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Medtronic begins study of ICD with leads outside the heart

The device, called the Extravascular Implantable Cardioverter Defibrillator, will provide the same therapies as traditional transvenous ICDs.

Medical Devices

Medtronic releases gamification program to improve diabetes outcomes

The initiative rewards patients for staying in the optimal glycemic range.

Digital Health

TGA seeks industry input on cybersecurity, medtech software guidance

The agency has commissioned reports to inform approaches that support companies and protect patients.

Policy & Regulation

Burn treatment earns expanded compassionate use approval

The suspension offers a way to achieve permanent closure in burns and other wounds while reducing the amount of skin harvested at the time of surgery.

Medical Devices

Massachusetts fumbles on telehealth parity bill

Last year, the American Telemedicine Association gave the state an "F."

Digital Health

CVS rolls out virtual care offering in 9 states

Minute Clinic Video Visits leverage Teladoc's technology platform and are available through the CVS app.

Digital Health

FDA warns manufacturing fault with membrane test creates fetal death risk

The rupture test results could be misinterpreted, leading to serious adverse events.

Policy & Regulation

Analysts question mental health app sector's employer-focused strategy

GlobalData thinks developers should do more to target and serve individuals and families.  

Digital Health

Boston Scientific inks Veniti takeover to access untapped stent market

The $160 million buy moves the company into the nascent venous stent sector.

Medical Devices

Senseonics rolls out 90-day continuous glucose monitoring

The Eversense system will compete with Abbott's FreeStyle Libre monitor, which last month cleared FDA approval.

Medical Devices

UnityPoint's second data breach this year could prompt expanded lawsuit

The Des Moines-based nonprofit notified 1.4 million people last week that a phishing attack may have compromised their information.

Policy & Regulation

Zocdoc steps back on pricing change amid physician pushback

Doctors filed an online petition demanding the online care-scheduling startup drop a planned booking fee for new patients.

Digital Health

Regs, patient perceptions threaten to throttle neuromodulation growth

Analysts think electrical stimulation devices may struggle to fulfill their commercial potential, challenging the perception that they will soon address a range of unmet neurological medical needs.

Medical Devices

MDLive, Beacon partner on virtual behavioral health visits

Last week, MDLive closed a $50 million funding round with investors including Cigna and Health Care Service Corp.

Digital Health

UK regulators reassure medtech sector about Brexit impact

The MHRA expects little to change until 2021 but the risk of significant near-term upheaval remains.

Medical Devices

Boston Children's expands sequencing of patients with epilepsy, IBD

The hospital hopes to learn more about disease pathways and identify novel drug targets.

Research

CMS' Verma stands firm on 2015 EHR deadline, move to open APIs

Meanwhile, the coalition Health IT Now sent a letter to ONC chiding the government for failing to implement information blocking provisions of the 21st Century Cures Act.

Medical Devices

Cardinal Health posts Q4 loss as Cordis struggles

The drug and medical product distribution giant said it is working to turn around the Cordis business under a new management team. 

Medical Devices

New blood test can rule out heart attack faster

The new test showed greater sensitivity and precision than the fourth-generation conventional test currently in use in the United States.

Research

Varian acquires maker of patient monitoring system

The radiation therapy company said the buy expands its motion-management portfolio, part of its cancer care strategy.

Medical Devices

Drugs make up more US health spending than thought, report suggests

Research published in Health Affairs finds drugs accounted for 15% of total U.S. healthcare spending in 2016, higher than the oft-cited 10% figure.

M&A

Cerner bookings, revenue see strong growth in Q2

Seven large transactions contributed more than $75 million to bookings, with Cerner President Zane Burke calling the deals "a full box of chocolates ... all very desirable." 

M&A

FCC seeks comments on $100M telehealth pilot

The commission noted many low-income consumers, especially in rural areas, lack access to affordable or adequate broadband.

Policy & Regulation

NIST offers 'how to' for securing EHRs on mobile devices

Such devices are ubiquitous in healthcare, raising concerns about security and privacy of personal health information.

Policy & Regulation

CMS clears payment for Boston Scientific's newly bought Sentinel

The ruling by the agency was a reversal from an earlier draft and came the day BSX closed its buy of Claret Medical, which makes the device.

Medical Devices