Page 2

Congress expands Sunshine payment reporting rules

A bill expected to be signed by the president requires companies report payments to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists and certified nurse-midwives.

Policy & Regulation

ICU Medical taps Imprivata for device cybersecurity support

The collaborators will work to protect network-connected infusion pumps.

Medical Devices

Stryker pens deals with Synaptive, Ziehm to boost navigation unit

The partnerships cover a 3D brain modeling program and intraoperative imaging device.

Medical Devices

Siemens' latest 1.5T MRI scanner gets FDA nod

An increased focus on early disease diagnosis is helping drive rapid growth in the global MRI market.

Medical Devices

Framework aims to employ e-triggers to improve diagnostic safety

Authors writing in BMJ Quality and Safety offer tools they say would not only detect potential diagnostic events and monitor error rates but also help to identify patients at greater risk of future adverse events.

Diagnostics

RightEye's eye-tracking system gets FDA clearance

The company is carving a niche for its vision screening technology with applications in reading assessment and sports vision training, in addition to functional vision and brain issues.

Medical Devices

Many mastectomy patients later require imaging and biopsies, study finds

The Mount Sinai research provides data to inform the choice between mastectomy and breast-conservation therapy.

Imaging

Researchers develop biodegradable nerve stimulation device

The hope of reducing risks with permanent implants drove stent makers such as Abbott to develop absorbable versions, but it halted sales after its version failed to catch on with interventional cardiologists.

Medical Devices

RadNet buys Medical Arts to expand New York imaging network

The takeover is the latest in a string of deals intended to boost RadNet's East Coast presence.

M&A

Eximo Medical gains FDA clearance for atherectomy laser

The device is the first 355 nm laser system cleared in the United States to treat peripheral artery disease and is designed to address unmet clinical needs for multiple vascular conditions.

Medical Devices

Bose self-fitting hearing aid gets FDA approval

The product is the first to be cleared by the agency that can be purchased and programmed without a doctor's prescription.

Medical Devices

Prostate cancer imaging agent meets one of two study endpoints

The results mark Progenics Pharmaceuticals' second clinical trial for a prostate cancer imaging agent to show mixed results in as many months.

Clinical Trials

1 in 5 health IT execs say malware has hit devices

Out-of-date operating systems and unavailability of patch solutions remain major cybersecurity risks for medical devices.

Medical Devices

UK recalls 58K pregnancy tests after false positive reports

The digital displays of some devices erroneously told users they were pregnant.

Policy & Regulation

Remote patient monitoring cuts hospital admissions, ER visits, report finds

Heart disease and COPD are the most popular uses, but other less acute chronic conditions are starting to find traction with the technology, the industry and KLAS report found.

Medical Devices

Fitbit rolling out Charge 3 with focus on sleep tracking

The wearables company said it will also go live with a beta version of its Fitbit Labs Sleep Score program in November.

Digital Health

Blackberry announces healthcare applications for Spark platform, blockchain ledger

The tech company also announced a secure, real-time software program to assist developers of connected medical devices.

Medical Devices

Karius posts clinical data on heart infection test

The test identified the pathogen affecting one of the three patients failed by traditional methods.

Clinical Trials

CMS tweaks local coverage policy to speed access to medical devices

AdvaMed CEO Scott Whitaker said that the CMS actions are commendable, but more should be done.

Medical Devices

Q3 digital health funding soars to $3.3B across 93 deals

The quarter saw six megadeals over $100 million, bringing the year's total so far to 10, Rock Health reports.

M&A

Survey exposes lack of understanding of EU device regulations

Most companies are unsure of the full implications of the soon-to-be-enforced rules.

Policy & Regulation

Survey shows gaps in digital health uptake despite enthusiasm

Two-thirds of doctors have no plans to adopt virtual visits or home monitoring in the near future, according to a new EY report.

Digital Health

European Parliament passes device-friendly changes to draft HTA law

The amendments will limit the types of devices that undergo joint clinical assessments.

Medical Devices

Regulatory professionals working in devices paid far less than pharma peers

Reg managers in the drug industry take home around 75% more than their device counterparts.

Medical Devices