News & Analysis as of

Medical Devices Patient Safety Healthcare

Hinshaw & Culbertson - Health Care

Beyond the Glow: Key Medical Spa Compliance Challenges and Legal Pitfalls

The medical spa industry is rapidly growing, driven by technological advances and shifting consumer preferences for cosmetic and wellness services. While this growth offers many business opportunities for healthcare...more

Knobbe Martens

Global Market Size and Technological Advancements for Implantable Medical Devices Continue to Grow

Knobbe Martens on

A recent report by Precedence Research estimates the global market size for implantable medical devices will grow from USD 97.62 Billion in 2024 to USD 178.15 Billion by 2034: The rapid increase in the global market size of...more

Gardner Law

FDA’s New Draft Guidance on Cybersecurity

Gardner Law on

The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more

Robinson+Cole Data Privacy + Security Insider

FDA Announces Playbook for Medical Device Cybersecurity

On October 1, 2018, the Food and Drug Administration (FDA) issued its “Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook” to address continued threats to medical devices that could affect...more

Searcy Denney Scarola Barnhart & Shipley

What are experts saying about Stryker Accolade V40?

Stryker Accolade V40 LFIT Hip Implant Dissociation - Over the past few years, various orthopedic surgeons around the country and their patients have faced a catastrophic failure of Stryker’s Accolade and V40 LFIT hip...more

Searcy Denney Scarola Barnhart & Shipley

Are Stryker V40 Femoral Heads (CoCr) Defective?

Stryker V40 Femoral Heads (CoCr) Associated With Spontaneous and Catastrophic Head-Neck Dissociation - Stryker may face yet another crisis associated with their total hip replacement medical devices – and this time it...more

Searcy Denney Scarola Barnhart & Shipley

Australia Concerned About Stryker Made LFIT Femoral Heads

On September 27, 2016, the Department of Health Therapeutic Goods Administration (the Australian equivalent of the Food & Drug Administration) issued a hazard alert relating to LFIT Anatomic CoCr V40 femoral heads...more

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