Smith & Nephew, a London-based medical device maker, has launched its new single-use negative pressure wound system in the European market.

Empatica picked up an FDA 510(k) clearance for Embrace after the device detected every seizure in a 135-patient clinical trial.

Intarcia halted a pair of phase 3 trials, but they are not required for the FDA to approve its drug-device diabetes treatment.

Apple has told participants in its heart study that their data will be used to seek FDA approval for an investigational device.

The designation sets MedyMatch up to receive advice from the FDA as it goes about advancing the software toward a filing for approval.

Paris-based SafeHeal has begun a CE mark study for its Colovac device that is designed to be used as a bypass after a rectal resection.

Gottlieb thinks revisions are needed to give the FDA authorities that are a better fit for modern diagnostics than the current 510(k) pathway.

Officials put the rule forward to enable earlier Medicare coverage of medical devices, only to withdraw it nine months later.

The regulatory nod marks the first time the CFDA has cleared a plasma-based EGFR mutation companion diagnostic for use.