Medical Devices

ECRI warns insufficient AI governance threatens patient...

ECRI included other medtech-related threats on its list of patient safety concer...

New study demonstrates genAI value in mental health care

Patients who received mental health care augmented by genAI attended 42% more th...

Merit Medical enrols first subject in trial of Bloom Mi...

Merit Medical has enrolled the first patient in the PREEMIE study of the Bloom M...

Amid deglobalising trade, experts seek AI safeguards fo...

The role of AI in supply chain management proved to be the focal issue at the re...

FDA clears Beckman Coulter’s DxC 500i Clinical Analyzer

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Beckma...

3D printing medical devices: industry unlocks new possi...

3D printing in the medical device space is on the rise, though challenges remain...

Orthofix’s fired execs’ lewd, ‘graphic’ texts surface i...

Orthofix didn’t originally specify the reasons behind the 2023 firing of its CEO...

FDA clears Miach Orthopaedics ACL implant for expanded use

The US Food and Drug Administration (FDA) has cleared Miach Orthopaedics Bridge-...

Shoulder Innovations secures $40m to advance arthroplas...

Shoulder Innovations has secured $40m in a Series E equity financing round, to m...

BVI Medical raises $1bn as it targets larger global foo...

BVI Medical has raised $1bn via private equity firm TPG for new product launches...

Dexcom receives warning letter based on FDA inspections...

The company does not expect the warning letter to materially impact its manufact...

FTC sues to block GTCR’s ‘unlawful acquisition’ of Surm...

The US Federal Trade Commission (FTC) has sued to block GTCR’s proposed $627m me...

Cutting calibration and consumables: new cardiac tech p...

Vygon claims its bedside monitoring devices can save hospitals thousands per yea...

New FDA pulse oximetry guidelines could stall under Trump

The draft guidance addresses concerns that pulse oximeters are less accurate for...

FDA grants 510(k) clearance to Zimmer’s new revision kn...

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Zimmer...

Medtronic announces two-year trial outcomes of Evolut TAVR

Medtronic has announced the SMART trial’s two-year outcomes of Evolut TAVR for a...

Capstan Medical’s robotic platform used for first mitra...

Buoyed by $110m in funding three months ago, Capstan Medical has reported the fi...

Navigating Diagnostic Deserts: How Portable Ultrasound ...

Providing affordable point-of-care diagnostic tools can be instrumental in quick...

Inari Medical introduces thrombectomy system for arteri...

Inari Medical has launched the Artix thrombectomy system, engineered specificall...

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