News & Analysis as of

Medical Devices Wireless Technology

Dechert LLP

Dechert Re:Torts - Key Developments in Product Liability and Mass Torts - Issue 10

Dechert LLP on

Senators Focus Attention on Litigation Funding’s Opacity - Building on the momentum we previously noted related to litigation funding, on September 14, Senator John Kennedy introduced the Protecting Our Courts from Foreign...more

Akerman LLP - Health Law Rx

Valentine’s Day: Listen to Your Heart, But Not On a Cell Phone

Physicians at Henry Ford Hospital in Detroit made a “stunning” heart-altering discovery. New and improved magnets in the iPhone 12 (“12”) may cause heart defibrillators and pacemakers to malfunction, particularly when carried...more

Mintz - Health Care Viewpoints

Seeking FCC Flexibility on the Sale of Wireless Medical Devices During COVID-19

We’ve written previously about the role of the Federal Communications Commission (FCC) in regulating wireless medical devices, chiefly in determining the operating frequency and certain technical rules that ensure...more

Mintz - Health Care Viewpoints

FCC Simplifies Evaluations of Certain Wireless Medical Devices

The Federal Communications Commission (FCC) regulates wireless medical devices in conjunction with the Food and Drug Administration (FDA), with the FCC’s role related to certain technical concerns such as the successful...more

Robinson+Cole Data Privacy + Security Insider

Security Vulnerabilities Identified In Wireless Syringe Infusion Pumps

The U.S. Department of Homeland Security (DHS) recently issued a warning that Smiths Medical Medfusion 4000 wireless syringe infusion pumps contain a security vulnerability that can be exploited by hackers to alter the...more

Robinson+Cole Data Privacy + Security Insider

FDA Recalls St. Jude Medical Pacemakers for Cybersecurity Patches

The Food and Drug Administration (FDA) has issued a recall of 465,000 St. Jude Medical pacemakers in order to push a mandatory firmware patch of vulnerabilities in six types of radio controlled cardiac pacemakers....more

Robinson+Cole Data Privacy + Security Insider

St. Jude Medical On Hot Seat for Cybersecurity Flaws in Home Monitoring System

The Food and Drug Administration (FDA) recently issued a warning letter to St. Jude Medical, alleging that it failed to properly investigate issues with the batteries in its defibrillator implants and for failing to fix the...more

Knobbe Martens

Stimwave’s Wireless Pain Relief SCS System Receives FDA Clearance

Knobbe Martens on

Fort Lauderdale-based company Stimwave Technologies announced today that its eight-electrode wireless, micro-technology neuromodulation device for relief of chronic back and leg pain received FDA 510(k) clearance. The Company...more

Knobbe Martens

Intellirod Spine Signs Licensing and Distribution Agreements With X-Spine Systems Inc.

Knobbe Martens on

Intellirod Spine LLC is, according to its website, a medical device company developing wireless sensing technologies for use in spinal care.  According to Orthopedic Design and Technology, Loadpro is the company’s forthcoming...more

Knobbe Martens

Shift Labs Continues Trend Toward Consumer Wireless Healthcare Devices

Knobbe Martens on

The medical device market is expanding into more private healthcare products in hopes of bringing healthcare directly to the user.  For example, the increase in popularity of wearable diagnostic devices, such as FitBit,...more

King & Spalding

National Cybersecurity and Communications Integration Center Highlights Vulnerabilities in Healthcare Technology

King & Spalding on

In a recent bulletin, the National Cybersecurity and Communications Integration Center (NCCIC) at the U.S. Department of Homeland Security described the vulnerabilities associated with medical devices in the healthcare...more

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