AAMI News December 2019

News in Brief

Implantable Heart Pump Wins FDA Breakthrough Designation

The Food and Drug Administration (FDA) has awarded breakthrough status for an implantable and fully internal left ventricular assist device (LVAD), or heart pump.

Developed by Medtronic, the new LVAD design is intended to increase oxygenated blood flow through the body for patients with advanced heart failure without the need for wires leading to an external power source.

The FDA’s voluntary Breakthrough Devices Program, finalized in February, is intended to create a more agile process for clearing devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions, according to the agency, while potentially accepting greater benefit–risk uncertainty.

By receiving a breakthrough designation, Medtronic’s LVAD will receive “priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions,” said the company in a press release.

The purchase of Fitbit may boost Alphabet’s Wear OS platform.

Google to Buy Fitbit for $2.1 Billion

Alphabet, the parent company of Google, has announced it will acquire Fitbit for $2.1 billion. The deal is expected to close in 2020. According to a report from Fortune Business Insights, the global wearable industry was valued at more than $24.5 billion in 2018 and is growing rapidly.

Google’s purchase of the popular wearable device manufacturer is expected to boost its Wear OS smartwatch platform and to introduce Google-made wearable devices into the market. The wearables industry is currently led by electronics giants such as Apple and Xiaomi, and has been blurring the lines with medical devices.

“With Google’s resources and global platform, Fitbit will be able to accelerate innovation in the wearables category, scale faster, and make health even more accessible to everyone,” said Fitbit CEO and cofounder James Park, in a press release.

To quell privacy worries, Rick Osterloh, senior vice president of devices and services, wrote in a blog post that health and wellness data from Fitbit devices will not be used for Google ads, and Fitbit users will have the ability to review, move, or delete their data.

AAMI Seeks Board, Nominating Committee Candidates

AAMI is seeking nominees for leadership and director positions on the AAMI Board of Directors and positions on the Board’s Nominating Committee. Individuals selected for Board posts attend two in-person meetings and two conference calls each year during their three-year term.

Other criteria used to identify AAMI leaders include credibility, leadership, interest, and experience. Board members also display attributes including professionalism, strong decision-making skills, a “big picture” perspective, honesty, candor, straightforwardness, integrity, and loyalty.

To apply, go to www.survey monkey.com/r/FX3FFSY to submit a completed leadership form, statement of interest, and curriculum vitae by Dec. 27.

Stryker to Buy Wright Medical for $5.4 Billion

Stryker has announced the purchase of Wright Medical Group, in Amsterdam, at a cost of $5.4 billion.

The acquisition is expected to provide significant opportunities to advance innovation, improve outcomes, and reach more patients,” said Kevin Lobo, Stryker’s chairman and chief executive officer, in a press release.

The acquisition of Wright Medical is expected to expand the Kalamazoo, MI–based Stryker’s presence in the trauma, upper extremities, and shoulder orthopedics markets. The deal is expected to close in 2020, pending antitrust clearance.

Nominate a Colleague for an AAMI Award

Help health technology’s finest be recognized for their achievements by nominating them for an AAMI or an AAMI Foundation award. The winners will receive a monetary prize, a plaque commemorating their achievements, and recognition at the AAMI Exchange, June 12–15 in New Orleans, LA.

“Health technology professionals are constantly working to advance the effectiveness of the field and overall patient safety. AAMI and the AAMI Foundation are pleased to recognize the best and brightest in the field through our awards program, honoring those leaders who are paving the way,” said MaryJane Thomas, director of membership development at AAMI. “I encourage you to nominate your colleagues who have inspired you with their innovation and dedication.”

Nominations are due Jan. 6. Go to www.aami.org/awards to learn more about the awards program.

India Expands Medical Device Regulations

India’s Ministry of Health and Family Welfare has announced a new initiative to register and regulate all medical devices under the administration of the Central Drugs and Standard Control Organisation (CDSCO) to improve patient safety and quality of care.

Currently, only 23 of about 5,000 devices are registered and regulated in India. Under the new plan, medical device manufacturers will report all adverse events to CDSCO and will need to have CDSCO approval to make, import, or distribute any device.

The new plan is scheduled to take effect Dec. 1, with the hope of having all medical devices completely under CDSCO’s regulatory framework in three to four years.

Uber Integrates with EHR

Healthcare delivery organizations using electronic health records (EHR) systems from Cerner’s will soon be able to schedule an Uber ride for patients to get to and from their non-emergency appointments. By integrating  Cerner’s EHR platform with a HIPAA-compliant platform from Uber Health, the company hopes to reduce no-shows, lower costs, and improve patient outcomes.

The rideshare service will not require patients to have an Uber account, an app, or a smartphone. All transportation scheduling and billing will occur directly through the EHR.