Brian Bossetta

New York

Senior Writer at Medtech Insight

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Articles

Beyond The Bladder: Incontinence Impacts Mental Health

6 days ago | insights.citeline.com | Brian Bossetta

Beyond The Bladder: Incontinence Impacts Mental Health09 May 2025In recognition of Mental Health Awareness month, Sarah Jenkins, executive director at the National Association for Continence, discussed the mental health issues that often come with incontinence.
Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

1 week ago | insights.citeline.com | Brian Bossetta

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert SaysThe US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.
California Medtech Firms Resolve Patent Dispute Over Delivery Catheters

1 week ago | insights.citeline.com | Brian Bossetta

California Medtech Firms Resolve Patent Dispute Over Delivery Catheters Route 92 says it has reached a settlement with Q’Apel Medical over patent claims concerning its Tenzing delivery catheters.
Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources

1 week ago | insights.citeline.com | Brian Bossetta

Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.
Medtronic Presents Data To Boost Hugo’s Odds Of Getting FDA Nod

2 weeks ago | insights.citeline.com | Brian Bossetta

Medtronic Presents Data To Boost Hugo’s Odds Of Getting FDA Nod Medtronic says results from a recent study on the Hugo robotic-assisted surgery system substantiate its safety and effectiveness for various urological procedures. The company also announced it has submitted the system to the FDA for approval for a urological indication.
Q’Apel Medical Recalls, Discontinues Stroke Therapy System After FDA Warning Letter, Class I Designation

3 weeks ago | insights.citeline.com | Brian Bossetta

Q’Apel Medical Recalls, Discontinues Stroke Therapy System After FDA Warning Letter, Class I DesignationQ’Apel Medical has pulled its aspiration system for stroke thrombectomy from the market after concerns raised by the US FDA in a February warning letter.
AdvaMed Unveils Its First ‘AI Roadmap’ To Help Lawmakers Navigate Regulating The Technology Through Rocky Times

3 weeks ago | insights.citeline.com | Brian Bossetta

AdvaMed Unveils Its First ‘AI Roadmap’ To Help Lawmakers Navigate Regulating The Technology Through Rocky TimesMembers of AdvaMed’s digital health tech board of directors discussed the organization’s efforts to aid the Trump administration and Congress in answering AI policy questions, especially as companies deal with mounting regulatory uncertainty.
FDA Issues A Pair Of Early Alerts For Intravascular Catheters

3 weeks ago | insights.citeline.com | Brian Bossetta

FDA Issues A Pair Of Early Alerts For Intravascular CathetersThe US FDA continues to issue early alerts as part of its communications pilot aimed at improving how the agency manages recalls. This time, the agency is notifying users about two separate intravascular catheters.
Looking Back Towards The Future. At 75, Medtronic Continues To Push The Boundaries Of What’s Possible

4 weeks ago | insights.citeline.com | Brian Bossetta

Looking Back Towards The Future. At 75, Medtronic Continues To Push The Boundaries Of What’s PossibleAs it celebrates 75 years shaping the medtech industry, Medtronic invited Medtech Insight to its Minneapolis headquarters to get a closer look at the company’s past, what it’s working on now, and what’s on the horizon.
End Of The Road? Court LDT Decision May Leave FDA With Few Options

1 month ago | insights.citeline.com | Brian Bossetta

End Of The Road? Court LDT Decision May Leave FDA With Few Options Now that a federal judge has ruled the US FDA exceeded its authority by unilaterally assuming regulatory oversight of lab-developed tests, what’s the agency’s next move? And does it really have one?

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Brian Bossetta

Articles

Beyond The Bladder: Incontinence Impacts Mental Health

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

California Medtech Firms Resolve Patent Dispute Over Delivery Catheters

Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources

Medtronic Presents Data To Boost Hugo’s Odds Of Getting FDA Nod

Q’Apel Medical Recalls, Discontinues Stroke Therapy System After FDA Warning Letter, Class I Designation

AdvaMed Unveils Its First ‘AI Roadmap’ To Help Lawmakers Navigate Regulating The Technology Through Rocky Times

FDA Issues A Pair Of Early Alerts For Intravascular Catheters

Looking Back Towards The Future. At 75, Medtronic Continues To Push The Boundaries Of What’s Possible

End Of The Road? Court LDT Decision May Leave FDA With Few Options

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Emails

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