focusing on innovation in the face of softening demand for older devices, and Advamed weighs in on the medical device user fees deal. St. Jude Banks on New Technologies in 2012  St. Jude will start selling minimally invasive aortic heart valves and an ablation device to treat hypertension in Europe by the end of the year, Starks said. Analysts estimate the valve market, now led...
We've already looked at MED's most popular feature articles of the year, but what piqued your interest on the MED blog this year? The medical device excise tax got readers riled up, as did industry scandals such as Biotronik's allegedly shady sales tactics (perhaps a bit of schadenfreude?). See the rest below, and leave a comment with your favorites. 1.) Boston Scientific CEO to...
Apparently, MED readers have a thing for Android. Google's operating system for mobile devices showed up in two of our ten most popular features of 2011 (and took the top spot in 2010). Other popular topics this year included standards, software, sensors, and wireless technologies.  Did you have a favorite feature that didn't make the list? If so, share it in the comments below. 1. )...
CardioMEMS, a company specializing in devices for remote health monitoring, was dealt a blow by FDA last week with regard to its CardioMEMS Champion Heart Failure Monitoring System. The administration's Circulatory Systems Devices advisory panel voted 7-3 against when asked if the device is effective and 6-4 against when asked if its benefits outweigh its risks, according to the StarTribune...
FDA today released draft guidance for artificial pancreas device systems for treatment of type 1 diabetes, an event one advocacy group is hailing as a “huge opportunity for patients.” A press release issued by FDA says the draft guidance provides “flexible recommendations for design and testing” of the systems—including leeway in the choice of clinical study length...
Insulin pump with infusion set. Photo by Mbbradford at en.wikipedia [Public domain], from Wikimedia Commons. FDA today received a petition urging the administration to issue “clear and reasonable” gui dance for development of an artificial pancreas. More than 100,000 people throughout the United States signed the petition, which was launched by the Juvenile Diabetes...
This week, Samsung surpassed Apple to become the No. 1 seller of smartphones. Also, more fallout from the Medtronic insulin pump hacking, and St. Jude gets clearance for an OCT-enabled device. St. Jude Gets Clearance for OCT-enabled Artery Disease System (StarTribune) Hackable Medtronic Insulin Pump Leads to Company Probe (MPMN) Cook Group Chairman: Medical Device Tax Will Kill 15% of Medtech...
Last week's Question of the Week asked about the state of venture capital for medical device startups. While we've heard a lot lately about the dearth of VC funding for device companies, today's New York Times has a story about where that money is going. While they might be holding back from investing in device companies directly, the Times says venture capitalists have emerged as an ally in the...
The iPhone 4S hits stores. Also, senators introduce legislation intended to speed medical device review. iPhone 4S Makes its Retail Debut (The Wall Street Journal) Klobuchar, Paulsen Continue to Stump for Industry on Capitol Hill (MD+DI) Designer of C Programming Language Dies (New York Times) Dr. Leslie Saxon on the Future of Telehealth (MD+DI) Smartphone-Based Ultrasound: The New Medical...
This week, we mourn Steve Jobs and marvel at how he changed the course of healthcare. Also, a look at the effectiveness of telehealth and how medical electronics are helping to diagnose pain. Medical Electronics: Perfecting a Pain Detector (EBN) FDA, CMS to Jointly Review Medical Devices (DOTmed.com) How the iPhone Is Enabling a Revolution in Connected Medical Devices (Medical Electronic Device...
Over at our sister publication EE Times, Dave Kleidermacher, of Green Hills Software, sounds off about the controversial IOM report that recommended FDA scrap the 510(k) process. Kleidermacher agrees with the report's conclusion, and he's a more frank in his criticism of the 510(k) process than the IOM: . . . [T]he medical industry's certification process for life-critical devices, such as...
For medical device designers who dream of seeing their devices among the sleek gadgets on Apple Store shelves, MIT's Technology Review has put together a how-to guide to get them there. The first step, of course, is to obtain FDA clearance, but it doesn't stop there. Designers also have to apply to the company's MFi licensing program, submit a prototype, and sign a nondisclosure agreement....
In this week's news, life sciences VC funding is up, the New England Journal of Medicine defended IOM's recommendations that the 510(k) process be scrapped, and a look at the medical electronics industry in India. New England Journal of Medicine Authors Defend IOM's Controversial 510(k) Decision (MD+DI) An Interview on the Medical Electronics Market in India (Express Healthcare) Life Sciences VC...
This week's big stories included a possible roadblock for computer chip progress, security issues for diabetes devices, and device companies weighing in on possible changes to the 510(k) process. Guest Blog: With Tax Unlikely to be Repealed, It's Time for Companies to Plan for Reality (MD+DI) Glucose Monitors and Insulin Pumps Can Be Hacked (DailyTech) The NY Times Op Ed Page Questions the...
Anytime FDA starts proposing new regulations for medical devices, designers understandably get wary. But according to experts, the administration’s proposed regulations for medical mobile apps might result in more clarity than confusion.   According to the draft guidance issued last week, FDA is proposing to regulate apps that “are used as an accessory to a medical device already...
Anytime FDA starts proposing new regulations for medical devices, designers understandably get wary. But according to experts, the administration’s proposed regulations for medical mobile apps might result in more clarity than confusion.   According to the draft guidance issued last week, FDA is proposing to regulate apps that “are used as an accessory to a medical device already...
In this week's link roundup, 40 medical manufacturing facilities now call Tijuana, Mexico home. Also, EMRs are easy to steal, and the life sciences sector saw a 37% rise in venture capital in the second quarter of this year. Medtech Goes South of the Border (EMDT) VC Investments Rise 19% in Q2 2011, Life Sciences Dollars Jump 37% from Q1 2011 (MX) FDA Moves to Consolidate Drugs, Devices, Tobacco...
As promised, FDA has issued draft guidance laying out plans for the oversight of mobile applications used for medical or healthcare purposes. In a press release dated July 19, the administration explained that the proposed guidelines will only impact applications that “are used as an accessory to a medical device already regulated by the FDA” or “transform a mobile...
In this week's stories, Electrocomponents plc, the world leader in electronics and maintenance products, says demand for electronics is shrinking. Also, developers are jumping from Android to Apple, and FDA and CDRH are keeping secrets. One Company Says Global Demand for Electronics is Slowing (Bloomberg) FDA, CDRH Keeping Secrets Despite Transparency Initiative (MD+DI) Samsung Study Finds No...
The Advanced Medical Technology Association on Monday laid out a set of policy recommendations it says should be implemented in order to maintain the United States' position as the world leader in medical technology innovation. "We know medical technology has a bright future. The question is: will that future be made in America—or somewhere else?" AdvaMed President and CEO ...
Some decisions are easy (yes, I WILL have dessert). Others are not. Take the question of whether women in their 40s should get a mammogram. Some say yes, others say not necessarily. Add to the mix a certain daytime talk show host who suggested that radiation from mammograms could be contributing to increased rates of thyroid cancer, and it’s not surprising that many women are confused....
Play nice. That would be my advice for both the European Commission's health and consumers department and FDA. And it hasn't typically been a problem. But EC officials were miffed after CDRH director Jeffrey Shuren made some opaque remarks about the safety of medical devices in the United States vs. the European Union. Devices reach the market faster in Europe, but Shuren has repeatedly said...