News

Health Diagnostic CEO resigns as feds start doctor payment investigation

Health Diagnostic Laboratory CEO Tonya Mallory resigned from her position at the same time a federal investigation was launched to look into the company's blood-sample practices.

FDA to weigh in on cybersecurity concerns

Amid growing concern over the cybersecurity of medical devices, the FDA is weighing in on the issue and addressing product safety at an upcoming conference.

A trio of med tech IPOs line up: Sientra, Nexstim and Exagen

Three med tech companies recently have disclosed their intentions to go public. These include breast implant maker Sientra, noninvasive neurostimulation player Nexstim and rheumatology diagnostics company Exagen.

Philips splits in two, making HealthTech its sole priority

Philips has decided to split into two companies: one will be devoted to its Healthcare and Consumer Lifestyle businesses, while the other will spin off and be composed of the Lighting business.

Ivantis gets $71M for glaucoma device, while Minerva secures $21M to reduce menstrual bleeding

In one of the largest medical device venture rounds this year, eye care company Ivantis today announced that it has raised an additional $25 million in its Series B financing, taking the total to $71 million for the developer of a tiny intracanalicular scaffold for glaucoma patients.

Study finds app better than docs at detecting jaundice

Worried your newborn has jaundice? There's--almost--an app for that. Researchers have reported data from a trial with 100 newborns for the app; they found it has greater accuracy in detecting jaundice than visual exams performed by doctors and that it matches the accuracy of blood tests for bilirubin.

T2 Biosystems wins FDA approval for sepsis diagnostic system

T2 Biosystems won FDA approval to market its diagnostic system for sepsis, riding on the tailwinds of last month's IPO and moving the company forward on its path toward full commercialization of the product.

Treasury's crackdown on inversion could scupper Medtronic-Covidien deal

Treasury Secretary Jacob Lew yesterday unveiled a plethora reforms to make tax inversion more difficult and less attractive, potentially killing a plethora of pending mergers with foreign companies, including Medtronic's $43 billion tie-up with Ireland's Covidien. 

Medtronic gains approval, launches Tyrx antibacterial envelope in Europe

Already cleared by the FDA last year, the Tyrx Absorbable Antibacterial Envelope has won a CE mark for use with cardiac devices, and Medtronic has launched it in Europe.

CVRx gets $15M to advance hypertension, heart failure treatment device

On the heels of a $42 million Series F closed last fall, CVRx is picking up an additional $15 million in a debt facility from Silicon Valley Bank. But that's chump change in the long run for this startup, which has raised about $265 million since its 2001 inception.

Mobile health device maker iHealth gets $25M from China's largest electronics company

iHealth is not new to the mobile health device game. Launched in 2010, as a subsidiary of medical device manufacturer Andon Health--it markets several mobile-compatible devices including blood pressure and blood glucose monitors. In fact, iHealth had the first health device carried in Apple retail stores.

Why are so many companies failing to pay the device tax?

The 2.3% medical device excise tax raised $913 million in the first half of 2013, or about 75% of what was anticipated. A look at the number of filers reveals a large part of the problem. Out of estimates as high 15,000 only 5,107 medical device tax forms were filed.

Dartmouth mobile app detects depression and stress levels

Lonely, depressed, stressed? There's a smartphone app that can read your mood like a book. At Dartmouth, student researchers developed and tested StudentLife, an app that can detect depression and stress levels.

University of Louisville working on 'bioficial heart' using 3-D printing

Researchers at the University of Louisville say they are closing in on being able to conduct human clinical trials of implanting prevascularized patches for the heart that are created through 3-D bioprinting technology they developed.

Physicians defend power morcellator devices amid industry fallout

Amid mounting regulatory and industry criticism for gynecological tools used in minimally invasive procedures, physicians continue to defend the devices as a viable surgical option.

Apple HealthKit delayed by bug as major EHR players commit

The health revolution has been put on hold. The long-awaited HealthKit from Apple will take a few weeks longer. Instead of launching as expected on Wednesday, due to a bug its debut has been pushed to the end of September, Reuters reports. The health and fitness application platform is expected to allow consumers and healthcare providers to better track, access and share health data.

Med tech veteran, Venture Valkyrie offers healthcare prescriptions

Health care venture capitalist, Lisa Suennen shared her take on what it would take to improve the situation. She recommends inexpensive new outpatient monitoring technologies, regulatory adjustments to encourage the system to play fair and more transparency in medical pricing, as well as patient education based of behavioral economics to help people take care of their own health.

British startup launches crowdfunding effort for 3-D printed orthotic devices

As 3-D printing gains traction within the industry, British startup Andiamo is launching a crowdfunding effort to develop 3-D printed orthotic devices for disabled children.

UDI architect shares compliance tips on eve of regulation's first deadline

"Mr. UDI" gave industry advice on complying with the complex unique device identification rules as medical device companies barrel toward the Sept. 24 deadline for adding identifiers to high-risk devices. Former FDA official Jay Crowley has acquired the nickname for his role in implementing and designing the UDI system. He is now a consultant for USDM Life Sciences.

Court ruling against FDA enables more combination products to be classified as devices

The U.S. District Court for the District of Columbia rejected the FDA's attempt to classify Prevor's Diphoterine Skin Wash as a drug rather than a device for the second time, dealing industry a victory in the sometimes contentious arena of product classification decisions.