News

iHealth integrates apps, devices with Apple HealthKit

iHealth launched three mobile health apps on Apple's HealthKit and announced the integration of 9 medical devices onto HealthKit, all programmed to work in the new iOS8.

Israeli devicemaker eyes lucrative sleep disorder market

As devicemakers cast an eye toward a lucrative sleep disorder market, Itamar Medical is joining the ranks and anticipating positive third-quarter results buoyed by recent sales agreements and commercialization efforts for its sleep monitoring devices.

Study: Publicly available information about 510(k) devices' safety and effectiveness lacking

A study published Sept. 29 in The Journal of the American Medical Association concluded that publicly available information to support the safety and effectiveness of implanted, 510(k)-cleared devices is lacking.

Microsoft, Aerocrine partner to send asthma device data to the cloud

Aerocrine has partnered with Microsoft in a pilot project to send data from nitric oxide monitoring devices to the cloud for analysis.

Activist investor intensifies pressure on Volcano

Engaged Capital has stepped up its campaign to wring shareholder value from Volcano after a stock slide of more than 60% in the last year. The firm made a detailed case against the company in an open letter to the company on Sept. 29. Engaged Capital has been openly targeting the intravascular imaging and device player since it took a sizable position more than a year ago.

Homemade medical devices present both challenges and opportunities

Nightscout touts itself as an open source, do-it-yourself project to enable remote monitoring of blood glucose levels of patients with Type 1 diabetes.

Blood pressure monitoring device first to integrate with Apple's HealthKit

Qardio recently launched QardioArm, its blood pressure monitoring and data collection app into App Store realm. QardioArm is the first medical device to initially integrate with Apple's HealthKit.

Court rules that FDA cannot rescind 510(k)s without notice and comment procedures

The FDA's powers to reclassify devices were restricted by a federal appeals court ruling that said the agency does not have the inherent authority to reclassify devices. Rather, the FDA must follow Congress' procedural requirements when reclassifying devices, including notice and comment procedures. 

Medtronic may revise $42.9B deal with Covidien under new tax rules

In light of new U.S. tax rules tightening the reins on corporate inversions, Medtronic could be poised to revise its $42.9 billion deal with Ireland-based Covidien.

Implanted pulley device could aid those with nerve damage to their hands

Thanks to engineers at Oregon State University, people who have lost the use of their hands due to nerve trauma or a stroke might get their grip back with a simple pulley mechanism.

Analysts bullish on leadless pacing market, call it a $700M opportunity

Leadless pacemakers are a "game-changing technology" that could eventually grab as much as 40% of the overall pacemaker market, say Leerink Swann equity analysts.

Blackstone puts $100M into Chinese orthopedic device player

Investment group Blackstone has reportedly made a $100 million investment into Chinese orthopedic device company Xinrong Best Medical Instrument Co. This is the firm's first foray into a medical investment in China, but in March it did take private Chinese tech outsourcing company Pactera Technology.

DOD awards $67M in contracts to Zoll, Philips

A pair of contracts went to medical device makers from the U.S. Department of Defense on Sept. 23.

Researchers study noninvasive device to monitor brain blood flow

As the med tech industry casts its eye toward neurological implants that improve patient outcomes, researchers are developing a non-invasive technology that could protect against fatal complications by measuring blood flow in the brain.

UPDATED: Former AdvaMed board chair accused of insider trading; suspended from Versant Ventures

A federal grand jury yesterday indicted James Mazzo--CEO of Santa Ana, CA-based Advanced Medical Optics from 2002 to 2009--on 13 counts of insider trading, 13 counts of tender offer fraud and one count of securities fraud, according to the U.S. Attorney's office.

Tiny, skin-like wearable monitor to track cardiac health via color

Researchers have developed a new wearable medical device designed to continuously monitor tiny increments in temperature change on the skin's surface. It's only 5 centimeters square in size, worn directly on the skin and made of liquid photonic crystals on a flexible substrate.

FDA clarifies '5 unit' rule in custom device exemption guidance

The FDA yesterday issued a guidance on its custom device exemption for devices "created or modified in order to comply with the order of an individual," such an orthopedic joint made especially for a 7-foot patient.  

Thermo Fisher to develop 'universal' oncology companion diagnostic with GSK, Pfizer

Diagnostics giant Thermo Fisher Scientific has partnered with GlaxoSmithKline and Pfizer to create a companion diagnostic for solid tumors that will address multiple drug programs. The move is a first step to superseding the often highly fragmented development and use of companion diagnostics to determine the best course of treatment for a particular patient.

At least 23 digital health apps clear FDA this year

There have been roughly two dozen digital health-related FDA clearances so far in 2014.

HealthKit pulled from iPhone 6 after update crashes customers' phones

Apple's HealthKit data-sharing platform for mobile health apps has been pulled from the iPhone 6's operating system after an upgrade to iOS 8 disrupted cellular service, resulting in a bucketful of delayed app launches or upgrades, to the benefit of competitors.